Transepidermal water loss dynamics of human vulvar and thigh skin.

Refinement in procedures to assess skin surface water loss (SSWL) dynamics of the vulvar skin on a large sample of subjects (60) is described and compared to another semi-occluded skin site, the inner thigh. Vulvar SSWL significantly decreased over a 30-min period from 46.2 +/- 2.6 (SE) to 24.7 +/- 1.6 g m(-2) h (p < 0.001). The inner thigh, another semi-occluded region, showed no similar pattern for SSWL (6.2 +/- 0.3 to 6.6 +/- 0.5 g m(-2) h), and the values were significantly less than those for vulvar skin. There was no significant effect of age, body mass index or atopic status on vulvar SSWL.

The CTFA Evaluation of Alternatives Program: an evaluation of in vitro alternatives to the Draize primary eye irritation test. (Phase III) surfactant-based formulations.

The CTFA Evaluation of Alternatives Program is an evaluation of the relationship between data from the Draize primary eye irritation test and comparable data from a selection of promising in vitro eye irritation tests. In Phase III, data from the Draize test and 41 in vitro endpoints on 25 representative surfactant-based personal care formulations were compared. As in Phase I and Phase II, regression modelling of the relationship between maximum average Draize score (MAS) and in vitro endpoint was the primary approach adopted for evaluating in vitro assay performance. The degree of confidence in prediction of MAS for a given in vitro endpoint is quantified in terms of the relative widths of prediction intervals constructed about the fitted regression curve. Prediction intervals reflect not only the error attributed to the model but also the material-specific components of variation in both the Draize and the in vitro assays. Among the in vitro assays selected for regression modeling in Phase III, the relationship between MAS and in vitro score was relatively well defined. The prediction bounds on MAS were most narrow for materials at the lower or upper end of the effective irritation range (MAS = 0-45), where variability in MAS was smallest. This, the confidence with which the MAS of surfactant-based formulations is predicted is greatest when MAS approaches zero or when MAS approaches 45 (no comment is made on prediction of MAS > 45 since extrapolation beyond the range of observed data is not possible). No single in vitro endpoint was found to exhibit relative superiority with regard to prediction of MAS. Variability associated with Draize test outcome (e.g. in MAS values) must be considered in any future comparisons of in vivo and in vitro test results if the purpose is to predict in vivo response using in vitro data.

Talc: occurrence, characterization, and consumer applications.

Talc is a mineral compound with unique attributes and significant commercial importance. As used in consumer products, talc has a long and proven history of safe use. Direct consumer applications include body powders, other cosmetic formulations, pharmaceutical tableting, and some confectionery food products. Production, characterization, and consumer applications of FDA-regulated talc products, particularly cosmetics, are described. The implementation of stringent safety and quality control measures designed to ensure the absence of asbestos fibers from consumer talc products is discussed. Consumer exposure to talc-containing products is at least 350 times lower than permissible industrial exposure.

Evaluation of the cumulative (repeated application) eye irritation and corneal staining potential of FD&C yellow no. 5, FD&C blue no. 1 and FD&C blue no. 1 aluminium lake.

A protocol to evaluate the ocular irritation, staining, and embedding potential of FD&C colours (Yellow No. 5, Blue No. 1, Blue No. 1 Aluminium Lake) produced by repeated topical application to rabbit eyes is described. Test materials (3%, w/v in aqueous vehicle) were administered once daily, for a total of 21 days, to the conjunctival sac of the right eye of New Zealand White Rabbits (6 of each sex per group) at a dose volume of 30 microliters. Control animals (6 of each sex) received 30 microliters of the vehicle daily. All animals survived and were free of significant clinical signs of toxicity throughout the study. Ophthalmoscopic examinations revealed that all animals were free of abnormalities considered to be of clinical importance; all animals were free of significant signs of ocular irritation, staining and particle embedment. The results of this study support the safe use of these materials in consumer products intended for use in the eye area.