Amended safety assessment of sodium picramate and picramic acid.
Sodium picramate is the sodium salt of picramic acid, a substituted phenolic compound. Sodium picramate and picramic acid function as hair colorants; they are reportedly used in 31 and 3 hair-dye products, respectively. No concentration-of-use data were available for sodium picramate, but picramic acid was reported to be used at 0.6%. The Cosmetic Ingredient Review Expert Panel recognized that adding picramic acid to a hair-dye formulation likely results in formation of a salt such as sodium picramate, which suggested that safety test data for one ingredient would be applicable to the other. Hair dyes containing these ingredients bear a caution statement and patch test instructions for determining whether the product causes skin irritation. The panel finds that the available data support the safety of these colorants in hair dyes and expects that sodium picramate would be used at concentrations comparable to those reported for picramic acid.
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
Marks
James G
JG
Shank
Ronald C
RC
Slaga
Thomas J
TJ
Snyder
Paul W
PW
Alan Andersen
F
F
D019297:2,4-Dinitrophenol / Q000031:analogs & derivatives* / Q000032:analysis / Q000737:chemistry / Q000493:pharmacokinetics / Q000633:toxicity; D000818:Animals; D001419:Bacteria / Q000187:drug effects / Q000235:genetics; D015197:Carcinogenicity Tests; D002273:Carcinogens / Q000633:toxicity; D003358:Cosmetics; D005128:Eye Diseases / Q000139:chemically induced / Q000473:pathology; D005260:Female; D006202:Hair Dyes / Q000032:analysis / Q000737:chemistry / Q000493:pharmacokinetics / Q000633:toxicity*; D006801:Humans; D007509:Irritants / Q000633:toxicity; D009152:Mutagenicity Tests; D009153:Mutagens / Q000633:toxicity; D011247:Pregnancy; D011817:Rabbits; D012098:Reproduction / Q000187:drug effects; D012449:Safety; D012871:Skin Diseases / Q000139:chemically induced / Q000473:pathology
D002273:Carcinogens; D003358:Cosmetics; D006202:Hair Dyes; D007509:Irritants; D009153:Mutagens; C044454:picramic acid; D019297:2,4-Dinitrophenol