hangenic anti-bac gel mccallum manufacturing limited 15753

Hangenic Anti-bac Gel

McCallum Manufacturing

Limited 15753

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Product name Anti Bac Gel

Product Code -

Company (Customer) Name Bio Laboratories Limited

Company (Customer)Address

Unit 1, Atlas Point, Davenport Lane, WA14 5DT AltrinchamUnited Kingdom

Company (Customer) Phone 0161 941 2484 or 0161 903 9520

Company (Customer) Fax 0161 929 4193

Company (Customer)Responsible Contact

Head Office

Other Contact Details

ADSL Reference 15753

CPSR Completion Date 04-09-2017 08:58:02

The product is safe for use in the stated application, and complies with EC Regulation 1223/2009. This assessment is conditional on theResponsible Person complying with the conditions in the notes and any other purity restrictions listed.

Date and signature of safety assessor.

Signed:

Date: September 4, 2017

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PART A

Quantitative & Qualitative Composition of the Cosmetic Product

INCI Chemical name CAS EINECS Concentration inFormulation %

(w/w)

ALCOHOL DENAT. Ethanol plus denaturant/s N/A N/A 65.000000%

Function ANTIFOAMING ANTIMICROBIAL ASTRINGENT MASKING SOLVENT VISCOSITY CONTROLLING

EU 2013 Regs Not Controlled

AQUA Water 7732-18-5 231-791-2 32.920000%

Function SOLVENT


GLYCERIN Glycerol 56-81-5 200-289-5 1.000000%

Function DENATURANT HUMECTANT PERFUMING SOLVENT


TRIETHANOLAMINE 2,2',2''-Nitrilotriethanol 102-71-6 203-049-8 0.500000%

Function BUFFERING EMULSIFYING MASKING SURFACTANT

EU 2013 Regs III/62

ACRYLATES/C10-30ALKYL ACRYLATECROSSPOLYMER

C10-30 alkyl propenoate, polymerwith propenoic acid, butenoic acidand/or alkyl propenoates, productwith propenyl sucrose ether orpropenyl2,2-dihydroxymethyl-1,3-propanediol INN Name

N/A N/A 0.330000%

Function EMULSION STABILISING FILM FORMING VISCOSITY CONTROLLING



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INCI Chemical name CAS EINECS Concentration inFormulation %

(w/w)

PHENOXYETHANOL 2-Phenoxyethanol 122-99-6 204-589-7 0.150000%

Function PRESERVATIVE

EU 2013 Regs V/29 1% MAX

BENZALKONIUMCHLORIDE

benzalkonii chloridum 63449-41-2 /68391-01-5 /68424-85-1 /85409-22-9

264-151-6 /269-919-4 /270-325-2 /287-089-1

0.100000%

Function ANTIMICROBIAL ANTISTATIC DEODORANT PRESERVATIVE SURFACTANT

EU 2013 Regs VI/54 (MAX 0.1%) III/65 (MAX 3% as benzalkonium chloride) in Rinse-off hair (head) products Must belabelled "Avoid contact with the eyes"

Fragrance / Parfum Information

Name of Fragrance -

Code of Fragrance -

Fragrance Manufacturer -

Physical/Chemical Characteristics & Stability of the Cosmetic Product

Physical Descriptionof the Product

no specification provided

Aroma -

Colour -

Taste -

pH of Product -

Viscosity -

Specific Gravity -

Stability no stability testing data provided


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INCI Physical Description Chemical description

ALCOHOL DENAT. Colourless liquid with a characteristic odour. Molecular formula: C2H6OMolar mass: 46.07 g mol−1Density: 0.789 g/cm3Melting point: −114 °C, 159 K, -173 °FBoiling point: 78.37 °C, 352 K, 173 °Flog P: -0.18includes denaturant such as methanol, isopropylalcohol, acetone, methyl ethyl ketone, methylisobutyl ketone, and denatonium.

