Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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