Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Assessment based on a single in-vitro assay for gene mutation and a single in-vivo assay for cytogenicity.

Findings in the gene mutation test were negative, both in the presence and absence of a metabolic activation system, at concentrations up to 5000 microgram/plate. findings in the cytogenicity test were ambiguous, based on a dose related and statistically significant increase in micronucleated PCEs relative to controls. However, the observed increases was of low potency and within the range of

historical negative control data

Short description of key information:
Genetic toxicity:
Gene mutation (Bacterial reverse mutation assay / Ames test):
S. Typhimurium TA98: negative with and without metabolic activation; TA100: negative with and without metabolic activation; TA1535: negative with and without metabolic activation; TA1537: negative with and without metabolic activation; E. Coli WP2uvrA: negative with and without metabolic activation (OECD 471)

Mammalian erythrocyte micronucleus assay:
Ambiguous

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Non classification is justified on the basis that available data give no clear indication that the substance is genotoxic