AQUA Clear, odourless, tasteless liquid H2O

GLYCERIN Colourless, odourless, viscous liquid Chemical Name: 1,2,3-Propanetriol. Molecular Formula: C3H8O3. Molecular Weight: 92Purity 95 – 99.5% (water as an impurity withtrace levels of polyglycerol). Melting point 18°C. Boiling point 290°C at 1013 hPa. Relative density 1.26 at 20°C. Vapour pressure 0.000106 hPa at 25°C(calculated), and 0.0033 hPa at 50°C (measured). n-octanol –water partition coefficient log Kow -1.76. Water solubility Miscible.

TRIETHANOLAMINE Colourless liquid, Ammoniacal odour. Molecular formula C6H15NO3, Molar mass 149.19 g mol−1,Density 1.124 g mL−1 ,Melting point 22 °C, 294.75 K, 71 °F,Boiling point 335 °C, 608.55 K, 636 °F, Solubility in water 149 g L−1 (at 20 °C) ,log P−0.988


Fluffy powder, white, slight acetic odor Polymers of acrylic acid cross-linked withpolyalkenyl ethersSpecific Gravity: 1.40pH Value: 2.5-3.0 @ 1% in H20

PHENOXYETHANOL Oily, colourless, slightly viscous liquid. It has afaint aromatic or "rose-like" odour

Molecular formula: C8H10O2Molar mass: 138.16 g/mol Density: 1.102 g/cm3 Melting point: 11 - 13 °C Boiling point: 247 °CInsoluble in mineral oil, slightly soluble in water,and soluble in alcohol and ether, and in alkalinesolutions.’Phenoxyethanol is miscible with glycerine,propylene glycol, and benzene.It is stable in acid solutions.Partition coefficients for Phenoxyethanol are asfollows: 2.9 in isopropyl palmitate-water, 2.6 inpeanut oil-water, and 0.3 in mineral oil-water.


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INCI Physical Description Chemical description


Off-white semi-solid Linear Formula C6H5CH2N(CH3)2RCl (R=C8H17to C18H37)Melting point: 241.02oCVapour pressure: 3.53x 10-12 mm HGDensity: 0.9429 g/cm2 at 25oC.Soluble in water and alcohols

Microbiological Quality

Preservative Efficacy no preservative challenge testing data provided

Plate Count

Impurities, Traces & Packaging

Description of the Packaging& Suitability for Use

no packaging information provided

Notes of Impurities,Traces in the INCI

No impurities of concern have been identified in the raw material data supplied.

Normal & Reasonably Foreseeable Use

Description of IntendedApplication & Directions for Use

Anti-Bacterial Gel - to be applied to the hands.

Exposure to the Cosmetic Product

Site of Application area hands

Surface Area of Application (cm2)

860

Amount Applied (g) per day 2.16 g

Duration Leave-on


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Frequency 2/day

Retention Factor 1

Exposure Routes Dermal (incidental ocular and oral)

Target Population Adult 60kg

Calculated relative dailyexposure (mg/kg bw/day)

32.7

Typical consumer use of the product is taken from the SCCS’s Notes of Guidance and the EPA Exposure Factors Handbook

Exposure to the Substances

INCI Calculated RelativeDaily Exposure

Concentration % (w/w) Dermal Absorption Systemic ExposureDosage

ALCOHOL DENAT. 32.7 65.000000% 100.000000% 21.255000

AQUA 32.7 32.920000% 100.000000% 10.764840

GLYCERIN 32.7 1.000000% 100.000000% 0.327000

TRIETHANOLAMINE 32.7 0.500000% 100.000000% 0.163500


32.7 0.330000% 100.000000% 0.107910

PHENOXYETHANOL 32.7 0.150000% 100.000000% 0.049050


32.7 0.100000% 100.000000% 0.032700

Exposure data and method of calculation taken from the SCCS’s Notes of Guidance. The conventional conservative approach of assuming adermal absorption of 100% is taken where appropriate

Toxicological Profile of the Substances

Local Toxicity

INCI Eye Irritant Skin Irritant SkinIrritant

Skin Sensitizer Photo Sensitizer

ALCOHOL DENAT. Moderate No No No

AQUA No No No No

GLYCERIN No No No No


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INCI Eye Irritant Skin Irritant SkinIrritant

