Final Report on the Safety Assessment of Potassium Chlorate

Abstract

Potassium Chlorate is an inorganic salt that is intended for use in cosmetic ingredients as an oxidizing agent, but there are no current uses reported. Oral administration of Potassium Chlorate with 36C label to rats produced elimination of the label as chloride, chlorate, and chlorite, in descending order of percentage. Potassium Chlorate causes mechanical fragility in erythrocytes and is a catalase inhibitor. In animals dosed orally with Potassium Chlorate, renal tubular necrosis has been seen. Only one mutagenicity study was available, the results of which were negative. A 6-month study in male rats of the tumor promotion potential of Potassium Chlorate caused no effect. Chlorate salts are considered toxic to humans with the lethal ingested dose estimated at 15 to 35 g. Toxic effects of lower doses in humans are seen in the kidneys, gastrointestinal tract, and blood (erythrocytes). Toxic effects in humans appear to be cumulative. The available data were insufficient to support the safety of this ingredient in cosmetic formulations. Additional data are considered necessary to evaluate the safety of this ingredient, including purpose of use and likely concentration of use in cosmetics, 28-day dermal toxicity data, ocular irritation data (if intended for use on or near the eye), two mutagenicity studies (if results are positive, carcinogenicity data are needed), human irritation data as a function of dose, and human sensitization data. It cannot be concluded that this ingredient is safe for use in cosmetic products until the listed safety data have been obtained and evaluated.