title: Population differences in acute skin irritation responses. Race, sex, age, sensitive skin and repeat subject comparisons.
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.
authors.affiliation: The Procter & Gamble Co., Miami Valley Laboratories, Cincinnati, OH 45253-8707, USA.
authors.forename: Michael K
authors.initials: MK
authors.lastname: Robinson
mesh_terms: D019342:Acetic Acid / Q000009:adverse effects; D000328:Adult; D000367:Age Factors; D000368:Aged; D001213:Asian / Q000706:statistics & numerical data; D002210:Caprylates / Q000009:adverse effects; D017449:Dermatitis, Allergic Contact / Q000208:ethnology / Q000209:etiology*; D005233:Fatty Alcohols / Q000009:adverse effects; D005260:Female; D006801:Humans; D007509:Irritants / Q000009:adverse effects*; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D010328:Patch Tests; D012307:Risk Factors; D012737:Sex Factors; D012967:Sodium Dodecyl Sulfate / Q000009:adverse effects; D044465:White People / Q000706:statistics & numerical data
chemical_list: D002210:Caprylates; D005233:Fatty Alcohols; D007509:Irritants; D012967:Sodium Dodecyl Sulfate; C029383:n-decyl alcohol; C031492:octanoic acid; D019342:Acetic Acid