Skin Sensitizer Photo Sensitizer

TRIETHANOLAMINE Slight Slight No No


Minimal No No No

PHENOXYETHANOL Yes Mild No No


Yes Yes No No

Margin of Safety and Comments

INCI Margin of Safety (MOS) NOAEL SED

ALCOHOL DENAT. 113 2400 21.255000

AQUA No Data 10.764840

GLYCERIN 30581 10000 0.327000

TRIETHANOLAMINE 6116 1000 0.163500


No Data No Data 0.107910

PHENOXYETHANOL 7523 369 0.049050


398 13 0.032700


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INCI General Safety Comments Data Reference

ALCOHOL DENAT. Alcohol, also called ethanol or ethyl alcohol, isformed by the fermentation of sugars or can besynthetically produced. It is a 2-carbon alcohol.Alcohol denat. is alcohol which has been madeunpotable by a variety of substances. It is used incosmetics and personal care products primarily toconform to import, tax, and duty requirements.Alcohol is readily absorbed by the oral andinhalation routes and subsequently, metabolizedand excreted in humans. At exposures relevant toconsumer exposure during use of alcoholcontaining products, the alcohol dehydrogenasemetabolic route in the liver dominates and doesnot become saturated. Alcohol is not accumulatedin the body. Dermal uptake of alcohol is very low.Alcohol has a low order of acute toxicity by allroutes of exposure. Alcohol is widely used intopical applications and adverse effects areseldom reported. The Cosmetic IngredientReview Expert Panel investigated a variety of themost frequently used denaturants. Theydetermined that at the low concentrations atwhich they were present Alcohol Denat.denatured with t-Butyl Alcohol, Diethyl Phthalate,Methyl Alcohol, Salicylic Acid, Sodium Salicylate,and Methyl Salicylate is safe as used in cosmeticformulations with no qualifications. The availabledata, however, were not sufficient to support thesafety of Quassin, Brucine, and Brucine Sulfate,Alcohol Denat. denatured with those denaturants,or SD Alcohol 39 and SD Alcohol 40. It isconsidered safe at its current use andconcentration.

"Safety evaluation of topical applications ofethanol on the skin and inside the oral cavity", DirkW Lachenmeier , Journal of OccupationalMedicine and Toxicology 2008, 3:26doi:10.1186/1745-6673-3-26"OECD SIDS ETHANOL", SIDS Initial AssessmentReport For SIAM 19, Berlin, Germany, 19 – 22October 2004"Final report of the safety assessment of AlcoholDenat., including SD Alcohol 3-A, SD Alcohol 30,SD Alcohol 39, SD Alcohol 39-B, SD Alcohol 39-C,SD Alcohol 40, SD Alcohol 40-B, and SD Alcohol40-C, and the denaturants, Quassin, BrucineSulfate/Brucine, and Denatonium Benzoate.",Cosmetic Ingredient Review Expert Panel, Int JToxicol. 2008;27 Suppl 1:1-43.Absorption of Alcohol Hand Disinfectants, Prof.Axel Kramer, Institute of Hygiene andEnvironmental Medicine, University Hospital,Greifswald, Germany

AQUA The quality of water used in the production ofcosmetics and personal care products, calledprocess water, is monitored according tointernational guidelines on Good ManufacturingPractices known as ISO 22716.

-

GLYCERIN The weight of evidence indicates that glycerol isof low toxicity when ingested, inhaled or incontact with the skin. Glycerol is of a low order ofacute oral and dermal toxicity with LD50 values inexcess of 4000 mg/kg bw. Glycerol has lowpotential to irritate the skin and the eye. Glycerolis not a skin sensitiser. Repeated oral exposure toglycerol does not induce adverse effects otherthan local irritation of the gastro-intestinal tract.There are no CMR concerns.

