Final Report on the Safety Assessment of Steapyrium Chloride and Lapyrium Chloride

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Steapyrium Chloride and Lapyrium Chloride are quaternary ammonium salts used in cosmetic products as biocides or as antistatic agents at concentrations equal to or less than 5.0%. The oral LD50 of Steapyrium Chloride was estimated to be 8.2 g/kg. Subchronic studies in rats established a no-effect dose of 100 mg/kg. Only a very slight dermal irritation was produced on abraded or intact rabbit skin by 1.0% Steapyrium Chloride. A 50% solution of Lapyrium Chloride produced slight to moderate erythema under occluded conditions. Very slight ocular irritation was produced in the eye of the rabbit by a solution containing 1.0% Steapyrium Chloride. Steapyrium Chloride was nonmutagenic when tested in a Salmonella/microsome assay, both with and without activation. Steapyrium Chloride was neither an irritant nor sensitizer when tested at 100% concentration in a repeat insult occluded patch test on 164 individuals. Steapyrium Chloride does not absorb light in the UVA or UVB range and, therefore, would not be expected to be a phototoxic agent. Only limited formulation safety test data were available for Lapyrium Chloride. However, the structural characteristics of Lapyrium Chloride and Steapyrium Chloride are very similar. Therefore, the safety test data on Steapyrium Chloride were used for the safety evaluation of both compounds. On the basis of the available data in this report, it is concluded that Steapyrium Chloride and Lapyrium Chloride are safe as cosmetic ingredients.