Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The substance was tested in two Ames tests (Hazelton Laboratories,1993 and Safepharm Laboratories,1998) using Salmonella Typhimurium TA98, TA 100, TA 1535, TA1537 and TA1538 and Escherichia coli WP2uvr/A and concentrations ranging from 5000-50 micrograms/plate, with and without metabolic activation (EU Annex V, B14 test method). Precipitation of the test material from the dimethyl sulphoxide solvent was recorded between 1000-1500 micrograms/plate. There was no evidence of induction of mutations by the test substance or its S9 induced metabolites in any of the bacterial strains used in the test.

In the key chromosome aberration study (Corning Hazleton Laboratories Ltd., 1993), human peripheral lymphocytes were exposed in vitro to the test substance, with and without metabolic activation, at concentrations of 3-50 micrograms/plate for 3h or 3, 20 and 44h respectively using the EEC Annex V B10 test guideline. Fixation times were 20h for experiment 1 and 20 and 44h for experiment 2. 50 micrograms/plate was a saturated solution of the test substance in the culture medium. There was no evidence of induction of chromosome aberrations by the test substance or its S9 induced metabolites in human lymphocytes

A mammalian cell gene mutation test (Corning Hazelton Laboratories Ltd., 1998) was performed with the substance using mouse lymphoma LS178Y cells and concentrations ranging from 6.25-50 micrograms/plate with and without metabolic activation (EU Annex V method). Precipitation from the dimethyl sulphoxide solvent was recorded at 50 micrograms/ml and cytotoxicity above 50 micrograms/ml. No statistically significant increases in mutation frequency were observed following treatment with the test substance or its S9 induced metabolites. Mutation frequencies in the negative control cultures fell within normal ranges, and clear increases in mutation were induced by the positive controls.

 

Short description of key information:
The test substance is non-mutagenic in the bacterial reverse mutation assay (Ames test) using the Annex V B14 test guideline and the in vitro mammalian cell gene mutation test (mouse lymphoma ) using the Annex V B17 guideline; and is non-clastrogenic in the in vitro mammalian cell chromosome aberration test (CHL) test using the Annex V B guideline. .

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The available in vitro test data are considered reliable and suitable for classification purposes under regulation 1272/20008. The substance is not therefore classified for mutagenicity under EU CLP criteria.