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.

First tier modeling of consumer dermal exposure to substances in consumer articles under REACH: a quantitative evaluation of the ECETOC TRA for consumers tool.

The demonstration of safe use of chemicals in consumer products, as required under REACH, is proposed to follow a tiered process. In the first tier, simple conservative methods and assumptions should be made to quickly verify whether risks for a particular use are expected. The ECETOC TRA Consumer Exposure Tool was developed to assist in first tier risk assessments for substances in consumer products. The ECETOC TRA is not a prioritization tool, but is meant as a first screening. Therefore, the exposure assessment needs to cover all products/articles in a specific category. For the assessment of the dermal exposure for substances in articles, ECETOC TRA uses the concept of a 'contact layer', a hypothetical layer that limits the exposure to a substance contained in the product. For each product/article category, ECETOC TRA proposes default values for the thickness of this contact layer. As relevant experimental exposure data is currently lacking, default values are based on expert judgment alone. In this paper it is verified whether this concept meets the requirement of being a conservative exposure evaluation method. This is done by confronting the ECETOC TRA expert judgment based predictions with a mechanistic emission model, based on the well established theory of diffusion of substances in materials. Diffusion models have been applied and tested in many applications of emission modeling. Experimentally determined input data for a number of material and substance combinations are available. The estimated emissions provide information on the range of emissions that could occur in reality. First tier tools such as ECETOC TRA tool are required to cover all products/articles in a category and to provide estimates that are at least as high as is expected on the basis of current scientific knowledge. Since this was not the case, it is concluded that the ECETOC TRA does not provide a proper conservative estimation method for the dermal exposure to articles. An alternative method was proposed.

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.

Health impact assessment of a skin sensitizer: Analysis of potential policy measures aimed at reducing geraniol concentrations in personal care products and household cleaning products.

A methodology to assess the health impact of skin sensitizers is introduced, which consists of the comparison of the probabilistic aggregated exposure with a probabilistic (individual) human sensitization or elicitation induction dose. The health impact of potential policy measures aimed at reducing the concentration of a fragrance allergen, geraniol, in consumer products is analysed in a simulated population derived from multiple product use surveys. Our analysis shows that current dermal exposure to geraniol from personal care and household cleaning products lead to new cases of contact allergy and induce clinical symptoms for those already sensitized. We estimate that this exposure results yearly in 34 new cases of geraniol contact allergy per million consumers in Western and Northern Europe, mainly due to exposure to household cleaning products. About twice as many consumers (60 per million) are projected to suffer from clinical symptoms due to re-exposure to geraniol. Policy measures restricting geraniol concentrations to <0.01% will noticeably reduce new cases of sensitization and decrease the number of people with clinical symptoms as well as the frequency of occurrence of these clinical symptoms. The estimated numbers should be interpreted with caution and provide only a rough indication of the health impact.