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Updated: Jul 21, 2026

An In Vitro Skin Irritation Test (SIT) using the EpiDerm Reconstructed Human Epidermal (RHE) Model
Published on: July 14, 2009
Population differences in acute skin irritation responses. Race, sex, age, sensitive skin and repeat subject
1The Procter & Gamble Co., Miami Valley Laboratories, Cincinnati, OH 45253-8707, USA.
Abstract:
The variability in human skin irritation responses has been well documented and can confound our ability to accurately assess differences in skin reactivity between human subpopulations. In the current analysis, results were compiled from nine acute irritation patch test studies, conducted at three test facilities over a 5-year period. Four irritant test chemicals, 20% sodium dodecyl sulphate, 100% decanol, 100% octanoic acid and 10% acetic acid, were tested in sufficient numbers of test subjects to enable the stratification of results for different human subpopulations. An increased reactivity was noted for Asian versus Caucasian subjects for each of three test chemicals, in contrast to the previously described individual study results from which these data were drawn. Male subjects were directionally or significantly more reactive to each of the test chemicals than female subjects. The oldest age cluster of subjects (56-74 years of age) was directionally or significantly less reactive than younger age clusters. There was virtually identical reactivity between self-assessed 'sensitive' and normal skin groups. Lastly, there was little correlation between the results from individual subjects tested in two or more studies with the same chemicals. These results add to our general understanding of population differences in skin reactivity and the potential implications for ingredient and product skin safety testing and risk assessment.

