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Skin Lab International hypoallergenic test report
Skin Lab International hypoallergenic test report
This report details the results of a dermatological test conducted using the h-RIPT method on a sample identified as MASKA MEDYCZNA SAFE®. The test was performed by Skin Lab International Sp. z o.o. and is based on the sample provided by the Principal, Medical Protection Sp. z o.o. Sp. k.
Research Basis
The research was initiated upon receipt of an order form and test samples from the Principal, with confirmation of microbiological purity. The Principal is responsible for the quality composition of the samples.
Purpose of Research
The study aimed to evaluate the product for any irritating and sensitizing properties.
Legal Framework
The research adhered to several regulations and guidelines, including the European Parliament and Council Regulation (EC) No 1223/2009, Cosmetics Europe guidelines, and the WMA Declaration of Helsinki.
Volunteers Selection
Fifteen volunteers with sensitive skin were selected based on European and Polish law, and all participants provided informed consent. They were under constant dermatological supervision throughout the study.
Methods of Research
The test followed the Jadassohn-Bloch method, modified by Rudzki, involving triple application of the product and observation of skin reactions. Results were classified on a scale from 0 to 4.
Results
- All volunteers showed no signs of erythema or edema after each application.
- The average irritation index was calculated as 0, classifying the product as non-irritating.
Conclusion
The product was well tolerated by the skin, showing no irritating or allergenic properties, and is classified as non-irritating.
Authorization
The report was authorized by Aleksandra Dutka, Junior Research Assistant, and approved by a dermatologist and venereologist.
Catalog excerpts
REPORT FROM DERMATOLOGICAL TEST – h-RIPT* method Specialized Research Laboratory Sample number / test number: 06/10/20/D/8 MASKA MEDYCZNA SAFE® Identification number given by Principal (series / production date / internal number): Product composition / INCI: DWIE WARSTWY ZEWNĘTRZNE: SPUNBOND 100% POLIPROPYLEN JEDNA WARSTWA WEWNĘTRZNA FILTRUJĄCA - 100% POLIPROPYLEN GUMKI ZAUSZNE - POLIESTER 70% / SPANDEX 30% Principal / Responsible person: Information given by the Principal Sample name: MEDICAL PROTECTION SP. Z O. O. SP. K. BIAŁY KAMIEŃ 2/U6, 02-593 WARSZAWA Comments on sample state / deviation: Volunteers group: Skin type: The test results refer only to the tested sample (06/10/20/D/8), for the composition and information provided responsibility lays on Principal. This report may not be reproduced in part. The responsibility of Skin Lab International Sp. z o.o. is limited only to the data contained in its original. The service confirmed by this report is subject to the General Terms and Conditions for Research Implementation available at www.skinlab.pl. Contact: Skin Lab International Sp. z o.o., Zacisze 6/7 St., 31-156 Kraków, tel: 797 700 986, 508 50
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REPORT FROM DERMATOLOGICAL TEST – h-RIPT* method Specialized Research Laboratory 1. BASIS FOR RESEARCH IMPLEMENTATION ▪ ▪ Order form and test samples delivered by Principal Confirmation of microbiological purity / microbiological insensitivity The Principal is responsible for compliance with the declared quality composition of the samples sent for testing. 2. PURPOSE OF RESEARCH Product evaluation in terms of irritating and sensitizing properties. 3. LEGAL BASE OF RESEARCH ▪ ▪ ▪ ▪ ▪ ▪ ▪ Regulation of the European Parliament and Council Regulation (EC) No 1223/2009 of November 30, 2009, relating...
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REPORT FROM DERMATOLOGICAL TEST – h-RIPT* method Specialized Research Laboratory 6. RESULTS 6.1. VOLUNTEERS IDENTIFICATION AND READINGS FROM THE TEST - POINT CLASSIFICATION RESULT SEX VOLUNTTER IDENTIFICATION NUMBER 6.2. IRRITATION INDEX (xśr) The average irritation index is calculated from the sum of the scores for erythema and edema. Based on the irritation index, the product is classified according to the scale. AVERAGE IRRITATION INDEX (xśr) PRODUCT CLASSIFICATION non-irritating slightly irritating moderately irritating strongly irritating sum of the scores Average irritation index for tested...
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REPORT FROM DERMATOLOGICAL TEST – h-RIPT* method Specialized Research Laboratory 7. CONCLUSION A dermatological study conducted on volunteers who were not allergic to any of the ingredients of the tested product confirms that the tested product is well tolerated by the skin, as it did not show any irritating or allergenic properties. The product can be classified as NON-IRRITATING. Aleksandra Dutka Junior Research Assistant Signed with qualified electronical signature Doctor of medicine Report approved by: DERMATOLOGIST AND VENEROLOGIST KR 5562935 Signed with qualified electronical signature...
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