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Non-Animal Testing Strategy for Safety Assessment of Cosmetic Products

Non-Animal Testing Strategy for Safety Assessment of Cosmeti...

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中国毒理学会第七次全国毒理学大会暨第八届湖北科技论坛

作者： Xuejun Yin Alphonsus Dang Oven Yuan Jenny Jiang cristi gomez Department of Product Safety Mary Kay Inc. Department of Medical Affairs Mary Kay(China) Cosmetics Co.Ltd

For over twenty-five years,non-animal testing（NAT） strategy has been routinely used as a reliable and the only approach for safety assessment by many cosmetic companies in the U.S and much of industry around the *** integrated strategy mainly consists of three sequential review and approval processes,namely,ingredient review,preclinical assessment,and clinical ***,all new ingredients have to go through an approval process that requires safety data collected from literature and suppliers and that generated by various alternatives to animal testing（AAT）.During the formulation development,AAT in lieu of traditional animal testing is extensively used to provide preclinical information on mildness and usability of the *** others,EpiOcular assay and bovine corneal opacity and permeability（BCOP） assay（for ocular irritation）,EpiDerm assay（for dermal irritation）,and 3T3 neutral red uptake assay（for phototoxicity） are the most commonly used AAT *** formulas,identified by the AAT,will be further tested in clinical studies including facial/eye sting/discomfort test（for sensory irritation）,48-hour skin patch or 14-day cumulative skin irritation test（for primary irritation）,repeated insult patch test（RIPT,for dermal irritation and sensitization） and safety in-use study（overall evaluation under "real-world" use） among *** studies are performed by experienced study directors with or without supervision of a board-certificated dermatologist or *** assure the best suitability of the products to certain groups of consumers,many such studies are conducted in groups of specific panelists such as those having sensitive skin/eyes or wearing contact *** are also often tested in panelists selected from different cultural and genetic backgrounds to reach the best suitability of a product to a given *** from traditional safety assessment that relies heavily on animal testing,the NAT strategy uses AAT d

关键词： Alternative Animal Testing EpiOcular BCOP EpiDerm

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Application of the KeratinoSens assay to prediction of dermal sensitization hazard for botanical cosmetic ingredients

Application of the KeratinoSens assay to prediction of derma...

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中国毒理学会第六届全国毒理学大会

作者： David GAN Kimberly NORMAN Nicole BARNES Hans A.RAABE cristi gomez Xuejun J.YIN John HARBELL Mary Kay Inc.

OBJECTIVE The goal of the study was to determine the potential for the KeratinoSens assay to identify electrophile allergens within a botanical extract *** In the KeratinoSens assay,the induction of a luciferase gene under the control of the antioxidant response element(ARE) derived from the human gene AKR1C2 gene is *** parallel,cytotoxicity is assessed by both Neutral Red Uptake(NRU)and MTT *** samples included gluteraldehyde(GA),dimethyl maleate(DM)and cinnamic aldehyde(CA)spiked into four different botanical extracts(including different excipient solvent systems).Test concentrations ranged up to 1 g·L(of complete extract)and a test concentration was considered positive if the relative viability was≥70%and the fold induction of luciferase was 1.5x relative to the solvent *** was measured relative to the EC1.5 of the neat sensitizer as a function of sensitizer concentration and extract *** independent trials were performed on each test *** No appreciable cytotoxicity was observed with any of the *** spiked at 1%to 2%were sufficient to induce a positive up regulation of the ARE below the maximum test material concentration of up to 1 g·*** responses occurred at cell survivals well in excess of 70%.The botanical matrix impacted recovery for both gluteraldehyde and dimethyl maleate *** recovery of the GA spike required at least a -3 fold increase in concentration relative to the chemical alone and botanical extract #3 reduced the activity below *** DM and CA showed activity at about the same effective concentrations as the neat chemical although the DM showed reduced activity in botanical extract #3 as *** These data suggest that the KeratinoSens assay has the potential to identify electrophile allergens within a botanical extract matrix.

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Comparisons of prevalence of sensitive skin in populations from United States and China

Comparisons of prevalence of sensitive skin in populations f...

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中国毒理学会第六届全国毒理学大会

作者： Xuejun J YIN CHEN Wei CHEN Jie Josh A.LAUDRILLE Alphonsus H.DANG JIANG Yi-hong cristi gomez Mary Kay Inc. Mary Kay(China)Cosmetics Co.Ltd

＜正＞OBJECTIVE This study evaluates prevalence and characteristics of sensitive skin in the United States and China,compares data collected from the two countries and two methods,and examine possible factors that may be associated with sensitive *** A self-assessed questionnaire was answered by each of 1626 women and 165 men from the United States and 649 women and 143 men from China,randomly selected,who were over the age of 18 years old and lived in Greater Dallas area,TX,USA and Shanghai,China,*** US subjects consisted of 22.5%African Americans,7.1%Asians,57.3%Caucasians,10.9%Hispanic,and2.1%"Others" which was defined by unknown or unreported *** survey required subjects to identify whether or not they perceived their skin to be *** a diagnostic test was performed on all selected subjects with 10% aqueous lactic acid at two test facilities（Richardson,TX and Shanghai,China）.Positive results of the test are an indication for clinically-diagnosed sensitive *** Twenty nine percent of the US subjects including 29%of women and 25%of men described themselves as having sensitive *** had the highest incidence of self-perceived sensitive skin（48%）,followed by African Americans （30%,P＜0.01）,Caucasians（28%,P＜0.01）,"Others"（26%,P＜0.01）,and Hispanic（20%, P＜0.01）.The 30 s and 40 s age groups reported slightly heightened incidences of sensitive skin compared to other age clusters（30%-31%vs.24%-28%）.Subjects with light and dark skin reported a similar incidence of sensitive skin（35%and 36%） and both were significantly higher than that for medium skin tone subjects（P＜0.01）.Incidence of self-perceived sensitive was reported the highest in dry skin subjects（53%） and lowest in normal skin subjects（23%）.Results of the lactic acid test indicated that 57%of the US subjects had clinically diagnosed sensitive *** of sensitive skin in women was slightly but significantly higher than that in men（57%vs.55%,P＜0.01）.Asians a

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