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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Short description of key information:
In an in-vivo micronucleus test, at doses of 780mg/kg body weight (Males and Females, single oral administration), the test substance was non-mutagenic under the described conditions.

Endpoint Conclusion:

Justification for classification or non-classification

The test substance was found to be non-mutagenic in the mouse micronucleus test.

In an in-vitro mammalian chromosome aberration test using V79 A2 Fibroblasts (Chinese hamster lung), no structural or numerical chromosomal aberrations were observed in the absence of metabolic activation. In the presence of metabolic activation the number of structural chromosomal aberrations was distinctly increased at the highest, highly cytotoxic concentration evaluated at both sampling times (18 and 24 hours after start of the 4-hour treatment period. Due to the lack of effect at less or non-toxic concentrations, and due to a lack of any concentration relationship, the biological significance of the positive result remains equivocal.

Results obtained with the test substance in Salmonella typhimurium strains TA 1535, TA 1537, TA 98 (+/- S9-mix) and TA100 (in absence of S9 mix) do not indicate mutagenic activity. However, Salmonella typhimurium strain TA 100 did exhibit mutagenic activity in the presence of S9 mix. A dose-related precipitation was observed at all concentrations, affecting the validity of the study. In consideration of the low water solubility of the test substance, precipitation indicates a reduced potential for cellular-uptake.

In view of the negative micronucleus test, the observation of aberrations only at cytotoxic doses in V79 lung fibroblasts, and the equivocal results of the bacterial mutagenicicty test (affected by precipitation), the balance of evidence indicates that the test substance does not meet the criteria for classification for germ cell mutagenicity.