the report from dermatological research of … · product purpose shampoo the responsible person is...
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B – (659/11/2016)
THE REPORT FROM DERMATOLOGICAL RESEARCH OF COSMETICAL PRODUCT
WITH HALF OPEN PATCH TEST
Product
Komili Bebe
Responsible Person
Sca Yildiz Kağit Ve Kişisel Bakim Üretim A.Ş.
Report number B-1529/16 Issue date 19.12.2016
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2/5
Table of contents 1. RESEARCH BASIS ........................................................................................................................................ 3
2. PRODUCT CHARACTERISTIC ..................................................................................................................... 3
3. METHODOLOGY ........................................................................................................................................... 3
4. THE AIM OF STUDY ..................................................................................................................................... 4
5. SUBJECT – VOLUNTEERS SELECTION ..................................................................................................... 4
6. RESULTS ...................................................................................................................................................... 4
7. CONCLUSION ............................................................................................................................................... 5
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3/5
1. RESEARCH BASIS Order date 29.11.2016
Order number 659/11/2016
Research time frame 05.12.2016 – 16.12.2016
Report issue date 19.12.2016
CUSTOMER NAME
Pim Eğitim ve Danişmanlik Hizmetleri, Göktürk Mah. Çamlık Cad. 3 Meşe Sok. No: 3 New Life Sit. B Blok D:17 Eyüp-İstanbul 34077 Turkey
RESPONSIBLE PERSON NAME
Company name Sca Yildiz Kağit Ve Kişisel Bakim Üretim A.Ş.
Address
Product name Komili Bebe Ingredients Aqua, Cocamidopropyl Betaine, Polysorbate-20, Olive Oil PEG-7 Esters, Sodium Laureth
Sulfate, Lauryl Glucoside, PEG/PPG-120/10-Trimethylolpropane Trioleate, Laureth-2, Sodium Benzoate, Phenoxyethanol, Olea Europaea Fruit Oil (Olive Oil), Citric Acid, Parfum
2. PRODUCT CHARACTERISTIC Product Package Supplementary – clear plastic jar labeled with name of the product Product Appearance Clear liquid with pleasant scent
Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition and microbiological purity of the delivered research samples.
3. METHODOLOGY The study was conducted in accordance with Regulation of the European Parliament and Council
Regulation (EC) No 1223/2009 of 50 November 2009 on cosmetic. The study was conducted in accordance with recommendation of Cosmetics Europe – The
Personal Care Association Guidelines: product test guidelines for the Assessment of Human Skin Compatibility 1997 guidelines for the evaluation of the Efficacy of Cosmetic Products 2008.
Patch tests according to Jadassohn-Bloch with Rudzki modifications were conducted under careful supervise of medical specialists – dermatologists. The assessment of the allergenic and irritant features was made on a group of 30 healthy volunteers with a diagnosis-proven in studies or history of various types of allergies, atopic dermatitis, hypersensitivity to cosmetics and/or household chemicals /not currently taking any medication that may have any effect on the result of the test/, familiarized with contraindications and recommendations for the study. The probands’ selection, samples application and reading took place in Diagnostic Test in Bialystok. The tested preparation in a commercial formulation is applied to chamber cell-petal patches of Finn Chamber® which are put around a vane. Patches are removed after 48 hours and the first reading is conducted. Another reading takes place 72 hours after insertion of the sample. A dermatologist
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4/5
based on the observations of skin reactions evaluates allergenic action of the conducted substance. Positive reaction (erythema) confirms allergenic properties of the formulation, negative reaction (no erythema) confirms the absence of allergenic properties of the formulation.
4. THE AIM OF STUDY The aim is to assess irritating and allergenic properties of the product in a healthy adult volunteer
by single insert of patch test and the reading of skin reaction after 48 and 72 hours.
5. SUBJECT – VOLUNTEERS SELECTION The selection of probands – volunteers was conducted by a dermatologist according to the
Declaration of Helsinki of 1964 (with subsequent amendments), Polish laws, Cosmetics Europe directives with applying inclusion and exclusion criteria. 30 people took part in the study at the age of 20 - 59 years old: 15 women and 15 men who met the requirements for entering the study and agreed to informed consent to participate in the study. The skin at the selected area was normal, without any lesions. Subjects were informed not to use any kinds of antihistamines or pharmacological agents at the time of test, which may affect the tests’ results.
