THE REPORT OF A DERMATOLOGICAL EXAMINATION OF THE COSMETIC PRODUCT WITH THE USE OF SEMI-OPEN PATCH TEST

Transcription

1 The Cosmetics Research Institute B (454/08/2016) THE REPORT OF A DERMATOLOGICAL EXAMINATION OF THE COSMETIC PRODUCT WITH THE USE OF SEMI-OPEN PATCH TEST Product Responsible entity Chocolate Shock massage candle Candleland Katarzyna Kmiecik Stefana Batorego 37/ Warsaw, Poland Report number B-0946/16 Date of issue 29 August 2016 Dr Koziej private limited commandite company TIN: Rumiana 1 NCR: Warsaw, Poland drkoziej.com biuro@drkoziej.com 1

2 TABLE OF CONTENTS 1. The basis for the examination Product specification Survey methodology The aim of the survey Selection of probands Test results Conclusions

3 1. THE BASIS FOR THE EXAMINATION The date of receipt 10 August 2016 The period of research Aug 2016 Report number B-0946/16 The date of issue 29 August 2916 PERSONAL DATA OF ORDERING PARTY Candleland Katarzyna Kmiecik, Stefana Batorego 37/131, Warszawa PERSONAL DATA OF THE RESPONSIBLE ENTITY Name of company Address Candleland Katarzyna Kmiecik Stefana Batorego 37/131, Warsaw, Poland Product name Qualitative composition Chocolate Shock massage candle Hydrogenated Soybaen Oil, Butyrospermum Parkii, Theobroma Cacao (Seed Butter), Parfum, Benzyl Benzoate, Prunus Amygdalus Dulcis Oil 2. PRODUCT SPECIFICATION Package Replacement packaging the pull-out cardboard box Presentation 10 candles of a pleasant scent Purpose Massage candles The responsible entity is liable for the product consistency of declared qualitative and quantitative composition and microbiological purity of the samples for the test. 3. SURVEY METHODOLOGY - The survey was carried out in accordance with the Regulation (EC) No 1223/2009 of the European Parliament and of the Council on the cosmetic products. - The tests were conducted under the recommendation of the Cosmetics Europe The Personal Care Association Guidelines: - product test guidelines for the Assessment of Human Skin Compatibility guidelines for the evaluation of the Efficacy of Cosmetic Products The Jadahsson-Bloch s patch tests with the Rudzki s modification were conducted under the responsibility of specialist dermatologists. The evaluation of allergenic and irritant properties of the preparation was carried out by the examination of 30 volunteers in a good health condition with no allergological anamnesis. All volunteers were introduced to all the contradictions and recommendations of the examination. The processes of evaluation, testing and reading take place in the Diagnostic-test laboratory. The examined preparation is applied into epidermal patches of Finn Chamber, which are attached on the interscapular area. The samples are removed after 48 hours, and the first reading takes place. The next reading is performed 72 hours after the sample application. With the observation of the skin reaction as a basis, a specialist dermatologist assesses the irritancy and allergenicity of the examined substance. The positive reaction (erythema) proves the allergenic properties of the preparation, and the negative reaction (no erythema) proves the lack of such properties of it. 3

4 4. THE AIM OF THE SURVEY This test is intended to assess the irritant and allergenic properties of the product on an adult, healthy volunteer by the application of the patch test and reading of the skin reaction after 48 and 72 hours. 5. SELECTION OF PROBANDS The selection of probands volunteers was carried out by the specialist dermatologist in accordance with the Helsinki Declaration of 1964 (as amended and supplemented), the Polish and EU laws, the Guidelines of Cosmetics Europe applying the inclusion and exclusion criteria. There were 30 people aged who took part in the examination process: 16 women and 14 men, who met the accuracy requirements of the test and who gave informed consent for the test participation. The skin was healthy with no lesions. The respondents were informed not to use antihistamines or any pharmaceuticals that could influence the final test results. 6. TEST RESULTS Proband Age Sex Result Proband Age Sex Result 1 24 F Negative (-) F Negative (-) 2 38 M Negative (-) F Negative (-) 3 45 F Negative (-) M Negative (-) 4 53 M Negative (-) F Negative (-) 5 36 F Negative (-) M Negative (-) 6 39 M Negative (-) M Negative (-) 7 26 M Negative (-) F Negative (-) 8 51 F Negative (-) F Negative (-) 9 47 M Negative (-) F Negative (-) M Negative (-) M Negative (-) F Negative (-) F Negative (-) M Negative (-) M Negative (-) M Negative (-) M Negative (-) F Negative (-) F Negative (-) F Negative (-) F Negative (-) Key: E (redness) (0) zero; (1) slight; (2) average; (3) intensive; (4) very intensive O (edema) (0) zero; (1) slight; (2) average; (3) intensive; (4) very intensive S (scaling) (0) zero; (1) slight; (2) average; (3) intensive; (4) very intensive (?) indeterminate result/skin irritation caused by a patch M male; F female TEST RESULT: All probands achieved negative results in patch tests, which proves that the product did not cause irritant or allergenic reactions on respondents. 4

5 7. CONCLUSIONS 1. The patch test proves that Chocolate Shock massage candle has no irritant or allergenic properties. 2. This opinion does not discuss the issue of people allergic to any of the ingredients that preparation contains. 3. The examined preparation meets the requirements imposed on cosmetic products with the properties declared as safe for human health. 4. This opinion does not contain the element analysis of the product. The signature and stamp of the specialist Adam A. Wroński, Ph.D. Aleksander Wroński, Ph.D. 1. The test report may be reproduced only in whole. Any other form of copying requires the written consent of the Contractor. 2. The report has been drawn up in duplicate (1 Principal, 2 Diagnostic-Test). 3. The results concern only the product of the composition provided by the Ordering Party. 4. Diagnostic-Test does not keep the materials or samples of products provided by the Ordering Party after finishing the examination. The Cosmetic Research Institute 5