Edgewell Personal Care (United States)

A comprehensive review of existing toxicity and human exposure data for the ultraviolet filter avobenzone (butyl methoxydibenzoylmethane) was conducted to assess its safety as currently used in over-the-counter sunscreen formulations. Avobenzone has a suitable safety profile without any clear markers of toxicity or endpoints of concern. There are sufficient clinical studies and in vitro and in vivo toxicity studies in animal models to assess avobenzone’s pharmacokinetics, pharmacodynamics, and potential toxicological properties, supportive of its long history of safe use. No harmonized dermal absorption value was available, but the clinical data indicate low percutaneous absorption of avobenzone in humans (≤0.59% of the applied dose). There were no data to characterize the distribution of avobenzone; however, four tentative metabolites of avobenzone have been identified, and limited excretion in urine was demonstrated in human biomonitoring studies. Avobenzone generally did not cause dermal irritation or sensitization, but indications of photoallergy have been reported in clinical case studies. The acute toxicity profile indicated that avobenzone has minimal toxicity. The no-observed-adverse-effect level (NOAEL) for general toxicity from a rat dietary subchronic toxicity study was 450 mg/kg/day. There was no evidence of avobenzone effects on immune tissues or the estrogen, androgen, or thyroid systems. Although there were no formal 2-year carcinogenicity studies for avobenzone, a 90-day dietary exposure study in rats did not show any increase in hyperplasia of any tissue or evidence of cytotoxicity, and avobenzone has not shown any indication of genotoxicity either in vitro or in vivo. Together, this indicates that key events for modes of action for avobenzone are absent and carcinogenicity in humans is unlikely. Based on the selected rat subchronic NOAEL and conservative assumptions for estimating the systemic exposure dose (SED) from the application of sunscreen products, margins of exposure (defined as the ratio of NOAEL to SED) greater than 100 were obtained for avobenzone. Therefore, the available data show that avobenzone is unlikely to pose a risk to human health when used in sunscreen products at concentrations up to the permitted maximum usage levels in the United States and Canada, which is 3%.

With increasing concern over the environmental safety of cosmetic and personal care product ingredients discharged to the aquatic environment, a need to evaluate the risk of recreational ultraviolet filter (UVF) emissions in coastal marine environments has grown in prominence. A commonly used UVF, octocrylene (OC), has been detected in several monitoring studies of coastal environments, emphasizing the need for a marine environmental safety assessment. A review of the literature identified that there is a paucity of reliable marine chronic toxicity data available to generate toxicological thresholds for OC. While leveraging freshwater data is possible, this results in the incorporation of significant uncertainty in the assessment as key marine taxa (such as echinoderms, mollusks, or cnidarians) cannot be suitably represented. To help remedy this, U. S. Environmental Protection Agency Test Method 1008.0 (Sea urchin, Arbacia punctulata, Fertilization Test) was conducted to evaluate the chronic toxicity of OC on sea urchins. All test acceptability criteria were met, and concentrations of OC were adequately maintained in the test system. The resultant fertilization 10% effect concentration was 41.5 µg/L, indicating that A. punctulata fertilization is less sensitive to OC exposure than freshwater invertebrate reproduction results to date. This data point serves to further the octocrylene marine chronic ecotoxicological profile, but ultimately more data are needed prior to conducting a robust environmental safety assessment.

Generally speaking, when people talk about "hair breakage" they are typically referring to the idea that as they comb or brush their hair, the fibers are elongating and snapping at some weak point in the fiber length. It is well established that as people chemically treat their hair, the keratin proteins are degraded further and the hair become more brittle and susceptible to breakage. For the consumer, hair breakage is registered as hair fibers noted in their comb or brush, and in the drain that they see after a cosmetic treatment. However, a fundamental question that needs to be asked is whether or not the hairs that are seen in the drain are really the result of hair breakage (i.e., a fiber snapping) or are they the result of hairs that are actually being extracted from the scalp by their root bulbs. If the bulk of the hair fibers are actually extracted by the bulb, than it seems somewhat superfluous to try and improve hair strength by improving the exterior of the fiber. The fiber is dead and topical treatments can only smooth, and possibly moisten already established fiber structure and integrity. This paper will attempt to address hair strength by looking at the scalp and follicle as the target for treatment, showing that topical application of a product containing a blend of well-known skin active ingredients can demonstrate potential reductions in hair extractions. An in vivo testing protocol in which 15 voluntary participants with at least 12" hair length were professionally shampooed, and then treated, half-head, with a commercial conditioner, or the same conditioner that contained 5% of a mixture of yeast peptides, fruit acids and green tea polyphenols every day for five days will be discussed. At the beginning and end of the treatment period, the number of hairs that either broke along the fiber, or extracted by the bulb were gathered, separated and counted for both the treated and untreated side of the head. The results of this one-week study demonstrate that the number of hairs that actually break pales in comparison to the number of hairs that are extracted complete with intact root bulb from the follicle.