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N,N-Dimethylbenzylamine diluted in DMSO was tested for point mutations in the Ames-test according to OECD TG 471 and GLP using Salmonella typhimuriun TA98, TA100, TA1535, TA1537, TA1538 in the presence and in the absence of a metabolic activation system and concentrations ranging between 1.58 and 5000 µg/plate. Cytotoxicity was observed at the highest test concentration. Under the conditions of this test N,N-dimethylbenzylamine did not induce point mutations (BG Chemie 1986).

Furthermore, N,N-dimethylbenzylamine diluted in DMSO was tested for genotoxicity in Chinese hamster V79 cells according to OECD TG 376 (HPRT-test) in the presense and in the absence of a metabolic activation system (S9 -mix from rat liver). The concentrations used ranged between 85.0 and 1360.0 µg/ml. Based on the negative result N,N-dimethylbenzylamine was considered to be non-mutagenic in this test system (Harlan CCR, 2011, at the request of Lanxess Deuschland GmbH).

N,N-Dimethylbenzylamine was tested in a chromosome aberration test with and without metabolic activation in Chinese Hamster ovary (CHO) cells according to Japanese Guidelines for Screening Mutagenicity Testing of chemicals in concentrations up to 3000 µg/ml.. This chemical induced structural chromosomal aberrations in the presence of a metabolic activation system. The lowest concentration producing cytogenetic effects in vitro was with metabolic activation: 0.213 mg/ml.(MHLW 1997).

However, N,N-dimethylbenzylamine was also assessed for its mutagenic potenial in vivo using the Micronucleus Test in vivo with bone marrow cells of the mouse. The doses of the test substance administered orally by gavage were 15, 50 , 150 mg/kg bw . Toxicity was examined in a pre-experiment: 150 mg/kg bw was the highest non-lethal dose but animals showed reduction of spontaneous activity and no food and water uptake was observed for up to 1 hour post application in that test.

The preparation of cells in the main test was done 24, 48 and 72 hours after the treatment with the high dose and 24 hours after the treatment with the medium and low dose. In each experimental group 1000 cells from each of 10 animals were scored.

There was no enhancement of the number of cells with micronuclei in the groups treated with the test substance as coompared with the negative controls treated with the solvent. On the other hand the sensitivity of the test system was demonstrated by significantly enhanced micronuclei rates after treatment with 30 mg/kg bw cyclophposphamide (positive control).

The results allow to draw the conclusion that the test substance did not induce micronuclei in mouse bone marrow cells under the experimental conditions described (BG Chemie 1987).

Overall, based on the available results, N,N-dimethylbenzylamine is considered to be non-mutagenic

Short description of key information:
N,N-dimethylbenzylamine does not induce mutagenic activity in the Ames test and in the HPRT test in vitro with Chinese Hamster V79 cells but induces chromosome aberrations in Chinese Hamster Ovary cells in the presence of a metabolic activation system but not in the absence of a metabolic activation system. However, the In-vivo Micronucleus Test in mouse bone marrow cells yielded a negative result. Therefore. N.N-dimethylbenzylamine is considered to be a Non-mutagen.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Up to now N,N-dimethylbenzylamine is not classified in one of the categories of mutagenic substances..

Based on the available results no classification or labelling has to be required.