Final Report on the Safety Assessment of Sodium Picramate

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Abstract
Sodium Picramate is used as a colorant in cosmetic products at concentrations up to 1.0%. The LD50 for Picramic Acid as assayed in mice was 378 mg/kg. The percutaneous toxicity of an oxidative hair dye formulation containing 0.1 % Sodium Picramate on abraded and nonabraded skin applied biweekly for 13 weeks produced neither gross nor microscopic changes. A 2.5% aqueous solution of this cosmetic ingredient was neither an ocular nor skin irritant. In a skin sensitization study, 2% Picramic Acid induced mild sensitization reactions in four of 15 guinea pigs. Picramic Acid was mutagenic in the Ames assay but nonmutagenic at the TK locus in L5178Y mouse lymphoma cells, in the mouse dominant lethal assay or in the mouse bone marrow cytogenetic assay. An oxidative hair dye containing 0.01 % Picramic Acid applied weekly for 2 years to the skin of mice was noncarcinogenic. A hair dye containing 0.1% Sodium Picramate was nonteratogenic when applied dermally. The studies cited indicate that 0.2% Sodium Picramate may be a mild sensitizer in humans. Due to this potential for sensitization, it is recommended that the safe use limit of Sodium Picramate in cosmetic products be set at 0.1 %.

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