ABSTRACT
The first step in regulatory evaluation of substances involves the identification of their intrinsic hazards, including the potential for skin sensitization. This is, quite properly, entirely different from assessment of the risks to human health, which might arise from incorporation of substances in products. EU guidance on regulations concerning the classification of skin sensitizers suggests a range of sources of information be deployed in the hazard identification process. These include chemical structure, predictive animal tests, and various types of human data. Where the information is clear-cut, then uncertainties rarely arise. However, for some materials, discordant information arises, perhaps because the substance is on the borderline of test sensitivity and classification (sensitizing materials of insufficient potency do not classified according to the EU scheme), due to conflicting results in predictive tests or for other reasons. In this study, we review data on a number of substances where a classification decision is complicated by such discordances and seek to use these examples to demonstrate how best to make a weight of evidence decision on whether a substance should, or should not, be classified as a skin sensitizer.
Subject(s)
Allergens/classification , Dermatitis, Allergic Contact/diagnosis , Allergens/adverse effects , Animals , Benzalkonium Compounds/adverse effects , Betaine/adverse effects , Betaine/analogs & derivatives , Cyclohexenes/adverse effects , Dermatitis, Allergic Contact/etiology , False Negative Reactions , False Positive Reactions , Humans , Limonene , Nitriles/adverse effects , Parabens/adverse effects , Preservatives, Pharmaceutical/adverse effects , Sodium Dodecyl Sulfate/adverse effects , Solvents/adverse effects , Sulfanilic Acids/adverse effects , Surface-Active Agents/adverse effects , Terpenes/adverse effectsABSTRACT
We report on a single case of a lichen planus like contact dermatitis caused by colour developers. We emphasize similarities to lichen planus with regard to clinical, histopathological and immunohistological aspects.
Subject(s)
Dermatitis, Contact/diagnosis , Dermatitis, Occupational/diagnosis , Lichen Planus/chemically induced , Phenylenediamines/adverse effects , Photography , Sulfonamides/adverse effects , Adult , Dermatitis, Contact/pathology , Dermatitis, Occupational/pathology , Humans , Lichen Planus/diagnosis , Lichen Planus/pathology , Male , Patch Tests , Structure-Activity Relationship , Sulfanilic Acids/adverse effects , Toluene/adverse effects , Toluene/analogs & derivativesABSTRACT
The effects of sulfanilic acid, a major azo food dye metabolite, were studied in normal developing rat pups and pups treated with 6-hydroxydopamine (60HDA). Chronic daily intraperitoneal injection of sulfanilic acid during the first postnatal month elicited hyperactivity and impaired shock escape performance in vehicle pups. No differences were noted in 60HDA treated rat pups receiving sulfanilic acid. These findings, which are similar to the results of our study of chronic administration of a food dye mix, suggest that sulfanilic acid may be one of the causative agents in food dye-induced behavioral changes in developing rats. While our work suggests a significant effect of azo food dyes on the developing rat central nervous system, species differences in parameters such as absorption, metabolism, and blood-brain barrier properties do not permit any extrapolation of these observations to proposed effects in children.
