Basic Yellow 87

Definition and Structure Basic Yellow 87 (CAS No. 68259-00-7) is a hair colorant that conforms to the structure in Figure 1.1 It is reported to be used in semi-permanent and, after mixing with an oxidative agent, in oxidative hair dye formulations.3 Figure 1. Basic Yellow 87 Chemical Properties Available chemical properties of Basic Yellow 87 are provided in Table 1. Basic Yellow 87 is a yellow solid with the formula weight of 337.4 Da (methosulfate).2,3 The log Pow is -1.69 (20-25 ºC). Method of Manufacture No method of manufacturing data were found in the published literature, and unpublished methods were not submitted. Composition/Impurities The purity of Basic Yellow 87, as determined by high performance liquid chromatography (HPLC), was reported to be 61.1% - 92.6%.3,4 Purity determined by ultraviolet-visible spectroscopy (UV-Vis) was reported to be 87.7% -92.9%.4 Water content was reported to be < 0.5%. Potential impurities and solvent residues may include < 0.1% colored by-product and < 0.1% isopropanol, respectively.3 Salts of formulation or counter ions may include sodium chloride (< 1.7%), methyl sulfate (up to 35.7%), and sulfate (< 0.9%).3,4 Heavy metal content was reported to be < 2 mg/kg (< 1 mg/kg for mercury and cadmium, each).4  Distributed for Comment Only -- Do Not Cite or Quote USE Cosmetic The safety of the cosmetic ingredient addressed in this assessment is evaluated based on data received from the US Food and Drug Administration (FDA) and the cosmetics industry on the expected use of this ingredient in cosmetics, and does not … [kırpıldı — bölüm toplam 6369 karakter]

In Vitro In vitro and animal ocular irritation studies summarized here are detailed in Table 7. In an in vitro study using isolated chicken eyes, Basic Yellow 87 (99.2% pure) was irritating when tested neat and not irritating when tested at a 5% aqueous dilution.2 A mixture containing 0.24% Basic Yellow 87 (test concentration of 0.12% Basic Yellow 87 after dilution with another mixture) was a mild irritant in a bovine corneal opacity and permeability assay.14 In a rabbit ocular irritation study, Basic Yellow 87 (87.7% pure) was moderately irritating.2,3 MARGIN OF SAFETY The SCCS calculated the margin of safety for a product containing 1% Basic Yellow 87 (non-oxidative conditions) to be 184.4 This calculation is based on an adjusted NOAEL (10% bioavailability due to the low oral bioavailability as shown in an ADME study) of 0.676 mg/kg bw/d from a 13-wk oral rat study (as cation) and a systemic exposure dose (SED) of 0.0037 mg/kg bw (skin area surface of 580 cm2 x absorption through skin of 0.38 (cation) µg/cm2 x 0.001 (unit conversion)/typical human bw of 60 kg). The margin of safety under oxidative conditions was reported to be very similar. HAIR DYE EPIDEMIOLOGY Hair dyes may be broadly grouped into oxidative (permanent) and direct (temporary or semi-permanent) dyes. The oxidative dyes consist of precursors mixed with developers to produce color, while direct hair dyes consist of preformed colors. Basic Yellow 87 is reported to be used in semi-permanent and oxidative hair dye formulations. While the safety of individual hair dye ingredients is not addressed in epidemiology studies that seek to determine links, if any, between hair dye use and disease, such studies do provide broad information. The Panel determined that the available hair dye epidemiology data do not … [kırpıldı — bölüm toplam 2134 karakter]

Dermal irritation and sensitization studies on Basic Yellow 87 summarized here are detailed in Table 6. A mixture containing 0.24% Basic Yellow 87 (test concentration of 0.12% Basic Yellow 87 after dilution with another mixture) was predicted to be non-irritating in an EpiDerm™ skin model.12 No dermal irritation was observed in rabbits tested with 0.5 g Basic Yellow 87 (87.7% pure) in 0.5 ml distilled water.2,3 No skin reactions were observed in male and female Himalayan spotted guinea pigs that were treated for 15 d with up to 5% Basic Yellow 87 (> 92% pure).3 Basic Yellow 87 was not peptide reactive in a direct peptide reactivity assay (DPRA; purity tested not reported), and was not sensitizing in a guinea pig maximization test with 1% intradermal induction, a 50% topical induction, and a 50% challenge (tested at > 92% pure). A formulation with 70% Basic Yellow 87 produced sensitization in 10% of animals in a guinea pig maximization test with a 1% intradermal induction, a 25% topical induction, and a 25% challenge.13 Phototoxicity/Photosensitization Studies Dermal phototoxicity/photosensitization studies on Basic Yellow 87 summarized here are also detailed in Table 6. Basic Yellow 87 was not phototoxic and did not induce photosensitization in Himalayan spotted albino guinea pigs at concentrations up to 50%.3

No carcinogenicity studies were found in the published literature, and unpublished data were not submitted.

In vitro and in vivo genotoxicity studies on Basic Yellow 87 summarized here are detailed in Table 5. Basic Yellow 87 was not mutagenic in Ames tests at up to 5000 µg/plate (87.7% and unreported purity), nor in a gene mutation test using Chinese hamster V79 cells, with and without metabolic activation, at up to 600 µg/ml (88.6% pure).2-4 Basic Yellow 87 (91.6% pure; tested at up to 950 µg/ml) was mutagenic and/or clastogenic in a gene mutation test with mouse lymphoma cells,  Distributed for Comment Only -- Do Not Cite or Quote with and without metabolic activation; however, a chromosomal aberration test of Basic Yellow 87 (90.5% pure; tested at up to 288 µg/ml) was negative for clastogenic and/or aneugenic activity.3,4 In vivo testing found that Basic Yellow 87 (88.6% pure) did not induce an increased frequency of polychromatic erythrocytes or increased mean number in normochromatic erythrocytes in a mammalian erythrocyte micronucleus test when mice were given a single oral dose by gavage at up to 125 mg/kg bw.3 No increase in unscheduled DNA synthesis was observed in hepatocytes after rats were exposed to a single dose of up to 500 mg/kg Basic Yellow 87 (88.6% pure).