Registration Dossier
Registration Dossier
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EC number: 231-127-1 | CAS number: 7440-18-8
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
No reliable in vitro genotoxicity data were identified.
Endpoint conclusion
- Endpoint conclusion:
- no study available
Genetic toxicity in vivo
Description of key information
No reliable in vivo genotoxicity data were identified.
Endpoint conclusion
- Endpoint conclusion:
- no study available
Mode of Action Analysis / Human Relevance Framework
No data identified.
Additional information
No reliable genotoxicity data for ruthenium metal were identified. However, exposure and availability considerations provide good support for the conclusion that genotoxicity testing can be waived.
Ruthenium is considered to be non-bioavailable following oral and dermal exposure, as evidenced by transformation/dissolution and bio-elution test data.
It is not expected to reach the lungs in appreciable quantities (based on respiratory tract deposition modelling data). Thus, inhalation will not be a significant route of exposure.
Since a chemical is required to be bioavailable in order to induce genotoxicity, ruthenium is not considered to pose a toxicity hazard for this endpoint. Consequently, no testing for genotoxicity of ruthenium is considered justified.
Justification for classification or non-classification
No reliable genotoxicity data are available for ruthenium. However, such effects are not expected, based on a lack of (bio)availability following exposure via the oral, dermal and inhalation routes. As such, there is no evidence to classify it for germ cell mutagenicity according to EU CLP criteria (EC 1272/2008).
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