Registration Dossier

Administrative data

Description of key information

oral: 4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane after oral administration was found to be >300 mg/kg bw and <2000 mg/kg bw in rats.
dermal: 4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane after dermal application was found to be greater than 2000 mg/kg bw in male and female rats.

Key value for chemical safety assessment

Additional information

Acute toxicity: oral

All animals of the 2000 mg/kg test group were found dead within 1 hour after the administration. Two animals of the 300 mg/kg test group died. One animal was found dead on study day 1 and another on study day 6 (delayed mortality).

Clinical signs in all animals of the 2000 mg/kg bw test group revealed gasping, and respiration noises at hour 0. In two of this animals poor general state and staggering was noted at the same reading point while in the third animal impaired general state was observed. The first animal that died in the 300 mg/kg test group impaired general state, piloerection and dyspnoea were observed from hour 1 until hour 5 after administration.

Two of the surviving animals of the test group showed impaired general state, piloerection and dyspnoea from hour 2 until study day 1. In addition reduced feces were noted on study day 1 in theses animals. The other animal, died on day 6, revealed impaired general state, piloerection and dyspnoea from hour 4 until hour 5. The mean body weights of two surviving animals of the 300 mg/kg administration group decreased or remained constant during the first post-exposure observation week but increased during the second week. The mean body weights of the other surviving animals did not adequately increase during the first post-exposure observation week but increased during the second week. [BASF, 2011]

Acute toxicity: dermal

In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the undiluted test item 4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane to the clipped skin (dorsal and dorso-lateral parts of the trunk) and covered by semi- occlusive dressing for 24 hours. The application area comprised at least 10% of the total body surface area. The animals were observed for 14 days. Under the conditions of this study the median lethal dose (LD50) of 4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane after dermal application was found to be greater than 2000 mg/kg bw in male and female rats. [BASF, 2011]

Justification for classification or non-classification

4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane is harmful after oral administration (EU: R22; GHS acute oral cat. 4, H302) according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.

4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane does not need to be labeled according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.