AMENDED FINAL REPORT Safety Assessment of PPG-9-Buteth-12, PPG-12-Buteth-16, PPG-26-Buteth-26, and PPG-28-Buteth-35 ABSTRACT

PPG12-Buteth16, PPG-9-Buteth12, PPG-26-Buteth-26, and PPG-28-Buteth-35 are polyoxypropylene, polyoxyethylene ethers of butyl alcohol that function as hair conditioning agents, miscellaneous skin conditioning agents, surfactant/emulsifying agents. In addition, PEG-12-Buteth-16 is used as a solvent in cosmetic formulations. This latter ingredient is used at concentrations up to 31% in hair grooming aids (e.g., hair tonics), 1-4% in shampoos, and less than 1% in other types of cosmetics. PPG-28-Buteth-35 is used at concentrations up to 1% in shampoos. Uses in cosmetic products have been reported for PPG-9-Buteth-12 and PPG-26-Buteth-26, but no current concentration of use data are available. All of the PPG Buteths in this safety assessment are highly water soluble and have molecular weights above 1000. Very little acute toxicity was seen in rats, mice, and rabbits with oral exposure to various PPG Buteths. Some deaths were seen in acute dermal toxicity studies in rabbits using various PPG Buteths, but even the surviving animals exhibited erythema, edema, ecchymosis, and desquamation. Acute, short-term, and subchronic inhalation studies with various PPG Buteths were negative as well. Hepatic and renal lesions were observed in subchrenic oral toxicity studies of PPG-24-Buteth-27 and PPG-33Buteth-45 in rats. In a chronic feeding study involving rats and one involving dogs, no significantly different incidence of neoplasms or other lesions were seen with PPG-7-Buteth10 and PPG-33-Buteth45. While PPG-24-Buteth-27 produced mild ocular toxicity, mixed results were seen with PPG-26Buteth-26, and no irritation with several other PPG Buteths. PPG Buteths produced skin irritation in animal tests. In two lifetime skin painting studies in mice, PPG-7-Buteth-10 and PPG-33-Buteth-45 did not induce papillomas or carcinomas. Some evidence was found that PPG-24-Buteth-27 could act as a tumor promotor, but only at high concentrations. Clinical testing of PPG-26-Buteth-26 produced no skin irritation or sensitization. Clinical testing of PPG-12-Buteth-16 likewise produced no skin irritation or sensitization. Based on its large molecular weight alone, it is unlikely that PPG-28-Buteth-35 would be associated with any skin irritation or sensitization. PPG-9-Buteth-12 has a lower molecular weight than the PPG Buteths for which there has been shown an absence of skin sensitization and irritation, but it is highlysolubleinwaterandhasamolecularweightoverlO00. Thesefactorssuggestthatskinabsorption would be very limited and it would be unlikely that PPG-9-Buteth12 would produce skin irritation or sensitization. Because PPG Buteths are butanol-initiated random linear copolymers, there is a concern that a reproductive and developmental toxin, n-butyl alcohol could be present. Data were provided showing the absence of n-butyl alcohol in PPG-26-Buteth.26 from which it may be inferred that this compound is not found in other PPG Buteths. Based on the available data, it may be concluded that PPG-12-Buteth-16, PPG-9-Buteth-12, PPG-26-Buteth-26, and PPG-28-Buteth-35 are safe as used in cosmetic formulations.