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Safety Assessment of Polyoxyalkylene Siloxane Copolymers,

Alkyl-Polyoxyalkylene Siloxane Copolymers, and Related Ingredients as Used in Cosmetics

Status: Draft Tentative Report for Panel Review Release Date: August 18, 2014 Panel Meeting Date: September 8 -9, 2014

The 2014 Cosmetic Ingredient Review Expert Panel members are: Chairman, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Ronald A. Hill, Ph.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; James G. Marks, Jr., M.D.; Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR Director is Lillian J. Gill, D.P.A. This report was prepared by Lillian C. Becker, Scientific Analyst/Writer.

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MEMORANDUM

To: CIR Expert Panel and Liaisons

From: Lillian C. Becker, M.S. Scientific Analyst and Writer

Date: August 18, 2014

Subject: Polyoxyalkylene siloxane copolymers, alkyl-polyoxyalkylene siloxane copolymers, and related ingredients (alkyl polysiloxanes) as used in cosmetics

At the June, 2014 meeting the Panel issued an insufficient data announcement for 111 polyoxyalkylene siloxane copolymers, alkyl-polyoxyalkylene siloxane copolymers, and related ingredients (alkyl polysiloxanes). The data needs were:

(1) molecular weight ranges of all of the ingredients;

(2) impurities and explanation of how they are removed (especially for allyl alcohol ethoxylate and alkylated impurities); and

(3) dermal penetration, irritation, and sensitization data for the smallest ingredient(s) in this group (assumed to be PPG-2 dimethicone and PEG-3 dimethicone). If these smaller ingredients penetrate the skin or cause sensitization, then dermal penetration, irritation, and sensitization data for the next larger ingredients should be submitted, and data up to the ingredient size demonstrated to be non-penetrating and non-sensitizing.

The Silicones Environmental Health and Safety Center (SEHSC) submitted size ranges for some of the ingredients. Molecule size ranges were provided for about one-third of the ingredients in this report.

mailto:[email protected]

http://www.cir-safety.org/



The Council provided a patch test, an HRIPT of a product containing PEG-3 dimethicone, as well as impurity data. Safety data on cetyl PEG/PPG-10/1 dimethicone and PEG-12 dimethicone were also submitted. Data were also submitted under the chemical names copolyol b and c. Chemical characterization was not provided. The data were included for read-across purposes. The Panel may decide that this information is not useful and remove it. No data were found or submitted on allyl alcohol ethoxylates. However, some data on impurities were submitted that may satisfy the Panel’s needs. The Panel is to examine the provided data and decide if it is sufficient to come to a conclusion on the safety of these cosmetic ingredients, and then issue a Tentative Report with a conclusion dependent on the sufficiency of the data. The Panel should also develop the basis for the Discussion. If the data are not sufficient, then the Panel should include a list of data needs in the Discussion. The Panel has the option to issue a Tentative Report with a mixed conclusion.



Distributed for Comment Only -- Do Not Cite or Quote

History – Polyoxyalkylene Siloxane Copolymers, Alkyl-Polyoxyalkylene Siloxane Copolymers, and Related Ingredients

1982 - A safety assessment of dimethicone copolyol with a safe as used conclusion. “Dimethicone copolyol” was an umbrella term of polymers of dimethylsioxane with polyoxyethylene and/or polypropylene side chains. These polymers included straight-chain dimethicone polymers (up to 10000 repeating units of dimethyl polysiloxanes); cyclized dimethicones; silica-activated dimethicones; and cyclinized dimethicone copolyol forms.

2005 – The conclusion was reaffirmed. The Panel noted that the INCI naming conventions had changed for these ingredients and listed ingredients that would be included under the term “dimethicone copolyol”.

November, 2013 – SLR was issued for Alkoxy Polysiloxanes that include the “dimethicone copolyols”.

March, 2014 – The Panel tabled the report to allow the Silicones Environmental Health and Safety Center to assemble data and submit it to CIR. At the request of SEHSC, the name of the group of ingredients was changed to ”Polyoxyalkylene Siloxane Copolymers, Alkyl-Polyoxyalkylene Siloxane Copolymers, and Related Ingredients”.

June, 2014 – The Panel examined the new data from SEHSC and issued an Insufficient data announcement. The data needs were:

(1) molecular weight ranges of all of the ingredients;

(2) impurities and explanation of how they are removed (especially for allyl alcohol ethoxylate and alkylated impurities); and

(3) dermal penetration, irritation, and sensitization data for the smallest ingredient(s) in this group (assumed to be PPG-2 dimethicone and PEG-3 dimethicone). If these smaller ingredients penetrate the skin or cause sensitization, then dermal penetration, irritation, and sensitization data for the next larger ingredients should be submitted, and data up to the ingredient size demonstrated to be non-penetrating and non-sensitizing.

September, 2014 – The Panel will examine the data on the molecular weights submitted by SEHSC. The Panel is to issue a Tentative Report.


ALKOXY POLYSILOXANE Data Profile for March, 2014. Writer - Lillian Becker

ADME Acute toxicity Repeated dose toxicity Irritation Sensitization

Derm

al P

enetration

Log Kow

Use

Oral

Derm

al

Inhale

Oral

Derm

al

Inhale

Ocular

Irritation

Derm

al Irr. A

nimal

Derm

al Irr H

uman

Sensitization

Anim

al

Sensitization

Hum

an

Repro/D

evel toxicity

Genotoxicity

Carcinogenicity

Phototoxicity

Behenoxy Dimethicone X

Behenoxy PEG-10 Dimethicone

Bis-Cetyl/PEG-8 Cetyl PEG-8 Dimethicone

X X

Bis-Hydroxyethoxypropyl Dimethicone

X

Bis-Isobutyl PEG/PPG-10/7/Dimethicone Copolymer

Bis-Isobutyl PEG-13/Dimethicone Copolymer

Bis-Isobutyl PEG-24/PPG-7/Dimethicone Copolymer

X

Bis-PEG-1 Dimethicone

Bis-PEG-4 Dimethicone X



Bis-PEG-12 Dimethicone X

Bis-PEG-12 Dimethicone Beeswax

X

Bis-PEG-12 Dimethicone Candelillate

X

Bis-PEG-15 Methyl Ether Dimethicone

X X X X X X X X X


Bis-PEG-8 PEG-8 Dimethicone

Bis-PEG/PPG-14/14 Dimethicone

X X X


Bis-PEG/PPG-16/16 PEG/PPG-16/16 Dimethicone

X



X

Bis-PEG/PPG-20/5 PEG/PPG-




Derm

al P

enetration

Log Kow

Use

Oral

Derm

al

Inhale

Oral

Derm

al

Inhale

Ocular

Irritation

Derm

al Irr. A

nimal

Derm

al Irr H

uman

Sensitization

Anim

al

Sensitization

Hum

an

Repro/D

evel toxicity

Genotoxicity

Carcinogenicity

Phototoxicity

20/5 Dimethicone Bis-Stearoxy Dimethicone

Bis-Stearoxyethyl Dimethicone

Cetyl PEG/PPG-10/1 Dimethicone

X X X X X X X X

Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone

Cetyl PEG/PPG-7/3 Dimethicone

Cetyl PEG-8 Dimethicone

Lauryl Isopentyl-PEG/PPG-18/18 Methicone

X

Lauryl PEG/PPG-18/18 Methicone X X X

Lauryl PEG-10 Methyl Ether Dimethicone

Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone

Lauryl PEG-8 Dimethicone X

Lauryl PEG-8 PPG-8 Dimethicone

Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone

X X X X X X

Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone

Methoxy PEG-11 Methoxy PPG-24 Dimethicone

Methoxy PEG/PPG-25/4 Dimethicone

X

Methoxy PEG-13 Ethyl Polysilsesquioxane

PEG/PPG-10/2 Dimethicone

PEG/PPG-10/3 Oleyl Ether Dimethicone



PEG/PPG-14/4 X




Derm

al P

enetration

Log Kow

Use

Oral

Derm

al

Inhale

Oral

Derm

al

Inhale

Ocular

Irritation

Derm

al Irr. A

nimal

Derm

al Irr H

uman

Sensitization

Anim

al

Sensitization

Hum

an

Repro/D

evel toxicity

Genotoxicity

Carcinogenicity

Phototoxicity

Dimethicone PEG/PPG-15/15 Dimethicone X




PEG/PPG-17/18 Dimethicone X




PEG/PPG-19/19 Dimethicone X X X X X X



PEG/PPG-20/22 Butyl Ether Dimethicone

PEG/PPG-20/22 Methyl Ether Dimethicone










PEG/PPG-25/25 Dimethicone X X X X X X X








Derm

al P

enetration

Log Kow

Use

Oral

Derm

al

Inhale

Oral

Derm

al

Inhale

Ocular

Irritation

Derm

al Irr. A

nimal

Derm

al Irr H

uman

Sensitization

Anim

al

Sensitization

Hum

an

Repro/D

evel toxicity

Genotoxicity

Carcinogenicity

Phototoxicity






PEG-10 Dimethicone X

PEG-10 Methyl Ether Dimethicone

X

PEG-10 Polydimethylsiloxyethyl Dimethicone/Bis-Vinyl Dimethicone Crosspolymer


X

PEG-12 Dimethicone X X X X X X X X X X X



PEG-3 Dimethicone X X X


X

PEG-4 PEG-12 Dimethicone

PEG-6 Dimethicone X


PEG-7 Dimethicone X


PEG-8 Cetyl Dimethicone X

PEG-8 Dimethicone X

PEG-8 Dimethicone Dimer Dilinoleate

PEG-8 Dimethicone/Dimer Dilinoleic Acid Copolymer

X

PEG-8 Methicone X PEG-8 Methyl




Derm

al P

enetration

Log Kow

Use

Oral

Derm

al

Inhale

Oral

Derm

al

Inhale

Ocular

Irritation

Derm

al Irr. A

nimal

Derm

al Irr H

uman

Sensitization

Anim

al

Sensitization

Hum

an

Repro/D

evel toxicity

Genotoxicity

Carcinogenicity

Phototoxicity

Ether Dimethicone PEG-8 PEG-4 Dimethicone

PEG-8 PPG-8 Dimethicone

PEG-9 Dimethicone X


PEG-9 Polydimethylsiloxyethyl Dimethicone

X X X X

Polysilicone-13 X PPG-12 Butyl Ether Dimethicone

PPG-12 Dimethicone X

PPG-2 Dimethicone X X X

PPG-25 Dimethicone

PPG-27 Dimethicone

PPG-4 Oleth-10 Dimethicone

Stearoxy Dimethicone X

Stearoxymethicone/Dimethicone Copolymer

X

Polydimethylsiloxane polymer X X X

Siloxanes and silicones X X

Dimethicone copolyols X X X


Search History –

SciFinder – Compound search by identifier - 31 hit, One useful. Search for sub-structures – 7550 hits. Removed patents – 18 hits, 0 useful. Compound class search – 14691 hits. Narrowed for “toxicity” – 171 hits, 1 useful. ECHA – Ingredient names, “dimethicone”, Alkoxy Polysiloxanes, Alkoxylated Polysiloxanes, Alkoxylated Dimethicone, Alkoxylated Methicone – no hits. HPVIS – “Dimethicone”, “Methicone”, “siloxane”, “polysiloxane”, “copolyol” and CAS Nos. No hits. PubMed – “alkoxy polysiloxane”, alkox* polysiloxane”, “alkox* dimethicone”, “alkox*

methicone”, “PEG dimethicone”, PPG dimethicone”, PEG methicone”, PPG methicone”, “Dimethicone Copolyol”, “copolyol” - ~70 total hits, 0 useful.

Scifinder Search Terms

Alkoxy Polysiloxanes Alkoxylated Polysiloxanes Alkoxylated Dimethicone Alkoxylated Methicone Behenoxy Dimethicone Behenoxy PEG-10 Dimethicone 1136947-78-8 Bis-Cetyl/PEG-8 Cetyl PEG-8 Dimethicone Bis-Hydroxyethoxypropyl Dimethicone 1136947-78-8 Bis-Isobutyl PEG/PPG-10/7/ Dimethicone

Copolymer 158451-77-5 Bis-Isobutyl PEG-13/Dimethicone Copolymer 197980-52-2 Bis-Isobutyl PEG-24/PPG-7/ Dimethicone

Copolymer Bis-PEG-1 Dimethicone Bis-PEG-4 Dimethicone Bis-PEG-8 Dimethicone Bis-PEG-10 Dimethicone Bis-PEG-12 Dimethicone Bis-PEG-12 Dimethicone Beeswax Bis-PEG-12 Dimethicone Candelillate Bis-PEG-15 Methyl Ether Dimethicone Bis-PEG-20 Dimethicone Bis-PEG-8 PEG-8 Dimethicone Bis-PEG/PPG-14/14 Dimethicone 151662-01-0 Bis-PEG/PPG-15/5 Dimethicone

Bis-PEG/PPG-16/16 PEG/PPG-16/16 Dimethicone Bis-PEG/PPG-18/6 Dimethicone Bis-PEG/PPG-20/20 Dimethicone Bis-PEG/PPG-20/5 PEG/PPG-20/5 Dimethicone Bis-Stearoxyethyl Dimethicone 128446-57-1 Cetyl PEG/PPG-10/1 Dimethicone 191044-49-2 Cetyl PEG/PPG-10/1 Dimethicone Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone Cetyl PEG/PPG-7/3 Dimethicone Cetyl PEG-8 Dimethicone Lauryl Isopentyl-PEG/PPG-18/18 Methicone 1112315-26-0 Lauryl PEG/PPG-18/18 Methicone Lauryl PEG-10 Methyl Ether Dimethicone Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl

Dimethicone Lauryl PEG-8 Dimethicone Lauryl PEG-8 PPG-8 Dimethicone Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl

Dimethicone Methoxy PEG-11 Methoxy PPG-24 Dimethicone 472975-82-9 Methoxy PEG/PPG-25/4 Dimethicone Methoxy PEG-13 Ethyl Polysilsesquioxane PEG/PPG-10/2 Dimethicone PEG/PPG-10/3 Oleyl Ether Dimethicone PEG/PPG-12/16 Dimethicone


PEG/PPG-12/18 Dimethicone PEG/PPG-14/4 Dimethicone PEG/PPG-15/15 Dimethicone PEG/PPG-15/5 Dimethicone PEG/PPG-16/2 Dimethicone PEG/PPG-16/8 Dimethicone PEG/PPG-17/18 Dimethicone PEG/PPG-18/12 Dimethicone PEG/PPG-18/18 Dimethicone PEG/PPG-18/6 Dimethicone PEG/PPG-19/19 Dimethicone PEG/PPG-20/15 Dimethicone PEG/PPG-20/20 Dimethicone PEG/PPG-20/22 Butyl Ether Dimethicone 67762-87-2 PEG/PPG-20/22 Methyl Ether Dimethicone 125857-75-2 PEG/PPG-20/23 Dimethicone PEG/PPG-20/29 Dimethicone PEG/PPG-20/6 Dimethicone PEG/PPG-22/22 Butyl Ether Dimethicone PEG/PPG-22/23 Dimethicone PEG/PPG-22/24 Dimethicone PEG/PPG-23/23 Butyl Ether Dimethicone PEG/PPG-23/6 Dimethicone PEG/PPG-24/18 Butyl Ether Dimethicone 67762-87-2 PEG/PPG-25/25 Dimethicone PEG/PPG-27/27 Dimethicone PEG/PPG-27/9 Butyl Ether Dimethicone PEG/PPG-3/10 Dimethicone PEG/PPG-30/10 Dimethicone PEG/PPG-4/12 Dimethicone PEG/PPG-6/4 Dimethicone PEG/PPG-6/11 Dimethicone PEG/PPG-8/14 Dimethicone PEG/PPG-8/26 Dimethicone PEG-10 Dimethicone 68937-54-2 PEG-10 Methyl Ether Dimethicone 68938-54-5


PEG-11 Methyl Ether Dimethicone PEG-12 Dimethicone PEG-14 Dimethicone PEG-17 Dimethicone PEG-3 Dimethicone PEG-32 Methyl Ether Dimethicone PEG-4 PEG-12 Dimethicone PEG-6 Dimethicone PEG-6 Methyl Ether Dimethicone PEG-7 Dimethicone PEG-7 Methyl Ether Dimethicone PEG-8 Cetyl Dimethicone PEG-8 Dimethicone PEG-8 Dimethicone Dimer Dilinoleate PEG-8 Dimethicone/Dimer Dilinoleic Acid Copolymer PEG-8 Methicone PEG-8 Methyl Ether Dimethicone PEG-8 PEG-4 Dimethicone PEG-8 PPG-8 Dimethicone PEG-9 Dimethicone PEG-9 Methyl Ether Dimethicone PEG-9 Polydimethylsiloxyethyl Dimethicone Polysilicone-13 158451-77-5 197980-52-2 PPG-12 Butyl Ether Dimethicone PPG-12 Dimethicone PPG-2 Dimethicone 68440-66-4 68554-64-3 PPG-25 Dimethicone 68957-00-6 PPG-27 Dimethicone PPG-4 Oleth-10 Dimethicone Stearoxy Dimethicone 68554-53-0 Stearoxymethicone/Dimethicone Copolymer Dimethicone Copolyol

SciFinder and PubMed - “Allyl alcohol ethoxylate” - 0 hits Google - “Allyl alcohol ethoxylate” ± “Toxicity” – 0 hits SciFinder - Structure search – 1300+ hits. Culled by “toxicity”, “dermal”, “human” – 3

hits, none useful Patents by O’Lenick did not contain helpful information.


Minutes – Alkoxy Polysiloxanes June, 2014

Dr. Belsito’s Team

DR. BELSITO: Okay, let's move on. DR. SNYDER: Polysiloxanes. DR. BELSITO: Polysiloxanes. DR. SNYDER: Tabled in March for the Silicones Environmental, Health, and Safety Center. DR. BELSITO: Yes. So, tabled, and we agreed with the recommendations from them to change the title of the report. And we did get some toxicity data that were incorporated. And Wave 2 -- we got data on an eyebrow pencil, 15 percent. DR. SNYDER: Fifteen -- negative. DR. BELSITO: Negative. And so this is under -- DR. SNYDER: Alkyl. Oxy. DR. BELSITO: Alkyl -- (inaudible). I've got it. I just have to get to my document and see what I said. <<HYDROQUINONE/p-HYDROXYANISOL>> DR. BELSITO: Okay, safe as used. Way too dead as limited but negative sensitization irritation at maximum concentration of 15 percent, and I didn't expect these molecules to absorb so I said safe as used. DR. LIEBLER: Same. DR. BELSITO: Okay. I have a comment here, "Delete paragraph, not needed," but I don't know where that goes. Oh, in the introduction -- was I able to delete stuff? So, what does your introduction say? After "dilinoleic acid as a cosmetic ingredient that has not yet been reviewed by the Panel," do you have more in your introduction? DR. SNYDER: I have five paragraphs. DR. BELSITO: I deleted them all, I think. DR. SNYDER: Could we talk about the straight chain versus the cyclical? Do you have that?


DR. BELSITO: No. After that, it says "dilinoleic acid as a cosmetic ingredient that has not yet been reviewed the Panel." The next thing I have is "dimethicone copolyol summary 1982." So, I deleted -- I didn't think any of those – I thought the paragraph wasn't needed. SPEAKER: Where is he? He's here. DR. SNYDER: Yes, it's much lighter. DR. BELSITO: Yes. DR. SNYDER: We've got two paragraphs (inaudible) the 1982 report, and then we've got the Silicones Environmental, Health, and Safety Center; (inaudible), summaries of this data. Do you have that? DR. BELSITO: No. Anyway, I have a comment that I deleted them. I didn't think they were needed. What do you think? (Laughter) DR. SNYDER: Well, I think we need them, because this does not include any cyclical; it's linear. DR. BELSITO: Okay. Okay. DR. SNYDER: Right, yes. DR. BELSITO: So, let me get rid of that comment, and Lillian will just ignore the fact that those things don't exist in my report. So, we need the inhalation boilerplate. Page 30. So, then under toxic kinetics. Comment that -- Have we clarified that, that because of their proclivity to wet surfaces, they can penetrate and irritate the skin? I mean, hydrating the skin allows for enhanced penetration, but these are such big molecules I just don't see them penetrating under a hydrating condition. MS. BECKER: This applies to the low-molecular-weight ones. DR. BELSITO: Okay. On page 35 you said "a local lymph node assay." What you're described is not a local lymph node assay. This was a guinea pig maximization test I assume, because a local lymph node assay is painting the ears and harvesting the lymph nodes and looking at uptake of tritiated thymidine, and what's being described is a sensitization and challenge test with intradermal injections. It looks like guinea pig maximization. Page 53. So, this is -- on page 53 it should be "Table 4" not "Table 3." And – but those were the only corrections that I had to the report. DR. BERGFELD: I thought we were concerned with some of the little PEGs and their absorption or are we not concerned about that anymore? DR. BELSITO: Well, I wasn't. Dan? Paul? DR. SNYDER: (Inaudible) DR. BELSITO: So, safe as used.


DR. LIEBLER: Well, this report, yes. I'm not concerned about it. Safe as used. DR. BELSITO: Okay. DR. BERGFELD: Okay. I think that was a question that came up last time. DR. BELSITO: Okay. DR. EISENMANN: There is still some additional information she could put in the report. There's Australian NCMAS assessments. There are one, two, three, four, five components for which there are assessments available. They don't give a lot of detail, but they do give a little bit of information like -- and these are compounds for which there isn't any information in the reports yet. DR. BELSITO: Okay, so we can add then in. But as far as you're concerned, they're not going to change our conclusions. Okay, so we'll do that. So, we're doing that as a safe as used, and you'll provide that information to Lillian, the Counsel or…? DR. EISENMANN: She has the list of ingredients for which there are assessments (inaudible), yes. MS. BECKER: Right. One of them wouldn't come up. Let me talk to you about that. One of them I just couldn't find. DR. EISENMANN: Okay.

Dr. Marks Team DR. MARKS: I said we'd start at 1:05 and it's 1:04 so let's begin. We have the polysiloxanes and

this is the second time we've seen these ingredients. We decided in a March meeting to table it until more data was submitted by the Silicones Environmental Health and Safety Center. So we have a lot of data, we've got a lot in wave two and we have 111 ingredients. So I guess we'll start since we tabled it. How are those ingredients, the 111? Do any stand out and, let me see, that begins on page -- depends on which page you want to go to. It's a long list. Page seven. So anything, Ron, Ron, and Tom, that of the 111 just does not fit?

DR. SHANK: Nothing stood out.

DR. MARKS: Okay.

DR. SLAGA: Same here.

DR. MARKS: Okay. Then on this –

MS. BECKER: I'd like us to look at table one.

DR. MARKS: Do what?


MS. BECKER: Probably best to look at table one as opposed to a list just because it's got the definitions and the nice drawings.

DR. MARKS: Okay. Nothing stands out so all 111 -- that's the right number isn't it, Lillian?

MS. BECKER: I believe so. I believe so. I'm checking.

DR. MARKS: So next question is Tom and Ron, how's the toxicology? Any needs? Or have we gotten enough data now that we can issue a tentative report?

DR. SHANK: I would like somebody to identify which are the smallest of these compounds and then do we have data on those? We have a lot of data that I'd be more interested in those are more likely to be crossing the epidermis.

DR. MARKS: And that's what we mentioned in the annotated notes that Lillian sent me. Concern about the impurities and then what is the smallest molecular weight compound. So we still don't -- which is –

DR. SHANK: And it has to be easy to get. I would think they would be PEG-2 dimethicone with PEG-3 dimethicone. Dr. Hill?

DR. HILL: Yeah. No, I think that's the right one.

DR. SHANK: That's about right?

DR. HILL: Yup.

DR. MARKS: So your guess would be PEG-2 and PEG-3 dimethicone?

DR. SHANK: Yes.

DR. MARKS: Now is there anybody here from the Silicone Industry that could answer that? Which is the smallest molecular weight compounds? Then that way this issue could be resolved.

MS. GUERRO: We're here but we can't answer that. We did conduct -- based on conversation at the meeting we did conduct the data all with that in mind and some of the data that we did receive but we can't go back and clarify what the -- naming which is the smallest.

MS. GILL: So they did not answer the specific question about the smaller ones?

MS. GUERRO: They provided -- yeah, the data that was provided was very general in ranges for all but we can go back and see what they provided.

MS. BECKER: Okay. So otherwise there's no more data coming?

MS. GUERRO: Yeah.


MS. BECKER: Okay.

DR. MARKS: Okay. So with that in mind, Ron?

DR. SHANK: Well, I'm trying to -- see what I have in my notes here is for PPG 2 dimethicone we

have eye irritant, it's an eye irritant and it was negative in the Ames Test. But I think we need more than that. And then I don't have anything for PEG 3 dimethicone. So I would think we would need absorption data on the two smallest ones and sensitization data.

