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Key value for chemical safety assessment

Additional information

Genetic toxicity in vitro:

In two independent GLP compliant Ames tests, performed according to OECD guideline 471, 4 Salmonella typhimurium strains (TA 1535, TA 1537, TA 98, and TA 100) were used to test the mutagenic potential of the test substance(20, 80, 320, 1280 and 5120 µg/plate), both with and without metabolic activation system (Batelle 1985). The test substance did not show any mutagenic activity in any strain.

Genetic toxicity in vivo:

In a GLP-compliant micronucleus test, tested according to OECD guideline 474, 5 non-consanguinous OF-1 albino mice originating from an SPF colony per sex per treatment group were treated once by oral gavage with the test substance 4000 mg/kg bw dissolved in distilled water followed by a 20, 44, 68 hour exposure period (Batelle 1985). In a preliminary range finding study the concentration of 4000 mg/kg bw was chosen for the main-test.A positive control (Thio-TEPA) administered at a concentrationof 20 mg/kg bw showed pronounced evidence of mutagenicity 44 h after administration. No mutagenic effect wasobserved in bone marrow smears taken 20, 44 and 68 h after administration ofthe test substance.

Short description of key information:
The test substance does not show any genetic toxicity in vitro (Ames test) and in vivo (Erythrocyte micronucleus test).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available genotoxicity studies, the test substance does not need to be classified for genotoxicity according to the Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008