Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

The key study followed standard guidelines at the time, involving the use of five strains of Salmonella typhimurium (TA98, TA100, TA1535, TA1573 and TA102) exposed to concentrations up to 100 % using a preincubation method in the presence or absence of metabolic activation. The test substance was found to be non-mutagenic to bacterial strains in this test.


Justification for selection of genetic toxicity endpoint
A Klimisch 2 (Reliable with restrictions), GLP compliant, guideline study, available as an unpublished report. Test substance is 84.8 % gold.

Short description of key information:
A GLP regulatory guideline Ames test (OECD471) performed with the test substance (84.8% gold).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The test substance (84.8 % gold) was found to be non-mutagenic to bacterial strains. However, mutagenicity studies in mammalian cells were waived on the basis of results from a bio-elution test in which showed no gold metal release above the limit of detection (1 µg/L). Consequently, it is not possible to classify the test substance for this endpoint.