DR. MARKS: Yeah, we have it on sensitization on the larger molecules, PEG-12 and the combination PEG is not a sensitizer, but not on that small one. So let's go back what you were saying there. So on -- would accept either PEG-2 or -3 you would want? So you would want the absorption?

DR. SLAGA: Either one would be fine.

DR. MARKS: The absorption and then sensitization and irritation, although you said the PEG-2 there was an -- it was an eye irritant. And obviously if it's absorbed then you need to have repro and all that. Anything from a cancer point of view?

DR. SLAGA: No. I think the irritation and sensitization would be fine. Especially if we have genotoxicity.

DR. SHANK: For the PPG-2 –

DR. SLAGA: 2.

DR. SHANK: -- we have Ames Test and it was negative.

DR. MARKS: Anything else, Tom, from your point of view or Ron Hill? So we're still back to the smallest molecular weight.

DR. SLAGA: Yeah, we would have the –

DR. MARKS: What's the skin –

DR. SLAGA: -- mammalian genotoxicity too.

DR. MARKS: Pardon?

DR. SLAGA: Mammalian genotoxicity.

DR. MARKS: You'd want that also? Mammalian genotoxicity.

DR. SLAGA: We do it for the higher molecular weight ones.


DR. MARKS: So this is I would think then where we are as far as industry is do we say this is a

formal insufficient data notice? We don't go out with a tentative report insufficient.

MS. GILL: We've asked for it before so we would be going out with an insufficient data announcement.

DR. MARKS: Yeah, Formula ISD, okay.

DR. SLAGA: Okay.

DR. MARKS: And then next time we could move forward. Could we for the higher weight? What is issue?

DR. SLAGA: Safe as used for the home.

DR. MARKS: Insufficient data announcement. The others, what would be the cut off on the safe as used then? Or should we –

DR. SLAGA: I would say until we have date on the or -3, or -3.

DR. MARKS: Can we draw a line and safe as long as -- or should we not tackle that now? And we may not. I just was kind of anticipating looking forward could we say, or was it -- I think I had PEG-12 was okay from any irritation sensitization point of view on page 10, 30 or 5.

MS. BECKER: On page 10 on the profile, PEG-12 seems to be the smallest that you have a large number of Xs.

DR. MARKS: Yeah, mm-hmm. Just thinking forward and how does it look from the rest of that? Of course we don't know the absorption of PEG-12. Do we have that?

MS. BECKER: I just lost it. I clicked on something. No we do not.

DR. MARKS: Okay. So.

DR. HILL: There was one unresolved issue I had from last time which was we have this statement in here -- oops, I looked at the wrong reference -- so when -- no I looked at the right reference -- when alkoxy polysiloxanes are manufactured there's an excess of allyl alcohol ethoxylate that's used. I don't find where we went back and captured any information about the toxicology of that to give us any suggestion whether that's a concern or not. And we don't have any information as to how releasable that is from any of these numerous products that could be manufactured by that process. And apparently we haven't got anything new on that.

MS. BECKER: No. I was hoping that we would.

DR. HILL: Me too.


MS. BECKER: Yeah. I was expecting more data. We do have absorption on PEG-15 methyl ether

dimethicone.

DR. HILL: Yeah, but PEG-15.

MS. BECKER: Yeah. But if we're looking for a cutoff that's –

DR. HILL: Do we have the molecular weight for that one? I mean I can calculate it but any molecular weight would be an average.

MS. BECKER: Right.

DR. MARKS: Okay. No we do not or?

DR. HILL: I'm looking. No.

DR. MARKS: So I think tomorrow what I'll do is move that an insufficient data announcement occur and what we need is which of these compounds is the smallest molecular weight compound. Assuming that it's probably going to be PEG-2 and PEG-3 dimethicone, we need absorption, sensitization, and irritation, and mammalion genotoxicity. Is that right, Tom? You'd like to see that on those two? And the 111 ingredients are okay. Does sound -- does that capture the team's?

DR. SHANK: That's good.

DR. MARKS: Okay. Any other –

MS. BECKER: I have a question.

DR. MARKS: Sure, Lillian.

MS. BECKER: Assuming that the small ones are absorbed do you want to continue up the size chain until they stop being absorbed?

DR. MARKS: So it's the small absorbed and it's clean in terms of repro and development on such. Do we need to have the higher ones? That's a good -- so Ron Shank and Ron Hill?

DR. SHANK: Well, yes. There has to be some point if the small ones are absorbed then we have to find out how big do you have to go when they're not absorbed. If we have the molecular weights of each one that would help.

DR. HILL: The bis PEG 15 is -- we do have an approximate molecular weight. That's 1600. It's in her table.

MS. GILL: PEG, PEG-25 is 17000 for molecular weight. Table 3.


DR. SHANK: There are three table 3s. So which table 3 is that?

DR. MARKS: What page? Okay.

DR. SHANK: Okay. So it's the first table 3 on page 51, PDF 51. So there are some molecular weights but not very many. And these are going to be mixtures? Is that right? Ron?

DR. HILL: Well, they're -- yeah. Because of the nature of those polymerization reactions that generate the PEGs it will be a distribution, so 15 would be the most prominent as I understand it and then they will range on either side –

DR. SHANK: Smaller or bigger.

DR. HILL: -- a little smaller or a little bigger.

DR. MARKS: You want me to mention that in the insufficient data announcement or notice that we also would like to get the molecular weights of the ingredients?

DR. SHANK: Yes.

DR. SLAGA: You can ask if we want.

DR. MARKS: Yeah, okay.

DR. HILL: Ideally we'd like the average and something about the distribution. We probably won't get it but ideally.

DR. MARKS: Weigh the ingredients. Oh, man, okay. Average and distribution. Anything else? So again just to repeat tomorrow I'll know that we issue an insufficient data notice. We want to know what the smallest molecular weight compound is, presumably PEG 2 and PEG 3 dimethicone, need the absorption, sensitization, irritation, and mammalion genotoxicity. We would also like to get the molecular weights of the ingredients, the average and the distribution. That's listed on page 51. Okay. Anything else on the polysiloxanes?

MS. BECKER: Are you asking for molecular weights for all of them?

DR. MARKS: I think as many as we can get.

MS. BECKER: Okay.

DR. SLAGA: At this stage.

DR. MARKS: As many as possible. Okay. Do the industry reps, do you have any questions?

MS. GUERRO: Yes. Would it be possible to get the specific genotox testing that you all are looking for, the genotox?


DR. SHANK: We usually don't recommend a specific test. Test the bacterial system which you

have and the mammalian system.

MS. GUERRO: Okay, okay.

DR. SHANK: There are usually a battery of geotoxicity tests that are done. DR. MARKS: Okay. Any other comments? Next ingredient.

Day Two

DR. BERGFIELD: Thank you. All right, moving on to the next item, Dr. Marks, the Polysiloxanes.

DR. MARKS: Which are -- so this is actually a second look at the alkoxy polysiloxanes. Man, did I get that close Ron Hill?

DR. SLAGA: Perfect.

DR. MARKS: So the second look means, we really at this point are evaluating 111 ingredients in this group, so it's a large number of ingredients. Our team felt all 111 ingredients were okay to include. And we wanted, after looking at the data, felt that an insufficient data notice. We were concerned, what's the smallest molecular weight compound? Is it the PEG-2 and -3 dimethicone? Is so, we need absorption, sensitization, irritation, mammalian genotox. And then we also wanted the molecular weights of as many of the possible ingredients. And we realized there's an average, and there will be a distribution. So I move that we issue an insufficient data notice on these, with the purpose of getting, particularly the smallest molecular weight compound and getting data on that -- safety data.

DR. BERGFIELD: Any comments by the Belsito team?

DR. BELSITO: Well we felt safe as used, that based upon size and lack of percutaneous absorption but I'll let Dan and my other colleagues address that.

DR. MARKS: Okay, and then I'll have Ron Shank.

DR. LIEBLER: My impression on these was that the size was large enough to preclude any significant absorption, but I couldn't point to an absolute lowest molecular weight, cut off for all the ingredients we're looking at. I couldn't say that. I would say that it's probably true for just about everything, if not everything, but I couldn't point to a number.

DR. BERGFIELD: Ron Hill, then Ron Shank.

DR. HILL: I was going to say, one that I mentioned yesterday is that we had information that allele alcohol ethoxylate can remain in the product at up to 30 percent by weight, but we didn't have further information. Does it stay there under conditions of cosmetic use? And if it doesn't stay there, we didn't


capture any toxicology relevant to that. The other thing I think I forgot to say yesterday is I was still looking for information, so as to rule out the presence of a low molecular weight impurities with alkylating capability, we don't have that either.

DR. BERGFIELD: Ron Shank.

DR. SHANK: I just don't understand what the problem is, in the chemistry. Why can't we find out what are the smallest molecules in this list?

DR. LIEBLER: I'm not saying we can't.

DR. SHANK: But we've asked for it before and don't have that information yet.

DR. LIEBLER: You didn't ask me.

DR. SHANK: And we have no absorption. We don't know that we have any absorption data for the smallest molecules. So I don't think we can say safe as used.

DR. BERGFIELD: So you've made a motion, Jim, and I've not heard a second. Is there a second, or a new motion?

DR. BELSITO: I'm waiting to second.

DR. LIEBLER: I'll second that.

DR. BERGFIELD: Is there any further discussion about insufficient data announcement?

DR. LIEBLER: And I also noted, it was late in the day when we did this. I was a little punchy. But I also did note it in my own notes about that 30 percent remaining ethoxylated allyl alcohol and I just noted that seemed excessive, and I wasn't sure if that was correct or consequential. Does it carry through to a finished product, et cetera? So that's another piece of information that should be clarified for us.

DR. BERGFIELD: Anything else? We've had a motion that's been made and seconded. We've had many comments, and clarifications as to what the needs are. Lillian, do we need to read those again? Christina?

DR. GILL: Christina has it.

DR. MARKS: I have it on my notes.

DR. BERGFIELD: Lillian, Lillian.

DR. MARKS: Low molecular weight, and then if it's -- and then absorption of that low molecular weight, if it's absorbed and then I want to see sensitization and irritation because if the molecular weight is low and it gets in, it could be a sensitizer. We have HRIPT on the PEG-15 at 100 percent as okay. So presumably the smaller ones will be okay too, but you know, let's see what we get out of it.


DR. BERGFIELD: And Dan, did you have another request?

DR. LIEBLER: Same as Ron, that clarify that 30 percent residual ethylated alcohol.

DR. MARKS: And then Tom yesterday, you mentioned mammalian genotox.

DR. SLAGA: With the lower molecular weight, just to be safe. I would -- it's early in -- over the

weekend.

DR. MARKS: Okay.

DR. BERGFIELD: Okay.

DR. BELSITO: Studies, I didn't put what compound. Sensitization and irritation at 15 percent which was the maximum concentration used.

DR. MARKS: Yeah, that was PEG-12.

DR. BELSITO: Okay.

DR. MARKS: So we presume that PEG-2 and -3 dimethicone will be the smallest molecular weight.

DR. BELSITO: Okay.

DR. MARKS: But we want to confirm that.

DR. BELSITO: Fine.

DR. MARKS: Okay.

DR. BERGFIELD: All right, I'm going to call the question then. All those in favor of insufficient data announcement. Unanimous, thank you. And I think we've heard all the remarks of the needs now.


Safety Assessment of Polyoxyalkylene Siloxane Copolymers,

Alkyl-Polyoxyalkylene Siloxane Copolymers, and Related Ingredients as Used in Cosmetics

Status: Draft Tentative Report for Panel Review Release Date: August 18, 2014 Panel Meeting Date: September 8 -9, 2014

The 2014 Cosmetic Ingredient Review Expert Panel members are: Chairman, Wilma F. Bergfeld, M.D., F.A.C.P.; Donald V. Belsito, M.D.; Ronald A. Hill, Ph.D.; Curtis D. Klaassen, Ph.D.; Daniel C. Liebler, Ph.D.; James G. Marks, Jr., M.D.; Ronald C. Shank, Ph.D.; Thomas J. Slaga, Ph.D.; and Paul W. Snyder, D.V.M., Ph.D. The CIR Director is Lillian J. Gill, D.P.A. This report was prepared by Lillian C. Becker, Scientific Analyst/Writer.

© Cosmetic Ingredient Review 1620 L Street, NW, Suite 1200 Washington, DC 20036-4702 ph 202.331.0651 fax 202.331.0088 [email protected]


INTRODUCTION This is a safety assessment of polyoxyalkylene siloxane copolymers, alkyl-polyoxyalkylene siloxane copolymers,

and related ingredients as used in cosmetics. This group, in general, is referred to as alkoxy polysiloxanes in this report. The functions of the 111 ingredients in this report include hair conditioning agents, viscosity increasing agents, emulsion stabilizers, and film formers (Table 1).

In 1982, the Cosmetic Ingredient Review (CIR) Expert Panel (Panel) published a safety assessment of dimethicone copolyol with a safe as used conclusion.1 At the time, the term dimethicone copolyol referred to polymers of dimethylsiloxane with polyoxyethylene and/or polyoxypropylene side chains. These polymers included straight-chain dimethicone polymers (up to 10 000 repeating units of dimethyl polysiloxanes); cyclized dimethicones; silica-activated dimethicones; and cyclized dimethicone copolyol forms. The summary of the 1982 safety assessment is provided below.

Since the 1982 report, the International Nomenclature Cosmetic Ingredient (INCI) naming conventions for dimethicone copolyols have changed and each of these ingredients now has an individually assigned name and is no longer covered under the umbrella-term dimethicone copolyol.2 In a re-review of dimethicone copolyol, which was published in 2005, the Panel identified several of these ingredients under the new naming convention and included them under the safe as used conclusion reaffirmation.1

Data were discovered on the European Chemicals Agency (ECHA) database.3 Data from the robust summaries, obtained from the ECHA database, are presented below.

This safety assessment does not include cyclic dimethicones, only linear copolymers. Data on copolyol B and C have been submitted without providing their structures or other specifications. The data on these compounds are included for possible read-across.

Several structurally-related ingredients, and ingredients that have some similar component moieties, of the ingredients in this report have been reviewed by the Panel. All of these ingredients were safe as used or safe with qualifications (Table 2).

Dimethicone Copolyol Summary, 1982

Dimethicones are polymers of methylsiloxane. Dimethicone Copolyols are Dimethicones copolymerized with polyalkoxy chains.1 The Copolyols are chemically and physically inert ingredients used in cosmetics in a concentration range of less than or equal to 0.l% -10% as surface tension depressants, wetting agents, emulsifiers, foam builders, plasticizers, and lubricants. Copolyol containing products may be applied to all surfaces of the body on an occasional or daily basis over a period of years.

Silicone compounds do not easily cross membrane barriers and are not absorbed through the skin. Silicones are not metabolized by the body or by microorganisms. Silicone fluids are relatively innocuous when administered orally and parenterally.

Dimethicone Copolyols were at most slightly toxic to the rat when administered orally in a single dose. Single dermal application of Copolyols to rats and rabbits were practically nontoxic. Copolyols were not primary skin or ocular irritants in the rabbit. Inhalation studies at ambient temperatures in the rat indicated that little hazard exists. An 89-day feeding study in the rat using two concentrations of a Copolyol B gave no evidence of subchronic oral toxicity. Subchronic dermal tests in the rabbit using two undiluted Copolyol A ingredients showed little effect other than slight to moderate skin irritation at the application sites.

Clinical studies on a total of 39 subjects indicated that both 40% Dimethicone Copolyol in aqueous solution and undiluted Dimethicone Copolyol are not primary skin irritants.

Fifty subjects showed no indication of skin irritation or sensitization when tested with undiluted Dimethicone Copolyol A ingredients. An unspecified concentration of Dimethicone Copolyol was found to be nonirritating and nonsensitizing when tested on 201 volunteers.

CHEMISTRY Definition and Structure

All of the ingredients in this report are alkoxylated derivatives of polysiloxanes, specifically dimethicones. Within this grouping, there are three primary configurations: 1) end-capped dimethicone, wherein a dimethicone polymer is terminated on either end with an alkoxy group (e.g., cetyloxy); 2) alkoxy-dimethicone/dimethicone co-polymers; and 3) some combination of 1 and 2 (Figure 1).


In general:

O Si O

CH3

CH3

Si

CH3

R

CH3

Si R

CH3

CH3n

O Si O

CH3

CH3

Si

CH3

H3C

CH3

Si O

CH3

Rx

Si

CH3

CH3

CH3

y

or/and

-wherein R is an alkoxy or polyalkoxy group

For example, Bis-Stearoxyethyl Dimethicone is the ingredient wherein R is stearoxyethyl:

O Si O

CH3

CH3

Si

CH3

CH3

Si

CH3

CH3x

OOH3C

H3C

Figure 1. Alkoxy Polysiloxanes

Physical and Chemical Properties The physical and chemical properties of the ingredients in this safety assessment are presented in Table 3.

Under the generic CAS No. 68937-54-2 (dimethylsiloxane, ethylene oxide block copolymer), the following were reported: melting point -14°C, boiling point >250°C, and density 1.035 g/mL at 25°C.4 Alkoxy polysiloxanes with a PEG moiety tend to be hydrophilic and soluble in water and alcohols.5 In general, the longer the PEG chain length, the greater the foaming potential and the higher the cloud point (ie, the temperature at which a solution of the ingredients begins to phase separate). As the number of alkoxy groups in the polymer increases, the water solubility increases.6 Compounds with >16 carbon atoms in the fatty acid group are the most hydrophobic.

Molecular weight affects the orientation/configuration of the alkoxy polysiloxanes on the surface of the skin and, in general, low molecular weight polymers are very good wetting agents.6

Cetyl PEG/PPG-10/1 dimethicone was reported to have a molecular weight >1000 Da; less than 5.5% of this ingredient had a molecular weight <500 Da and 9.0% <1000 Da.7 Less than 10% of PEG-9 polydimethylsiloxyethyl dimethicone was reported to be <1000 Da.7 Alkoxy polysiloxanes with <12 carbon atoms in the fatty acid group are liquid at room temperature; those with >14 carbon atoms are solids.8 Compounds with an unsaturated or branched fatty acid group are liquid at room temperature.9

Method of Manufacture Alkoxy polysiloxanes are produced by hydrosilylation. In most cases, a hydrogen dimethicone polymer block is reacted with an allyl alkoxylate and alpha-olefin delta-alkene.6,10 The product can be further polymerically modified with ethylene oxide or propylene oxide to produce PEG or PPG chains, respectively. Newer catalyst systems allow for the manufacture of dimethicone copolyol compounds that contain simple hydroxypropyl groups.6

Impurities Bis-PEG-15 methyl ethyl dimethicone was reported to contain 0.1% octamethylcyclotetrasiloxane.9 Analysis of three batches of bis-PEG-15 methyl ethyl dimethicone found that there was <1% of each of the following: Al, As, Ba, Be, Bi, Ca, Cd, Co, Cr, Cu, Fe, Hg, Mn, Mo, Ni, Pb, Sb, Sn, Sr, Tl, V, W, Zn, and Zr. A maximum concentration of 0.1% cyclotetrasiloxane and cyclopentasiloxane was reported. A supplier reported that an analysis of PEG-3 dimethicone did not detect chlorosilane (residual monomer; detection limit 100 ppm), but detected platinum (residual catalyst; <10 ppm), ethanol (residual solvent; <0.1%), polyethylene glycol (by-product; approximately 5%), octamethylcyclotetrasiloxane (D4; <0.1%), and decamentycyclotetrasiloxane (D5; <0.1%).11


A supplier reported that an analysis of PEG-12 dimethicone found that it contains 30%-40% poly(oxy-1,2-ethanediyl),-α-2-popen-1-yl-ω-hydroxy, therefore, the impurities will be related to both silicone and poly(oxy-1,2-ethanediyl,α-2-propen-1-yl-ω-hydroxy.12 Octamethylcyclotetrasiloxane (D4) and decamethylcyclotetrasiloxane (D5) were reported to be present at <0.1%. PEG/PPG-25/25 dimethicone is reported to contain <1% octamethylcyclotetrasiloxane.13 Pt-catalyst residues were reported to be <5 ppm. Cyclotetrasiloxane was reported to be present at a maximum concentration of 1.0%, and cyclopentasiloxane at no greater than 0.5%. Volatile organic compounds (VOC) were reported at <2%. A product brochure recited that e forms of PEG-12 dimethicone (ie, PEG-17 dimethicone, PEG-10 dimethicone, and PEG-20/PPG-23 dimethicone) are each “100% pure”.14 When alkoxy polysiloxanes are manufactured, there is an excess of allyl alcohol ethoxylate used.6 The excess remains in the product and may be present in concentrations up to 30% by weight.

USE Cosmetic

The Food and Drug Administration (FDA) collects information from manufacturers on the use of individual ingredients in cosmetics as a function of cosmetic product category in its Voluntary Cosmetic Registration Program (VCRP).15 Use categories are summarized in Table 4. The highest numbers of uses were reported for PEG-12 dimethicone (538 uses), PEG/PPG-18/18 dimethicone (461 uses), cetyl PEG/PPG-10/1 dimethicone (404 uses), and PEG-10 dimethicone (240 uses).

A survey was conducted by the Personal Care Products Council (Council) of the maximum use concentrations for ingredients in this group.16 These ingredients were reported to be used in every FDA VCRP product category; the highest numbers were reported in makeup, including lipsticks and products used around the eyes. The highest maximum concentrations of use were reported for stearoxy dimethicone (22% for hair conditioners), cetyl PEG/PPG010/1 dimethicone (15% for eyebrow pencils), PEG/PPG-17/18 dimethicone (14% for perfumes and 13% for hair products), cetyl PEG/PPG-10/1 dimethicone (13.6% for eye shadow), and bis-hydroxyethyoxypropyl dimethicone (12% for blushers).

The VCRP reported data under the previous umbrella name of these ingredients (Table 4).15 There are 28 uses reported for cetyl dimethicone copolyol, 322 uses for dimethicone copolyol, 5 uses for dimethicone copolyol crosspolymer, and 1 use for dimethicone copolyol methyl ether.

Table 5 lists the ingredients for which there were no uses reported by either the VCRP or the Council. Alkoxy polysiloxanes were reported to be used in aerosol spray moisturizers, suntan products, deodorants, body and

hand products, and hair sprays, including pump hair sprays. The highest maximum reported concentration in these products was 2.8% PEG-14 dimethicone in a pump hair spray. In practice, 95% to 99% of the droplets/particles released from cosmetic sprays have aerodynamic equivalent diameters >10 µm, with propellant sprays yielding a greater fraction of droplets/particles below 10 µm compared with pump sprays.17-20 Therefore, most droplets/particles incidentally inhaled from cosmetic sprays would be deposited in the nasopharyngeal and bronchial regions and would not be respirable (ie, they would not enter the lungs) to any appreciable amount.17,20 There is some evidence indicating that deodorant spray products can release substantially larger fractions of particulates having aerodynamic equivalent diameters in the range considered to be respirable.17 However, the information is not sufficient to determine whether significantly greater lung exposures result from the use of deodorant sprays, compared to other cosmetic sprays.

Non-Cosmetic Polydimethylsiloxanes are used for the siliconization of needles and syringes, lubrication of medical devices, and as topical formulation excipients in skin-protecting compositions, and drug carriers.21

TOXICOKINETICS Absorption, Distribution, Metabolism, and Excretion

Low molecular weight alkoxy polysiloxanes penetrate and irritate the skin, as the result of the proclivity of these substances to wet surfaces.6 BIS-PEG-15 METHYL ETHYL DIMETHICONE In a permeability test using pig skin and diffusion chambers (n=6), bis-PEG-15 methyl ethyl dimethicone was not detected in the receptor chamber (detection limit 0.5%) at 0, 16, 24, 40, 64, and 72 h.22 In a second run of the experiment (n=3), the test substance was not detected (detection limit 1.25%) in pooled samples at 72 h. In both experiments, the test substance (16 mg/4 cm2) was administered and left on the skin surface for 24 h and then washed off with a neutral shampoo.

