Affiliation:
1. Procter & Gamble Technology (Beijing) Co., Ltd. Beijing China
2. Procter & Gamble Services NV Strombeek‐Bever Belgium
3. Procter & Gamble Mason Business Center Mason Ohio USA
Abstract
AbstractBackgroundSafety‐in‐use (SIU) studies are commonly used by the cosmetic Industry to confirm the skin and ocular compatibility of cosmetic products under realistic in–use conditions. There are only limited case studies published about the design, outcome and interpretation of product SIU studies.ObjectiveA series of SIU case studies is presented to demonstrate the considerations in study design and how the methodology can help in supporting skin and ocular safety profile of facial cosmetic products within a population of different ethnicities with normal and self‐perceived sensitive skin.Subjects/MethodsIn a series of four single‐blinded SIU studies, more than 250 female study subjects of different ethnicities and with normal and self‐assessed sensitive skin were asked to use different facial cosmetic products including lotions, essences and cleansers according to the instructed usage conditions of these products. Each study was specifically designed according to product usage scenarios and target consumer groups. The primary measures of safety were based on dermal evaluations by a dermatologist for erythema and dryness/scaling and by an ophthalmologist for any visible signs of an ocular condition on eyelids, conjunctivae and cornea. The study subjects were also asked for any self‐perceived skin or eye reactions. Dermal and ocular irritation potential of the products under realistic product usage conditions was evaluated according to the measures.ResultsAcross all studies, objectively and self‐assessed mean scores for skin and eye effects did not indicate any cumulative response of the investigated products over the study period.ConclusionsAs a suitable tool for assessing and establishing the skin and eye compatibility of facial cosmetic products, SIU studies can be designed according to specific consumer groups, skin types and product usage scenarios to better predict realistic in‐use conditions. It can demonstrate the safe use of the investigated products for people of different ethnicities, skin types and with normal or self‐assessed sensitive skin, single product use or regimen use. The test results are consistent with the inherently low irritation potential of the products.
Reference17 articles.
1. Regulation (Ec) No 1223/2009 Of The European Parliament and of the Council Of 30 November 2009 On Cosmetic Products.2009.
2. BernauerU BodinL ChaudhryQ CoenraadsPJ GoetzNV.The SCCS notes of guidance for the testing of cosmetic ingredients and their safety evaluation – 11th revision ‐ SCCS/1628/21.2021.
3. SCCNFP.Opinion concerning guidelines on the use of human volunteers in compatibility testing of finished cosmetic product adopted by the SCCNFP during the plenary session of 23 June 1999.1999.
4. SCCNFP.Basic criteria of the protocols for the skin compatibility testing of potentially cutaneous irritant cosmetic ingredients or mixtures of ingredients on human volunteers.1999.
5. CE.Product test guidelines for the assessment of human skin compatibility.1997.