The ingredients m-Phenylenediamine and m-Phenylenediamine Sulfate are aromatic amines that function as hair colorants in cosmetic products. Both are currently used in hair dye products at concentrations of up to 3%. Percutaneous absorption of m-Phenylenediamine has been demonstrated in animals. Three metabolites excreted in urine have been identified. The oral LD50 of m-Phenylenediamine in rats is between 360 and 650 mg/kg. Subchronic studies in rats (oral) indicated some lesions in the liver but no kidney injury, while one study in rabbits (dermal) indicated some liver and kidney toxicity. Another dermal study in rabbits failed to show any liver or kidney toxicity. Skin irritation and sensitization were found in guinea pigs exposed to m-Phenylenediamine. Clinical data indicated some evidence of sensitization. A short-term study in rats (oral) reported an absence of any neurotoxicity. One study in female rats identified fetotoxicity but no evidence of terata. Other studies reported neither birth defects nor fetal deaths. Both positive and negative results were found in various mutagenesis assay systems. In studies with mice and rats, neither m-Phenylenediamine (both oral and dermal exposure) nor hair dye formulations (dermal exposure only) containing m-Phenylenediamine were carcinogenic. Based on the concentrations of m-Phenylenediamine shown to produce sensitization in animal studies, it was concluded that these ingredients can be used safely in hair dyes at concentrations of up to 10%.

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间苯二胺和间苯二胺硫酸盐安全性评估的最终报告1

成分间苯二胺和间苯二胺硫酸盐是芳香胺，在化妆品中用作染发剂。两者目前都以高达 3% 的浓度用于染发产品。间苯二胺的经皮吸收已在动物身上得到证实。已鉴定出尿液中排泄的三种代谢物。间苯二胺在大鼠体内的口服 LD50 介于 360 至 650 毫克/公斤之间。大鼠的亚慢性研究（口服）表明肝脏有一些损伤，但没有肾损伤，而兔子的一项研究（皮肤）表明一些肝脏和肾脏毒性。另一项对兔子的皮肤研究未能显示任何肝脏或肾脏毒性。在暴露于间苯二胺的豚鼠中发现皮肤刺激和致敏。临床数据表明一些致敏证据。一项对大鼠的短期研究（口服）报告没有任何神经毒性。一项对雌性大鼠的研究确定了胎儿毒性，但没有证据表明存在畸胎。其他研究既没有报告出生缺陷，也没有报告胎儿死亡。在各种诱变分析系统中都发现了阳性和阴性结果。在对小鼠和大鼠的研究中，间苯二胺（口服和皮肤接触）和含有间苯二胺的染发剂配方（仅皮肤接触）均不致癌。根据动物研究中显示的间苯二胺浓度会产生致敏作用，得出的结论是，这些成分在高达 10% 的浓度下可以安全地用于染发剂中。其他研究既没有报告出生缺陷，也没有报告胎儿死亡。在各种诱变分析系统中都发现了阳性和阴性结果。在对小鼠和大鼠的研究中，间苯二胺（口服和皮肤接触）和含有间苯二胺的染发剂配方（仅皮肤接触）均不致癌。根据动物研究中显示的间苯二胺浓度会产生致敏作用，得出的结论是，这些成分在高达 10% 的浓度下可以安全地用于染发剂中。其他研究既没有报告出生缺陷，也没有报告胎儿死亡。在各种诱变分析系统中都发现了阳性和阴性结果。在对小鼠和大鼠的研究中，间苯二胺（口服和皮肤接触）和含有间苯二胺的染发剂配方（仅皮肤接触）均不致癌。根据动物研究中显示的间苯二胺浓度会产生致敏作用，得出的结论是，这些成分在高达 10% 的浓度下可以安全地用于染发剂中。