TOXICOLOGICAL STUDIES Acute Toxicity

Oral – Non-human BIS-PEG-15 METHYL ETHYL DIMETHICONE The oral LD50 of bis-PEG-15 methyl ethyl dimethicone was > 4640 mg/kg for rats. No further information was provided.9,23


CETYL PEG/PPG-10/1 DIMETHICONE The oral LD50 of cetyl PEG/PPG-10/1 dimethicone was > 5000 mg/kg for Wistar rats (n=5).12 The rats were observed for 14 days. There were no mortalities; one rat exhibited ano-genital staining on day 1. LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE The oral LD50 of lauryl PEG-9 polydimethylsiloxyethyl dimethicone was reported to be 5000 mg/kg for rats.24 There were no adverse effects observed. PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE The oral LD50 of PEG-9 polydimethylsiloxyethyl dimethicone in rats was reported to be >5000 mg/kg.7 No mortalities or clinical signs were observed. PEG/PPG-19/19 DIMETHICONE The oral LD50 of PEG/PPG-19/19 dimethicone (100%) was > 16 mL/kg in CFE rats (n=5/sex).25 Controls were administered with tragacanth mucilage (0.5%). Clinical signs included piloerection and diuresis. All rats appeared healthy four days after dosing and gained weight normally. Necropsies were unremarkable. PEG/PPG-25/25 DIMETHICONE There were no mortalities or clinical signs in Sprague-Dawley rats (n=5/sex) orally administered a single dose of PEG/PPG-25/25 dimethicone (2007 mg/kg).26 There were no behavioral abnormalities or physiological findings. Body weights were similar to controls. The test substance was administered neat. The rats were observed for 14 days and then necropsied. The authors concluded that the oral LD50 is ≥ 2007 mg/kg. Dermal – Non-human BIS-PEG/PPG-14/14 DIMETHICONE The dermal LD50 of bis-PEG/PPG-14/14 dimethicone, under occlusion, in Wistar rats (n=10) was >2000 mg/kg. The time of exposure was not provided. No mortalities or clinical signs were observed. 27 Slight erythema was observed in 4 of the rats. PEG/PPG-19/19 DIMETHICONE When PEG/PPG-19/19 dimethicone (2000 mg/kg) was administered to the dorso-lumbar region of New Zealand White rabbits (n=5/sex) for 24 h, none of the rabbits died during the course of the study.25 There were no observed signs of systemic effects, except that one male rabbit had few feces on Day 3 of the study. There was slight to well-defined irritation in most of the rabbits, which resolved by the end of the study. There were no treatment-related effects on body-weight gain, nor were there macroscopic effects observed upon necropsy of the animals. The rabbits were observed for 15 days. PEG-12 DIMETHICONE The estimated acute dermal LD50 was > 5 g/kg PEG-12 dimethicone in male albino rabbits (n=5).25 One rabbit in the high-dose group was euthanized in a moribund condition. In the remaining animals, only slight exfoliation at the application site was observed. No test material-related lesions were observed microscopically in any of the rabbits. The test material (2 or 5 mg/kg) was administered to the clipped skin for 24 h on a cotton bandage under plastic wrap. Inhalation – Non-Human PEG-12 DIMETHICONE In an acute inhalation study of PEG-12 dimethicone (0.68 mg/L) using Sprague-Dawley rats (n=5/sex), there were no deaths in the control or test groups, and no abnormalities were observed during the 4-h exposure or the observation.25 Necropsies revealed no abnormalities in any major organs or tissues. DIMETHICONE COPOLYOLS

In inhalation toxicity studies using rats (strains not specified) for several dimethicone copolyols, mortality only occurred at elevated temperatures in studies of dimethicone copolyol C at a concentration of 23.47 mg/L (33% of test animals after 4 h) and at an unspecified concentration (100% mortality after 8 h).12 The same dimethicone copolyol caused no mortalities at lower temperatures and/or for shorter time periods. These chemicals were not characterized. Inhalation – Human

The ECHA database recites that dimethicones (under generic CAS No. 68937-54-2 and generic name polydimethylsiloxane polymer) are harmful if inhaled.3 No further information was provided.

Repeated Dose Toxicity


Oral – Non-human BIS-PEG-15 METHYL ETHYL DIMETHICONE There were no clinical signs observed when CD Sprague Dawley rats (n=5/sex) were orally administered bis-PEG-15 methyl ethyl dimethicone (0, 50, 200, 1000 mg/kg/d in corn oil) for 4 weeks.28 There were no deaths during the study. Body weights and feed consumption were not affected by treatment. Clinical pathology, microscopic examination of the tissues, and necropsies were unremarkable. There was an increase in liver weights in the male rats of the high-dose group. CETYL PEG/PPG-10/1 DIMETHICONE There were no mortalities when cetyl PEG/PPG-10/1 dimethicone (5000 mg/kg/d) was administered by gavage to Wistar rats (n=5/sex) for 14 days.7 One rat exhibited ano genital staining on day 1. PEG-12 DIMETHICONE

The oral no observed adverse effect level (NOAEL) of PEG-12 dimethicone was 1000 mg/kg/d for Sprague-Dawley rats (n=5/sex) when administered for 29 days.25 There were no test substance-related microscopic pathological findings. There were no signs of toxicity and no deaths occurred. Functional observation battery (FOB) assessments, manipulation, and motor-activity tests did not reveal any test-substance-related effects. The only treatment-related clinical chemistry and organ weight findings were decreased albumin/globulin ratio and increased liver weight in the 1000 mg/kg/d females. However, there were no microscopic changes in the livers. DIMETHICONE COPOLYOLS

There were no mortalities or adverse effects when rats were fed dimethicone copolyol C (640 and 2880 mg/kg/d) for 89 days.12 No further details were provided. Dermal – Non-human PEG/PPG-19/19 DIMETHICONE When PEG/PPG-19/19 dimethicone (0, 100, 300, 1000 mg/kg/d) was dermally administered to female New Zealand White rabbits (n=10/sex) for 29 days, the authors reported a no observed effect level (NOEL) for systemic toxicity was 1000 mg/kg/d.25 Each treatment was in place for 6 h. There were no deaths or clinical signs. Local irritation was observed at the application site of the majority of rabbits of all treatment groups. These signs were generally limited to erythema, edema, exfoliation, and scabs. Body weight, body-weight change and feed consumption were not affected by treatment. There were no ocular findings attributable to treatment and hematological and blood chemistry investigations were unremarkable. Absolute and relative organ weights were unaffected by treatment. There were no treatment-related macroscopic findings at necropsy, except those associated with the local signs of irritation at the application sites. Diffuse subcutaneous inflammation, acanthosis and follicular abscess were revealed upon microscopic examination of the application sites. PEG-12 DIMETHICONE PEG-12 dimethicone (100, 300, or 1000 mg/kg) did not produce any signs of systemic toxicity when dermally administered to New Zealand White rabbits (n=10/sex) 6 h/d under semi-occlusion for 29 days.25 There were no deaths. Very slight erythema was observed in all treated groups, and the incidence of erythema increased in a dose-dependent manner; it was highest in females. One female in the highest dose group showed severe erythema, which resolved by the end of the study. Dermal administration of PEG-12 dimethicone produced no ophthalmologic findings attributable to treatment. Hematological and blood chemistry testing did not reveal any toxicological effects. Organ weights were unaffected by treatment. There were no treatment-related macroscopic findings at necropsy, other than those associated with the local signs of irritation at the dermal application sites. Microscopic examination yielded a number of findings at the application site, including diffuse subcutaneous inflammation, acanthosis and a single case of follicular abscess. Ulcers were found on the application sites of females in the low- and mid-dose groups. DIMETHICONE COPOLYOLS

There were no mortalities or behavioral effects in a 28-day percutaneous toxicity study of dimethicone copolyol B (200 mg/kg/d) using rabbits (n=10).12 Slight-to-moderate erythema and edema were found at the administration sites after day 2. There was no weight loss in the test group. Histopathology showed a decrease in spermatogenesis in one of the treated rabbits. Characterization of this chemical was not provided.

REPRODUCTIVE AND DEVELOPMENTAL TOXICITY PEG-12 DIMETHICONE Dermally administered PEG-12 dimethicone (100%; 0, 50, 100 or 200 mg/kg) was not embryotoxic or teratogenic in New Zealand White rabbits on days 6 through 18 of gestation.25 No adverse effects were observed in mean maternal body weight, feed consumption or liver weights of the treated rabbits. No differences were observed in the number of implantation sites, number of live fetuses per litter, mean litter size, fetal body weight or crown-rump length between the control and


treated groups. The incidence of resorption among the total fetal population of rabbits treated with test material was similar to that of the control group. No single alteration was observed in any the treated litters which was different from the control group. No treatment related signs of toxicity or behavioral changes were observed in any of the pregnant rabbits. Three rabbits in the 50-mg/kg/d group, 1 in the 100-mg/kg/d group, and 3 in the 200-mg/kg/d group died during the study. Some pregnancies were terminated because of Pasteurella multocida infection, a known abortifacient in rabbits. PEG-12 dimethicone or water (control) was administered to the skin of pregnant New Zealand white rabbits on days 6 through 18 of gestation. Litters were collected by cesarean section on day 29 and the fetuses examined for external, visceral or skeletal defects. GENERIC SILOXANES AND SILICONES, DI-METHYL, 3-HYDROXYPROPYL METHYL ETHOXYLATED

New Zealand albino rabbit does (n=30) exhibited increased numbers of resorption sites when siloxanes and silicones, 3-hydroxypropyl methyl, di-methyl ethoxylated (generic compounds that fall within the description of the ingredients in this safety assessment; CAS No. 68937-54-2; 200 mg/kg in corn oil) were dermally administered to shaved backs of the does (~10% body surface) on gestation days 6 to 18.29 The two control groups were administered the vehicle or nothing. Does were killed and necropsied on gestation day 29. There were no deaths attributed to the test material. One pup in the treatment group displayed clubbing of the extremities, partial acranius, and an umbilical hernia. The 24-hour survival of fetuses, abnormalities in the fetuses, and number of abnormal fetuses were similar across both control groups. No dermal effects were reported for the dams. Subsequent testing of the test substance demonstrated that it was neither embryotoxic nor teratogenic when dermally administered to New Zealand white rabbits at doses of 50, 100, or 200 mg/kg (data not provided).

GENOTOXICITY BIS-PEG-15 METHYL ETHYL DIMETHICONE In a reverse mutation assay using Salmonella typhimurium (strains TA98, TA100, TA1535, and TA1537) including a plate incorporation test and a pre-incubation test, bis-PEG-15 methyl ethyl dimethicone (0, 33, 100, 333, 1000, 2500, and 5000 μg/plate) was not genotoxic with or without metabolic activation.30 CETYL PEG/PPG-10/1 DIMETHICONE Cetyl PEG/PPG-10/1 dimethicone (250, 500, 1000, 5000 µg/plate) was not mutagenic in S. typhimurium (strains TA98, TA100, TA1535, TA1537) and Escherichia coli (WP2), with or without metabolic activation.7 LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE Lauryl PEG-9 polydimethylsiloxyethyl dimethicone was reported to be non-mutagenic in an Ames test.24 No details were provided. LAURYL PEG/PPG-18/18 METHICONE In a reverse mutation assay using S. typhimurium (strains TA98, TA100, TA1535, and TA1537) and E. coli (WP2 urA pKM101 and WP2 pKM101), lauryl PEG/PPG-18/18 methicone (0, 15, 50, 150, 500, and 1500 μg/plate in ethanol) was not genotoxic with or without metabolic activation.25 Precipitate was observed at 1500 µg/plate, but no appreciable toxicity was observed. PEG/PPG-19/19 DIMETHICONE

In a reverse mutation assay using S. typhimurium (strains TA98, TA100, TA1535, TA1537, and TA1538), PEG/PPG-19/19 dimethicone (0, 0.5, 5, 100, and 500 μg/plate) was not genotoxic with or without metabolic activation.25 PEG/PPG-25/25 DIMETHICONE In a reverse mutation assay using S. typhimurium (strains TA98, TA100, TA1535, TA1537) including a plate incorporation test and a pre-incubation test, PEG/PPG-25/25 dimethicone (33, 100, 333, 1000, 2500, 5000 μg/plate) was not genotoxic with or without metabolic activation.31

PEG-12 DIMETHICONE In a reverse mutation assay using S. typhimurium strains (strains TA98, TA100, TA1535, TA1537) and E. coli (strain WP2uvrA), PEG-12 dimethicone was not mutagenic up to 5000 µg/plate, with or without metabolic activation. PPG-2 DIMETHICONE

In a reverse mutation assay using S. typhimurium (strains TA97, TA98, TA100, TA1535) and E. coli (WP2), PPG-2 dimethicone (0, 312.5, 625, 1250, 2500, and 5000 μg/plate in dimethylsulfoxide (DMSO)) was not genotoxic with or without metabolic activation.25 When repeated with another strain of S. typhimurium (strains TA1535), PPG-2 dimethicone (0, 15 625, 31 250, 62 500, 125 000 and 250 000 µg/plate in ethanol) was not genotoxic with or without metabolic activation.

CARCINOGENICITY


Data on carcinogenicity of polyoxyalkylene siloxane copolymers, alkyl-polyoxyalkylene siloxane copolymers, and related ingredients were not found in the published literature nor were unpublished data provided.

IRRITATION AND SENSITIZATION Irritation

Dermal – Non-human BIS-CETYL/PEG-8 CETYL PEG-8 DIMETHICONE

Bis-cetyl/PEG-8 cetyl PEG-8 dimethicone (100%; 0.5 mL; MW > 10 000 ) was a dermal irritant when administered to the intact or abraded skin of New Zealand White rabbits (n=6) under occlusion for 24 h.25 The Draize scores were 2, 1.995, and 1.915 for all test sites, intact skin, and abraded skin, respectively. Well-defined erythema was observed on 5/6 abraded sites and 5/6 intact sites at 24 h. Barely perceptible erythema was observed at 1 intact site and 1 abraded site. Barely perceptible edema was observed at all sites at 24 h. By 72 h both incidence and severity of erythema and edema had subsided, but were not totally resolved. BIS-PEG-15 METHYL ETHYL DIMETHICONE Bis-PEG-15 methyl ethyl dimethicone was not an acute skin irritant to rabbits. No further information was provided.9,23 CETYL PEG/PPG-10/1 DIMETHICONE

When administered to the intact or abraded skin of New Zealand White rabbits (n=6) for 24 h, cetyl PEG/PPG-10/1 dimethicone (MW < 1000; 0.5 mL) caused very slight redness (grade 1) in 5 of 6 abraded sites and 5 of 6 intact sites.25 The Draize scores were 0.4 for both intact and abraded skin. There was no edema observed for any rabbit for any time point. All test sites were normal at 72 h.

When administered to the intact or abraded skin of New Zealand White rabbits (n=6) for 24 h, cetyl PEG/PPG-10/1 dimethicone (MW > 10 000; 0.5 mL) caused slight irritation in all tested rabbits.25 The Draize scores were 1.17, 0.75, and 1.58 for all test sites, intact skin, and abraded skin, respectively. At 24 h, all abraded sites and most intact sites exhibited erythema, most of these with edema. Irritation was more severe on the abraded sites. At 72 h, only 2 abraded sites had very slight erythema; all other irritations had cleared.

The authors of another study concluded that cetyl PEG/PPG-10/1 dimethicone (assumed 100%; 0.5 mL) had some potential for dermal irritation, but well below the threshold to be classified as hazardous, when administered to the clipped skin of New Zealand White rabbits (n=6) for 24 h under occlusion.7 The rabbits were observed for 72 h after the removal of the test substance. Erythema was observed in all rabbits at 24 h and in 4 rabbits at 72 h. At 24 h, the Draize scores for erythema was reduced in 5 of 6 rabbits. The scores at patch removal were of 2-3. At 24 h, the Draize score for edema reduced from all 6 rabbits with a score of 1 to 2 of 6 with a score of 1.

Cetyl PEG/PPG-10/1 dimethicone (100%; 0.5 mL) was reported to be a potential dermal irritant in New Zealand White rabbits (n=6), but was not classified as an irritant using the National Occupational Health and Safety Commission’s (NOHSC) criteria for classifying hazardous substances.12 The test substance was administered to 2.5 cm2 clipped, intact skin. Low-level erythema and edema were observed on day 1, which were reduced or resolved by day 3. LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE Lauryl PEG-9 polydimethylsiloxyethyl dimethicone (assumed 100%; 0.5 mL) was reported to be slightly irritating to rabbit skin (n=6).24 The testing protocol was reported to be similar to the protocol detailed in the Organization for Economic Co-operation and Development (OECD) Test Guidelines (TG) 404. The test substance was administered to the intact and abraded skin of the rabbits under an occlusive patch for 24 h, then observed at 24 and 72 h after the patch was removed. Slight-to-moderate erythema was observed in all rabbits tested, at both the intact and abraded sites at 24 h, which was resolved in 5 of 6 guinea pigs at 72 h. The remaining guinea pig exhibited moderate erythema and slight edema at both the intact and abraded sites at 72 h. PEG/PPG-25/25 DIMETHICONE PEG/PPG-25/25 dimethicone (100%; 0.5 mL) was not a dermal irritant when administered to the skin of male New Zealand hybrid albino rabbits (n=6) for 4 h under semi-occlusion. The test sites were examined at 1, 24, 48, and 72 h after removal. All scores for erythema and edema were 0 at all observation times. PEG-12 DIMETHICONE

In a patch test of PEG-12 dimethicone (100%; 0.5 mL) using female New Zealand White rabbits (n=3), a single semi-occlusive application of the test material to intact clipped skin for 4 h elicited very slight erythema, which resolved within 72 h, and no edema.25 The Primary Irritation Index (PII) was calculated to be 0.44. The sites were scored for irritation at 60 min and 24, 48 and 72 h.

PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE


PEG-9 polydimethylsiloxyethyl dimethicone (20% and 100%) was a slight dermal irritant to the intact and abraded skin of rabbits.7

Slight to well-defined erythema, with some scaling, was observed when PEG-9 polydimethylsiloxyethyl dimethicone (5% in corn oil; 0.5 mL) was administered to the skin of rabbits 5 days per week for 2 weeks.7

PEG-9 polydimethylsiloxyethyl dimethicone was predicted to be a non-irritant in an in vitro EpiSkin small model assay.7 GENERIC SILOXANES AND SILICONES, DI-METHYL, 3-HYDROXYPROPYL METHYL ETHOXYLATED Siloxanes and silicones, di-methyl, 3-hydroxypropyl methyl ethoxylated (10% in distilled water; 0.5 mL; MW 1000 - 5000) was not an irritant when administered to the clipped intact or abraded skin of New Zealand White rabbits (n=6) for 24 h under occlusion.25 The remaining test material was wiped from the skin when the patch was removed. The skin was evaluated for irritation 24 and 72 h after patch removal. Dermal – Human CETYL PEG/PPG-10/1 DIMETHICONE In a patch test (n=20), a brow pencil containing cetyl PEG/PPG-10/1 dimethicone (15%) was found to be non-irritating.32 The test substance was administered for 24 h under occlusion. In a maximization test (n=28), an eye brow pencil containing cetyl PEG/PPG-10/1 dimethicone (15%) was not sensitizing and there were no signs of irritation the during induction period.33 Aqueous sodium laurel sulfate (SLS; 0.25%; approximately 0.05 mL) was administered to the test site (eg, volar forearm, upper outer arm, or the back) for 24 h before the test substance (0.05 mL) was administered, under occlusion, for 48 h (72 h if applied on a Friday). The test site was examined at each patch removal. Because the test substance contained volatile ingredients, the test substance was allowed to air dry for 30 min before occlusion was applied. The induction was repeated 5 times. If there was irritation observed at the removal of an induction patch, the next step would be performed without the SLS. After a 10-day rest, the challenge was performed with the SLS (5.0%) pretreatment on a naïve site and the challenge patch was left in place for 48 h. The site was observed for irritation/sensitization 15-30 min and 24 h after patch removal. PEG-12 DIMETHICONE

When PEG-12 dimethicone (0.5%, 2%, and 5%) was administered simultaneously with SLS (1% aqueous) to the backs of subjects (n=48 female, 5 male) under occlusion for 24 h, the test material provided protection against the primary dermal irritation produced by the SLS compared to the SLS-only control.25 The high dose provided the greatest protection. The sites were evaluated for erythema and edema 24 and 48 h after patch removal. PEG-3 DIMETHICONE A lip makeup base that contained PEG-3 dimethicone (5%) was found to be non-irritating in a patch test (n=11). 34 The test substance was administered to the scapular part of the back and left in place under occlusion for 48 h. In Vitro PEG-12 DIMETHICONE

In an in vitro human reconstructed epidermis cytotoxicity test (SkinEthic), PEG-12 dimethicone was rated as a non-irritant.12 The negative control (water) yielded 100% viability and the test substance was associated with 66.4% viability. The positive control produced the expected results. The cells were exposed to the test substance for 42 min and the cells were evaluated 42 h after exposure. Ocular As the molecular weight of alkyl polysiloxanes (exact compounds, species, and number not provided) increased, irritation scores decrease, as measured using the Draize Irritation Rating Scale (Table 6).6 BIS-PEG-15 METHYL ETHYL DIMETHICONE

Bis-PEG-15 methyl ethyl dimethicone was not an acute eye irritant in rabbits. No further information was provided.9,23

BIS-PEG/PPG-14/14 DIMETHICONE Bis-PEG/PPG-14/14 dimethicone was a slight ocular irritant when administered to the eyes of New Zealand White rabbits (n=3).27 Slight swelling of the conjunctiva, with slight ocular secretion, was observed in 1 rabbit at 1h. The rabbits were examined at 1, 24, 48, and 72 h.


CETYL PEG/PPG-10/1 DIMETHICONE Cetyl PEG/PPG-10/1 dimethicone (100%; 0.1 mL) caused no opacity or iritis of the eyes of New Zealand White rabbits (n=6).7 Redness and conjunctival effects were observed on days 1 and 2. The conjunctival effects were resolved by day 3; redness was well reduced by day 3.

Cetyl PEG/PPG-10/1dimethicone (100%; 0.1 mL) was reported to be a potential ocular irritant in New Zealand White rabbits (n=6) but was not classified as an irritant using the NOHSC’s criteria for classifying hazardous substances.12 Conjunctival effects were observed on day 1, which was resolved, except for redness, at 72 h. LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE Lauryl PEG-9 polydimethylsiloxyethyl dimethicone was reported to be slightly irritating to the eyes of rabbits (n=3).24 The test substance was administered to the eyes, which were either washed or not washed in accordance with a similar procedure described in OECD TG 404. In all rabbits of both the non-washed and washed eye groups, slight conjunctival irritation was observed at 1 and 24 h, which was completely resolved by 48 h. PEG-12 DIMETHICONE

In a repeated eye irritation test of PEG-12 dimethicone (0.1 mL) using male rabbits (n=6), there were no signs of irritation of the cornea or iris observed in any of the rabbits, but slight, transient conjunctival redness was noted 24 h following each instillation.25 The test substance was administered daily for 5 days and observations continued for 7 more days.

In a second study, the average mean eye irritation scores after exposures PEG-12 dimethicone and sodium lauryl sulfate (SLS) together versus those after exposures to SLS alone, decreased from 10.4 (out of 38) to 1 and from 19.0 to 5.8, respectively, over the course of 7 days after administration.25 The treated eyes of the rabbits in both groups showed signs of irritation consisting of moderate conjunctival redness, swelling and discharge. Rabbits treated with SLS alone also showed transient corneal opacity and iridal congestion. The test material in SLS solution yielded evidence of rapid reduction in ocular irritation over a period of 48 h, compared to SLS alone. These results indicated that the test material effectively reduced eye irritation in rabbits exposed to SLS. A 1:1 ratio of PEG-12 dimethicone (100%) and SLS (3%) or a solution of SLS alone were administered into the right eye of male rabbits (n=6) per group. Observations were made by slit lamp at 1, 6, 24, 48, and 72 h, and at 7 days after exposure. PEG/PPG-25/25 DIMETHICONE In a Draize test, PEG/PPG-25/25 dimethicone (100%; 0.1 mL) was a slight ocular irritant when administered to the eyes of male New Zealand hybrid albino rabbits (n=6) for 4 h.35 All irritation signs, except for mild congestion, were resolved by 72 h. PPG-2 DIMETHICONE Male rabbit (n=3) eyes treated with PPG-2 dimethicone (100%)/SLS (3%) in a 1:1 mixture (0.1 mL) showed reduced irritation during the first 48 h, compared with SLS alone.25 The mean irritation scores for the treatment group decreased from a peak of 4.7 (out of 13.0) to 0.3 at 48 h. The rabbits were examined for indications of pain and discomfort, and ocular observations were made using a hand-held slit-lamp at 1, 24, 48, 72 h and 7 days, with sodium fluorescein (except for the 1-hour reading). All treated eyes exhibited signs of irritation including moderate-to-marked redness, slight swelling and discharge. One rabbit had moderate corneal irritation at 24h only. All eyes appeared normal with no signs of irritation in any of the rabbits when examined at 72 h and at 7 days post-instillation. GENERIC POLYSILOXANE POLYMERS The ECHA Summary and Classification and Labeling database states that PEG-dimethicones (CAS No. 68937-54-2 and generic name polydiemethylsiloxane polymer) causes serious eye irritation.3 In Vitro PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE PEG-9 polydimethylsiloxyethyl dimethicone was predicted to be slightly irritating in the Hen’s Egg Test Chorioallantoic Membrane (HET-CAM) assay and the isolated Calf Cornea (BCOP) assay.7 GENERIC POLYSILOXANE POLYMERS

In two tests using the Skin2 Epi-Ocular™ Tissue Model OCL-100 kit, silicone polyether (polydimethylsiloxane/ polyethoxy copolymer; generic term that could represent any of the alkoxy polysiloxanes with the name PEG-x Dimethicone; 100%), was classified as yielding none-to-mild irritation and minimal irritation.36 There was minimal-to-no effect on corneal opacity and permeability, compared to the controls. There were no histological changes observed.

