Quantitative risk assessment of the aggregate dermal exposure to the sensitizing fragrance geraniol in personal care products and household cleaning agents.

A quantitative risk assessment was performed to establish if consumers are at risk for being dermally sensitized by the fragrance geraniol. Aggregate dermal exposure to geraniol was estimated using the Probabilistic Aggregate Consumer Exposure Model, containing data on the use of personal care products and household cleaning agents. Consumer exposure to geraniol via personal care products appeared to be higher than via household cleaning agents. The hands were the body parts receiving the highest exposure to geraniol. Dermal sensitization studies were assessed to derive the point of departure needed for the estimation of the Acceptable Exposure Level (AEL). Two concentrations were derived, one based on human studies and the other from dose-response analysis of the available murine local lymph node assay data. The aggregate dermal exposure assessment resulted in body part specific median exposures up to 0.041 µg/cm(2) (highest exposure 102 µg/cm(2)) for hands. Comparing the exposure to the lowest AEL (55 µg/cm(2)), shows that a range of 0.02-0.86% of the population may have an aggregated exposure which exceeds the AEL. Furthermore, it is demonstrated that personal care products contribute more to the consumer's geraniol exposure compared to household cleaning agents.

Aggregate exposure assessment using cosmetic co-use scenarios: II. Application and validation for phthalates.

Aggregate exposure assessments using co-use scenarios could provide more realistic estimations than single product exposure assessment. Co-use scenarios for cosmetic products were determined from a ranking of the frequency of occurrence of co-use patterns and the number of cosmetics used. We conducted aggregate exposure assessments using the co-use scenarios and validated the new methodology by comparing the results to those of a receptor-based aggregate exposure assessment. The aggregate exposures of di(2-ethylhexyl)phthalate (DEHP), di-n-butyl phthalate (DnBP) and diethyl phthalate (DEP) in cosmetics were estimated by co-use scenarios for cosmetics. The co-use scenario-based AED increased with the number of cosmetics in the co-use scenarios, and was higher in female and younger groups. The major contributors in females were facial cream for DEHP, nail polish for DnBP, and shower cologne or perfume for DEP. The major contributors in males were body lotion for DEHP, facial sunscreen for DnBP, and hair styling product for DEP. The distribution of the co-use scenario based AEDs displayed a similar trend to that of the receptor-based AEDs, with the 95th percentiles of the AED slightly underestimated in the co-use scenario. The applied methodology could provide reasonable aggregate exposures with relatively few resources required.

Skin sensitisation quantitative risk assessment (QRA) based on aggregate dermal exposure to methylisothiazolinone in personal care and household cleaning products.

Contact allergy to preservatives is an important public health problem. Ideally, new substances should be evaluated for the risk on skin sensitisation before market entry, for example by using a quantitative risk assessment (QRA) as developed for fragrances. As a proof-of-concept, this QRA was applied to the preservative methylisothiazolinone (MI), a common cause of contact allergy. MI is used in different consumer products, including personal care products (PCPs) and household cleaning products (HCPs). Aggregate exposure to MI in PCPs and HCPs was therefore assessed with the Probabilistic Aggregated Consumer Exposure Model (PACEM). Two exposure scenarios were evaluated: scenario 1 calculated aggregate exposure on actual MI product concentrations before the restricted use in PCPs and scenario 2 calculated aggregate exposure using the restrictions for MI in PCPs. The QRA for MI showed that in scenarios 1 and 2, the proportion of the population at risk for skin sensitisation is 0.7% and 0.5%, respectively. The restricted use of MI in PCPs does not seem very effective in lowering the risk on skin sensitization. To conclude, it is important to consider aggregate exposure from the most important consumer products into consideration in the risk assessment.