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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Bacterial reverse mutation assays

The gene mutation potential of the test substance (99.18% pure) was evaluated in a bacterial reverse mutation assay (Ames test). The test was performed according to the OECD test guidelines 471 (adopted 1983) under GLP conditions with the Salmonella Typhimurium strains TA 98, TA 100, TA 1535 and TA 1537. The concentration of the test substance ranged from 20 to the limit concentration of 5000 µg/plate in both experiments (standard plate test and preincubation test) and DMSO was used as solvent. Cytotoxicity was observed in the standard plate test at 5000 µg/plate in TA1537 and TA 100 without metabolic activation and at 2500 µg/plate in TA100 with metabolic activation. No precipitation was observed in any strain. The induced number of revertants per plate was comparable to the vehicle control conditions for all strains tested, with and without metabolic activation. Thus, the test substance was not mutagenic in bacteria under the test conditions chosen. The actual guideline requires an additional strain (E. Coli or TA 102) and an additional positive control beside 2-aminoanthracene with metabolic activation. Nevertheless, the study is considered suitable for assessment of the gene mutation potential of the test substance (BASF AG, 1992).

Short description of key information:
BASF AG 40M0319/914182, 1992, reliability score = 2; result: negative

Endpoint Conclusion:

Justification for classification or non-classification

Dangerous substance Directive (67/548/EEC)

The available experimental test data are considered reliable and suitable, but are not sufficient for the purpose of classification.  


Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable, but not sufficient for the purpose of classification.