Sensitization


Non-Human BIS-CETYL/PEG-8 CETYL PEG-8 DIMETHICONE

In a guinea pig maximization test, bis-cetyl/PEG-8 cetyl PEG-8 dimethicone (100%; 0.5 mL; MW > 10 000) was not sensitizing in guinea pigs (n=20).25 Very faint to faint erythema (0.5-1) was noted at several test sites at 24 and 48 h. Very faint erythema (0.5) was observed at 2 test sites 24 h after challenge; very faint erythema persisted at one site at 48 h. No erythema was noted at any test site following rechallenge. In the induction phase, the test or control substance was administered via intradermal induction followed by topical application 6 days later. The intradermal injections were made in combination with Freunds Complete Adjuvant (FCA). A challenge dose of the test or positive control substance (at the highest non-irritating concentration) was administered to a naive site of each animal 12 days later. The sites were scored 24-48 h later. The positive control was 2-mercaptobenzothiazole BIS-ISOBUTYL PEG-24/PPG-7/DIMETHICONE COPOLYMER Bis-isobutyl PEG-24/PPG7/dimethicone copolymer was not sensitizing in Harley albino guinea pigs (n=10/sex).25 The challenge concentration was 25% (in petrolatum). The guinea pigs were administered 3 pairs of intradermal injections (dose not specified), with and without the test material. During the second week of the induction phase, topical applications of the test material (dose not specified) were made to the induction site. Two weeks after the topical induction, the challenge applications were made to virgin sites for 24 h. The challenge concentration was the highest non-irritating concentration of the test article (25% in petrolatum). The guinea pigs were examined at 48 and 72 h for erythema, edema and other effects. BIS-PEG-15 METHYL ETHYL DIMETHICONE

Bis-PEG-15 methyl ethyl dimethicone was not a sensitizer in a Magnusson and Kligman assay using guinea pigs (n=20; control=10).37 Induction was performed by injection at a concentration of 20% (in Alembicol D or Freund’s complete adjuvant [FCA]) followed a week later by dermal application to the injection site at a concentration of 75%. The challenge was 2 weeks later by topical application at 50%. One death unrelated to the test substance occurred. There were responses in 15 guinea pigs in the test group and seven in the control group. There were no reactions when the guinea pigs were re-challenged at 5% in petrolatum.

CETYL PEG/PPG-10/1 DIMETHICONE

Cetyl PEG/PPG-10/1 dimethicone (100%) was not a dermal sensitizer in guinea pigs (n=20) when challenged at 100%.7 The test substance was administered with FCA (50%) during induction. The test sites were pretreated with sodium lauryl sulfate (10%) at the challenge.

Cetyl PEG/PPG-10/1 dimethicone (induction at 100% or 10% in FCA) was found not to be a dermal sensitizer in Dunkin Hartley guinea pigs (n=20).12 Dermal challenge was at 100% 24 h after the test site was treated with SLS. The results of the controls were as expected. LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE Lauryl PEG-9 polydimethylsiloxyethyl dimethicone was reported to not be a sensitizer in a Beuhler guinea pig sensitization test.24 Concentrations and number of guinea pigs tested were not provided. PEG/PPG-19/19 DIMETHICONE

In a sensitization test using albino Dunkin-Hartley guinea pigs (n=20; controls=5), PEG/PPG-19/19 dimethicone (5% in water; 0.1 mL) was not a sensitizer when administered to clipped and shaved skin.25 Positive controls were exposed to hexyl cinnamic aldehyde (HCA). No effects were noted by treatment with the test substance on clinical parameters or body weight gain. Severe irritation was noted at all sites injected with FCA, slight to moderate irritation at injection sites injected with the test substance, and slight irritation at the sites injected with HCA, but no irritation was seen at the control injection sites. Upon topical application, slight to well-defined redness was noted with the test substance and HCA, but slight redness was seen in some control guinea pigs. After the second topical application, effects were the same for the test and control animals, although the HCA exposed animals exhibited more marked and longer lasting effects indicative of skin sensitization.

On Day 1 of the study, 3 pairs of intradermal injections (0.1 mL/site) of one of the following were made in the shaved region: a 50:50 dilution of FCA in Water; the test (5% solution of the test substance in water) or control materials (water or 10% HCA in Alembicol D); or 50:50 dilution of FCA with either the test or control solutions. Dermal responses were evaluated 24 h later. Six days after the injection, the same site on each animal was again cleared of hair and sodium lauryl sulfate (10%; 0.5 mL in petrolatum) was gently rubbed on the site. The next day, a filter paper patch was soaked with neat test or control materials (size of patch and volume of test material not provided), placed on the hair-free area, and removed after 48 h. Skin reactions were evaluated upon removal of the dressing. After 2 weeks, the left flank of each guinea pig was clipped and shaved and a filter paper patch, soaked with the test material or the control materials, was administered to the hair-free sites for 24 h. The sites were evaluated upon removal of the patch, and 24 and 48 h later. All animals were observed daily for signs of ill health or toxicity, and body weights were taken prior to the first injection and at study termination.25


PEG/PPG-25/25 DIMETHICONE In a sensitization test using albino Dunkin-Hartley guinea pigs (n=40/sex), PEG/PPG-25/25 dimethicone (100%; 0.1 mL) was not a sensitizer when administered to the skin.35 The induction phase included 3 series of 2 injections of FCA (50%), PEG/PPG-25/25 dimethicone (2.0% in 50/50 FCA /water) or PEG/PPG-25/25 dimethicone (2.0% w/v in water). This concentration (2%) was chosen because it provoked a weak to moderate irritation response during preliminary testing. Challenge was dermally administered (2.0%; 0.5 mL) on an occlusive patch left in place for 24 h. PEG-12 DIMETHICONE

In a Magnusson and Kligman sensitization assay, PEG-12 dimethicone was not sensitizing when dermally administered to Dunkin-Hartley guinea pigs (test substance, n=20; negative control, n=10; positive control, n=5).25 There were no signs of toxicity and there were no body-weight changes. Most of the guinea pigs of the positive-control group reacted to hexyl cinnamic aldehyde (10% v/v). The incidence and severity of reactions in the test group and negative control group were considered to represent skin irritation rather than sensitization.

The intradermal induction consisted of 2 injections of 1:1 FCA: water (0.1 mL), 2 injections of the test substance (50% in water; 0.1 mL), and 2 injections of the test material (50% in FCA; 0.1 mL). The control animals were treated similarly to test animals except that the test material was omitted. Six days after injection, the application sites for the test group and negative control group were pre-treated with SLS (10% w/w in petrolatum; 0.5 mL) on the day prior to topical induction. During the topical induction phase, the test material (100%; 0.4 mL), hexyl cinnamic aldehyde (100%), or vehicle were administered under occlusion for 48 h. Challenge doses, administered 2 weeks after the topical induction, were administered to the anterior shaved sites on the flanks under occlusion. The treatment group and negative control group were treated on 3 sites per guinea pig with the test material at 100% and 50% water, and the vehicle under occlusion for 24 h. Dermal reactions to the challenge were evaluated using the Draize scale at 24 and 48 h after patch removal. Determination of sensitization potential was made by comparison of the challenge reactions in induced animals versus the respective control group. 25 PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE

PEG-9 polydimethylsiloxyethyl dimethicone was not a dermal sensitizer in guinea pigs.7 Concentrations and number of guinea pigs tested were not provided. Human LAURYL PEG/PPG-18/18 METHICONE

In a human repeat insult patch test (HRIPT; n=103), lauryl PEG/PPG-18/18 methicone (100%; 0.2 mL) was not sensitizing.25 None of the subjects exhibited signs of irritation or sensitization during any part of the study. Nine patches were administered every 48 or 72 h under semi-occlusion. Substances were not reapplied until Monday if the applications had been made on the previous Friday. Patches were administered to the infrascapular area of the back to one side of the midline. After a 12-14 day rest period, the same dose method was used on a previously unexposed site. The subjects removed the patches 24 h after they were administered. The sites were examined 24 and 48 h after the challenge patch was removed.

PEG-3 DIMETHICONE A makeup base (0.2 mL) containing PEG-3 dimethicone (3%) was found to be non-sensitizing in an HRIPT (n=51).38 No adverse effects were observed during induction or challenge phases. There were 9 sequential 24-h administrations of the test substance to the backs of each subject. The test substance was administered to a naïve site after a 2-week rest. Test sites were examined after each patch was removed during the induction phase and at 24 and 72 h after challenge.

Other Dermal Effects Comedogenicity Dimethicone, dimethicone copolyol, and silicone wax (10% in dimethicone) were reported to be non-comedogenic using the rabbit ear assay.39

SUMMARY This is a safety assessment of alkoxy polysiloxanes as used in cosmetics. The functions of these ingredients include hair conditioning agents, viscosity increasing agents, emulsion stabilizers, and film formers.

Alkoxy polysiloxanes are alkoxylated derivatives of polysiloxanes, specifically dimethicones. These ingredients were reported to be used in every FDA product category, the highest instances in makeup and

products used around the eyes. The highest reported uses were for PEG-12 dimethicone with 538 uses, cetyl PEG/PPG-10/1 dimethicone with 404 uses, PEG/PPG-18/18 dimethicone with 461 uses, and PEG-10 dimethicone with 240 uses. The highest concentrations of use were reported for stearoxy dimethicone in hair conditioners at 22%, cetyl PEG/PPG-10/1 dimethicone in eyebrow pencils at 15%, PEG/PPG-17/18 dimethicone in perfumes at 14% and hair products at 13%, cetyl PEG/PPG-10/1 dimethicone in eye shadow at 13.6%, and bis-hydroxyethyoxypropyl dimethicone in blushes at 12%.


Bis-PEG-15 methyl ethyl dimethicone did not penetrate pig ear skin in in vitro experiments. The oral LD50 of bis-PEG-15 methyl ethyl dimethicone was >4640 mg/kg for rats. The oral LD50 of cetyl

PEG/PPG-10/1 dimethicone was > 5000 mg/kg in rats. The oral LD50 of lauryl PEG-9 polydimethylsiloxyethyl dimethicone was reported to be 5000 mg/kg in rats. The oral LD50 of PEG-9 polydimethylsiloxyethyl dimethicone in rats was reported to be >5000 mg/kg. The oral LD50 of PEG/PPG-19/19 dimethicone was > 16 mL/kg in rats. There were no mortalities or clinical signs in rats orally administered 2007 mg/kg PEG/PPG-25/25 dimethicone.

The dermal LD50 was > 5000 mg/kg PEG-12 dimethicone for rabbits. There were no observed signs of systemic effects when 2000 mg/kg PEG/PPG-19/19 dimethicone was dermally administered to rabbits. The dermal LD50 of bis-PEG/PPG-14/14 dimethicone rats was >2000 mg/kg.

In an acute inhalation study of PEG-12 dimethicone at 0.68 mg/L in air, there were no deaths and no abnormalities were observed among the rats during the 4-h exposure or the observation period.

There were no clinical signs observed when rats were orally administered up to 1000 mg/kg/d bis-PEG-15 methyl ethyl dimethicone for 4 weeks. There were no mortalities when 5000 mg/kg cetyl PEG/PPG-10/1 dimethicone was administered by gavage to rats for 14 days. The oral NOAEL of PEG-12 dimethicone was 1000 mg/kg for rats when administered for 29 days.

PEG-12 dimethicone up to 1000 mg/kg did not produce any signs of systemic toxicity when dermally administered to rabbits 6 h/d for 29 days. The NOEL for dermally administered PEG/PPG-19/19 dimethicone was 1000 mg/kg/d for 29 days for rabbits.

Rabbit does exhibited increased numbers of resorption sites when 200 mg/kg siloxanes and silicones, 3-hydroxypropyl Me, di-Me, ethoxylated were dermally administered to shaved backs on gestation days 6 to 18. Dermally administered PEG-12 dimethicone up to 200 mg/kg was not embryotoxic or teratogenic in rabbits on days 6 through 18 of gestation. Dermally administered siloxanes and silicones, 3-hydroxypropyl methyl, di-methyl ethoxylated on gestation days 6-18 was not teratogenic to rabbits.

In a reverse mutation assay using S. typhimurium, including a plate incorporation test and a pre-incubation test, bis-PEG-15 methyl ethyl dimethicone was not genotoxic, with or without metabolic activation, up to 5000 μg/plate. Cetyl PEG/PPG-10/1 dimethicone was not mutagenic to S. typhimurium and E. coli up to 5000 µg/plate, with or without metabolic activation. Lauryl PEG-9 polydimethylsiloxyethyl dimethicone was reported to be non-mutagenic in an Ames test. Lauryl PEG/PPG-18/18 methicone was not genotoxic to S. typhimurium and E. coli up to 1500 μg/plate. PPG-2 dimethicone was not genotoxic to S. typhimurium and E. coli up to 5000 μg/plate and up to 250 000 µg/plate for the TA1535 strain of S. typhimurium. PEG-12 dimethicone was not mutagenic up to 5000 µg/plate, with or without metabolic activation, in a reverse mutation assay using S. typhimurium and E. coli. PEG/PPG-19/19 dimethicone was not genotoxic to S. typhimurium up to 500 μg/plate. In a reverse mutation assay using S. typhimurium, including a plate incorporation test and a pre-incubation test, PEG/PPG-25/25 dimethicone was not genotoxic, with or without metabolic activation, up to 5000 μg/plate.

In a patch test, bis-cetyl/PEG-8 cetyl PEG-8 dimethicone at 100% with a MW > 10 000 was a dermal irritant when administered to the intact or abraded skin of rabbits for 24 h. The Draize scores were 2, 1.995, and 1.915 for all test sites, intact skin, and abraded skin, respectively.

Cetyl PEG/PPG-10/1 dimethicone with a MW <1000 caused very slight redness (grade 1) in 5/6 abraded sites and 5/6 intact sites at 24 h in rabbits; the Draize scores were 0.4 for both intact and abraded skin. Cetyl PEG/PPG-10/1 dimethicone with a MW > 10 000 caused slight irritation in all tested rabbits when administered to the intact or abraded skin of rabbits. The Draize scores were 1.17, 0.75, and 1.58 for all test sites, intact skin, and abraded skin, respectively. Cetyl PEG/PPG-10/1 dimethicone at 100% had some potential for dermal irritation, but well below the threshold to be classified as hazardous, when administered to the skin of rabbits.

Lauryl PEG-9 polydimethylsiloxyethyl dimethicone at 100% was reported to be slightly irritating to rabbit skin. PEG-9 polydimethylsiloxyethyl dimethicone at 20% and 100% was a slight dermal irritant to the intact and abraded skin of rabbits. Slight to well-defined erythema, with some scaling, was observed at 5%. PEG-12 dimethicone at 100% elicited very slight erythema, which resolved within 72 h, in rabbits. The PII was calculated to be 0.44. PEG/PPG-25/25 dimethicone at 100% was not a dermal irritant when administered to the skin of rabbits for 4 h.

A lip makeup base that contained 5% PEG-3 dimethicone was found to be non-irritating in a human patch test. PEG-9 polydimethylsiloxyethyl dimethicone was found to be a potential non-irritant in and in vitro EpiSkin small

model assay. A brow pencil containing 15% cetyl PEG/PPG-10/1 dimethicone was non-irritating in a patch test and a

maximization test. A lip makeup base that contained 5% PEG-3 dimethicone was non-irritating in a patch test. PEG-12 dimethicone at 0.5%, 2%, and 5% provided protection against the dermal irritation effect of 1% SLS in

humans. In an in vitro human reconstructed epidermis cytotoxicity test (SkinEthic™), PEG-12 dimethicone was rated as a non-irritant.

Bis-PEG-15 methyl ethyl dimethicone was not an acute eye irritant in rabbits. Bis-PEG/PPG-14/14 dimethicone, cetyl PEG/PPG-10/1 dimethicone, lauryl PEG-9 polydimethylsiloxyethyl, PEG-9 polydimethylsiloxyethyl dimethicone, and PEG/PPG-25/25 dimethicone were mild ocular irritants to rabbits. In a repeated eye irritation test of PEG-12 dimethicone, rabbit eyes showed no signs of irritation of the cornea or iris, but slight, transient conjunctival redness was noted at 24 h following each of 5 instillations.


PEG-9 polydimethylsiloxyethyl dimethicone was predicted to be a slightly irritating in the HET-CAM and the BCOP assays. Increased molecular weight was reported to decrease the potential of ocular irritation.

The eyes of rabbits treated with PPG-2 dimethicone or PEG-12 dimethicone mixed with SLS showed reduced irritation compared with treatment with SLS alone.

The following were not sensitizers to guinea pigs: bis-cetyl/PEG-8 cetyl PEG-8 dimethicone at 100% and MW > 10 000 bis-isobutyl PEG-24/PPG7/dimethicone copolymer at 100% bis-PEG-15 methyl ethyl dimethicone at 20% cetyl PEG/PPG-10/1 dimethicone at 100% lauryl PEG-9 polydimethylsiloxyethyl dimethicone PEG-12 dimethicone at 100% PEG/PPG-19/19 dimethicone at 5% PEG/PPG-25/25 dimethicone at 100% PEG-9 polydimethylsiloxyethyl dimethicone Lauryl PEG/PPG-18/18 methicone at 100% was not sensitizing in an HRIPT. None of the subjects exhibited signs of

irritation or sensitization during any part of the study. A makeup base containing 3% PEG-3 dimethicone was nonsensitizing in an HRIPT Dimethicone-based compounds were not comedogenic.

DISCUSSION The Discussion will be further developed by the Panel at the September, 2014 meeting. The Panel noted that of these ingredients for which the size was reported, all were greater than 500 Da. PEG-3

dimethicone is expected to be one of the smallest molecules of these ingredients and it has a reported size of greater than 1000 Da. However, there is no size of PPG-2 dimethicone.

The Panel discussed the issue of incidental inhalation exposure from aerosol spray moisturizers, suntan products,

deodorants, body and hand products, and hair sprays, including pump hair sprays. The limited data available from acute inhalation studies suggest little potential for respiratory effects at relevant doses. However, there were no chronic inhalation studies available. The Expert Panel believes that the sizes of a substantial majority of the particles of these ingredients, as manufactured, are larger than the respirable range and/or aggregate and agglomerate to form much larger particles in formulation. These ingredients are reportedly used at concentrations up to 2.8% in cosmetic products that may be aerosolized and up to 4% in other products that may become airborne. The Panel noted that 95%–99% of droplets/particles would not be respirable to any appreciable amount.

Furthermore, droplets/particles deposited in the nasopharyngeal or bronchial regions of the respiratory tract present no toxicological concerns based on the chemical and biological properties of this ingredient. Coupled with the small actual exposure in the breathing zone and the concentrations at which the ingredients are used, the available information indicates that incidental inhalation would not be a significant route of exposure that might lead to local respiratory or systemic effects. The Panel considered other data available to characterize the potential for alkoxy polysiloxanes to cause systemic toxicity, irritation, sensitization, reproductive and developmental toxicity, and genotoxicity.

They noted the lack of systemic toxicity at high doses in several acute and repeated-dose oral exposure studies, little or no irritation or sensitization in multiple tests of dermal and ocular exposure (including testing of products containing alkoxy polysiloxanes), and the absence of genotoxicity in multiple Ames tests. In addition, some of these ingredients are large macromolecules (MW >1000) and some are insoluble in water. A detailed discussion and summary of the Panel’s approach to evaluating incidental inhalation exposures to ingredients in cosmetic products is available at http://www.cir-safety.org/cir-findings.

CONCLUSION The Conclusion will be developed by the Panel at the September, 2014 meeting.


http://www.cir-safety.org/cir-findings

http://www.cir-safety.org/cir-findings

TABLES

Table 1. Definitions and idealized structures of the ingredients in this safety assessment based on the International Cosmetic Dictionary and Handbook.2

Ingredient CAS No. Definition / Structure Function Behenoxy Dimethicone Behenoxy Dimethicone is a dimethyl siloxane polymer that conforms

generally to the formula. Skin-conditioning agent – emollient

O Si O

CH3

CH3

Si

CH3

O

CH3

Si O

CH3

CH3n

H3C

H3C

Behenoxy PEG-10 Dimethicone 1136947-78-8

Behenoxy PEG-10 Dimethicone is the product obtained by the reaction of Hydrogen Dimethicone with Behenyl Alcohol and PEG-10 allyl ether.

Humectant; viscosity increasing agent – aqueous

O Si O

CH3

CH3

Si

CH3

R

CH3

Si Si

CH3

Rx

R

CH3

CH3y

O

where R may be a behenyl grouping or -(CH2)3O(CH2CH2O)8H


Bis-Cetyl/PEG-8 Cetyl PEG-8 Dimethicone is the silicone compound that conforms generally to the formula, where R may be a cetyl grouping or -(CH2)3O(CH2CH2O)8H.

Emulsion stabilizer

O Si O

CH3

CH3

Si

CH3

R

CH3

Si Si

CH3

Rx

R

CH3

CH3y

O

where R may be a cetyl grouping or -(CH2)3O(CH2CH2O)8H

Bis-Hydroxyethoxypropyl Dimethicone 222416-17-3

Bis-Hydroxyethoxypropyl Dimethicone is the siloxane polymer that conforms generally to the formula.

Skin-conditioning agent – emollient

O Si O

CH3

CH3

Si

CH3

CH3

Si

CH3

CH3x

OOH

OHO

Bis-Isobutyl PEG/PPG-10/7/ Dimethicone Copolymer 158451-77-5 (generic)

Bis-Isobutyl PEG/PPG-10/7/Dimethicone Copolymer is a random copolymer of polyethylene glycol, polypropylene glycol and Dimethicone containing an average of 10 moles of ethylene oxide and 7 moles of propylene oxide.

Surfactant – emulsifying agent

Bis-Isobutyl PEG-13/Dimethicone Copolymer 197980-52-2

Bis-Isobutyl PEG-13/Dimethicone Copolymer is a block copolymer made by reacting Bis-Hydrogen Dimethicone with the bis-methallyl ether of PEG-13.

Film former

O Si O

CH3

CH3

Si

CH3

H

CH3

Si

CH3

CH3x

OO

13

CH3

CH3

Si

CH3

CH3

OSiO

CH3

CH3

Si

CH3

H

CH3x

y Bis-Isobutyl PEG-24/PPG-7/ Dimethicone Copolymer 158451-77-5 (generic)

Bis-Isobutyl PEG-24/PPG-7/Dimethicone Copolymer is a block copolymer of polyethylene glycol, polypropylene glycol and Dimethicone containing an average of 24 moles of ethylene oxide and 7 moles of propylene oxide.

Film former; humectant

Bis-PEG-1 Dimethicone Bis-PEG-1 Dimethicone is Dimethicone end-blocked with an average of 1 mole of ethylene oxide.

Hair conditioning agent; plasticizer; skin-conditioning agent – miscellaneous; surfactants – dispersing agent



Ingredient CAS No. Definition / Structure Function

O Si O

CH3

CH3

Si

CH3

CH3

Si

CH3

CH3x

OOH

OHO

Bis-PEG-4 Dimethicone Bis-PEG-4 Dimethicone is the siloxane polymer that conforms

generally to the formula: Hair conditioning agent; plasticizer; skin-conditioning agent – emollient

O Si O

CH3

CH3

Si

CH3

CH3

Si

CH3

CH3x

OOH

OHO

4 4

Bis-PEG-8 Dimethicone Bis-PEG-8 Dimethicone is Dimethicone end-blocked with an

average of 8 moles of ethylene oxide. Hair conditioning agent; plasticizer; skin-conditioning agent – miscellaneous; surfactants – dispersing agent

O Si O

CH3

CH3

Si

CH3

CH3

Si

CH3

CH3x

OOH

OHO

8 8


average of 10 moles of ethylene oxide Dispersing agent – nonsurfactant; hair conditioning agent; plasticizer; skin-conditioning agent – miscellaneous

O Si O

CH3

CH3

Si

CH3

CH3

Si

CH3

CH3x

OOH

OHO

10 10


average of 12 moles of ethylene oxide. Hair conditioning agent; skin-conditioning agent – emollient

O Si O

CH3

CH3

Si

CH3

CH3

Si

CH3

CH3x

OOH

OHO

12 12

Bis-PEG-12 Dimethicone Beeswax [151661-97-1]

Bis-PEG-12 Dimethicone Beeswax is the partial ester of the fatty acids derived from beeswax and a derivative of Dimethicone, end-blocked with an average of 12 moles of ethylene oxide.

