Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

The substance was negative in the following tests:

1) Ames Test - salmonella

2) Prival Test - salmonella

3) HPRT assay (by read across)

4) In vitro chromosome aberration assay (by read across)

5) In vivo Micronucleus test (by read across)

Two separate bacterial reverse mutation tests, showed that the test substance does not have any mutagenic properties in different Salmonella and E. Coli strains. In addition, no genotoxic properties have been seen in the in vitro HPRT assay and the in vitro chromosome aberration test or the in vivo mouse micronucleus test with various read-across substances.

Short description of key information:
Not genotoxic

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The above studies have all been ranked reliability 1 according to the Klimisch et al system. This ranking was deemed appropriate because the studies were conducted to GLP an in compliance with agreed protocols. Sufficient dose ranges and numbers are detailed; hence it is appropriate for use based on reliability and animal welfare grounds. As the effects are considered adaptive rather than toxicological, no classification is proposed.

The above results triggered no classification under the Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008). No classification for prolonged effects is therefore required.