6. RESULTS Subject Age Code Sex Erythema Oedema Scaling Subject Age Code Sex Erythema Oedema Scaling
1 C 44 F (0) (0) (0) 16 26 A M (0) (0) (0) 2 B 25 M (0) (0) (0) 17 37 C F (0) (0) (0) 3 A 38 M (0) (0) (0) 18 42 C M (0) (0) (0) 4 B 41 F (0) (0) (0) 19 48 B F (0) (0) (0) 5 C 20 M (0) (0) (0) 20 31 A F (0) (0) (0) 6 A 55 F (0) (0) (0) 21 53 C M (0) (0) (0) 7 B 38 F (0) (0) (0) 22 28 B M (0) (0) (0) 8 A 46 F (0) (0) (0) 23 44 A F (0) (0) (0) 9 C 22 M (0) (0) (0) 24 59 C F (0) (0) (0)
10 B 57 F (0) (0) (0) 25 45 A M (0) (0) (0) 11 A 22 M (0) (0) (0) 26 33 C M (0) (0) (0) 12 B 47 M (0) (0) (0) 27 37 B M (0) (0) (0) 13 C 39 F (0) (0) (0) 28 42 C F (0) (0) (0) 14 A 25 F (0) (0) (0) 29 47 C M (0) (0) (0) 15 A 50 M (0) (0) (0) 30 52 B F (0) (0) (0)
Legend: E (erythema) - (0) – zero; (1) – weak; (2) – moderate; (3) – strong; (4) – very strong O (oedema) - (0) – zero; (1) – weak; (2) – moderate; (3) – strong; (4) – very strong S (scaling) - (0) – zero; (1) – weak; (2) – moderate; (3) – strong; (4) – very strong (-) – negative result, (?) – questionable result M – man, F – woman A – positive allergenic screening, B – hypersensitive skin, C – confirmed allergy
RESULTS: In 30 subjects, the results of patch tests were negative, which means that the product does not cause irritation or allergy reaction in those subjects.
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5/5
7. CONCLUSION 1. Having conducted patch tests, one may state that the Komili Bebe does not have irritant or allergenic
action. 2. The issued opinion does not apply to anybody with an allergy to any of the ingredients of the tested
preparation. 3. The issued opinion does not include analysis of the composition of the product. 4. The tested preparation fulfills requirements for cosmetic products of declared specification i.e. hypo –
allergic, in regards to human health safety. Stamp and Signature of investigator
Adam A. Wroński MD. PhD. Aleksander Wroński MD. PhD 1. The report may be reproduced only in its entirety. Another form of copying requires the written consent of the Contractor. 2. Report from research carried out in two identical copies (copy 1 – Customer, copy 2 –Diagnostic-Test). 3. The results refer only to the product of the composition given by the Principal. 4. The study is an in vivo study, i.e. assessment of the impact of cosmetics on the skin under the Act on cosmetics dated March 30,
2001 and does not constitute a clinical trial within the meaning of the Act on the Law of the pharmaceutical dated 6 September 2001.
5. The presented results apply only to the sample. After completion of the study Dr. Koziej Sp. o.o. sp. k. does not store provided by the Customer testing of materials or samples of the products tested.
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B – (658/11/2016)
THE REPORT FROM DERMATOLOGICAL RESEARCH OF COSMETICAL PRODUCT
WITH HALF OPEN PATCH TEST
Product
Komili Bebe
Responsible Person
Sca Yildiz Kağit Ve Kişisel Bakim Üretim A.Ş.
Report number B-1553/16 Issue date 19.12.2016
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2/5
Table of contents 1. RESEARCH BASIS ........................................................................................................................................ 3
2. PRODUCT CHARACTERISTIC ..................................................................................................................... 3
3. METHODOLOGY ........................................................................................................................................... 3
4. THE AIM OF STUDY ..................................................................................................................................... 4
5. SUBJECT – VOLUNTEERS SELECTION ..................................................................................................... 4
6. RESULTS ...................................................................................................................................................... 4
7. CONCLUSION ............................................................................................................................................... 5
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3/5
1. RESEARCH BASIS Order date 29.11.2016
Order number 658/11/2016
Research time frame 05.12.2016 – 16.12.2016
Report issue date 19.12.2016
CUSTOMER NAME
Pim Eğitim ve Danişmanlik Hizmetleri, Göktürk Mah. Çamlık Cad. 3 Meşe Sok. No: 3 New Life Sit. B Blok D:17 Eyüp-İstanbul 34077 Turkey
RESPONSIBLE PERSON NAME
Company name Sca Yildiz Kağit Ve Kişisel Bakim Üretim A.Ş.
Address
Product name Komili Bebe Ingredients Aqua, Cocamidopropyl Betaine, Polysorbate-20, Olive Oil PEG-7 Esters, Sodium Laureth
Sulfate, Lauryl Glucoside, PEG/PPG-120/10-Trimethylolpropane Trioleate, Laureth-2, Sodium Benzoate, Phenoxyethanol, Olea Europaea Fruit Oil (Olive Oil), Citric Acid, Parfum
2. PRODUCT CHARACTERISTIC Product Package Supplementary – clear plastic jar labeled with name of the product Product Appearance Clear liquid with pleasant scent
Product purpose Shampoo The responsible person is responsible for conformity with declared qualitative and quantitative composition and microbiological purity of the delivered research samples.