Hair conditioning agent; skin-conditioning agent – occlusive

O Si O

CH3

CH3

Si

CH3

CH3

Si

CH3

x

O

R

O

O

12

y

O

12

wherein

is residue of beeswax fatty acids

O

R

HO OH

Bis-PEG-12 Dimethicone Candelillate Bis-PEG-12 Dimethicone Candelillate is the partial ester of the fatty

acids derived from candelilla wax and a derivative of Dimethicone, end-blocked with an average of 12 moles of ethylene oxide.

Hair conditioning agent; skin-conditioning agent – occlusive




O Si O

CH3

CH3

Si

CH3

CH3

Si

CH3

x

O

R

O

O

12

y

O

12

wherein

is residue of candelilla wax fatty acids

O

R

HO OH

Bis-PEG-15 Methyl Ether Dimethicone Bis-PEG-15 Methyl Ether Dimethicone is the methyl ether of a

derivative of Dimethicone end-blocked with an average of 15 moles of ethylene oxide.

Hair conditioning agent; skin-conditioning agent – miscellaneous; surfactants – emulsifying agent

O Si O

CH3

CH3

Si

CH3

CH3

Si

CH3

x

O

H3C

O

15

y

O

15OHHO

Bis-PEG-20 Dimethicone Bis-PEG-20 Dimethicone is the siloxane polymer that conforms

generally to the formula, where n has an average value of 20. Hair conditioning agent; skin-conditioning agent – miscellaneous

O Si O

CH3

CH3

Si

CH3

CH3

Si

CH3

CH3x

OOH

OHO

20 20

Bis-PEG-8 PEG-8 Dimethicone Bis-PEG-8 PEG-8 Dimethicone is a derivative of Dimethicone

containing alkoxylated side chain with an average of 8 moles of ethylene oxide, and end-blocked with an average of 8 moles of ethylene oxide.

Hair conditioning agent

O Si O

CH3

CH3

Si

CH3

CH3

Si

CH3

x

O

OO

8

HO8

y

HO OH

8

Bis-PEG/PPG-14/14 Dimethicone 151662-01-0

Bis-PEG/PPG-14/14 Dimethicone is Dimethicone end-blocked with an average of 14 moles of ethylene oxide and an average of 14 moles of propylene oxide.

Skin-conditioning agents – emollients; surfactant – emulsifying agent

O Si O

CH3

CH3

Si

CH3

CH3

Si

CH3

CH3x

OO

OO

14 14

OHHO

CH3 CH3

1414

Bis-PEG/PPG-15/5 Dimethicone Bis-PEG/PPG-15/5 Dimethicone is Dimethicone end-blocked with

the random addition of an average of 15 moles of ethylene oxide and 5 moles of propylene oxide.

Emulsion stabilizer; humectant




O Si O

CH3

CH3

Si

CH3

CH3

Si

CH3

CH3x

OO

OO

15 15

OHHO

CH3 CH3

55


Bis-PEG/PPG-16/16 PEG/PPG-16/16 Dimethicone is a derivative of Dimethicone containing an alkoxylated side chain with an average of 16 moles of ethylene oxide and 16 moles of propylene oxide, and end-blocked with an average of 16 moles of ethylene oxide and 16 moles of propylene oxide.

Skin-conditioning agent – occlusive; surfactant – emulsifying agent

O Si O

CH3

CH3

Si

CH3

CH3

Si

CH3

x

O

OO

16

O16

y

O O16

HO OH

OH

CH3 CH3

CH3

16

16 16


the random addition of an average of 18 moles of ethylene oxide and 6 moles of propylene oxide.

Skin-conditioning agent – emollient; surfactant – emulsifying agent

O Si O

CH3

CH3

Si

CH3

CH3

Si

CH3

CH3x

OO

OO

18 18

OHHO

CH3 CH3

66


an average of 20 moles of ethylene oxide and an average of 20 moles of propylene oxide.

Skin-conditioning agent – emollient; surfactant – emulsifying agent

O Si O

CH3

CH3

Si

CH3

CH3

Si

CH3

CH3x

OO

OO

20 20

OHHO

CH3 CH3

2020


Bis-PEG/PPG-20/5 PEG/PPG-20/5 Dimethicone is a derivative of Dimethicone containing an alkoxylated side chain with an average of 20 moles of ethylene oxide and 5 moles of propylene oxide, and end-blocked with an average of 20 moles of ethylene oxide and 5 moles of propylene oxide.

Emulsion stabilizer; surfactant – emulsifying agent




O Si O

CH3

CH3

Si

CH3

CH3

Si

CH3

x

O

OO

20

O20

y

O O20

HO OH

OH

CH3 CH3

CH3

5

5 5

Bis-Stearoxy Dimethicone Bis-Stearoxy Dimethicone is the polymer formed by the reaction

between Bis-Hydrogen Dimethicone and allyl stearyl ether. Film former; skin-conditioning agent - emollient

Bis-Stearoxyethyl Dimethicone 128446-57-1

Bis-Stearoxyethyl Dimethicone is the silicone polymer that conforms generally to the formula:


O Si O

CH3

CH3

Si

CH3

CH3

Si

CH3

CH3x

OOH3C

H3C

Cetyl PEG/PPG-10/1 Dimethicone 191044-49-2

Cetyl PEG/PPG-10/1 Dimethicone is a copolymer of Cetyl Dimethicone and an alkoxylated derivative of Dimethicone containing an average of 10 moles of ethylene oxide and 1 mole of propylene oxide.

Skin-conditioning agent – miscellaneous; surfactant – emulsifying agent


Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone is the copolymer of Cetyl Dimethicone and a butyl ether of a derivative of Dimethicone containing an average of 15 moles of ethylene oxide and 15 moles of propylene oxide.


Cetyl PEG/PPG-7/3 Dimethicone Cetyl PEG/PPG-7/3 Dimethicone is a copolymer of Cetyl Dimethicone and an alkoxylated derivative of Dimethicone containing an average of 7 moles of ethylene oxide and 3 moles of propylene oxide.


Cetyl PEG-8 Dimethicone Cetyl PEG-8 Dimethicone is the polydimethylsiloxane that conforms to the formula where n has an average value of 8.


Lauryl Isopentyl-PEG/PPG-18/18 Methicone 1112315-26-0

Lauryl Isopentyl-PEG/PPG-18/18 Methicone is the copolymer formed by the reaction of Methicone with dodecene and a dimethyallyl-terminated polyethylene oxide/polypropylene oxide copolymer.


Lauryl PEG/PPG-18/18 Methicone Lauryl PEG/PPG-18/18 Methicone is an alkoxylated derivative of Lauryl Methicone containing an average of 18 moles of ethylene oxide and 18 moles of propylene oxide.


Lauryl PEG-10 Methyl Ether Dimethicone

Lauryl PEG-10 Methyl Ether Dimethicone is the silicone polymer that conforms generally to the formula.



http://online.personalcarecouncil.org/jsp/IngredientDetail.jsp?monoid=19652



Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone

Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone is the silicone compound that conforms generally to the formula.


Lauryl PEG-8 Dimethicone Lauryl PEG-8 Dimethicone is the polydimethylsiloxane that

conforms to the formula, where n has an average value of 8. External analgesics; surfactant – emulsifying agent

Lauryl PEG-8 PPG-8 Dimethicone Lauryl PEG-8 PPG-8 Dimethicone is a terpolymer obtained by

reacting Hydrogen Dimethicone with dodecene, the allyl ether of PEG-8, and the allyl ether of PPG-8.


Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone

Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone is the silicone polymer that conforms generally to the formula

Hair conditioning agent; hair fixative; skin-conditioning agent – miscellaneous; surface modifier; surfactant – emulsifying agent; surfactant – solubilizing agent; viscosity increasing agent – aqueous


Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone is a derivative of Dimethicone in which some of the methyl groups on the siloxane backbone have been replaced by lauryl, polyglyceryl-3, and polydimethylsiloxyethyl groups. It conforms generally to the formula.

Hair conditioning agent; skin-conditioning agent – miscellaneous; surfactant – cleansing agent; surfactant – emulsifying agent; surfactant – solubilizing agent; viscosity increasing agent – aqueous




Methoxy PEG-11 Methoxy PPG-24 Dimethicone 472975-82-9

Methoxy PEG-11 Methoxy PPG-24 Dimethicone is the methyl ether of an alkoxylated derivative of dimethicone containing an average of 11 moles of ethylene oxide and 24 moles propylene oxide.

Antifoaming agent

Methoxy PEG/PPG-25/4 Dimethicone Methoxy PEG/PPG-25/4 Dimethicone is the methyl ether of an alkyoxylated derivative of Dimethicone containing an average of 25 moles of ethylene oxide and 4 moles of propylene oxide.


Methoxy PEG-13 Ethyl Polysilsesquioxane

Methoxy PEG-13 Ethyl Polysilsesquioxane is the polymerized resin of polysilsesquioxane containing ethyl methoxy PEG-13 groupings.

Humectant

PEG/PPG-10/2 Dimethicone PEG/PPG-10/2 Dimethicone is the alkoxylated derivative of Dimethicone containing an average of 10 moles of ethylene oxide and 2 moles of propylene oxide.

Hair conditioning agent; skin-conditioning agent – emollient

PEG/PPG-10/3 Oleyl Ether Dimethicone PEG/PPG-10/3 Oleyl Ether Dimethicone is the oleyl ether of a derivative of Dimethicone containing an average of 10 moles of ethylene oxide and 3 moles of propylene oxide.

Emulsion stabilizer; hair conditioning agent; skin-conditioning agent – miscellaneous; surfactant – emulsifying agent; surfactant – solubilizing agent


Antifoaming agent; skin-conditioning agent – miscellaneous; slip modifier; surfactant – emulsifying agent






Anticaking agent; surfactant – emulsifying agent







Ingredient CAS No. Definition / Structure Function PEG/PPG-16/8 Dimethicone PEG/PPG-16/8 Dimethicone is the alkoxylated derivative of

Dimethicone containing an average of 16 moles of ethylene oxide and 8 moles of propylene oxide.


PEG/PPG-17/18 Dimethicone PEG/PPG-17/18 Dimethicone is the alkoxylated derivative of Dimethicone containing an average of 17 moles of ethylene oxide and 18 moles of propylene oxide






PEG/PPG-18/6 Dimethicone PEG/PPG-18/6 Dimethicone is alkoxylated derivative of Dimethicone containing a random addition of an average of 18 moles of ethylene oxide and 6 moles of propylene oxide.








PEG/PPG-20/22 Butyl Ether Dimethicone 67762-87-2

PEG/PPG-20/22 Butyl Ether Dimethicone is the butyl ether of a derivative of Dimethicone containing an average of 20 moles of ethylene oxide and 22 moles of propylene oxide.

Hair conditioning agent; skin-conditioning agent – miscellaneous

PEG/PPG-20/22 Methyl Ether Dimethicone 125857-75-2

PEG/PPG-20/22 Methyl Ether Dimethicone is the methyl ether of a derivative of Dimethicone containing an average of 20 moles of ethylene oxide and 22 moles of propylene oxide.

Hair conditioning agent; surfactant – cleansing agent; surfactant – dispersing agent; surfactant – emulsifying agent


Emulsion stabilizer; hair conditioning agent; skin-conditioning agent – miscellaneous; slip modifier; surface modifier; surfactant – solubilizing agent







Hair conditioning agent; skin-conditioning agent – miscellaneous; surfactant – emulsifying agent


Emulsion stabilizer; hair conditioning agent; skin-conditioning agent – miscellaneous; slip modifier; surface modifier; surfactant – solubilizing agent





Hair conditioning agent; humectant; skin-conditioning agent – miscellaneous; surfactant – dispersing agent; surfactant – emulsifying agent



Ingredient CAS No. Definition / Structure Function PEG/PPG-23/6 Dimethicone PEG/PPG-23/6 Dimethicone is the alkoxylated derivative of

Dimethicone containing an average of 23 moles of ethylene oxide and 6 moles of propylene oxide.

Emulsion stabilizer; slip modifier; surface modifier; surfactant – solubilizing agent

PEG/PPG-24/18 Butyl Ether Dimethicone 67762-87-2


Hair conditioning agent; humectant; surfactant – cleansing agent; surfactant – dispersing agent; surfactant – emulsifying agent





PEG/PPG-27/9 Butyl Ether Dimethicone PEG/PPG-27/9 Butyl Ether Dimethicone is the butyl ether of a derivative of Dimethicone containing an average of 27 moles of ethylene oxide and 9 moles of propylene oxide.

Hair conditioning agent; skin-conditioning agent - miscellaneous; surfactant – emulsifying agent








Emulsion stabilizer; humectant






Antifoaming agent; plasticizer; skin-conditioning agent – miscellaneous; surfactant – dispersing agent

PEG-10 Dimethicone 68937-54-2 (generic)

PEG-10 Dimethicone is the polyethylene glycol derivative of Dimethicone containing an average of 10 moles of ethylene oxide.

Hair condition agent; skin-conditioning agent – miscellaneous

PEG-10 Methyl Ether Dimethicone 68938-54-5 (generic)

PEG-10 Methyl Ether Dimethicone is the methyl ether of a derivative of Dimethicone containing an average of 10 moles of ethylene oxide.

Hair condition agent; skin-conditioning agent – miscellaneous; surfactant – emulsifying agent


PEG-10 Polydimethylsiloxyethyl Dimethicone/Bis-Vinyl Dimethicone Crosspolymer is a copolymer of PEG-10 polydimethylsiloxyethyl dimethicone crosslinked with Bis-Vinyldimethicone.

Film former; skin-conditioning agent – emollient; slip modifier; surfactant – emulsifying agent










PEG-17 Dimethicone PEG-17 Dimethicone is the polyethylene glycol derivative of Dimethicone containing an average of 17 moles of ethylene oxide.




Ingredient CAS No. Definition / Structure Function PEG-3 Dimethicone 68937-54-2 (generic)

PEG-3 Dimethicone is the siloxane polymer that conforms generally to the formula


where n has an average value of 3.




PEG-4 PEG-12 Dimethicone PEG-4 PEG-12 Dimethicone is the reaction product of Hydrogen Dimethicone and allyl PEG-4 and allyl PEG-12.

Emulsion stabilizers



Humectant; plasticizer; slip modifier


PEG-6 Methyl Ether Dimethicone is the methyl ether of a polyethylene glycol derivative of Dimethicone containing an average of 6 moles of ethylene oxide




Film former



Hair condition agent; skin-conditioning agent – humectant; surfactant – emulsifying agent

PEG-8 Cetyl Dimethicone PEG-8 Cetyl Dimethicone is the polydimethylsiloxane that conforms to the formula

Skin-conditioning agent – miscellaneous





PEG-8 Dimethicone Dimer Dilinoleate PEG-8 Dimethicone Dimer Dilinoleate is the ester formed by the reaction of PEG-8 Dimethicone and Dilinoleic Acid.

Film former

PEG-8 Dimethicone/Dimer Dilinoleic Acid Copolymer

PEG-8 Dimethicone Dimer Dilinoleate is the ester formed by the reaction of PEG-8 Dimethicone and Dilinoleic Acid.


PEG-8 Methicone PEG-8 Methicone is the polyethylene glycol derivative of Methicone containing an average of 8 moles of ethylene oxide.

Hair condition agent; skin-conditioning agent – emollient



Hair conditioning agent; humectant; surfactant – cleansing agent; surfactant – dispersing agent

PEG-8 PEG-4 Dimethicone PEG-8 PEG-4 Dimethicone is the reaction product of Hydrogen Dimethicone and allyl PEG-8 and allyl PEG-4.

Hair conditioning agent; surfactant – emulsifying agent

PEG-8 PPG-8 Dimethicone PEG-8 PPG-8 Dimethicone is the polyoxypropylene, polyoxyethylene ether of Dimethicone with an average propoxylation value of 8 and an average ethoxylation value of 8.



PEG-9 Dimethicone is the siloxane polymer that conforms generally to the formula






PEG-9 Methyl Ether Dimethicone PEG-9 Methyl Ether Dimethicone is a siloxane polymer that conforms generally to the formula

Hair conditioning agent; skin-conditioning agent – miscellaneous; surfactant – emulsifying agent


PEG-9 Polydimethylsiloxyethyl Dimethicone

PEG-9 Polydimethylsiloxyethyl Dimethicone is the siloxane polymer that conforms generally to the formula.


Polysilicone-13 158451-77-5 197980-52-2

Polysilicone-13 is the siloxane polymer that conforms generally to the formula.

Hair conditioning agent

PPG-12 Butyl Ether Dimethicone PPG-12 Butyl Ether Dimethicone is a butyl ether of a derivative of

Dimethicone containing an average of 12 moles of propylene oxide. Hair conditioning agent; humectant; surfactant – dispersing agent; surfactant – emulsifying agent

PPG-12 Dimethicone PPG-12 Dimethicone is the polypropylene glycol derivative of Dimethicone containing an average of 12 moles of propylene oxide.

Hair conditioning agent; skin-conditioning agent – emollient

PPG-2 Dimethicone 68440-66-4 68554-64-3

PPG-2 Dimethicone is the polypropylene glycol derivative of Dimethicone containing an average of 2 moles of propylene oxide.

Skin-conditioning agent – miscellaneous; surfactant – dispersing agent

PPG-25 Dimethicone 68957-00-6 (generic)

PPG-25 Dimethicone is the polypropylene glycol derivative of Dimethicone containing an average of 25 moles of propylene oxide.

Hair conditioning agent; skin-conditioning agent - miscellaneous; surfactant – emulsifying agent

PPG-27 Dimethicone PPG-27 Dimethicone is the polypropylene glycol derivative of Dimethicone containing an average of 27 moles of propylene oxide.


PPG-4 Oleth-10 Dimethicone PPG-4 Oleth-10 Dimethicone is the silicone polymer that conforms generally to the formula

Film former




where R represents Oleth-10 and n has an average value of 4.

Stearoxy Dimethicone 68554-53-0

Stearoxy Dimethicone is a polymer of dimethylpolysiloxane with some methyl groups replaced by stearoxy groups.



Stearoxymethicone/Dimethicone Copolymer is the siloxane polymer that conforms generally to the formula.

Skin-conditioning agent – occlusive; viscosity increasing agent – nonaqueous

Table 2. Safety assessments of cosmetic ingredients related to the alkoxy polysiloxanes in this report of contain components

or similar components to the ingredients in this report (ie, silicates).

Ingredients Conclusion

Maximum use

concentration (%) Reference

Cyclomethicone, cyclotetrasiloxane, cyclopentasiloxane, cyclohexasiloxane, and cycloheptasiloxane

Safe in the present practices of use and concentration

94 40,41

Dimethicone copolyol Re-review also included: Dimethicone PEG-7 Phosphate, Dimethicone PEG-10 Phosphate, Dimethicone PEG/PPG-7 /4 Phosphate, Dimethicone PEG/PPG-12/4 Phosphate, Dimethicone PEG/PPG-20/23 Benzoate, Dimethicone PEG-8 Benzoate, Dimethicone PEG-6 Acetate, Dimethicone PEG-8 Adipate, PEG-3 Dimethicone, PEG-9 Dimethicone, PEG/PPG-20/29 Dimethicone, PEG/PPG-6111 Dimethicone, PEG-7 Dimethicone, PEG-8 Dimethicone, PEG-14 Dimethicone, PEG/PPG-14/4 Dimethicone, PEG/PPG-4/12 Dimethicone, PEG/PPG-20/20 Dimethicone, PEG/PPG-8114 Dimethicone, PEG/PPG-20/6 Dimethicone, PEG/PPG-20/15 Dimethicone, PEG-12 Dimethicone, PEG/PPG-18/ 18 Dimethicone, PEG/PPG-17 I 18 Dimethicone, PEG-10 Dimethicone, PEG/PPG-25/25 Dimethicone, PEG/PPG-19/19 Dimethicone, PEG/PPG-27 /27 Dimethicone, PEG/ PPG-22/23 Dimethicone, PEG/PPG-3110 Dimethicone, PEG/PPG-16/2 Dimethicone, PEG/PPG-22/24 Dimethicone, PEG/PPG-15115 Dimethicone, PEG-17 Dimethicone, PEG/PPG-20/23 Dimethicone, and PEG/PPG-23/6 Dimethicone.

Safe as cosmetic ingredients in the present practices of use and concentration. Conclusion confirmed at re-review.

10 1,42

Dimethicone crosspolymers: acrylates/bis-hydroxypropyl dimethicone crosspolymer, behenyl dimethicone/bis-vinyldimethicone crosspolymer, bis-phenylisopropyl phenylisopropyl dimethicone/vinyl dimethicone crosspolymer, bis-vinyldimethicone/bis-isobutyl PPG-20 crosspolymer, bis-vinyldimethicone crosspolymer, bis-vinyldimethicone/PEG-10 dimethicone crosspolymer, bis-vinyldimethicone/PPG-20 crosspolymer, butyldimethicone methacrylate/methyl methacrylate crosspolymer, C30-45 alkyl cetearyl dimethicone crosspolymer, C4-24 alkyl dimethicone/divinyldimethicone crosspolymer, C30-45 alkyl dimethicone/polycyclohexene oxide crosspolymer, cetearyl dimethicone crosspolymer, cetearyl dimethicone/vinyl dimethicone crosspolymer, cetyl dimethicone/bis-vinyldimethicone crosspolymer, cetyl hexacosyl dimethicone /bis-vinyldimethicone crosspolymer, crotonic acid/vinyl C8-12 isoalkyl esters /VA/bis-vinyldimethicone crosspolymer, dimethicone/bis-isobutyl PPG-20 crosspolymer, dimethicone/bis-vinyldimethicone/silsesquioxane crosspolymer, dimethicone crosspolymer, dimethicone crosspolymer-3, dimethicone/ divinyldimethicone/silsesquioxane crosspolymer, dimethicone/lauryl dimethicone/bis-vinyldimethicone crosspolymer, dimethicone/PEG-10 crosspolymer, dimethicone/PEG-10/15 crosspolymer, dimethicone/PEG-15 crosspolymer, dimethicone/phenyl vinyl dimethicone crosspolymer, dimethicone/polyglycerin-3 crosspolymer, dimethicone/PPG-20 crosspolymer, dimethicone/titanate crosspolymer, dimethicone/vinyl dimethicone crosspolymer, dimethicone/vinyltrimethylsiloxysilicate crosspolymer, diphenyl dimethicone crosspolymer, diphenyl dimethicone/vinyl diphenyl dimethicone/ silsesquioxane crosspolymer, divinyldimethicone/dimethicone crosspolymer, hydroxypropyl dimethicone/polysorbate 20 crosspolymer, isopropyl titanium triisostearate/triethoxysilylethyl polydimethylsiloxyethyl

Safe in the present practices of use and concentration described in this safety assessment.

46 43


Table 2. Safety assessments of cosmetic ingredients related to the alkoxy polysiloxanes in this report of contain components or similar components to the ingredients in this report (ie, silicates).

Ingredients Conclusion

Maximum use

concentration (%) Reference

dimethicone crosspolymer, lauryl dimethicone PEG-15 crosspolymer, lauryl dimethicone/ polyglycerin-3 crosspolymer, lauryl polydimethylsiloxyethyl dimethicone/bis-vinyldimethicone crosspolymer, PEG-10 dimethicone crosspolymer, PEG-12 dimethicone crosspolymer, PEG-8 dimethicone/polysorbate 20 crosspolymer, PEG-12 dimethicone/bis-isobutyl PPG-20 crosspolymer, PEG-12 dimethicone/ PPG-20 crosspolymer, PEG-10 dimethicone/vinyl dimethicone crosspolymer, PEG-10/lauryl dimethicone crosspolymer, PEG-15/lauryl dimethicone crosspolymer, PEG-15/lauryl polydimethylsiloxyethyl dimethicone crosspolymer, perfluorononyl dimethicone/methicone/amodimethicone crosspolymer, polydimethylsiloxyethyl dimethicone/bis-vinyldimethicone crosspolymer, polyglyceryl-3/lauryl polydimethylsiloxyethyl dimethicone crosspolymer, silicone quaternium-16/glycidoxy dimethicone crosspolymer, styrene/acrylates/dimethicone acrylate crosspolymer, trifluoropropyl dimethicone/PEG-10 crosspolymer, trifluoropropyl dimethicone/trifluoropropyl divinyldimethicone crosspolymer, trifluoropropyl dimethicone/vinyl trifluoropropyl dimethicone/silsesquioxane crosspolymer, trimethylsiloxysilicate/dimethicone crosspolymer, vinyl dimethicone/lauryl/ behenyl dimethicone crosspolymer, vinyl dimethicone/lauryl dimethicone crosspolymer, vinyl dimethicone/methicone silsesquioxane crosspolymer, vinyldimethyl/trimethylsiloxysilicate/dimethicone crosspolymer, vinyldimethyl/ trimethylsiloxysilicate stearyl dimethicone crosspolymer Silicates: Silica, alumina magnesium metasilicate, aluminum calcium sodium silicate, aluminum iron silicates, hydrated silica, and sodium potassium aluminum silicate

Safe as cosmetic ingredients in the practices of use and concentrations as described in this safety assessment when formulated to be non -respirable.