OECD SIDS Initial Assessment Report for SIAM 14(2002


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TRIETHANOLAMINE Triethanolamine is widely used in a number ofproducts in both reacted and non-reacted form.Consumer use of TEA is reported to be inpersonal care products, soaps, cosmetics,emollients, household detergents.Triethanolamine is of low toxicity following singleexposures. There were some signs of systemictoxicity at high exposure levels, and mild skinirritation following repeated exposures using thedermal route. It is not genotoxic, carcinogenic ortoxic to development or the reproductive system.According to Annex III/1,62 of the EC regulationsTriethanolamine is limited to maximumconcentration of 2.5% in leave-on products. Othermandated limitations are: - Do not use with nitrosating systems - Minimum purity: 99% - Maximum secondary amine content: 0.5%(applies to raw materials) - Maximum nitrosamine content: 50 microgram/kg - Keep in nitrite-free containers

"OECD SIDS, Initial Assessment Report For SIAM 3Williamsburg, Virginia, 13-16 February 1995""SIDS INITIAL ASSESSMENT PROFILE", SIAM 4,20-22 May 1996 "Opinion concerning Dialkyl- and Dialkanolaminesand their salts in cosmetic products adopted bythe SCCNFP during the 17th plenary meeting of 12June 2001",


C10-30 alkyl propenoate, polymer with propenoicacid, butenoic acid and/or alkyl propenoates,product with propenyl sucrose ether or propenyl2,2-dihydroxymethyl-1,3-propanediol.Acrylates/C10-30 Alkyl Acrylate Crosspolymer is apolymer of actylic acid and related chemicals. It isspecifically designed to make dispersions in waterless susceptible to lumping and easier to pumpand handle due to its low dispersion viscositybefore neutralization. It has a very low order ofacute toxicity. It may be a minimal ocular irritantbut is not a dermal irritant or sensitiser. It is notclassified as a carcinogen, mutagen, orreproductive toxin.

MSDS for Acrylates/C10-30 Alkyl AcrylateCrosspolymer from Personalformulator.comCarbopol and its Pharmaceutical Significance: AReview", Avinash H. Hosmani, 02/17/2006 (http://www.pharmainfo.net/reviews/carbopol-and-its-pharmaceutical-significance-review)Final Safety Assessment Crosslinked AlkylAcrylates as Used in Cosmetics, CIR Expert Panel,November 17, 2011

PHENOXYETHANOL Phenoxyethanol is an oily, slightly viscous liquid.Phenoxyethanol acts as a preservative (kills micro-organisms, or prevents or retards their growth andreproduction). Phenoxyethanol may contain freephenol (less than 1%)) or the diethoxylate ofPhenoxyethanol. 98% pure Cosmetic-gradePhenoxyethanol is generally free of ethyleneoxide (<l ppm). According to the classificationscheme of Hodge and Sterner, Phenoxyethanol ispractically nontoxic to slightly toxic when orallyadministered to rats and mice and practicallynontoxic when administered dermally to rats. Thetoxicokinetics default factor of 4.0 can be reducedto 1.0 yielding a minimum Margin of Safety (MoS)of 25 instead of 100 for the safety assessment of2-phenoxyethanol. Maximum authorizedconcentration 1.0%

"Final Report on the Safety Assessment ofPhenoxyethanol" JOURNAL OF THE AMERICANCOLLEGE OF TOXICOLOGY Volume 9, Number 2,199O"Draft Interim REL March 2010", ECHA databasePercutaneous penetration of 2-phenoxyethanolthrough rat and human skin., Roper CS, Howes D,Blain PG, Williams FM., Food Chem Toxicol. 1997Oct-Nov;35(10-11):1009-16


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Benzalkonium chloride, also known asalkyldimethylbenzylammonium chloride andADBAC, is a cationic surface-acting agentbelonging to the quaternary ammonium group. Itis a nitrogenous mixture ofalkylbenzyldimethylammonium chlorides ofvarious even-numbered alkyl chain lengths. Incosmetics and personal care products it mayfunction as a preservative, an anti-microbial, asurfactant, a deodorant, or an anti-static. It has amoderate acute oral toxicity and a low acutedermal toxicity, and is moderately toxic in repeat-dose studies. It is a severe ocular and dermalirritant but is not a sensitiser. It is not a carcinogen,mutagen, or reproductive toxin. Benzalkoniumchloride is effective at exceptionally lowconcentrations; contact lens solutions typicallycontain exceptionally low (0.002% to 0.01%)concentrations of benzalkonium chloride foreffective preservative action.Under annex III/68and VI/54 its use is restricted in all bar rinse offhair care products to 0.1% and the product mustbe labelled "Avoid contact with the eyes"

