Final report of the amended safety assessment of Quaternium-15 as used in cosmetics.
Quaternium-15 is an antimicrobial agent used in cosmetics as a cosmetic preservative and antistatic agent. Little systemic toxicity was reported in most single-dose or repeated-dose animal studies. Quaternium-15 was an oral teratogen, but not a dermal teratogen, in rats at doses that exceeded the expected cumulative exposure from cosmetics. The frequency of sensitization increased in North America but not in Europe, where Quaternium-15 is used less often. In almost all animal and human studies, Quaternium-15 at 0.2% was not a sensitizer. The weight of evidence suggested that a 0.2% concentration is not a sensitizer and that cosmetic products containing Quaternium-15 up to that level are safe.
Becker
Lillian C
LC
Cosmetic Ingredient Review, 1101 17th Street, NW, Suite 412, Washington, DC 20036, USA. cirinfo@cir-safety.org
Bergfeld
Wilma F
WF
Belsito
Donald V
DV
Klaassen
Curtis D
CD
Hill
Ronald
R
Leibler
Daniel
D
Marks
James G
JG
Shank
Ronald C
RC
Slaga
Thomas J
TJ
Snyder
Paul W
PW
Alan Andersen
F
F
D000279:Administration, Cutaneous; D000284:Administration, Oral; D000485:Allergens / Q000145:classification / Q000633:toxicity*; D000818:Animals; D000830:Animals, Laboratory; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000145:classification / Q000633:toxicity*; D003257:Consumer Product Safety; D006801:Humans; D007114:Immunization / Q000145:classification; D008709:Methenamine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000145:classification / Q000633:toxicity; D011310:Preservatives, Pharmaceutical / Q000008:administration & dosage / Q000633:toxicity*; D051381:Rats; D018570:Risk Assessment; D012882:Skin Tests; D013723:Teratogens / Q000145:classification / Q000633:toxicity*; D018675:Toxicity Tests
D000485:Allergens; D000890:Anti-Infective Agents; D011310:Preservatives, Pharmaceutical; D013723:Teratogens; C018375:quaternium-15; D008709:Methenamine