Final Amended Report of the Safety Assessment of Toluene-2,5-Diamine, Toluene-2,5-Diamine Sulfate, and Toluene-3,4-Diamine as Used in Cosmetics

Abstract

Toluene-2,5-diamine, toluene-2,5-diamine sulfate, and toluene-3,4-diamine are diaminotoluenes used as colorants in permanent hair dyes and tints. Toluene-2,5-diamine is used in 79 products at concentrations up to 3%; toluene-2,5-diamine sulfate is used in 168 products at concentrations up to 4%. Toluene-3,4-diamine does not appear to be in current use. Previously, the Cosmetic Ingredient Review Expert Panel determined that all 3 ingredients were safe for use as hair dyes. New data suggest that differences in toxicity, especially with respect to carcinogenicity, may exist as a function of placement of amine groups around the benzene ring. The Expert Panel concluded that toluene-2,5-diamine and toluene-2,5-diamine sulfate and are safe as hair dye ingredients in the present practices of use and concentrations but that there are insufficient data supporting the safety of toluene-3,4-diamine.

Analysis of mutagenic components of oxidative hair dyes with the Ames test

“…27 Therefore, the American Cosmetic Ingredient Review (CIR) expert group concluded that DATS is safe as a hair dye ingredient when used according to present practices and at a concentration ≤ 4.0%. 23…”

“…22 In the EU and US, the concentration of DATS in oxidative hair dyes is 0.1-4.0%. 23 The Safety and Technical Standards for Cosmetics of China (2015 version) stipulates that the concentration of DATS should not exceed 4.0%. As this concentration is a mandatory provision, the concentration of DATS in oxidative hair dyes approved for marketing in China meets the requirement.…”

“…27 Therefore, the American Cosmetic Ingredient Review (CIR) expert group concluded that DATS is safe as a hair dye ingredient when used according to present practices and at a concentration � 4.0%. 23 Considering the above, the EU only carries out safety assessments on each raw material in oxidative hair dyes and carries out risk assessments on the final product of hair dyes instead of genotoxicity tests. 17 In China, due to the need to perform the Ames test for oxidative hair dyes, this will result in a problem.…”

Analysis of mutagenic components of oxidative hair dyes with the Ames test

“…27 Therefore, the American Cosmetic Ingredient Review (CIR) expert group concluded that DATS is safe as a hair dye ingredient when used according to present practices and at a concentration ≤ 4.0%. 23…”

“…22 In the EU and US, the concentration of DATS in oxidative hair dyes is 0.1-4.0%. 23 The Safety and Technical Standards for Cosmetics of China (2015 version) stipulates that the concentration of DATS should not exceed 4.0%. As this concentration is a mandatory provision, the concentration of DATS in oxidative hair dyes approved for marketing in China meets the requirement.…”

“…27 Therefore, the American Cosmetic Ingredient Review (CIR) expert group concluded that DATS is safe as a hair dye ingredient when used according to present practices and at a concentration � 4.0%. 23 Considering the above, the EU only carries out safety assessments on each raw material in oxidative hair dyes and carries out risk assessments on the final product of hair dyes instead of genotoxicity tests. 17 In China, due to the need to perform the Ames test for oxidative hair dyes, this will result in a problem.…”

Hair Dye-Induced Retinopathy Mimicking Mek-Inhibitor Retinopathy

“…Scalp irritation and placement of amine groups around the benzene ring may explain differences in toxicity between hair dye products. 7 All of our retinopathy cases have been notified to the ANSM (French National Agency for Medicines and Health Products). We believe that hair dye retinopathy is likely to be underdiagnosed, because the associated visual loss is usually mild.…”

Comprehensive Review of Hair Dyes: Physicochemical Aspects, Classification, Toxicity, Detection, and Treatment Methods

“… , For this reason, its color remains in the hair for only a few days and is easily removed by simply washing the hair. − …”

Analysis of mutagenic components of oxidative hair dyes with the Ames test

“…27 Therefore, the American Cosmetic Ingredient Review (CIR) expert group concluded that DATS is safe as a hair dye ingredient when used according to present practices and at a concentration ≤ 4.0%. 23…”

“…22 In the EU and US, the concentration of DATS in oxidative hair dyes is 0.1-4.0%. 23 The Safety and Technical Standards for Cosmetics of China (2015 version) stipulates that the concentration of DATS should not exceed 4.0%. As this concentration is a mandatory provision, the concentration of DATS in oxidative hair dyes approved for marketing in China meets the requirement.…”

“…27 Therefore, the American Cosmetic Ingredient Review (CIR) expert group concluded that DATS is safe as a hair dye ingredient when used according to present practices and at a concentration � 4.0%. 23 Considering the above, the EU only carries out safety assessments on each raw material in oxidative hair dyes and carries out risk assessments on the final product of hair dyes instead of genotoxicity tests. 17 In China, due to the need to perform the Ames test for oxidative hair dyes, this will result in a problem.…”

Hair Dye-Induced Retinopathy Mimicking Mek-Inhibitor Retinopathy

“…Scalp irritation and placement of amine groups around the benzene ring may explain differences in toxicity between hair dye products. 7 All of our retinopathy cases have been notified to the ANSM (French National Agency for Medicines and Health Products). We believe that hair dye retinopathy is likely to be underdiagnosed, because the associated visual loss is usually mild.…”

Comprehensive Review of Hair Dyes: Physicochemical Aspects, Classification, Toxicity, Detection, and Treatment Methods

“… , For this reason, its color remains in the hair for only a few days and is easily removed by simply washing the hair. − …”

Analysis of mutagenic components of oxidative hair dyes with the Ames test

“…27 Therefore, the American Cosmetic Ingredient Review (CIR) expert group concluded that DATS is safe as a hair dye ingredient when used according to present practices and at a concentration ≤ 4.0%. 23…”

“…22 In the EU and US, the concentration of DATS in oxidative hair dyes is 0.1-4.0%. 23 The Safety and Technical Standards for Cosmetics of China (2015 version) stipulates that the concentration of DATS should not exceed 4.0%. As this concentration is a mandatory provision, the concentration of DATS in oxidative hair dyes approved for marketing in China meets the requirement.…”

“…27 Therefore, the American Cosmetic Ingredient Review (CIR) expert group concluded that DATS is safe as a hair dye ingredient when used according to present practices and at a concentration � 4.0%. 23 Considering the above, the EU only carries out safety assessments on each raw material in oxidative hair dyes and carries out risk assessments on the final product of hair dyes instead of genotoxicity tests. 17 In China, due to the need to perform the Ames test for oxidative hair dyes, this will result in a problem.…”

Hair Dye-Induced Retinopathy Mimicking Mek-Inhibitor Retinopathy

“…Scalp irritation and placement of amine groups around the benzene ring may explain differences in toxicity between hair dye products. 7 All of our retinopathy cases have been notified to the ANSM (French National Agency for Medicines and Health Products). We believe that hair dye retinopathy is likely to be underdiagnosed, because the associated visual loss is usually mild.…”

Comprehensive Review of Hair Dyes: Physicochemical Aspects, Classification, Toxicity, Detection, and Treatment Methods

“… , For this reason, its color remains in the hair for only a few days and is easily removed by simply washing the hair. − …”