44 44

Acrylates copolymers: acrylates copolymer, ammonium acrylates copolymer, ammonium VA/acrylates copolymer, sodium acrylates copolymer, ethylene/acrylic acid copolymer, ethylene/calcium acrylate copolymer, ethylene/magnesium acrylate copolymer, ethylene/sodium acrylate copolymer, ethylene/zinc acrylate copolymer, ethylene/acrylic acid/VA copolymer, acrylates/PVP copolymer, acrylates/va copolymer, steareth-10 allyl ether/ acrylates copolymer, acrylates/steareth-50 acrylate copolymer, acrylates/steareth-20 methacrylate copolymer, acrylates/ammonium methacrylate copolymer, styrene/acrylates copolymer, styrene/acrylates/ammonium methacrylate copolymer, ammonium styrene/acrylates copolymer, sodium styrene/acrylates copolymer, acrylates/hydroxyesters acrylates copolymer, methacryloyl ethyl betaine/acrylates copolymer, lauryl acrylate/VA copolymer, VA/butyl maleate/isobornyl acrylate copolymer, ethylene/methacrylate copolymer, vinyl caprolactam/PVP/dimethylaminoethyl methacrylate copolymer, sodium acrylates/acrolein copolymer, PVP/dimethylaminoethylmethacrylate copolymer, AMP-acrylates copolymer, polyacrylic acid, ammonium polyacrylate, potassium aluminum polyacrylate, potassium polyacrylate, and sodium polyacrylate

Safe for use in cosmetic ingredients when formulated to avoid skin irritation

<50% 45

Dimethicone: stearoxy dimethicone, dimethicone, methicone, amino bispropyl dimethicone, aminopropyl dimethicone, amodimethicone, amodimethicone hydroxystearate, behenoxy dimethicone, C24-28 alkyl methicone, C30-45 alkyl methicone, C30-45 alkyl dimethicone, cetearyl methicone, cetyl dimethicone, dimethoxysilyl ethylenediaminopropyl dimethicone, hexyl methicone, hydroxypropyldimethicone, stearamidopropyl dimethicone, stearyl dimethicone, stearyl methicone, and vinyldimethicone

Safe as a cosmetic ingredient

80 46

Polyethylene glycols: PEG-6, -8, -32, -75, -150, -14M, and -20M Amended report: Triethylene Glycol and Polyethylene Glycols (PEGs)-4, -6, -7, -8, -9, -10, -12, -14, -16, -18, -20, -32, -33, -40, -45, -55, -60, -75, -80, -90, -100, -135, -150, -180, -200, -220, -240, -350, -400, -450, -500, -800, -2M, -5M, -7M, -9M, -14M, -20M, -23M, -25M, -45M, -65M, -90M, -115M, -160M and -180M and any PEGs ≥ 4

Safe in the present practices of use and concentration. PEGs are not to be used on damaged skin. Safe for use in cosmetics in the present practices of use and concentration.

50; 85 47,48

Polypropylene glycols: PG, tripropylene glycol, PPG-3, -7, -9, -12, -13, -15, -16, -17, 20, -26, -30, -33, -34, -51, -52, -69, and any PPG ≥3

Safe as cosmetic ingredients in when formulated to be nonirritating.

99 49,50

Siloxysilicates and silylates: trimethylsiloxysilicate, trifluoropropyldimethyl/trimethylsiloxy silicate, silica dimethyl silylate, silica silylate

Safe as used when formulated and delivered in the final product to be not irritating or sensitizing to the respiratory tract

30 51

Beeswax and euphorbia cerifera (candelilla) wax Safe as used in cosmetics under present practices of concentration and use. Confirmed at re-review.

>25 – 50; 56 42,52

Table 3. Chemical and physical properties of alkoxyl polysiloxanes.


Property Value Reference Bis-hydroxyethyoxypropyl dimethicone

Physical Form Liquid 53 Color Colorless to pale yellow 53 Molecular Weight g/mol >1000 53 Density/Specific Gravity @ 20oC 980 53 Water Solubility <0.001 53

Bis-isobutyl PEG/PPG-10/7 dimethicone copolymer Molecular Weight g/mol >1000 54

Bis-PEG-1 dimethicone Molecular Weight g/mol >1000 54

Bis-PEG-4 dimethicone Molecular Weight g/mol >500-1000 54


Bis-PEG-15 methyl ether dimethicone Molecular Weight g/mol >1000 54

Bis-PEG-12 dimethicone beeswax Color White to light yellow 55 Melting Point oC 62-72 55

Bis-PEG-15 methyl ether dimethicone Physical Form Solid 56 Color White, opaque 56 Odor Slight 23 Molecular Weight g/mol ~1600 9 Density/Specific Gravity 1.05 23 Viscosity kg/(s m)@ 25oC 52.5 23 Melting Point oC ~30 56 Water Solubility Dispersable 9,23 Other Solubility Castor oil Oleyl alcohol Propylene glycol Isopropanol Ethanol Glycerol Mineral oils Ester oils/waxes Olive oil

>10% soluble >10% soluble >10% soluble >10% soluble >10% soluble >10% soluble

Insoluble Insoluble Insoluble

56 56 56 56 56 56 56 56 56


Bis-PEG/PPG-14/14 dimethicone Physical Form Liquid 27 Color Yellowish 27 Density/Specific Gravity @ 25oC 0.97 27 Water Solubility 145 27

Cetyl PEG/PPG-10/1 dimethicone Physical Form Viscous liquid 7 Color Colorless 7 Molecular Weight g/mol >1000

500-1000 7,54 54

Density/Specific Gravity @ 25oC 0.941 7 Water Solubility mg/L @ 25oC 8 7

Lauryl PEG-9 polydimethylsiloxyethyl dimethicone Physical Form Color Colorless to light

brown, transparent to slightly hazy

24

Molecular Weight g/mol >1000 54 Density/Specific Gravity @ 25oC 940-980 24 Water Solubility mg/L @ 25oC Expected to have

low solubility in water based on its predominantly hydrophobic structure

24

Lauryl PEG-10 tris(trimethylsiloxy)silylethyl dimethicone


Table 3. Chemical and physical properties of alkoxyl polysiloxanes. Property Value Reference Physical Form Liquid 57 Color Light brown 57 Molecular Weight g/mol >1000 57 Density/Specific Gravity 960.8 57

Lauryl PEG/PPG-18/18 methicone Molecular Weight g/mol >1000 54

Lauryl polyglyceryl-3 polydimethylsiloxyethyl dimethicone Molecular Weight g/mol >1000 54

PEG/PPG-14/4 dimethicone Molecular Weight g/mol >1000 54






PEG/PPG-20/22 butyl ether dimethicone Molecular Weight g/mol >1000 54






PEG 20/PPG-23 dimethicone Physical Form Liquid 14 Color Clear, pale yellow 14 Density/Specific Gravity @ oC 1.023 14

PEG/PPG-20/15 dimethicone Physical Form Liquid 14 Color Clear, straw-colored 14 Density/Specific Gravity 1.04 14

PEG/PPG-25/25 dimethicone Physical Form Liquid 58,59 Color Yellowish 58,59 Odor Slight 58 Molecular Weight g/mol ~17 000 13 Density/Specific Gravity @ 25oC 1.03 58,59 Water Solubility > 10% soluble

Completely miscible 59 58

Other Solubility Octyl dodecanol Oleyl alcohol Isopropanol Ethanol Ethyl acetate Mineral oils Olive oil Propylene glycol Glycerol

> 10% soluble > 10% soluble > 10% soluble > 10% soluble

1%-10% soluble Insoluble Insoluble Insoluble Insoluble

59 59 59 59 59 59 59 59 59

PEG-10 dimethicone Physical Form


Table 3. Chemical and physical properties of alkoxyl polysiloxanes. Property Value Reference End-blocked Liquid 5 Color End-blocked

Clear, straw

5

Molecular Weight g/mol >1000 54 Density/Specific Gravity 1.002 14 Water Solubility Linear

Soluble

5

Other Solubility End-blocked Ethanol

Soluble

5

PEG-12 dimethicone Physical Form Pendant End-blocked Pendant Pendant

Liquid Liquid Liquid Liquid Liquid

12 5 5 5 5

Color Pendant End-blocked Pendant Pendant

Colorless to yellow Colorless

Clear, straw Amber

Pale yellow

12 5 5 5 5

Odor Characteristic 12 Molecular Weight g/mol 500-1000

~3000 54 12

Density/Specific Gravity 1.09 1.07

0.989 1.065-1.095

14 14 14 12

Water Solubility Pendant End-blocked Pendant

Fully soluble Soluble Soluble Soluble

12 5 5 5

Other Solubility Ethanol Pendant Ethanol Mineral oil End-blocked Ethanol Pendant Ethanol Mineral oil Pendant Ethanol

Soluble Soluble

Insoluble

Soluble

Soluble Insoluble

Soluble

12 5 5 5 5 5 5

PEG-14 dimethicone Molecular Weight g/mol >1000 54

PEG-17 dimethicone Physical Form Pendant

Liquid

Color Pendant

Straw

Molecular Weight g/mol >1000 54 Density/Specific Gravity 1.078 14 Water Solubility Pendant

Soluble

5

Other Solubility Pendant Ethanol Mineral oil

Soluble Insoluble

5 5



PEG-8 dimethicone Physical Form Pendent End-blocked

Liquid Liquid

5 5

Color Pendent End-blocked

Clear, pale yellow

Clear, straw

5 5

Molecular Weight g/mol >1000 54


Table 3. Chemical and physical properties of alkoxyl polysiloxanes. Property Value Reference Water Solubility Pendent

Insoluble

5

Other Solubility End-blocked Ethanol Mineral oil Pendant Ethanol Mineral oil

Soluble Insoluble

Soluble Soluble

5 5 5 5


PEG-9 methyl ether dimethicone Molecular Weight g/mol >1000 54

PEG-9 polydimethylsiloxyethyl dimethicone Molecular Weight g/mol >1000 54

PEG-9 polydiemthylsiloxyethyl dimethicone Physical Form Liquid 7 Color Colorless to light brown 7 Molecular Weight g/mol >1000 7 Density/Specific Gravity @ 25oC 990-1010 7 Water Solubility @ 20oC <1000 7

Polysilicone-13 Molecular Weight g/mol >1000 54

PPG-12 dimethicone Molecular Weight g/mol >1000 54

PPG-2 dimethicone Color Clear 60 Density/Specific Gravity 0.99 60 Water Solubility Pendant

Insoluble

60

Other Solubility g/L @ oC & pH Pendant Acetone

Soluble

60 PPG-25 dimethicone

Molecular Weight g/mol >1000 54 Stearoxymethicone/dimethicone copolymer

Molecular Weight g/mol >1000 54 Vinyl dimethicone crosspolymer

Molecular Weight g/mol >1000 54


Table 4. Frequency of use and concentration of use according to duration and exposure of alkoxy polysiloxane ingredients in cosmetics.15,16

Use type Uses

Maximum Concentration

(%) Uses


(%) Uses


(%) Uses


(%)

Behenoxy dimethicone

Bis-hydroxyethoxypropyl

dimethicone Bis-PEG-4 dimethicone Bis-PEG-12 dimethicone Total/range 20 0.5-3 19 0.7-12 9 0.4 NR 0.28

Duration of use Leave-on 17 0.5-3 19 0.7-12 3 NR NR 0.28 Rinse-off 3 0.5 NR NR 6 0.4 NR NR

Diluted for (bath) use NR NR NR NR NR NR NR NR

Exposure typea Eye area 6 NR 14 1.3-3.4 NR NR NR 0.28

Incidental ingestion 2 NR 2 0.7-1 NR NR NR NR

Incidental Inhalation-sprays 7b;2f NR NR NR NR NR NR NR

Incidental inhalation-powders 6c; 2f NR NR NR NR NR NR NR

Dermal contact 18 0.5-3 17 1.3-12 NR NR NR 0.28 Deodorant (underarm) NR NR NR NR NR NR NR NR

Hair-noncoloring NR NR NR NR NR 0.4 NR NR Hair-coloring NR NR NR NR NR NR NR NR

Nail NR NR NR NR NR NR NR NR Mucous

Membrane 2 NR 2 0.7-1 NR NR NR NR

Baby NR NR NR NR NR NR NR NR

Bis-PEG-12 dimethicone beeswax

Bis-PEG-12 dimethicone candelillate

Bis-PEG-15 methyl ether dimethicone

Bis-PEG/PPG-14/14 dimethicone

Total/range 23 0.01-5.7 19 0.5-5.1 2 1-1.5 77 0.2-5 Duration of use

Leave-on 23 0.01-5.7 19 0.5-5.1 2 1-1.5 77 0.2-5 Rinse-off NR NR NR NR NR NR NR 0.9


Exposure type Eye area 10 1-4.5 2 1 1 1 5 0.42-1.1

Incidental ingestion NR NR 14 5.1 NR NR 2 NR

Incidental Inhalation-sprays 2b; 4f 0.01b 1b NR NR 1.5 17b; 7f NR

Incidental inhalation-powders 2c; 4f NR NR NR NR NR 12c; 7f NR

Dermal contact 16 0.2-5.7 1 0.5 1 NR 65 0.2-5 Deodorant (underarm) NR NR NR NR NR NR NR 3d

Hair-noncoloring 2 0.01 3 NR NR NR 10 NR Hair-coloring NR NR NR NR NR NR NR NR


Membrane NR NR 14 5.1 NR NR 2 NR


Bis-PEG/PPG-16/16 Bis-PEG/PPG-20/20 Cetyl PEG/PPG-10/1 Lauryl PEG/PPG-18/18



Use type Uses


(%) Uses


(%) Uses


(%) Uses


(%) PEG/PPG-16/16

dimethicone dimethicone dimethicone methicone

Total/range 30 0.4-1.7 4 0.2-0.5 404 0.02-15 78 0.5-5 Duration of use

Leave-on 26 0.4-1.7 2 0.2-0.5 399 0.02-15 46 0.5-5 Rinse-off 4 0.65 2 0.5 5 0.5-2.5 32 2


Exposure type Eye area 15 0.99 NR NR 59 0.53-15 11 0.5-2.2

Incidental ingestion NR NR NR NR 46 0.098-3.8 2 3.8

Incidental Inhalation-sprays 4b; 4f 0.4b 1b 0.35b 52b; 26f 0.034-3b 9b; 2f 1.4b

Incidental inhalation-powders 4c; 4f 0.4c NR 0.35c 32c; 26f 0.34-3c; 0.4 6c; 2f NR

Dermal contact 28 0.4-1.7 4 0.2-0.5 334 0.034-15 37 0.5-5 Deodorant (underarm) NR NR NR NR NR 0.7-2d NR NR

Hair-noncoloring NR NR NR NR 11 0.5-3.5 39 1.4 Hair-coloring NR NR NR NR NR NR NR NR

Nail NR NR NR NR 8 0.02 NR NR Mucous

Membrane 3 NR 2 NR 46 0.098-3.8 2 3.8

Baby NR NR NR NR 1 NR NR NR

Lauryl PEG-8 dimethicone

Lauryl PEG-9 polydimethylsiloxyethyl

dimethicone Methoxy PEG/PPG-25/4

dimethicone PEG/PPG-14/4

dimethicone Total/range 2 1-5 27 0.2-6 NR 0.8-1.1 49 0.092-2

Duration of use Leave-on 2 1-5 27 0.2-6 NR 0.8-1.1 43 0.092-2 Rinse-off NR NR NR NR NR NR 2 NR

Diluted for (bath) use NR NR NR NR NR NR 4 NR

Exposure type Eye area NR NR 2 1-2 NR NR 17 0.95-2

Incidental ingestion 1 NR NR NR NR NR 4 0.95-1

Incidental Inhalation-sprays NR 1 10b; 5f 0.2 NR NR 18b 0.092-0.25b;

0.092-0.14 Incidental

inhalation-powders NR NR 9c; 5f NR NR NR 10c NR

Dermal contact 1 1-5 27 0.2-6 0.8-1.1 36 0.95-2 Deodorant (underarm) NR NR NR 0.29e NR NR 1 NR

Hair-noncoloring NR NR NR NR NR NR 9 0.092-0.25 Hair-coloring NR NR NR NR NR NR NR NR


Membrane 1 NR NR NR NR NR 8 0.95-1

Baby NR 5 NR NR NR NR NR NR

PEG/PPG-15/15 PEG/PPG-17/18 PEG/PPG-18/18 PEG/PPG-19/19



Use type Uses


(%) Uses


(%) Uses


(%) Uses


(%) dimethicone dimethicone dimethicone dimethicone

Total/range 12 NR 112 0.019-14 461 0.0001-10 40 0.32-10.7 Duration of use

Leave-on 8 NR 108 0.019-14 373 0.0001-10 40 0.32-10.7 Rinse-off 4 NR 4 0.5 87 0.0001-3 NR NR

Diluted for (bath) use NR NR NR NR 1 NR NR NR

Exposure type Eye area NR NR 44 0.6 29 0.015-9.8 9 1-10.7

Incidental ingestion NR NR NR NR 1 1.6 NR 2

Incidental Inhalation-sprays 6b NR 40b; 1 0.019-14b;

0.027-1 113b; 89f

0.0001-3b; 0.0001-1 1b; 4f 2-7b; 2

Incidental inhalation-powders NR NR 1c; 1 NR 33c; 89f NR 1c; 4f NR

Dermal contact 1 NR 6 14 335 0.0001-10 40 0.32-10.7 Deodorant (underarm) NR NR NR NR 21c 0.24-5d 17 NR

Hair-noncoloring 8 NR 62 0.019-13 106 0.0001-3 NR 2-7 Hair-coloring 3 NR NR NR 19 NR NR NR

Nail NR NR NR NR NR 0.1 NR NR Mucous

Membrane NR NR NR NR 24 0.0001-1.6 NR 2

Baby NR NR NR NR 1 NR NR NR

PEG/PPG-20/15 dimethicone




Total/range 68 0.00045-2 21 0.11-0.33 29 0.006-1.3 46 0.2-0.51 Duration of use

Leave-on 64 0.00045-2 20 0.11-0.33 21 0.0006-1.3 13 0.2-0.51 Rinse-off 4 NR 1 NR 8 0.1-0.25 33 0.28

Diluted for (bath) use NR 2.3 NR NR NR 0.0006 NR NR

Exposure type Eye area 6 1.1 4 0.27 NR NR 2 NR

Incidental ingestion NR NR NR NR NR NR NR NR

Incidental Inhalation-sprays 28b; 10f 0.046-1.4b;

0.35-0.9 14b 0.21-0.33b; 0.21 7b; 4f NR 6b; 2f 0.2-0.43b; 0.43

Incidental inhalation-powders 5c; 10f 0.54c; 0.54 6c NR 3c; 4f 0.0038c;

0.0038 5c; 2f NR

Dermal contact 39 0.00045-2.3 13 0.11-0.3 19 0.0006-1.3 38 0.28-0.51 Deodorant (underarm) NR 0.75d NR NR 1b 0.0006d NR 0.51d

Hair-noncoloring 25 0.046-1.4 8 0.21-0.33 10 0.1-1.3 8 0.2-0.43 Hair-coloring NR NR NR NR 0.25 NR NR

Nail 2 0.18-0.75 NR NR NR NR NR NR Mucous

Membrane NR 2.3 NR NR 4 0.0006 26 0.28


PEG/PPG-22/23 PEG/PPG-22/24 PEG/PPG-25/25 PEG/PPG-30/10



Use type Uses


(%) Uses


(%) Uses


(%) Uses


(%) dimethicone dimethicone dimethicone dimethicone

Total/range 4 0.00025-0.0025 22 0.1-1 2 0.7 34 0.00005-0.3

Duration of use

Leave-on 4 0.00025-0.0025 21 0.1-1 2 0.7 20 0.00005-0.3

Rinse-off NR NR 1 NR NR 0.7 14 NR Diluted for (bath)

use NR NR NR NR NR NR NR NR

Exposure type Eye area NR NR NR NR 1 NR NR NR


Incidental Inhalation-sprays 3b 0.00025-

0.0025b 8b; 1f 0.11-1b; 0.11-1 1b 0.7b 4b NR

Incidental inhalation-powders 3c 0.00025-

0.0025c 2c; 1f NR NR NR 2c NR

Dermal contact 4 NR 3 NR 1 NR 3 0.00005-0.3 Deodorant (underarm) NR NR NR NR NR NR NR NR

Hair-noncoloring NR NR 19 0.1-1 1 0.7 28 NR Hair-coloring NR NR NR NR NR NR 3 NR


Membrane NR NR NR NR NR NR NR NR



PEG/PPG-8/14 dimethicone PEG-10 dimethicone

PEG-10 methyl ether dimethicone

Total/range NR 0.6-2.9 NR 0.5-0.88 240 0.013-6 4 0.01-5 Duration of use

Leave-on NR 0.6-2.9 NR 0.05-0.75 238 0.013-6 3 0.1-3 Rinse-off NR 1.4 NR 0.12-0.88 2 0.1-6 1 0.001-5


Exposure type Eye area NR NR NR NR 46 0.38-4.2 NR NR

Incidental ingestion NR NR NR NR NR 4 NR NR

Incidental Inhalation-sprays NR 0.6-2.9b; 0.6-

1.7 NR 0.05-0.4b;0.05-0.12 39b; 44f 0.013-6b; 1 3b,f 0.16-3b; 0.16

Incidental inhalation-powders NR NR NR NR 33c; 44f 0.5c; 0.5 3c,f NR

Dermal contact NR 1 NR 0.1-0.88 229 0.013-5.3 4 0.3-5 Deodorant (underarm) NR NR NR NR NR 0.3d NR NR

Hair-noncoloring NR 0.6-2.9 NR 0.05-0.55 2 0.3-6 NR 0.1-3 Hair-coloring NR 1.4 NR NR NR 035-0.4 NR 0.01

Nail NR 0.95 NR NR NR NR NR NR Mucous

Membrane NR NR NR NR NR 4 NR NR


PEG-11 methyl ether PEG-12 dimethicone PEG-14 dimethicone PEG-17 dimethicone



Use type Uses


(%) Uses


(%) Uses


(%) Uses


(%) dimethicone

Total/range 26 0.1-7 538 0.0016-6.5 41 0.006-2.8 NR 0.48-0.79 Duration of use

Leave-on 22 0.1-7 311 0.0016-6.5 35 0.006-2.8 NR 0.48 Rinse-off 4 0.45-6 220 0.1-5 6 0.6-1.8 NR 0.79

Diluted for (bath) use NR NR 7 0.5-1 NR NR NR NR

Exposure type Eye area 8 0.75-7 10 0.0016-2 4 0.95-1 NR NR


Incidental Inhalation-sprays 8b; 5f 0.16-2b; 0.16 201 b;

18f 0.03-5b; 2f;

0.1-2 6 0.006-2.8b; 0.006-2.8 NR NR

Incidental inhalation-powders 8c; 5f NR 35c; 18f 0.2-2c; 2f; 0.6 NR NR NR NR

Dermal contact 25 0.1-7 230 0.0016-6.5 4 0.95-1 NR 0.48-0.79 Deodorant (underarm) NR 0.5d 10b 0.5-2.5d; 0.1 NR NR NR NR

Hair-noncoloring 1 0.16-2 288 0.03-5 37 0.006-2.8 NR NR Hair-coloring NR NR 9 0.1-1 NR NR NR NR

Nail NR NR 5 0.24 NR NR NR NR Mucous

Membrane NR NR 83 0.5-3 NR NR NR NR

Baby NR NR 2 4 NR NR NR NR

PEG-3 dimethicone PEG-32 methyl ether

dimethicone PEG-6 methyl ether

dimethicone PEG-7 dimethicone Total/range NR 0.5-5 1 NR 8 NR 2 1-5

Duration of use Leave-on NR 0.5-5 1 NR 5 NR 2 1-5 Rinse-off NR NR NR NR 3 NR NR NR


Exposure type Eye area NR NR NR NR NR NR NR NR

Incidental ingestion NR 0.5 NR NR NR NR NR NR

Incidental Inhalation-sprays NR NR NR NR NR NR 1b NR

Incidental inhalation-powders NR 3c; 3 NR NR NR NR NR NR

Dermal contact NR 1-5 1 NR NR NR 1 1-5 Deodorant (underarm) NR NR NR NR NR NR NR NR