3. METHODOLOGY The study was conducted in accordance with Regulation of the European Parliament and Council
Regulation (EC) No 1223/2009 of 50 November 2009 on cosmetic. The study was conducted in accordance with recommendation of Cosmetics Europe – The
Personal Care Association Guidelines: product test guidelines for the Assessment of Human Skin Compatibility 1997 guidelines for the evaluation of the Efficacy of Cosmetic Products 2008.
Patch tests according to Jadassohn-Bloch with Rudzki modifications were conducted under careful supervise of medical specialists – dermatologists. The assessment of the allergenic and irritant features was made on a group of 30 healthy volunteers no allergological history, familiarized with contraindications and recommendations for the study /not currently taking any medication that may have any effect on the result of the test/. The probands’ selection, samples application and reading took place in Diagnostic Test in Bialystok. The tested preparation in a commercial formulation is applied to chamber cell-petal patches of Finn Chamber® which are put around a vane. Patches are removed after 48 hours and the first reading is conducted. Another reading takes place 72 hours after insertion of the sample. A dermatologist based on the observations of skin reactions evaluates allergenic action of the conducted substance. Positive
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4/5
reaction (erythema) confirms allergenic properties of the formulation, negative reaction (no erythema) confirms the absence of allergenic properties of the formulation.
4. THE AIM OF STUDY The aim is to assess irritating and allergenic properties of the product in a healthy adult volunteer
by single insert of patch test and the reading of skin reaction after 48 and 72 hours.
5. SUBJECT – VOLUNTEERS SELECTION The selection of probands – volunteers was conducted by a dermatologist according to the
Declaration of Helsinki of 1964 (with subsequent amendments), Polish laws, Cosmetics Europe directives with applying inclusion and exclusion criteria. 30 people took part in the study at the age of 21 - 62 years old: 16 women and 14 men who met the requirements for entering the study and agreed to informed consent to participate in the study. The skin at the selected area was normal, without any lesions. Subjects were informed not to use any kinds of antihistamines or pharmacological agents at the time of test, which may affect the tests’ results.
6. RESULTS Subject Age Sex Erythema Oedema Scaling Subject Age Sex Erythema Oedema Scaling
1 30 F (0) (0) (0) 16 30 F (0) (0) (0) 2 23 F (0) (0) (0) 17 28 F (0) (0) (0) 3 27 M (0) (0) (0) 18 41 M (0) (0) (0) 4 48 M (0) (0) (0) 19 62 F (0) (0) (0) 5 58 F (0) (0) (0) 20 43 M (0) (0) (0) 6 44 F (0) (0) (0) 21 51 M (0) (0) (0) 7 36 F (0) (0) (0) 22 44 F (0) (0) (0) 8 26 M (0) (0) (0) 23 21 M (0) (0) (0) 9 49 F (0) (0) (0) 24 32 F (0) (0) (0)
10 51 M (0) (0) (0) 25 54 F (0) (0) (0) 11 32 M (0) (0) (0) 26 33 F (0) (0) (0) 12 56 F (0) (0) (0) 27 49 M (0) (0) (0) 13 42 M (0) (0) (0) 28 50 M (0) (0) (0) 14 35 F (0) (0) (0) 29 55 F (0) (0) (0) 15 40 M (0) (0) (0) 30 29 M (0) (0) (0)
Legend: E (erythema) - (0) – zero; (1) – weak; (2) – moderate; (3) – strong; (4) – very strong O (oedema) - (0) – zero; (1) – weak; (2) – moderate; (3) – strong; (4) – very strong S (scaling) - (0) – zero; (1) – weak; (2) – moderate; (3) – strong; (4) – very strong (-) – negative result, (?) – questionable result M – man, F – woman RESULTS: In 30 subjects, the results of patch tests were negative, which means that the product does not cause irritation or allergy reaction in those subjects.
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5/5
7. CONCLUSION 1. Having conducted patch tests, one may state that Komili Bebe does not have irritant or allergenic
action. 2. The issued opinion does not apply to anybody with an allergy to any of the ingredients of the tested
preparation. 3. The issued opinion does not include analysis of the composition of the product. 4. The tested preparation fulfills requirements for cosmetic products of declared specification, in regards
to human health safety. Stamp and Signature of investigator
Adam A. Wroński MD. PhD. Aleksander Wroński MD. PhD 1. The report may be reproduced only in its entirety. Another form of copying requires the written consent of the Contractor. 2. Report from research carried out in two identical copies (copy 1 – Customer, copy 2 –Diagnostic-Test). 3. The results refer only to the product of the composition given by the Principal. 4. The study is an in vivo study, i.e. assessment of the impact of cosmetics on the skin under the Act on cosmetics dated March 30,
2001 and does not constitute a clinical trial within the meaning of the Act on the Law of the pharmaceutical dated 6 September 2001.
5. The presented results apply only to the sample. After completion of the study Dr. Koziej Sp. o.o. sp. k. does not store provided by the Customer testing of materials or samples of the products tested.
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