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Administrative data

Key value for chemical safety assessment

Additional information

DCHA showed no mutagenic activity in 4 standard Ames tests with and without metabolic activation system but induced chromosomal aberrations in Chinese hamster (CHL) cells at high concentrations and short exposure time (exposure time: 6 hours (a) with S9-mix at 0,6 mg/ml; (b) without S9-mix at 0,8 and 1.0 mg/ml).

In in vivo study, using EU In Vivo Mammalian Erythrocyte Micronucleus Test, DCHA induced the production of the micronuclei, which is the result of chromosomal damage to the mitotic apparatus in the erythroblasts of the rats. On the other hand, under the conditions of the Mouse Bone Marrow Erythrocyte Micronuleus Test, a single oral administration of Dicyclohexylamine at doses up to and including 200 mg/kg did not induce a significant increase in the incidence of micronucleated polychromatic erythrocytes in bone marrow. As the next step, Dicyclohexylamine was tested in In Vivo Mammalian Spergmatogonial Chromosome Aberration Test in Rats by Oral Administration ) which resulted in negative results. Negative results were supported by read-accross data for N-methyl-dicyclohexylamine.


Justification for selection of genetic toxicity endpoint
Based on all in vitro and in vivo studies available, and the newest one (In Vivo Mammalian Spergmatogonial Chromosome Aberration Test of Dicyclohexylamine in Rats by Oral Administration), conclusion on non-mutagenic effects of the DCHA was made.

Short description of key information:
Except one, all in vitro studies for genotoxicity of DCHA, were negative. Regarding in vivo studies, there was 1 negative and 1 positive study on DCHA mutagenicity, hence, further testing for mutagenicity was proposed and resulted in negative results (DCHA tested up to the maximum tolerated dose of 250 mg Dicyclohexylamine/kg b.w. by oral administration showed no mutagenic properties in the mammalian spermatogonial chromosome aberration test of the rat at the two tested sampling times of 24 hours and 48 hours). Negative results are also supported by read/across data which all were negative.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on all data available, Dicyclohexylamineis not classified for mutagenicity.