Multigeneration reproduction and carcinogenicity studies in Sprague-Dawley rats exposed topically to oxidative hair-colouring formulations containing p-phenylenediamine and other aromatic amines

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

“…In conjunction with the 18-week toxicity study and the 2-generation reproduction studies described earlier in this report, Burnett et al 52 and Burnett and Goldenthal 65 reported that no evidence of carcinogenic activity was observed from topical applications of hair dyes containing 3% or 6% toluene-2,5-diamine sulfate. In the toxicity study, the incidence of alveologenic adenomas and carcinomas in the 3 groups of Swiss-Webster mice treated with 3% toluene-2,5-diamine sulfate was comparable to that reported in control groups.…”

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

“…In conjunction with the 18-week toxicity study and the 2-generation reproduction studies described earlier in this report, Burnett et al 52 and Burnett and Goldenthal 65 reported that no evidence of carcinogenic activity was observed from topical applications of hair dyes containing 3% or 6% toluene-2,5-diamine sulfate. In the toxicity study, the incidence of alveologenic adenomas and carcinomas in the 3 groups of Swiss-Webster mice treated with 3% toluene-2,5-diamine sulfate was comparable to that reported in control groups.…”

Repeated topical application of Para-phenylenediamine induces renal histopathological changes in rats

“…The changes were observed even at a dose as low as 3 mg/kg/day, which is lower than the no-observed-adverse-effect level (NOAEL) of 4 mg/kg/day, prescribed for this chemical (SCCNFP/0129/99). These differences may be due to the differences in the experimental animal (rabbit) as reported by Burnett and Goldenthal[17] or the route of application which was oral in earlier studies (SCCNFP/0129/99) in contradiction to the topical application used during the present investigation.…”

Personal hair dye use and the risk of bladder cancer: a case–control study from The Netherlands

“…Although we collected detailed information on duration of hair dye use, we have no information about year at first dye use. On the other hand, the presence of the most common permanent hair dye ingredient, p -phenylenediamine has remained unchanged for the last 50 years even though animal data support its carcinogenicity [33]. Also, a few new ingredients were introduced during the last 20 years [3].…”

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

“…In conjunction with the 18-week toxicity study and the 2-generation reproduction studies described earlier in this report, Burnett et al 52 and Burnett and Goldenthal 65 reported that no evidence of carcinogenic activity was observed from topical applications of hair dyes containing 3% or 6% toluene-2,5-diamine sulfate. In the toxicity study, the incidence of alveologenic adenomas and carcinomas in the 3 groups of Swiss-Webster mice treated with 3% toluene-2,5-diamine sulfate was comparable to that reported in control groups.…”

Repeated topical application of Para-phenylenediamine induces renal histopathological changes in rats

“…The changes were observed even at a dose as low as 3 mg/kg/day, which is lower than the no-observed-adverse-effect level (NOAEL) of 4 mg/kg/day, prescribed for this chemical (SCCNFP/0129/99). These differences may be due to the differences in the experimental animal (rabbit) as reported by Burnett and Goldenthal[17] or the route of application which was oral in earlier studies (SCCNFP/0129/99) in contradiction to the topical application used during the present investigation.…”

Personal hair dye use and the risk of bladder cancer: a case–control study from The Netherlands

“…Although we collected detailed information on duration of hair dye use, we have no information about year at first dye use. On the other hand, the presence of the most common permanent hair dye ingredient, p -phenylenediamine has remained unchanged for the last 50 years even though animal data support its carcinogenicity [33]. Also, a few new ingredients were introduced during the last 20 years [3].…”

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

“…In conjunction with the 18-week toxicity study and the 2-generation reproduction studies described earlier in this report, Burnett et al 52 and Burnett and Goldenthal 65 reported that no evidence of carcinogenic activity was observed from topical applications of hair dyes containing 3% or 6% toluene-2,5-diamine sulfate. In the toxicity study, the incidence of alveologenic adenomas and carcinomas in the 3 groups of Swiss-Webster mice treated with 3% toluene-2,5-diamine sulfate was comparable to that reported in control groups.…”

Repeated topical application of Para-phenylenediamine induces renal histopathological changes in rats

“…The changes were observed even at a dose as low as 3 mg/kg/day, which is lower than the no-observed-adverse-effect level (NOAEL) of 4 mg/kg/day, prescribed for this chemical (SCCNFP/0129/99). These differences may be due to the differences in the experimental animal (rabbit) as reported by Burnett and Goldenthal[17] or the route of application which was oral in earlier studies (SCCNFP/0129/99) in contradiction to the topical application used during the present investigation.…”

Personal hair dye use and the risk of bladder cancer: a case–control study from The Netherlands

“…Although we collected detailed information on duration of hair dye use, we have no information about year at first dye use. On the other hand, the presence of the most common permanent hair dye ingredient, p -phenylenediamine has remained unchanged for the last 50 years even though animal data support its carcinogenicity [33]. Also, a few new ingredients were introduced during the last 20 years [3].…”