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Toxicological information

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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) Chromosome aberration test.

Two separate bacterial reverse mutation tests showed that the substance does not have any mutagenic properties in different Salmonella strains. In addition, no genotoxic properties have been seen in in-vitro chromosome aberration. 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, additional testing of the test substance in an in vitro gene mutation study in mammalian cells does not appear scientifically necessary and this test has been waived.

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

Genetic toxicity "in vitro" is discussed below.

Value used for CSA:Genetic toxicity: negative


Short description of key information:
Summary of genotoxicity data

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 Klimish 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.