Final report on the safety assessment of Ammonium, Potassium, and Sodium Persulfate.

Ammonium, Potassium, and Sodium Persulfate are inorganic salts used as oxidizing agents in hair bleaches and hair-coloring preparations. Persulfates are contained in hair lighteners at concentrations up to 60%, in bleaches and lighteners at up to 22% and 16%, respectively, and in off-the-scalp products used to highlight hair strands at up to 25%. They are used in professional product bleaches and lighteners at similar concentrations. Much of the available safety test data are for Ammonium Persulfate, but these data are considered applicable to the other salts as well. Acute dermal, oral, and inhalation toxicity studies are available, but only the latter are remarkable, with gross lesions observed in the lungs, liver, stomach, and spleen. In short-term and subchronic feeding studies the results were mixed; some studies found no evidence of toxicity and others found local damage to the mucous membrane in the gastrointestinal tract, but no other systemic effects. Short-term inhalation toxicity was observed when rats were exposed to aerosolized Ammonium Persulfate at concentrations of 4 mg/m3 and greater. Ammonium Persulfate (as a moistened powder) was not an irritant to intact rabbit skin, but was sensitizing (in a saline solution) to the guinea pig. It was slightly irritating to rabbit eyes. Ammonium Persulfate was negative in the Ames test and the chromosomal aberration test. No significant evidence of tumor promotion or carcinogenicity was observed in studies of rats receiving topical applications of Ammonium Persulfate. The persulfates were reported to cause both delayed-type and immediate skin reactions, including irritant dermatitis, allergic eczematous dermatitis, localized contact urticaria, generalized urticaria, rhinitis, asthma, and syncope. The most common causes of allergic dermatitis in hairdressers are the active ingredients in hair dyes, and Ammonium Persulfate has been identified as a frequent allergen. A sensitization study that also examined the incidence of urticarial reactions was performed with 17.5% Ammonium, Potassium, and Sodium Persulfate under occlusive patches. At this concentration and exposure conditions, a mixture of these Persulfates was not sensitizing, and application of Ammonium, Potassium, and Sodium Persulfate did not result in an urticarial reaction. In normal use (i.e., not occluded and rinsed off), it was expected that a concentration greater than 17.5% would also be safe. Given the clinical reports of urticarial reactions, however, manufacturers and formulators should be aware of the potential for urticarial reactions at concentrations of Persulfates greater than 17.5%. Based on the available data, the Cosmetic Ingredient Review (CIR) Expert Panel concluded that Ammonium, Potassium, and Sodium Persulfate are safe as used as oxidizing agents in hair colorants and lighteners designed for brief discontinuous use followed by thorough rinsing from the hair and skin.

Final report on the safety assessment of biotin.

Biotin is a water-soluble vitamin used as a hair-conditioning agent and a skin-conditioning agent in many cosmetic products at concentrations ranging from 0.0001% to 0.6%. Although Biotin does absorb some ultraviolet (UV) radiation, the absorption shows no peaks in the UVA or UVB region. Biotin is rapidly metabolized and excreted in urine. Little acute oral toxicity is seen in animal tests. Short-term and subchronic toxicity studies likewise found no evidence of toxicity. Although intradermal injection of a small quantity of Biotin (0.1 ml) into guinea pig skin did not produce skin irritation, Biotin (0.1% at pH 7.3) did produce slight, transient ocular irritation in rabbit eyes. Biotin was not mutagenic in bacterial tests, but positive results were found in a Tradescantia micronucleus test. There was evidence of an increase in the number of resorptions in rats receiving Biotin by subcutaneous injection, with concomitant decreases in fetal, uterine, and placental weights. Another study of mice receiving Biotin orally or by subcutaneous injection found no differences between control and treatment groups. Although there is one case study reporting an urticarial reaction in the literature, there are a very large number of individuals exposed to Biotin on a daily basis, and there is not a parallel appearance of irritation, sensitization, or other adverse reactions. Based on these available data, it was concluded that Biotin is safe as used in cosmetic formulations.

Final report on the safety assessment of Acid Violet 43.

Acid Violet 43 is an anthraquinone color that may be used as a colorant in cosmetic formulations that are hair dyes, colors, and coloring rinses. Batches of Acid Violet 43 that are certified to meet the United States Food and Drug Administration (U.S. FDA) specifications are termed Ext. D & C Violet No. 2. Hair dyes and colors containing Acid Violet 43 are considered coal tar ingredients and, as such, routinely bear a caution statement regarding potential skin irritation and instructions for determining whether the product causes skin irritation in any given individual. Expected concentrations of use are less than or equal to 1%. Impurities include anthracenedione derivatives, p-toluidine, and p-toluidine sulfonic acid, as well as heavy metals. Based on extensive safety test data, the U.S. FDA has established specifications (including limits on impurities) for Ext. D & C Violet No. 2 that allow its use in any cosmetic. It is the certified color (Ext. D & C Violet No. 2) that has been evaluated in the following safety tests. Oral toxicity tests do not demonstrate significant acute toxicity. In a short-term dermal toxicity study using guinea pigs and a subchronic dermal toxicity study using rabbits, no signs of systemic toxicity and no significant local skin reactions were noted. This ingredient was not genotoxic in bacterial assays, nor was it carcinogenic when applied to mouse skin at a 1% concentration. Accordingly, Acid Violet 43 was determined to be safe for use in hair dye formulations, when impurities are limited as follows: < or = 18% volatile matter (at 135 degrees C) and chlorides and sulfates (calculated as sodium salts); < or = 0.4% water-insoluble matter; < or = 0.2% 1-hydroxy-9,10-anthracenedione; < or = 0.2% 1,4-dihydroxy-9,10-anthracenedione; < or = 0.1% p-toluidine; < or = 0.2% p-toluidine sulfonic acids, sodium salts; < or = 1% subsidiary colors; < or = 20 ppm lead (as Pb); < or = 3 ppm arsenic (as As); < or = 1 ppm mercury (as Hg); and with > or = 80% total color.