Final Report on the Safety Assessment of PPG-9, -25, and -40 Diethylmonium Chloride

Abstract

PPG-9, -25, and -40 Diethyhnonium Chloride are quaternary ammonium salts that function as antistatic agents in cosmetic formulations. Only PPG-9 and -25 Diethylmonium Chloride are reported to be used. Neither animal test data nor clinical test results were available. No data were provided in response to requests of interested parties to supply the needed data. Accordingly, the available data are insufficient to support the safety of these ingredients in cosmetics. The additional data needed include: (1) current concentration of use; (2) dermal absorption using PPG-9 Diethylmonium Chloride; if significantly absorbed, then a 28-day dermal toxicity study will be needed; (3) two genotoxicity assays, at least one in a mammalian system, of PPG-9 Diethyhnonium Chloride; if positive, then a 2-year dermal carcinogenicity study using NTP methods may be needed; (4) human skin sensitization and irritation at concentration of use; and (5) impurities data, especially nitrosamines. Depending on the findings in these studies, additional data such as reproductive and developmental toxicity may be needed.