Frank T. Sanders, ed. (August2006). Rer egi st rat ion El igi bi lity Deci si on for Al kylDimethyl Benzyl Ammonium Chloride(ADBAC) (Repor t). U. S. Envi ronme nt al Pr ot ect ionAgency Office of Prevention, Pesticides, and ToxicSubstances. pp. 114.e Health assessment of benzalkonium chlorideresidues in food, BfR opinion No 032/2012, 13 July2012

Undesirable Effects & Serious Undesirable Effects

None reported.

Information on the Cosmetic Product

No further information provided.

PART B

Assessment conclusion

=-= PROVISIONAL ASSESSMENT =-=

No product specification, packaging information, stability or preservative challenge information has been provided for this


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product. The following assessment is contingent on this information being supplied and found to be satisfactory.

The evaluation of the data available on the product and the information about the ingredients for the claimed use do not indicatea significant risk to users that outweighs any benefits of use. The clinical data indicate very low incidence of adverse events

The product is safe for use in the stated application, and complies with EC Regulation 1223/2009. This assessment is conditionalon the Responsible Person complying with the conditions in the notes and any other purity restrictions listed.

Labelled warnings and instructions of use

Avoid contact with eyes.

Reasoning

The toxicological data given in Part A section 8 indicate that the ingredients are safe for their intended use.

In general, the final product would not be considered an irritant or potential skin sensitiser if the total concentration of irritantingredients is less than 10% and the total concentration of skin sensitisers is less than 1%. These levels are not exceeded in theproduct. The product does not contain any known photosensitising ingredients.

Assessor’s credentials and approval of part B

Mark Richard Bowes-Cavanagh BSc (Hons) App. Chem CSci CChem MRSCAddress: Green Pastures, Totnes Road, Collaton St. Mary, Paignton, Devon,U.K.

Further Education 1991 - 1994 University Of Plymouth. Drake Circus, Plymouth.2nd Class BSc (HONS) - Degree in Applied Chemistry.

Specially Qualified In Qualitative & quantitative analysis of Material, Bio-organic, Analytical, Environmental, Physical, Organicand Inorganic chemistry.Close liaison with industrial processes and particular attention was given on GLP and all inferencesrecorded.Synthetic work and analysis using FTIR, IP, GC-MS, GC, HPLC, H-NMR, ICP--MS and bioassaypreparations.Final year dissertation entitled "Isothiocyanates of the Larval Cabbage Root Fly (D.Radicum) Attractants"

Career History 2000-Present Advanced Development & Safety Laboratories Ltd Paignton, Devon. TQ4 7PW.

Technical Director

Analysis and Signing-Off of Safety Assessments in accordance to Cosmetics Directives, EU, ASEAN,Canada and FDA and to 2013 regulations.Presentation of new products or raw materials to customers including point of sale, including newactives from In-Cosmetics and other trade shows.Negotiation of price points and order details with both internal departments and customers throughprocurement or sales.Research & Development of new products, including sourcing of new ingredients, componentry andfragrance.Sourcing of all packaging connected to new products, enabling product to arrive on time at third partymanufacturers.Management of bank accounts and supplier credit accounts.


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Legal paperwork to enable smooth transfer of product to Far East and FDA in USA though their internalgoverning bodies.Creation of website and update including ePDQ selling facility.Collation of orders with manufacturers including Quality Control and adherence to specifications.Organizing Trade Shows including NEC Fairs, Regional shows and Oversea Trade shows e.g. HongKong Beauty Show.Consultancy with manufacturers to establish new ranges for both them and feasibility to be successfulon the market.Preparation of stability testing on all products including product compatibility.Strategy planning for both ECL and with consultancy to clients on better systems within theirorganizations including training.

1999 - 2000 The Bodyline Group Plc, Paignton, Devon. TQ4 7QZ.

