Consumption and exposure to finished cosmetic products: A systematic review.

According to the European Regulation (EC) No. 1223/2009, cosmetic products should be safe for human health when used under normal or foreseeable conditions of use. To perform a safety evaluation, consumption data of finished cosmetic product are necessary to assess the corresponding consumer's exposure. The aim of this review was to highlight consumption (percentage of users, frequency of use, amount used, number of products daily used, types of products co-used …) and exposure data to cosmetic products available in the literature. A systematic approach was used following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines. Literature search was performed in February 2018 using Pubmed and Scopus databases. The following information was collected for the 82 publications included in this review: type of study, characteristics of the population (number, age, sex, region of origin), period of data collection, types of products studied, method(s) of data collection, consumption and/or exposure parameters obtained. Because of the high number of quantitative results obtained in the different studies, these data are not presented here. Readers interested in one or more studies are invited to consult the results available in the original publication(s). This work could be very useful for safety assessors or other persons working in the risk assessment field.

Consumption and exposure assessment to toothpaste in French families.

The aim of the study was to assess the consumption and the exposure to toothpaste in French families leaving the consumers free to use their own product at home according to their habits. Consumption data were collected on 104 families. 206 adults (103 women and 103 men) and 195 children aged 2-17 participated in the study. Differences in toothpaste consumption depending on gender and on age were highlighted. As an example, frequency data were higher in adult women (2.0 day-1 on average) than in adult men (1.8 day-1 on average); amount per use data were higher in adult men (1.2 g on average) than in adult women (0.9 g on average). The frequency of use and the amount of toothpaste used per application increased with age. The exposure to toothpaste decreased with age. Children aged 2-6 were the most exposed to toothpaste with a P95 value equal to 8.2 mg/kg bw/day. Adult's P95 exposure value was equal to 2.8 mg/kg bw/day. Exposure values were in the same order of magnitude for both genders in children and in adults. These new data will be useful for safety assessors, especially children data which remain scarce.

Chemical analysis and potential endocrine activities of aluminium coatings intended to be in contact with cosmetic water.

The objective of the work was to check the presence of Non-Intended Added Substances (NIAS) with hormonal activities in aluminium coatings extracts coded: AA, BBF, MC and RR, furnished by four different suppliers. Water samples were prepared at room temperature or at 40°C for three months to verify the storage effect on the coatings. Solid phase extraction was used to concentrate and to extract coating substances. Hormonal activities were checked in vitro using reporter gene bioassays. Except BBF, all extracts induced a weak but significant estrogenic agonist activity in the human cell line. Using an estrogenic antagonist (ICI-182, 780), the answer was demonstrated specific in the bioassay. RR was the only extract to induce a concentration dependent anti-androgenic response in the MDA-KB2 cell line. Analysis performed using GC-MS and HPLC-MS detected 12 substances in most of the extracts. 8 NIAS were present. Among them, 4 were identified with certainty: HMBT, BGA, DCU and BPA. Estrogenic potency was BPA>DCU>BGA>HMBT. HMBT was also anti-androgenic at high concentration. Combining chemical analysis and bioassays data, we demonstrated that in the RR and the RR40 extracts, the observed estrogenic response was mainly due to BPA, the anti-androgenic activity of RR could be due to a synergism between HMBT and BPA. For MC and AA, estrogenic responses appear to be due to the presence of DCU. Except BBF, storage conditions tended to increase estrogenic activities in all extracts. However, in term of risk assessment, activities observed were negligible. This work demonstrated that sensitive bioassays are pertinent tools in complement to chemical analysis to monitor and check the presence of NIAS with hormonal activity in coating extracts.

Consumption and exposure assessment to cosmetic products for children under 2 years old.

Today, the use of personal care products is an integral part of daily life. Little information about children's consumption and exposure to cosmetic products is available. The aim of the study was to assess the consumption and the exposure of French babies aged 0-23 months old to seven common baby care products: shampoo, shower gel, cleansing water, cleansing milk, moisturizing cream, bottom cream and wipes. Consumption and exposure were assessed using small age intervals in order to identify any differences. Exposure was calculated using a probabilistic method. These original data will be useful for safety assessors and safety agencies in order to protect consumers.

Baby care product development: artificial urine in vitro assay is useful for cosmetic product assessment.

As a result of infants' inability to control urination, the skin of the diaper area has special needs for protection from irritating effects of urine and prevention of diaper dermatitis such as products for cleansing and protection of the skin. Several in vitro models are currently available to assess tolerance. In vitro testing using artificial urine allows the protective effects of diaper-region cosmetics to be ascertained. Thus, a new model defined as "artificial urine in vitro assay" has been added to our traditional pre-clinical in vitro testing program. IL1-α is a highly active and pleiotropic pro-inflammatory cytokine. It plays a key role in inflammation and is the biological mirror of irritation induced by diaper dermatitis. This study determines, on human skin explants, if a cosmetic formula is (1) tolerated equally as well in the presence of artificial urine as in its absence and (2) is able to decrease IL1-α production induced by artificial urine or Sodium Dodecyl Sulfate. 31 tests including 17 in-house formulas, 10 bench-markers and 4 combinations of products were performed and data obtained are represented on a simple four-point scale (from practically non protective to very protective). It allows determination of formula-type groups that will have predictable protective properties in subsequent clinical trials and comparison with competitors' products. It is a useful aid in the formulation stage and provides readily-useable data for the cosmetic risk assessment.

Retrospective exposure data for baby and children care products: an analysis of 48 clinical studies.

To conduct a reliable safety assessment, accurate exposure information for cosmetic products and ingredients is needed. The aim of the present retrospective study was to determine the amount per application and the daily exposure for some of the most commonly used baby cosmetic products. Consumption data from 48 clinical studies performed on 1481 babies and children (from 0 to 10 years old) were reviewed and used to conduct a probabilistic evaluation of dermal exposure. Six categories of products were reviewed: rinseoff products for hair and body; rinse-off products for the whole body; leave-on products for face and body; cleansers for face and body; diaper dermatitis treatment products; shampoos. Subjects were provided with products and recorded detailed daily usage information over a 1-4-week period, depending on the study. Products were weighed at the start and upon completion of each study in order to determine the total amount of product used. The mean, median, standard deviation and 95th percentile were calculated for daily consumption and exposure, for several age groups from 0 to 10 years old. This study provides current baby cosmetic exposure information for commonly used products which will be useful for risk assessment purposes.