Registration Dossier

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Additional information

The substance was negative in the following tests:

1) Chromosome Aberration Assay – V79 Chinese Hamster Lung

2) HPRT Assay – V79 Chinese Hamster Lung

 

The substance was positive in the following test:

3) Ames Test – Salmonella and E. coli

 

Two separate gene mutation tests in mammalian cells demonstrated that the substance does not have any mutagenic properties in V79 Chinese Hamster Lung cells. In the bacterial mutation test strong positive effects were obtained with and without S-9 mix at doses which induced precipitations. The results lead to the conclusion that the susbstance is mutagenic in the bacterial systems with and without an exogenous metoblizing system. However it should be noted that the specific method according to Privall - Mitchell for azo dyes was not utilised in this study; hence the results may be due to redundancies within the method employed. This statement is further enforced by the negative mutagenicity results observed in the other in vitro 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, 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 In Vitro genetic toxicity studies

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.