Determinations of Potential Ingredient Toxicology.
Safety evaluations take into consideration a number of key factors including cosmetic ingredient function and use concentration; degree of chemical purity and stability; and potential for ingredients to be absorbed through the skin and/or mucous membranes, or via oral ingestion or inhalation. Assessment for potential adverse effects includes: evaluation of exposure to ingredients for short, intermediate or long periods of time (acute, subchronic, and chronic systemic toxicity); skin irritation; skin allergy; photoirritation; photoallergy; and determination of the potential for ingredients to adversely affect the body´s genetic material (genotoxicity), cause cancer (carcinogenicity), or negatively effect reproduction and fetal development.Evaluation & Testing of Human Health Impacts.
Following a thorough review of each ingredient in a cosmetic formulation, additional safety data on the finished product are reviewed. These may include cell culture (in vitro) and clinical (human) tests conducted on the final product and on products similar in composition to the product being evaluated. The potential for ingredient interactions within the product leading to unexpected adverse effects also is evaluated. Confirmatory testing of product compatibility and acceptability on human volunteers (clinical testing) is often undertaken with informed consent and with the appropriate safeguards to detect any undesirable effects that could occur.
Examination of Cumulative Exposure to the Human Body.
Typical consumers use multiple cosmetic and personal care products each day. Therefore, assessment of cumulative exposure to product ingredients from multiple sources is an important component in the overall assessment of product safety. In this regard, it is also important to take into account inadvertent (secondary) exposures (e.g. inhalation with hair spray use or ingestion from lipsticks, etc.).Factors to be considered in determining exposure levels for products and ingredients include product type, amount used per application, frequency of application, site of body contact, duration of product contact, concentration of individual ingredients in the final product, use by sensitive subpopulations (i.e., babies, the elderly, pregnant women), method of application, external factors (i.e., sunlight exposure, variation in use related to weather, local or temporal habits and trends, and cultural considerations), and possible conditions of foreseeable misuse.
