Risk assessment cosmetics

The foregoing discussion indicates that choice of an appropriate experimental model (one based on anticipated enviromnental exposure conditions or exposure during accidental or deliberate product use) is probably the most important aspect of the design of in vitro skin pmetration studies for risk assessment and will have a direct impact on the applicabihty of resultant data for use in environmental contaminants and cosmetic risk assessment Careful consideration of individual protocol elemmts will greatly enhance the quality of results, their usefulness in the prediction of skin pmetration in vivo, and the assessment of risk following actual human exposure. 

Gettings, S.D., Howes, D., and Walters, K.A. (1998). Experimental design considerations and use of in vitro skin penetration data in cosmetic risk assessment, in M.S. Roberts and K. A. Walters (eds.). Dermal Absorption and Toxicity Assessment, New York Dekker, pp. 459-487. 

Substances that are used only to formulate cosmetics or to manufacture food-packaging materials are dual regulated they still have to be registered under REACH, although they are subject to separate EU measures that involve an evaluation of their safety to humans. Hence, in order to avoid duplication of work, the REACH CSR only has to include an environmental risk assessment. 

In order to reduce animal testing under REACH, and also because of the ban on the marketing of cosmetic products/ingredients tested on animals, a broader strategy for risk assessment has been suggested. One element suggested in this strategy is the TTC concept. 

Chapter 5 of the document reviews the UFs used by UK Government departments, agencies, and their advisory committees in human health risk assessment. Default values for UFs are provided in Table 3 in the UK document with the factors separated into four classes (1) animal-to-human factor, (2) human variability factor, (3) quality or quantity of data factor, and (4) severity of effect factor. The following chemical sectors are addressed food additives and contaminants, pesticides and biocides, air pollutants, drinking water contaminants, soil contaminants, consumer products and cosmetics, veterinary products, human medicines, medical devices, and industrial chemicals. 

Geiwitz, James. THC in Hemp Foods and Cosmetics The Appropriate Risk Assessment. Obtained May 2002 from Canadian Ad Hoc Committee on Hemp Risks, www.industrrialhemp.net. 

MUNRO, I.C. and KREWSKI, D.R. (1981). Risk assessment and regulatory decision making, Food Cosmet. Toxicol. 19, 549-560. 

Koo H and Lee B (2004) Estimated exposure to phthalates in cosmetics and risk assessment. Journal of Toxicology and Environmental Health A 67(23-24) 1901-1914. 

See also Delaney Clause Food, Drug, and Cosmetic Act, US Food Quality Protection Act, US Good Laboratory Practices (GLP) Levels of Effect In Toxicological Assessment Pesticides Pharmacokinetics/Toxicokinetics Risk Assessment, Ecological Risk Assessment, Human Health Risk Characterization Toxicity Testing, Alternatives Uncertainty Analysis. 

See also Cosmetics and Personal Care Products Photoallergens Risk Assessment, Human Health Skin. 

Safety Commission Consumer Products Copper (Cu) Corrosives Corticosteroids Cosmetics and Personal Care Products Cotinine Coumarins Creosote Cresols Cromolyn Cumene Cumulative Risk Assessment Cyanamide Cyanide Cyanogen Chloride Cyclodienes Cyclohexamide Cyclohexane Cyclohexene Cyclophosphamide Cyclosporine Cyfluthrin Cypermethrin Cysteine Cytochrome P-450 "2,4-D (2,4-Dichlorophenoxy Acetic Acid)" Limonene Dalapon DDT/DDE/DDD Decane DEBT (Diethyltoluamide) DEE Deferoxamine DEHP (Di-Ethyl Hexyl Phthalate) Delaney Clause Deltamethrin Deodorants Detergent Developmental Toxicology Dextromethorphan Diazepam Diazinon Diazoxide Dibenzofuran " Dib enz [a, h] anthracene" Dibromochloropropane Dibutyl phthalate Dicamba Dichlone Dichlorobenzene Dichloroethanes "Dichloroethylene, 1,1-"... 

The probability and route of exposure of humans to a chemical are crucial parameters in risk assessment. By definition, in an extreme case where the probability of exposure is null, the risk is null. Thus, there is a considerable difference in the regulatory requirements for safety assessment of industrial chemicals and environmental contaminants that result in accidental exposures compared to chemicals designed for intentional exposure of the population, like cosmetics and pharmaceuticals. Each one of these categories is subjected to specific European laws. 

Food Safety Council, Scientific Committee, Quantitative risk assessment, in, Proposed System for Food. Safety, Assesament 1978, Food and Cosmetics Toxicology.16. Supplement 2, 109-136. 

Scientific Committee, Food Safety Council Genetic Toxicology Food Cosmetic Toxicology 18, 683-710 Quantitative Risk Assessment, ibid. 711-734(1980). 

It is interesting to note that, despite their widespread use and excellent safety profile, there is an increasing interest in the potential systemic exposure to preservatives following application in pharmaceutical and cosmetic products. In many cases, however, skin penetration data for preservatives are not available in the literature. In addition, much of the data that are publicly available have been obtained under conditions inappropriate to risk assessment. By far the most available data concerns the parabens. 

---