International Journal of Toxicology

Sodium Lauryl Sulfoacetate is a detergent used in cosmetic products. A 12% solution of the ingredient was slightly toxic to rats in an acute oral study. No treatment-related effects of significance were noted in rats in a subchronic study at a dose of 75 mg/kg/day. Some effects were observed at 250 and 750 mg/kg/day. Minimal to slight ocular irritation occurred in rabbits when tested with 3.0% Sodium Lauryl Sulfoacetate. A diluted product tested at 1% Sodium Lauryl Sulfate was nonirritating to the genital mucosa of rabbits. No skin irritation, sensitization, or phototoxicity was noted in guinea pigs exposed to a cosmetic product containing 2% Sodium Lauryl Sulfoacetate. Cosmetic products containing up to 16% Sodium Lauryl Sulfoacetate were nonmutagenic in the Ames Salmonella/microsome assay, both with and without activation. In clinical studies, Sodium Lauryl Sulfoacetate was a mild to strong skin irritant but not a sensitizer at concentrations up to 2.0%. The irritant effects are similar to those produced by other detergents, and the severity of the irritation appears to increase directly with concentration. It is concluded that Sodium Lauryl Sulfoacetate is safe for use in cosmetic products in the present practices of use and concentration.

Retinol is the naturally occurring form of vitamin A; Retinyl Palmitate is the ester of Retinol and Palmitic Acid. In acute oral studies, Retinol was slightly toxic to mice, and Retinyl Palmitate was practically nontoxic in mice and rats. Large single doses can be lethal. It is recognized that Retinol is essential for reproduction; however, high intake of Retinol has produced adverse effects on several reproductive functions. Vitamin A was nonmutagenic in several in vitro tests. There is no evidence that vitamin A is carcinogenic. However, the vitamin has both enhanced and inhibited responses to viral or chemical carcinogens. Cosmetic products containing 0.1-1% Retinyl Palmitate were, at most, slightly irritating and nonsensitizing when tested on a total of 607 subjects. Results of cumulative irritation tests of two products containing 0.1% Retinyl Palmitate indicated that the products were nonirritating and non-sensitizing. On the basis of the available animal and clinical data presented in this report, it is concluded that Retinyl Palmitate and Retinol are safe as cosmetic ingredients in the present practices of use and concentration.

Oleic, Lauric, Palmitic, Myristic, and Stearic Acids are fatty acids with hydrocarbon chains ranging in length from 12 to 18 carbons with a terminal carboxyl group. These fatty acids are absorbed, digested, and transported in animals and humans. Little acute toxicity was observed when Ofeic, Lauric, Palmitic, Myristic, or Stearic Acid or cosmetic formulations containing these fatty acids were given to rats orally at doses of 15-19 g/kg body weight. Feeding of 15% dietary Oleic Acid to rats in a chronic study resulted in normal growth and health, but reproductive capacity of female rats was impaired. Results from topical application of Oleic, Palmitic, and Stearic Acid to the skin of mice, rabbits, and guinea pigs produced little or no apparent toxicity. Studies using product formulations containing Oleic and Stearic acids indicate that neither is a sensitizer or photosensitizing agent. Animal studies also indicate that these fatty acids are not eye irritants. Lauric, Stearic, and Oleic Acids were noncarcinogenic in separate animal tests. In primary and cumulative irritation clinical studies, Oleic, Myristic, and Stearic Acids at high concentrations were nonirritating. Cosmetic product formulations containing Oleic, Lauric, Palmitic, and Stearic Acids at concentrations ranging up to 13% were not primary or cumulative irritants, nor sensitizers. On the basis of available data from studies using animals and humans, it is concluded that Oleic, Lauric, Palmitic, Myristic, and Stearic Acids are safe in present practices of use and concentration in cosmetics.

n-BuOH is a primary aliphatic alcohol that is used in cosmetic nail products as a solvent at concentrations up to 10%. In vitro tissue permeability studies indicate that human epidermis and dermis were permeable to n-BuOH. The single oral dose LD₅₀ of n-BuOH for rats ranged from 0.8 to 4 g/kg. The dermal LD₅₀ has been reported as 4.2 g/kg. n-BuOH does not cause skin irritation in rabbits but is a severe rabbit eye irritant. Inhalation of n-BuOH vapors caused intoxication of laboratory animals; high concentrations were sometimes fatal. n-BuOH was not mutagenic in the Salmonella/mammalian-microsome mutagenicity test. The ingredient did not induce sister chromatid exchange or chromosome breakage in chick embryo cells or in Chinese hamster ovary cells and did not induce micronuclei formation in V79 Chinese hamster cells. Two nail formulations containing 3.0% n-BuOH were tested on 558 and 421 subjects, respectively; neither was considered an irritant or sensitizer. Clinically, n-BuOH produced edema in 4 of 105 dermatological patients. Additional clinical studies indicated that nail enamel products containing n-BuOH were neither irritants, sensitizers, nor photoallergens. Inhalation of n-BuOH can cause human nose, throat, and eye irritation. On the basis of the information in the report and only as it regards the use of n-BuOH in nail products, the ingredient is considered to be safe in the present practices of use and concentration.