Hair-noncoloring NR NR NR NR NR NR 1 NR Hair-coloring NR NR NR NR 8 NR NR NR


Membrane NR 0.5 NR NR NR NR NR NR


PEG-8 cetyl dimethicone PEG-8 dimethicone PEG-8

dimethicone/dimer PEG-8 methicone



Use type Uses


(%) Uses


(%) Uses


(%) Uses


(%) dilinoleic acid copolymer

Total/range 5 0.0005 175 0.024-5.6 1 NR 10 0.5 Duration of use

Leave-on 5 0.0005 108 0.024-5.6 1 NR 10 0.5 Rinse-off NR NR 67 0.5-2 NR NR NR NR


Exposure type Eye area 1 NR 9 0.024-1.2 NR NR NR NR


Incidental Inhalation-sprays 2b,f NR 75b; 17f 0.059-1.7b;

0.1-0.24 1b NR 10b 0.5b

Incidental inhalation-powders 2c,f NR 38c; 17f 1c NR NR NR NR

Dermal contact 5 0.0005 142 0.38-5.6 NR NR NR NR Deodorant (underarm) NR NR NR NR NR NR NR NR

Hair-noncoloring NR NR 30 0.059-0.8 1 NR 10 0.5 Hair-coloring NR NR NR NR NR NR NR NR


Membrane NR NR 55 1 NR NR NR NR


PEG-9 dimethicone

PEG-9 polydimethylsiloxyethyl

dimethicone Polysilicone-13 PPG-12 dimethicone Total/range 25 0.0016-5.6 NR 0.3-4 11 0.003-4 17 0.0001-0.05

Duration of use Leave-on 23 0.0016-5.6 NR 0.3-4 4 0.003-1 17 0.0001-0.05 Rinse-off 2 0.5-1.5 NR NR 7 0.072-4 NR NR


Exposure type Eye area 16 0.0056-0.4 NR 0.3 NR NR NR 0.0006

Incidental ingestion NR NR NR 2 NR NR NR NR

Incidental Inhalation-sprays 3b; 2f 0.05-0.26b;

0.05 NR 4b 2b 0.003b;0.003 16b 0.0001-0.05b; 0.0008-0.05

Incidental inhalation-powders 3c; 2f NR NR 4c 2c NR NR NR

Dermal contact 9 0.0016-5.6 NR 0.3-4 11 NR 2 0.0001-0.0006 Deodorant (underarm) NR NR NR NR NR NR NR NR

Hair-noncoloring NR 0.059-0.5 NR NR NR 0.003-0.1 15 0.0008-0.05 Hair-coloring NR 0.05-1.5 NR NR NR 4 NR NR

Nail NR NR NR NR NR 1 NR NR Mucous

Membrane 1 NR NR 2 NR NR NR NR


PPG-2 dimethicone Stearoxy dimethicone Stearoxymethicone/

dimethicone copolymer Cetyl dimethicone

copolyole

Total/range 14 0.001-1 50 0.45-22 9 NR 32 NS



Use type Uses


(%) Uses


(%) Uses


(%) Uses


(%) Duration of use

Leave-on 14 0.001-1 49 0.45-6 9 NR 26 NS Rinse-off NR NR 1 22 NR NR 6 NS

Diluted for (bath) use NR NR NR NR NR NR NR NS

Exposure type Eye area NR NR 13 0.9-6 NR NR 4 NS

Incidental ingestion NR NR 11 0.99-5.5 2b 2 NR NS

Incidental Inhalation-sprays NR NR 9b; 8f NR 2b NR 1b; 3f NS

Incidental inhalation-powders NR NR 9c; 8f NR NR NR 1c; 3f NS

Dermal contact NR NR 38 0.45-6 7 0.2-2 24 NS Deodorant (underarm) NR NR NR NR NR NR NR NS

Hair-noncoloring NR NR 1 22 NR NR 6 NS Hair-coloring NR NR NR NR NR NR NR NS

Nail 14 0.001-1 NR NR NR NR 1 NS Mucous

Membrane NR NR 11 0.99-5.5 2 2 NR NS

Baby NR NR NR NR NR NR NR NS

Dimethicone copolyolg Dimethicone copolyol

crosspolymerg Dimethicone coployol

methyl etherg

Total/range 322 NS 5 NS 1 NS Duration of use

Leave-on 249 NS 5 NS 1 NS Rinse-off 73 NS NR NS NR NS

Diluted for (bath) use NR NS NR NS NR NS

Exposure type Eye area 11 NS NR NS NR NS

Incidental ingestion 8 NS NR NS NR NS

Incidental Inhalation-sprays 103b; 40f NS 3b; 2f NS NR NS

Incidental inhalation-powders 29c; 40f NS 2c; 2f NS NR NS

Dermal contact 190 NS 5 NS 1 NS Deodorant (underarm) 3b NS NR NS NR NS

Hair-noncoloring 121 NS NR NS NR NS Hair-coloring NS NR NS NR NS

Nail 1 NS NR NS NR NS Mucous

Membrane 22 NS NR NS NR NS

Baby NR NS NR NS NR NS NR=Not Reported; NS=Not Surveyed; Totals=Rinse-off + Leave-on Product Uses. Note: Because each ingredient may be used in cosmetics with multiple exposure types, the sum of all exposure type uses may not equal the sum total uses. a Because each ingredient may be used in cosmetics with multiple exposure types, the sum of all exposure types may not equal the sum of total uses. b It is possible these products may be sprays, but it is not specified whether the reported uses are sprays. c It is possible these products may be powders, but it is not specified whether the reported uses are powders. d Not spray. e Spray. f Not specified whether a powder or a spray, so this information is captured for both categories of incidental inhalation. g Old umbrella term for this class of ingredients still used in the VCRP.

Table 5. Ingredients that do not have any reported uses in the VCRP or concentrations of use reported to the Council.15,16

Behenoxy PEG-10 dimethicone PEG/PPG-12/16 dimethicone Bis-cetyl/PEG-8 cetyl PEG-8 dimethicone PEG/PPG-15/5 dimethicone


PEG/PPG-16/2 dimethicone PEG/PPG-16/8 dimethicone Bis-isobutyl PEG/PPG-10/7/dimethicone copolymer PEG/PPG-18/12 dimethicone Bis-isobutyl PEG-13/dimethicone copolymer PEG/PPG-18/6 dimethicone PEG/PPG-20/22 butyl ether dimethicone Bis-isobutyl PEG-24/PPG-7/dimethicone copolymer PEG/PPG-20/22 methyl ether dimethicone Bis-PEG-1 dimethicone PEG/PPG-20/29 dimethicone Bis-PEG-8 dimethicone PEG/PPG-22/22 butyl ether dimethicone Bis-PEG-10 dimethicone PEG/PPG-23/23 butyl ether dimethicone Bis-PEG-20 dimethicone PEG/PPG-23/6 dimethicone Bis-PEG-8 PEG-8 dimethicone PEG/PPG-24/18 butyl ether dimethicone Bis-PEG/PPG-15/5 dimethicone PEG/PPG-27/27 dimethicone Bis-PEG/PPG-18/6 dimethicone PEG/PPG-27/9 butyl ether dimethicone Bis-PEG/PPG-20/5 PEG/PPG-20/5 dimethicone PEG/PPG-3/10 dimethicone Bis-stearoxy dimethicone PEG/PPG-6/4 dimethicone Bis-stearoxyethyl dimethicone PEG/PPG-6/11 dimethicone Cetyl PEG/PPG-15/15 butyl ether dimethicone PEG/PPG-8/26 dimethicone Cetyl PEG/PPG-7/3 dimethicone PEG-10 polydimethylsiloxyethyl dimethicone/bis-vinyl

dimethicone crosspolymer Cetyl PEG-8 dimethicone PEG-3 methyl ether dimethicone Lauryl isopentyl-PEG/PPG-18/18 methicone PEG-4 PEG-12 dimethicone PEG-6 dimethicone Lauryl PEG-10 methyl ether dimethicone PEG-10/lauryl dimethicone crosspolymer Lauryl PEG-10 tris(trimethylsiloxy)silylethyl dimethicone PEG-12 dimethicone/bis-isobutyl PPG-20 crosspolymer Lauryl PEG-8 PPG-8 dimethicone PEG-15/lauryl polydimethylsiloxyethyl dimethicone

crosspolymer Lauryl polyglyceryl-3 polydimethylsiloxyethyl dimethicone PEG-7 methyl ether dimethicone Methoxy PEG-11 methoxy PPG-24 dimethicone PEG-8 dimethicone dimer dilinoleate Methoxy PEG-13 ethyl polysilsesquioxane PEG-8 methyl ether dimethicone PEG/PPG-10/2 dimethicone PEG-8 PEG-4 dimethicone PEG/PPG-10/3 oleyl ether dimethicone PEG-8 PPG-8 dimethicone PEG/PPG-12/16 dimethicone PEG-9 methyl ether dimethicone PEG/PPG-12/18 dimethicone PPG-12 butyl ether dimethicone PEG/PPG-15/5 dimethicone PPG-25 dimethicone PEG/PPG-16/2 dimethicone PPG-27 dimethicone PEG/PPG-16/8 dimethicone PPG-4 oleth-10 dimethicone

Table 6. Eye irritation rating of generic alkyl polysiloxanes according to molecular weight.6

Molecular weight

Draize score1

Day 1 Day 3 Day 7 632 28.3 17.0 4.3 701 13.0 9.0 2.0 1240 4.7 9.3 2.0 1917 4.0 2.0 0.0 2525 2.0 0.7 0.0 2594 0.0 0.0 0.0 1 Moderately irritating – 25.1-50; mildly irritating – 15.1-25.0; minimally irritating – 2.6 – 15.0; practically non-irritating – 0.6-2.5; non-irritating – 0-0.5.


REFERENCES 1. Elder RE. Final report on the safety assessment of dimethicone copolyol. Journal of the American College of Toxicology. 1982;1(4):33-54.

2. Nikitakis, J and Breslawec HP. International Cosmetic Ingredient Dictionary and Handbook. 15 ed. Washington, DC: Personal Care Products Council, 2014.

3. European Chemicals Agency. ECHA - European Chemicals Agency. http://echa.europa.eu/.

4. Chemical Book. Dimethylsiloxane, ethylene oxide block copolymer. http://www.chemicalbook.com/ChemicalProductProperty_EN_CB8143073.htm. Date Accessed 11-20-2013.

5. Momentive Performance Materials, Inc. Momentive marketing bulletin: Silsoft dimethicone copopyol conditioning agents [pamphlet]. Albany, NY: Momentive; 2011.

6. O'Lenick Jr, AJ. Dimethicone copolyol chemistry. Chapter: 6. In: Silicones for Personal Care. 2 ed. Carol Stream, IL: Allured Publishing Corporation; 2008:93-122.

7. National Industrial Chemicals Notificaton and Assessment Scheme (NICNAS). Full Public Report: Abil EM90. Sidney, Australia, Australian Government Department of Health and Ageing. 1997. http://online.personalcarecouncil.org/ctfa-static/online/NICNAS/PLC1119-FR-Final.pdf. Report No. PLC/1119. pp. 1-9.

8. O'Lenick Jr, AJ. Silicone esters. Chapter: 7. In: Silicones for Personal Care. 2 ed. Carol Stream, IL: Allured Publishing Corporation; 2008:123-142.

9. Wacker Silicones. 2012. Product dossier Belsil® DMC 6038 (Bis-PEG-15 Methyl Ether Dimethicone). Unpublished data submitted by Personal Care Products Council.

10. O'Lenick Jr, AJ. Alkyl dimethicone copolyol compounds. Chapter: 8. In: Silicones for Personal Care. 2 ed. Carol Stream, IL: Allured Publishing Corporation; 2008:143-162.

11. Personal Care Products Council. 7-24-2014. HRIPT on a product containing PEG-3 Dimethicone. Unpublished data submitted by Personal Care Products Council.

12. Anonymous. 2014. Safety assessment of PEG-12 Dimethicone. Unpublished data submitted by Personal Care Products Council.

13. Wacker Silicones. 2012. Product dossier Belsil® DMC 6031 (PEG/PPG-25/25 Dimethicone). Unpublished data submitted by Personal Care Products Council.

14. Momentive Performance Materials, Inc. Silicone specialties for personal care [pamphlet]. Albany, NY: Momentive Performance Materials, Inc.; 2012.

15. Food and Drug Administration (FDA). Frequency of use of cosmetic ingredients. FDA Database. 2014. Washington, DC: FDA.

16. Personal Care Products Council. 1-31-2014. Concentration of use by FDA Product Category: Alkoxy Polysiloxanes. Unpublished data submitted by Personal Care Products Council. 1 pages.

17. Bremmer HJ, Prud'homme de Lodder LCH, and van Engelen JGM. Cosmetics Fact Sheet: To assess the risks for the consumer; Updated version for ConsExpo 4. 2006. http://www.rivm.nl/bibliotheek/rapporten/320104001.pdf. Date Accessed 8-24-2011. Report No. RIVM 320104001/2006. pp. 1-77.

18. Johnsen MA. The Influence of Particle Size. Spray Technology and Marketing. 2004;14(11):24-27.

19. Rothe H. Special aspects of cosmetic spray safety evaluation. 2011. Unpublished information presented to the 26 September CIR Expert Panel. Washington D.C.

20. Rothe H, Fautz R, Gerber E, Neumann L, Rettinger K, Schuh W, and Gronewold C. Special aspects of cosmetic spray safety evaluations: Principles on inhalation risk assessment. Toxicol Lett. 8-28-2011;205(2):97-104.

21. Thomas X. Silicones in industrial applications. Chapter: 17. DeJaeger R and Gleria M. In: Inorganic Polymers. Nova Science Publishers; 2007:

22. Labor L&S AG. 1997. Summary: Cutaneous permeation of Belsil DMC 6038 (Bis-PEG-15 Methyl Ether Dimethicone) through pig skin in vitro. Unpublished data submitted by Personal Care Products Council.

23. Wacker Silicones. 2013. Material Safety Data Sheet Belsil® DMC 6038 (Bis-PEG-15 Methyl Ether Dimethicone). Unpublished data submitted by Personal Care Products Council.

24. National Industrial Chemicals Notificaton and Assessment Scheme (NICNAS). National Industrial Chemicals Notification and Assessment Scheme (NICNAS): Polymer of low concern public report, KF-6038. Sydney, Austrailia, Austrailian Government Department of


http://echa.europa.eu/

http://www.chemicalbook.com/ChemicalProductProperty_EN_CB8143073.htm

http://online.personalcarecouncil.org/ctfa-static/online/NICNAS/PLC1119-FR-Final.pdf

http://online.personalcarecouncil.org/ctfa-static/online/NICNAS/PLC1119-FR-Final.pdf

http://www.rivm.nl/bibliotheek/rapporten/320104001.pdf

Health and Ageing. 2012. http://online.personalcarecouncil.org/ctfa-static/online/NICNAS/PLC1018FR.pdf. Report No. PLC/1018. pp. 1-6.

25. Silicone Environmental, Health, and Safety Center. 2014. [Unpublished data submitted to CIR by SEHSC on April 30, 2014, including PEG/PPG-19/19 dimethicone, PEG-12 dimethicone, and lauryl PEG/PPG-18/18 methicone data points.]. SEHSC submission received by email and is available upon request from CIR.

26. Hazelton France. 1988. Summary: Test to evaluate the acute toxicity following a single oral administration (limit test), in the rat (VP 1661 (PEG/PPG-25/25 Dimethicone)). Unpublished data submitted by Personal Care Products Council.

27. National Industrial Chemicals Notificaton and Assessment Scheme (NICNAS). Full Public Report: E-1275. Sidney, Australia, National Industrial Chemicals Notification and Assessment Scheme. 2001. http://online.personalcarecouncil.org/ctfa-static/online/NICNAS/PLC245FR.pdf. Report No. PLC/245. pp. 1-14.

28. Research Toxicology Centre S.p.A. 1996. Summary: Belsil DMC 6038 (Bis-PEG-15 Methyl EtherDimethicone) 4 week oral toxicity study in rats followed by a 2 week recovery period. Unpublished data submitted by Personal Care Products Council.

29. Dow Corning Corporation. Initial submission: Rabbit teratology study (final report) on siloxanes and silicones, 3-hydroxypropyl Me, di-Me, ethoxylated with attachment and cover letter dated 021792. 1966. Report No. OTS0535681. pp. 1-26.

30. RCC. 1996. Summary: Salmonella typhimurium reverse mutation assay with Wacker Belsil DMC 6038 (Bis-PEG-15 Methyl Ether Dimethicone). Unpublished data submitted by Personal Care Products Council.

31. RCC. 1996. Summary: Salmonella typhimurium reverse mutation assay with Wacker silicone fluid L051 (PEG/PPG-25/25 Dimethicone). Unpublished data submitted by Personal Care Products Council.

32. Anonymous. 2006. Clinical evaluation report: Human patch test of a brow pencil containing 15% Cetyl PEG/PPG-1 011 Dimethicone. Unpublished data submitted by Personal Care Products Council.

33. KGL Inc. 2006. An evaluation of the contact-sensitization potential of a topical coded product (brow pencil containing 15% Cetyl PEG/PPG-10/1 Dimethicone) by means ofthe maximization assay. Unpublished data submitted by Personal Care Products Council.

34. Personal Care Products Council. 6-24-2014. Summary of a Patch Test on a Product Containing PEG-3 Dimethicone. Unpublished data submitted by Personal Care Products Council. 1 pages.

35. Hazelton France. 1988. Summary: Test to evaluate the acute cutaneous primary irritation and corrosivity, in the rabbit; test to evaluate the acute ocular irritation and reversibility, in the rabbit; test to evaluate sensitizing potential in the guinea pig (Magnusson & Kligman) (PEG/PPG-25/25 Dimethicone). Unpublished data submitted by Personal Care Products Council.

36. Cassidy SL and Stanton E. In vitro eye irritation studies on organosilicon compounds. Journal of Toxicology - Cutaneous & Ocular Toxicology. 1997;16(1):45-60.

37. Research Toxicology Centre S.p.A. 2014. Belsil DMC 6038 (Bis-PEG-15 Methyl Ether Dimethicone ). Summary: Delayed dermal sensitization study in the guinea pig. Unpublished data submitted by Personal Care Products Council.

38. Essex Testing Clinic Inc. 2003. Clinical safety evaluation repeated insult patch test of a product (makeup base) containing 3% PEG-3 Dimethicone. Unpublished data submitted by Personal Care Products Council.

39. Lanzet M. Comedogenic effects of cosmetic raw materials. Cosmetics & Toiletries. 1986;101(Feb):63-72.

40. Andersen FA. Final report on the safety assessment of cyclomethicone. Journal of the American College of Toxicology. 1991;10(1):9-19.

41. Johnson Jr, W, Bergfeld, WF, Belsito, DV, Hill, RA, Klaassen, CD, Liebler, DC, Marks Jr, JG, Shank, RC, Slaga, TJ, Snyder, PW, and Andersen, FA. Safety assessment of cyclomethicone, cyclotetrasiloxane, cyclopentasiloxane, cyclohexasiloxane, and cycloheptasiloxane. International Journal of Toxicology. 2011;30(Suppl 3):149S-227S.

42. Andersen FA. Annual review of cosmetic ingredient safety assessments -- 2002/2003. International Journal of Toxicology. 2005;24(Suppl. 1):1-102.

43. Becker LC, Bergfeld WF, Belsito DV, Klaassen CD, Liebler DC, Hill RA, Marks Jr JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Safety assessment of dimethicone crosspolymers as used in cosmetics. Washington, DC, Cosmetic Ingredient Review. 2012. pp. 1-62.

44. Becker LC, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks Jr JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Final report of the Cosmetic Ingredient Reveiw Expert Panel: Safety assessment of silica and related cosmetic ingredients. Washington, DC, Cosmetic Ingredient Review. 2009. pp. 1-81.

45. Fiume MZ, Bergfeld WF, Belsito DV, Klaassen CD, Marks, Jr JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Final report on the safety assessment of acrylates copolymer and 33 related cosmetic ingredients. International Journal of Toxicology. 2002;21(Suppl 3):1-50.


http://online.personalcarecouncil.org/ctfa-static/online/NICNAS/PLC1018FR.pdf



46. Nair B, Elmore AR, Bergfeld WF, Belsito DV, Klaassen CD, Marks, Jr JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Final Report on the Safety Assessment of Stearoxy Dimethicone, Dimethicone, Methicone, Amino Bispropyl Dimethicone, Aminopropyl Dimethicone, Amodimethicone, Amodimethicone Hydroxystearate, Behenoxy Dimethicone, C24-28 Alkyl Methicone, C30-45 Alkyl Methicone, C30-45 Alkyl Dimethicone, Cetearyl Methicone, Cetyl Dimethicone, Dimethoxysilyl Ethylenediaminopropyl Dimethicone, Hexyl Methicone, Hydroxypropyldimethicone, Stearamidopropyl Dimethicone, Stearyl Dimethicone, Stearyl Methicone, and Vinyldimethicone. International Journal of Toxicology. 2003;22(Suppl. 2):11-35.

47. Andersen FA. Final report on the safety assessment of polyethylene glycols (PEGs) -6, -8, -32, -75, -150, -14M, -20M. Journal of the American College of Toxicology. 1993;12(5):429-457.

48. Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks, Jr JG, Shank RC, Slaga TJ, and Snyder PW. Final Report of the Cosmetic Ingredient Review Expert Panel: Amended Safety Assessment of Triethylene Glycol and Polyethylene Glycols (PEGs)-4, -6, -7, -8, -9, -10, -12, -14, -16, -18, -20, -32, -33, -40, -45, -55, -60, -75, -80, -90, -100, -135, -150, -180, -200, -220, -240, -350, -400, -450, -500, -800, -2M, -5M, -7M, -9M, -14M, -20M, -23M, -25M, -45M, -65M, -90M, -115M, -160M and -180M and any PEGs >= 4 as used in Cosmetics . Washington, DC, Cosmetic Ingredient Review. 2010. pp. 1-49.

49. Berfeld WF, Belsito DV, Klaassen CD, Marks, Jr JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Final report on the safety assessment of propylene glycol and polypropylene glycols. Journal of the American College of Toxicology. 1994;13(6):437-491.

50. Fiume MZ, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler DC, Marks, Jr JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Final amended report of the Cosmetic Ingredient Review Expert Panel: Safety assessment of Propylene glycol, tripropylene glycol, and PPGs as used in cosmetics. Washington, DC, Cosmetic Ingredient Review. 2010. pp. 1-31.

51. Becker LC, Bergfeld WF, Belsito DV, Klaassen CD, Marks, Jr JG, Shank RC, Slaga TJ, Snyder PW, and Andersen FA. Final safety assessment: Silylates and surface modifiedsiloxysilicates as used in cosmetics. Washington, DC, Cosmetic Ingredient Review. 2011. pp. 1-25.

52. Elder RE. Final report on the safety assessment of candelilla wax, carnauba wax, Japan wax, and beeswax. Journal of the American College of Toxicology. 1984;3(3):1-41.

53. National Industrial Chemicals Notificaton and Assessment Scheme (NICNAS). Full public report: Polymer in 5562 Carbinol Fluid. Sidney, Austrailia, National Occupational Health and Safety Commission. 2004. http://online.personalcarecouncil.org/ctfa-static/online/NICNAS/PLC503FR.pdf. Report No. PLC/503. pp. 1-8.

54. Silicone Environmental, Health, and Safety Center (SEHSC). 7-17-2014. CIR alkoxy polysiloxanes data call in molecular weight results 14 July 2014. Unpublished data submitted by Silicone Envirronmental, Health, and Safety Center.

55. Koster Keunen. Siliconyl beeswax [pamphlet]. Watertown, TC: Koster Keunen; 2013.

56. Wacker Silicones. 2013. Technical data sheet Belsil® DMC 6038 (Bis-PEG-15 Methyl Ether Dimethicone). Unpublished data submitted by Personal Care Products Council.

57. National Industrial Chemicals Notificaton and Assessment Scheme (NICNAS). National Industrial Chemicals Notification and Assessment Scheme (NICNAS): Polymer of low concern public report. Sidney, Australia, NICNAS. 2014. Report No. PLC/1199. pp. 1-5.

58. Wacker Silicones. 2013. Material Safety Data Sheet Belsil® DMC 6031 (PEG/PPG-25/25 Dimethicone). Unpublished data submitted by Personal Care Products Council.

59. Wacker Silicones. 2013. Technical data sheet Belsil® DMC 6031 (PEG/PPG-25/25 Dimethicone). Unpublished data submitted by Personal Care Products Council.

