2: Final Report on the Safety Assessment of Quaternium-15

Abstract

Quaternium-15 is used as an antimicrobial preservative in cosmetic products at concentration ranges from ≤0.1 to 1%. The cosmeticingredient is not absorbed through human skin in significant amounts. Animal toxicity studies indicate that Quaternium-15 is mildly to moderately toxic depending on animal species, concentration, and route of exposure. Testicular atrophy and decreased spermatogenesis in immature rabbits were reported in one subchronic dermal study. Orally administered Quaternium-15 was teratogenic in rats when given by gavage to pregnant dams in doses ≥25 mg/kg per day. No teratogenic effects were observed at doses of 5 mg/kg per day. Dermally applied Quaternium-15 did not produce maternal toxicity, fetal toxicity, or fetal abnormalities at doses up to and including 500 mg/kg per day. No testicular effects were produced by Quaternium-15 in three subsequent studies on mature rabbits. Quaternium-15 was a moderate skin irritant in test animals at concentrations above 5%. Quaternium-15 was not a significant eye irritant in rabbits. Animal sensitization studies with Quaternium-15 produced conflicting results depending on the test methodologies used. Quaternium-15 does not appear to possess significant mutagenic activity. Primary irritation studies on Quaternium-15 in inert vehicles and formulations indicate that Quaternium-15 is not a primary skin irritant in humans. Quaternium-15 in inert vehicles may be a human sensitizer in some clinical patients. The sensitization potential of the preservative was much less pronounced when cosmetic products were tested on nonclinical subjects. Quaternium-15 may exhibit cross-sensitization with formaldehyde. Quaternium-15 is not a significant photosensitizing agent. Although Quaternium-15 is a potential skin sensitizer, it is concluded that Quaternium-15 is safe as a cosmeticingredient at concentrations not exceeding those presently in use.