Human safety study of body lotion containing Kathon CG.
The safety of Kathon CG biocide as a preservative in leave-on body lotions was assessed by 2 double-blind studies, using similar protocols. A total of 209 healthy male and female subjects aged 18 to 65 years, 100 in California (72 test subjects, 28 controls) and 109 in Florida (88 test subjects, 21 controls) completed the studies which included pre- and post-use phase diagnostic patch testing with Kathon CG 100 ppm active ingredient, and 13 weeks daily applications of either a test lotion containing Kathon CG 15 ppm active ingredient or a control lotion without Kathon CG. No evidence of irritation or sensitization attributable to use of the biocide was found during regular dermatological examinations during the use phase. Post-use phase patch testing produced negative results in all subjects with the exception of 1 control subject in Florida who had positive readings at the 2- and 4-week post-use phase patch testing. Overall, these studies show there is minimal, if any, risk of adverse effects associated with the use of Kathon CG 15 ppm active ingredient in a leave-on application.
Schwartz
S R
SR
Weiss
S
S
Stern
E
E
Morici
I J
IJ
Moss
J N
JN
Goodman
J J
JJ
Scarborough
N L
NL
D000293:Adolescent; D000328:Adult; D000368:Aged; D002986:Clinical Trials as Topic; D003358:Cosmetics / Q000633:toxicity*; D003877:Dermatitis, Contact / Q000209:etiology*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010592:Pharmaceutic Aids / Q000633:toxicity*; D011310:Preservatives, Pharmaceutical / Q000633:toxicity*; D013844:Thiazoles / Q000633:toxicity*; D013997:Time Factors
D003358:Cosmetics; D010592:Pharmaceutic Aids; D011310:Preservatives, Pharmaceutical; D013844:Thiazoles; C037057:Kathon 886