60. Dow Corning. New choices. More Opportinities. Dow Corning® FZ-series surfactants [pamphlet]. 2007.






Commitment & Credibility since 1976

MEMORANDUM

To: CIR Expert Panel and Liaisons

From: Lillian C. Becker, M.S. Scientific Analyst and Writer

Date: August 18, 2014

Subject: Data submitted for polyoxyalkylene siloxane copolymers, alkyl-polyoxyalkylene siloxane copolymers, and related ingredients (alkyl polysiloxanes) as Used in Cosmetics

Unpublished data have been submitted by the Personal Care Products Council (Council) and the Silicones Environmental Health and Safety Center (SEHSC). The data submitted are:

Data1: Summary of a patch test of PEG-3 dimethicone

Data2: HRIPT and characterization of a product containing PEG-3 dimethicone

Data3: Patch test and HRIPT of a product containing cetyl PEG/PPG-10/1 dimethicone

Data4: Table depicting size ranges of alkyl polysiloxanes (divided into <500 Da, 500-1000 Da, and >1000 Da)

Data5: Physical/chemical properties, impurities, in vitro irritation test summary, and Ames test of PEG-12 dimethicone. Even though the title only lists PEG-12 dimethicone, there are also data for cetyl PEG/PPG-10/1 dimethicone (acute toxicity, dermal and eye irritation, sensitization, and Ames test) and copolyols (inhalation and short-term dermal toxicity, and mid-term oral toxicity). Sticky notes and highlights have been added to the document to help with identifying which ingredient is being tested.




SEHSC Data Call-In Molecular Weight Ranges for CIR Alkoxypolysiloxanes

1

CHEMICAL <500 Daltons 500-1000 Daltons >1000 Daltons

Bis-Isobutyl PEG/PPG-10/7/ Dimethicone Copolymer 158451-77-5

X

Bis-PEG-1 Dimethicone X Bis-PEG-4 Dimethicone X (SEHSC may have

irritation/sensitization data; if available, will be provided by Aug.

8, 2014)

Bis-PEG-8 Dimethicone X Bis-PEG-15 Methyl Ether Dimethicone X Bis-PEG-20 Dimethicone X Cetyl PEG/PPG-10/1 Dimethicone 191044-49-2

X (irritation data provided to CIR in March 2014)

Cetyl PEG/PPG-10/1 Dimethicone X Lauryl PEG/PPG-18/18 Methicone X Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone

X


X

PEG/PPG-14/4 Dimethicone X PEG/PPG-15/15 Dimethicone X PEG/PPG-18/18 Dimethicone X PEG/PPG-19/19 Dimethicone X PEG/PPG-20/15 Dimethicone X PEG/PPG-20/20 Dimethicone X PEG/PPG-20/22 Butyl Ether Dimethicone 67762-87-2

X

PEG/PPG-20/23 Dimethicone X PEG/PPG-23/6 Dimethicone X PEG/PPG-25/25 Dimethicone X PEG/PPG-4/12 Dimethicone X PEG/PPG-8/26 Dimethicone X PEG-10 Dimethicone 68937-54-2 X Vinyl Dimethicone Crosspolymer X PEG-12 Dimethicone X (acute tox, irritation, sensitization,

repro tox. Subacute tox data provided to CIR in March 2014)

PEG-14 Dimethicone X PEG-17 Dimethicone X PEG-3 Dimethicone X PEG-32 Methyl Ether Dimethicone X PEG-8 Dimethicone X PEG-9 Dimethicone X PEG-9 Methyl Ether Dimethicone X PEG-9 Polydimethylsiloxyethyl Dimethicone

X

Polysilicone-13 158451-77-5, 197980-52-2

X

PPG-12 Dimethicone X PPG-25 Dimethicone 68957-00-6 X



2



X

Behenoxy Dimethicone Behenoxy PEG-10 Dimethicone 1136947-78-8


Bis-Hydroxyethoxypropyl Dimethicone 1136947-78-8

Bis-Isobutyl PEG-13/Dimethicone Copolymer 197980-52-2

Bis-Isobutyl PEG-24/PPG-7/ Dimethicone Copolymer

Bis-PEG-10 Dimethicone Bis-PEG-12 Dimethicone Bis-PEG-12 Dimethicone Beeswax Bis-PEG-12 Dimethicone Candelillate Bis-PEG-8 PEG-8 Dimethicone Bis-PEG/PPG-14/14 Dimethicone Bis-PEG/PPG-15/5 Dimethicone Bis-PEG/PPG-16/16 PEG/PPG-16/16 Dimethicone

Bis-PEG/PPG-18/6 Dimethicone Bis-PEG/PPG-20/20 Dimethicone Bis-PEG/PPG-20/5 PEG/PPG-20/5 Dimethicone

Bis-Stearoxyethyl Dimethicone 128446-57-1


Cetyl PEG/PPG-7/3 Dimethicone Cetyl PEG-8 Dimethicone Lauryl Isopentyl-PEG/PPG-18/18 Methicone 1112315-26-0

Lauryl PEG-10 Methyl Ether Dimethicone Lauryl PEG-10 Tris(Trimethylsiloxy)silylethyl Dimethicone

Lauryl PEG-8 Dimethicone Lauryl PEG-8 PPG-8 Dimethicone Methoxy PEG-11 Methoxy PPG-24 Dimethicone 472975-82-9

Methoxy PEG/PPG-25/4 Dimethicone Methoxy PEG-13 Ethyl Polysilsesquioxane PEG/PPG-10/2 Dimethicone PEG/PPG-10/3 Oleyl Ether Dimethicone PEG/PPG-12/16 Dimethicone PEG/PPG-12/18 Dimethicone PEG/PPG-15/5 Dimethicone PEG/PPG-16/2 Dimethicone



3


PEG/PPG-16/8 Dimethicone PEG/PPG-17/18 Dimethicone PEG/PPG-18/12 Dimethicone PEG/PPG-18/6 Dimethicone PEG/PPG-20/22 Methyl Ether Dimethicone 125857-75-2

PEG/PPG-20/29 Dimethicone PEG/PPG-20/6 Dimethicone PEG/PPG-22/22 Butyl Ether Dimethicone PEG/PPG-22/23 Dimethicone PEG/PPG-22/24 Dimethicone PEG/PPG-23/23 Butyl Ether Dimethicone PEG/PPG-24/18 Butyl Ether Dimethicone 67762-87-2

PEG/PPG-27/27 Dimethicone PEG/PPG-27/9 Butyl Ether Dimethicone PEG/PPG-3/10 Dimethicone PEG/PPG-30/10 Dimethicone PEG/PPG-6/4 Dimethicone PEG/PPG-6/11 Dimethicone PEG/PPG-8/14 Dimethicone PEG-10 Methyl Ether Dimethicone 68938-54-5

PEG-10 Polydimethylsiloxyethyl Dimethicone/Bis-

PEG-11 Methyl Ether Dimethicone PEG-4 PEG-12 Dimethicone PEG-6 Dimethicone PEG-6 Methyl Ether Dimethicone PEG-7 Dimethicone PEG-7 Methyl Ether Dimethicone PEG-8 Cetyl Dimethicone PEG-8 Dimethicone Dimer Dilinoleate PEG-8 Dimethicone/Dimer Dilinoleic Acid Copolymer

PEG-8 Methicone PEG-8 Methyl Ether Dimethicone PEG-8 PEG-4 Dimethicone PEG-8 PPG-8 Dimethicone PPG-12 Butyl Ether Dimethicone PPG-2 Dimethicone 68440-66-4, 68554-64-3

PPG-27 Dimethicone PPG-4 Oleth-10 Dimethicone Stearoxy Dimethicone 68554-53-0


Personal Care Products Council

Memorandum

TO: Lillian Gill, D.P.A.

Committed to Safety, Quality & Innovation

Director- COSMETIC INGREDIENT REVIEW (CIR)

FROM: Beth A. Lange, Ph.D. Industry Liaison to the CIR Expert Panel

DATE: July 31,2014

SUBJECT: Information on PEG-12 Dimethicone

Anonymous. 2014. Safety assessment ofPEG-12 Dimethicone

1620 L Street, N.W., Suite 1200 I Washington, D.C. 200361202.331.1770 I 202.331.1969 (fax) I www.personalcarecouncil.org


Safety assessment

To whom it may concern

1. IDENTITY OF THE CHEMICAL

INCI name: PEG-12 Dimethicone

Other Names: Siloxanes and Silicones, di-Me, 3-hydroxypropyl Me, ethoxylated

CAS number: 68937-54-2

2. PHYSICAL AND CHEMICAL PROPERTIES

Appearance at 20°C: Colourless to yellowish liquid with a characteristic odour

Specific Gravity: 1,065- 1,095

Solubility in I Miscibility with water: Fully miscible in water, ethanol

pH-value: not applicable

Dissociation Constant: not applicable, nonionic

Self-inflammability: not self-igniting

Explosive Properties: not explosive

Reactivity/Stability: stable to hydrolysis

Flash point: >200°C

Viscosity: Dynamic at 20°C: 250-400 mPas

Molecular Weight: approx 3,000 g

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3. PURITY OF THE CHEMICAL

Degree of Purity: 60-70%

Impurities:

contains 30-40% of Poly(oxy-1,2-ethanediyl), .alpha.-2-propen-1-yl-.omega.-hydroxy; therefore, impurity profile will consist of impurities related to both silicone component and Poly(oxy-1,2-ethanediyl), .alpha.-2-propen-1-yl-.omega.-hydroxy.

Octamethylcyclotetrasiloxane (D4) (CAS: 556-67-2; EINECS: 209-136-7) : <0.1%

Decamethylcyclotetrasiloxane (DS) (CAS: 541-02-6; EINECS: 208-764-9) : <0.1%

Related compound:

Poly(oxy-1,2-ethanediyl), .alpha.-2-propen-1-yl-.omega.-hydroxy-: (CAS: 27274-31-3): 30-40%

4. EVALUATION OF TOXICOLOGICAL DATA

Toxicological evaluation is based on the silicone derivative, the major component

Many tests have been conducted to better understand the toxicological impact of silicone [1-2]. These extensive studies have focused on linear polydimethylsiloxanes (POMS) and cyclic (cycles containing 4, 5 or 6 units dimethylsiloxane, often classified under the names abbreviated as 04, 05, 06, respectively). The toxicological profile of silicones has been and continues to be established in great detail and confirms the safety of these fluids in the areas of use and levels of exposure given by the manufacturer.

The toxicological evaluation of the product is made on the basis of toxicological studies conducted with this molecule and refers also to toxicological studies with a related product (A): chemical structures (grafted copolymer) of cetyl PEG/PPG-1 0 I a dimethicone. The differences are on the chain length and number of alkyl group (ratio R, R' and R"). It refers also to data obtained from a review of dimethicone copolyols.

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4.1 Studies performed with PEG-12 Dimethicone

4.1.1 In vitro skin irritation study on human reconstructed epidermis

The evaluation of the capability of a test item to induce skin irritation effects by a cytotoxicity test on in vitro human reconstructed epidermis (SkinEthic model) was performed. Following the application of the test item on the epidermis for 42 minutes and a 42 hour post-treatment incubation, cellular viability was evaluated by the measurement of the succinate deshydrogenase mitochondriale activity of the living cells. This study was carried out according to the ECVAM protocol of April 27th, 2007, the 846 method of the official journal of the European Union dated August, 24th 2009 and the OECD draft of June 6th, 2008.

The results were as follows:

Assessment of viability Conclusion Mean Standard Viability

deviation %

Negative control 1.79 0.16 100 Non irritant Distilled water

Positive control 0.03 0.00 1.6 Irritant

5055%

PEG-12 Dimethicone 1.19 0.22 66.4 Non irritant

Test validation:

The positive control shows a viability percentage lower than 40%. This result allows the validation of the test.

Results

The mean viability observed for the test item is 66.4%.

Conclusion

Under the retained experimental conditions the PEG-12 Dimethicone tested pure may be classified as non-irritant for the skin.

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4.1.2 Bacterial reverse mutation assay: determination of the mutagenic activity of a test item on Salmonella typhimurium (Ames test) according to the OECD 471

Method

The test was performed on five Salmonella typhimurium strains.

The test item dilutions were prepared in DMSO. A preliminary cytotoxicity test was performed on S. typhimurium TA 100. The test was performed with and without S9.

The preliminary study did not show any cytotoxicity of the test system, therefore this concentration range was used for the genotoxicity test 1 (plate incorporation method). According to the results obtained for test 1, the same dilution range was used for the test range 2 (preincubation method).

Conclusion

In the light of the results of this study, we can conclude that the test item will not show any mutagenic or pro-mutagenic activity at the recommended use concentration.

4.2. Studies performed with Product A

Summary of the acute toxicity of A

Test Species Results Reference

Acute oral toxicity Rat LD50>5000 mg/kg 3

Skin irritation Rabbit Irritant potential* 4

Eye irritation Rabbit Irritant potential* 5

Skin sensitization Guinea pig No sensitizer 6

* not classified as an irritant according to NOHSC's Approved Criteria for Classifying Hazardous Substances (7)

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Cetyl PEG/PPG-10/1 dimethicone

4.2.1 Oral Toxicity (3)

Species/strain: rat/Wistar

Number/sex of animals: 5/sex

Observation period: 14 days

Method of administration: gavage, single dose 5 000 mg.kg-1

Clinical observations: one animal had ano-genital staining at day 1

Mortality: nil

Morphological findings: nil

Test method: according to US Federal Hazardous Substances Control Act (FHSA) Guidelines (8)

LD50: > 5 000 mg.kg-1

Result: low acute oral toxicity

4.2.2 Skin Irritation (4)

Species/strain: rabbit/ New Zealand White

Number/sex of animals: 6/not specified

Observation period: 72 hours

Method of administration:

0.5 ml of test chemical applied to clipped test site (2.5 cm2) and occluded for 24 hours; test site then wiped clean.

Draize scores (9): intact skin

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Animal number

Time after 1 2 3 4 5 6 treatment (days

Erythema

1 2 2 2 2 1 2

3 1 0 1 1 0 2

Oedema

1 1 1 1 1 1 1

3 0 0 0 1 0 1


Result: some irritant effects, however below threshold for classification as hazardous (irritant) according to NOHSC's criteria (7)

4.2.3 Eye Irritation (5)

Species/strain: rabbiUNew Zealand White

Number/sex of animals: 6 females

Observation period: 72 hours

Method of administration: 0.1 ml in one eye

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Draize scores of unirrigated eyes (9): no corneal opacity or iritis in any test animal

Animal Day 1 Day 2 Day3 number

Conjunctiva R c D R c D R c D

1 2 1 2 2 1 2 1 0 0

2 2 1 2 1 1 1 1 0 0

3 2 1 2 2 1 2 1 0 0

4 1 1 2 1 1 2 0 0 0

5 2 1 2 2 1 2 0 0 0

6 2 1 2 2 2 2 2 0 0

R: redness, C: chemosis, D: discharge


Result: conjunctival effects only; with the exception of redness, all absent at 72 hours; not classified as an eye irritant according to NOHSC's criteria (1 0)

4.2.4 Skin Sensitization (6)

Species/strain: guinea-pig/Dunkin Hartley

Number of animals: 20 test animals, 10 na"fve control, 10 na·ive rechallenge, 10 positive control, 5 positive na·ive control, 5 positive na"fve control rechallenge

Induction procedure:

Intradermal induction:

50% Freund's complete adjuvant (FCA) solution in distilled water; test substance at 100% (determined to be non-irritating in preliminary screen); 10% test substance in distilled water mixed in 1:1 with 50% FCA solution; control - 50% mixture of water in 50 % FCA solution; positive control- mercaptobenzothiazole (60% w/w in ethanol), 95% ethanol, 10% mercaptobenzothiazole in 95% ethanol 1:1 FCA 50% in distilled water, 95% ethanol 1:1 FCA 50% in distilled water

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Topical induction:

test substance (1 00%), dry Hilltop chamber applied at dose site, mercaptobenzothiazole (60% w/w in ethanol), 95% ethanol

Challenge procedure:

24 hours before challenge, the site was treated with 1 0% sodium lauryl sulfate test substance (1 00%), mercaptobenzothiazole (60% w/w in ethanol),

Rechallenge procedure:

test substance (1 00%), mercaptobenzothiazole (60% w/w in ethanol),

Challenge outcome:

Control animals Test animals

Time after patch 24 hours 48 hours 24 hours 48 hours removal

Number of animals with positive 0/20 0/20 0/20 0/20

response

Challenge concentration: 100%

Test method: in accordance with OECD guidelines with minor deviations

Result: not a skin sensitizer in guinea-pigs; controls gave appropriate responses 4.2.5 Genotoxicity

Salmonella typhimurium Reverse Mutation Assay (10)

Strains: TA 98, TA 100, TA 1535, TA 1537 and Escherichia coli strain WP2uvrA

Concentration range: 250, 500, 1 000, 5 000 g.plate-1 with or without S9 activation

Test method: similar to OECD guidelines

Result: not mutagenic; controls gave appropriate response

4.3. Absorption, Metabolism, and Excretion

Silicone compounds do not easily cross membrane barriers (11 ). They are not absorbed through the skin due to their high molecular weight (12, 13). Silicones are not readily absorbed through the gut and are not extensively deposited in tissues when they do gain access to the body (12, 14, 15).

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4.4. Other Toxicological Data from scientific review

These refer to a number of toxicology studies that support the data described above. In addition the tests which are absent from the above suite (dermal toxicity, inhalational toxicity and repeat dose studies) are described for various dimethicone copolyols.

A dermal 28-day percutaneous toxicity study using dimethicone copolyol B at 200 mg.kg-1.day-1 resulted in nil mortality or behavioural effects. Slight to moderate erythema and oedema were found at the application sites after day 2. There was no weight loss in test animals and the only histopathological result of significance was a depression in spermatogenesis in one of the 10 test rabbits. Inhalation toxicity studies in rats are described for a range of dimethicone copolyols. Mortality only occurred at elevated temperatures to concentrations of dimethicone copolyol C of 23.47 mg.L-1 (33% of test animals after 4 hours) and at an unspecified concentration (100% mortality after 8 hours). The same dimethicone copolyol produced nil mortality at lower temperature and/or for shorter time periods. When rats were fed dimethicone copolyol C at a dose of 640 and 2 880 mg.kg-1.day-1

for 89 days there were no mortalities or any deleterious effects.

4.5 Overall Assessment of Toxicological Data

PEG-12 Dimethicone product is non-irritant (pure) in an in vitro irritation study on human reconstructed epidermis. It was not mutagenic in a Salmonella typhimurium reverse mutation assay with or without S9 activation.

A summary of toxicological information on dimethicone copolyols indicates a good tolerance of the products of this chemical class.

This good tolerance is mainly due to the fact that dimethicone polyols are products that do not penetrate through the skin. An acute toxicity study by oral route shows a low level of toxicity. Skin and eye irritation toxicity studies show an irritant potential (Draize score) but they are not classified as irritant according to NOHSC's Criteria for Classifying Hazardous Substances. Furthermore they are not a sensitizer when applied pure on the skin in a Magnusson and Kligman test.

A dermal 28-day percutaneous toxicity study using dimethicone copolyol B at 200 mg.kg-1.day-1 produced only slight to moderate erythema and oedema at the application sites and a depression in spermatogenesis in one of the 10 test rabbits (all males).

Inhalation toxicity studies in rats are described for a range of dimethicone copolyols. Mortality only occurred at elevated temperatures, nil mortality occurring at lower temperature and/or for shorter time periods at elevated temperatures.

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Copolyols

A repeat dose study using dimethicone copolyol C for a duration of 89 days resulted in no mortalities or deleterious effects at a dose of 2 880 mg.kg-1.day-1.

Overall, despite the relatively limited available results on this PEG-12 Oimethicone product, it appears not to have a deleterious toxicological profile, especially as a summary provided for dimethicone copolyols indicates that they are of limited toxicological significance in these systems.

4.6. ASSESSMENT OF SAFETY FOR IMPURITIES AND RELATED COMPOUNDS

Some impurities are present at a very low level (<0.1 %), namely Octamethylcyclotetrasiloxane (04), Oecamethylcyclopentasiloxane (05). They are not, at that level, a hazard to human health, although the impurities 04 and 05 are still questionable from a toxicological point of view. The SCCS considered, at that time, to have insufficient information to deliver an opinion on acceptable levels in 04 and 05.

From a general point of view, the Committee on Mutagenicity of Chemicals in Food, Consumer Products and the Environment (COM) considers that the use of the Threshold of Toxicological Concern (TTC) concept can also be used as a pragmatic guide to selection of relevant impurities which require genotoxicity assessment when comparing the impurities present in two or more chemical substances. Thus exposure to new or increased exposures to impurities but at exposures :S 0.15 IJg/day would not require further investigation. All relevant impurities identified from a comparison of two or more substances should be subjected to a QSAR evaluation and a decision made as to whether genotoxicity testing of relevant impurities using the Ames test and in vitro micronucleus test (MNvit).

So, the genotoxicity testing strategy adopted to assess impurities can vary widely and needs to be designed on a case-by-case basis.

Related compound:

Poly(oxy-1 ,2-ethanediyl), .alpha.-2-propen-1-yl-.omega.-hydroxy-: (CAS: 27274-31-3) is an allyl oxy derivative of polyethylene glycol, and does not represent a toxicological concern at the dose used.

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4.7. ASSESSMENT OF ENVIRONMENTAL EFFECTS

No ecotoxicological data were provided. The high molecular weight of the substance suggests that it will not cross biological membranes, and will therefore be of low toxicity and not bioaccumulate. It is well accepted that polydimethylsiloxane fluids become permanently adsorbed to sediment and should not exert adverse environmental effects. Physical effects such as surface entrapment have been observed when testing aquatic invertebrates in clean laboratory water. Similar effects are not expected in natural environments where a large variety of other surfaces provide opportunities for deposition (17).

Otherwise, PDMS is not biodegradable; however, work has shown that it undergoes depolymerisation when it returns to the environment [18-19]. The reaction pathway depends on the relevant medium (air, water, sludge) but in each case the same final decomposition products are generated: carbon dioxide, water and silicic acid (20).

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REFERENCES

[1] www.silicones-science.com/responsible_sresearch.html.html [2] www.sehsc.com/science.asp [3] Shapiro, R. 1990, FHSA acute oral toxicity limit test. Report W T -102, Product Safety Labs, East Brunswick, New Jersey, USA. [4] Shapiro,R. 1990, FHSA dermal irritation test. Report W T-104, Product Safety Labs, East Brunswick, New Jersey, USA. [5] Shapiro,R. 1990, FHSA primary eye irritation test. Report No T-103, Product Safety Labs, East Brunswick, New Jersey, USA. [6] Shapiro,R. 1995, Dermal sensitization- Magnuson-Kiigman method. Report No E50516-1 R, Product Safety Labs, East Brunswick, New Jersey, USA. [7] National Occupational Health and Safety Commission 1994, Approved Criteria for Classifying Hazardous Substances (NOHSC: 1008 (1994)), Australian Government Publishing Service, Canberra. [8] Federal Hazardous Substances Act (FHSA) Regulations, guidelines [9] Draize, J.H. 1959, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the US, 49. [1 0] Pant, K.J. 1995, Evaluation of a test article in the Salmonella typhymurium/Escherichia coli plate incorporation/preincubation mutation assay in the presence and absence of aroclor-induced rat liver S-9 with a confirmatory study. Report W 0358-2140, Sitek research laboratories, Rockville, Maryland, USA. [11] HINE, C.H., ELLIOTT, E.W., WRIGHT, R.R., CAVALLI, R.D., and PORTER, C.D. (1969). Evaluation of a silicone lubricant injected spinally. Toxicol. Appl. Pharmacol. 15(3), 566-73. [12] CARTER, 11, B.N. and SHERMAN, R.T. (1957). Dimethicone (silicone) skin protection in surgical patients. Arch. Surg. 116-7. [13] McGREGOR, R.R. (1960). Toxicology of the Silicones. I. The Bulletin of the Dow-Corning Center for Aid to Medical Research. 2(4), 15-6. [14] BATEMAN, F.J.A. (1956). Silicone barrier cream in prevention of bed sores. Brit. Med. J. 554. [15] SUSKIND, R.R. (1955). The present status of silicone protective creams. Ind. Med. Surg. 24,413-6. [16] SIDS Dossier on 1-Hexadecene, Apr 28, 2005. [17] Hamelik, J.L. 1992 Silicones. In: NT de Oude (ed), The Handbook of Environmental Chemistry, Volume 3 Part F, Anthropogenic Compounds: Detergents. Springer-Verlag, p 383-394 [18] www.silicones-science.com/responsible_environment.html [19] Stevens C., Environmental fate and effects of dimethicone and cyclotetrasiloxane from personal care applications, Intern. Journ. Of Cosmetic Science, 1998, 20(5), p. 296. [20] Garaud JL., Les Silicones 50 d'innovation en cosmetique, L'actualite chimique, 2008 - n°323-324,29-34

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