Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The substance was negative in the following tests:

1)           Ames Test – Salmonella & E. Coli

2)           In vitro gene mutation test in mouse lymphoma L5178Y cells

3)           In vitro chromosome aberration assay in Chinese hamster lung fibroblasts (V79)

No effects were noted in any of the studies conducted. Repeat-dose studies with oral treatment in rats did not reveal any tumorigenic properties which could be related to the administration of the test substance. Consequently, the substance is considered not to be potentially mutagenic.

The following information is taken into account for any hazard / risk assessment:

Value used for CSA: Genetic toxicity: negative

Short description of key information:
Summary of genetic toxicity

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. 

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 genetic toxicity is therefore required.