Technical Manager2010-2012 LF Beauty

To manage the team to ensure products are developed to specified standards to meet customer andcompany requirements ensuring that all relevant technical standards are applied.Lead the R&D team and ensure close working relationships between R&D and key internaldepartments: NPD, Process, Commercial, PurchasingManage workload to ensure product developments are in line with critical paths.To keep abreast of new technology with a view to:- introduction into existing products- introduction into new products- use in innovation presentations- use in technical bulletinsEnsure that products developed by R&D are:- Market focused- Legal (according to claim and composition)- Safe to use- Stable (will not separate, discolour etc.)- Can be manufactured consistently to specificationAssess external testing product development requirements. Ensure testing is focused, best value andaccurately costed.To liaise with customers in order to provide them with required levels of technical support, backed bythe supply of all data, samples and specifications.To liaise with outside suppliers in order to:- find new sources of innovation- find equivalent raw materials at competitive costs- tested externally, where internal facilities are inadequate for the purpose- at minimum costAssist as necessary in the development of the R&D budget.Ensure R&D spending is in line with agreed budgets and that external testing is properly targeted.Undertake succession planning within the department and ensure that sufficient developmentaltraining takes place.To reduce failure rate in process through managing pilot production programme and troubleshootingbulk production issues.The management, leadership, performance management, development, recruitment and training of allstaff within the function to ensure that department performance and customer service are optimised.

Technical Manager1999 - 2000 The Bodyline Group Plc, Paignton, Devon. TQ4 7QZ

Direct involvement with sales in initiating new projects and servicing the account.Upgrading the company’s capabilities in order to achieve ISO 9001 by March 2000.Appearance on The Shopping Channel to promote Bodyline Products because of my technical salesskills.


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Organized trade shows for Bodyline Group including, NEC Cosmetic Fair, Frankfurt show.Operating and maintaining a discipline factory environment with close control of logistical planning.Close liaison with technical departments of all customers to ensure product quality and safety isparamount.Develop customer accounts to enable maximum potential for both the customer and the company.Drive the dynamic creative engine of the company to achieve franchise Bodyline shops in Europe andOceania.Increase bottom line profit by efficiently programming in projects and maximizing the workforce toachieve manufacturing wages lower ever before.Maximize output due to cash flow considerations enabling Bodyline to invest in other project ventures.Evaluate customer requirements to measure Bodylines to achieve maximum profit margin and toenable projects capability of achieving product goal or sub-contracting to other contacts.Close liaison with suppliers to accomplish cost saving initiatives to complete within the critical path.Organizing meetings between departments and collaborating with managers to ensure a smoothproject path.

Research & Development Chemist1999 - 1995 The Bodyline Group Plc, Paignton, Devon. TQ4 7QZ.

Formulated a more comprehensive range of products to promote the Bodyline range within the costparameters and our animal testing declaration (1985).Achieved suspensions for sophisticated skin care and innovative designs.Produced varied emulsified systems according to customer requirements and production facilities.Introduced new systems into the Research & Development arena to achieve high standards inconjunction with EEC directives on stability and safety of products.Researched into most commercially used preservatives within cosmetic sector according to product,cost and customers needs.Initiate point of sale and manufacturing information for customers on recommended applications andbenefits of product.Oversee Quality Assurance to answer customer enquiries and required contingency measures.Evaluation of all additives in product to achieve maximum stability and safety, to prolong shelf-life.

Zeneca Environmental Laboratory, Brixham, Devon.

Work Experience in Vertebrae Laboratory monitoring temperature, pH and other environmentalparameters.

Achievements Member of the Royal Society Of Chemistry and a "Chartered"Chemist and Scientist.Member of The Society Of Cosmetic Scientists.Member of the British Toxicology Society

Date and signature of safety assessor.

Signed:

Date: September 4, 2017

This assessment is based on information supplied by the client, raw material manufacturers and published information in recognisedauthoritative sources. Whilst best endeavours have been used to check the accuracy of this information, the undersigned cannot be heldresponsible for any erroneous information supplied and used for preparing this assessment.


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