Registration Dossier
Registration Dossier
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EC number: 231-127-1 | CAS number: 7440-18-8
Endpoint summary
Administrative data
Description of key information
No skin or respiratory tract sensitisation data are available.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No skin sensitisation data (human, laboratory animal or in vitro) were identified for ruthenium metal.However, exposure and availability considerations provide good support for the conclusion that a skin sensitisation study can be waived.
Ruthenium is considered to be non-bioavailable following dermal exposure, as evidenced by transformation/dissolution and bio-elution test data. Moreover, skin contact during production and/or use is expected to be negligible.
Since a chemical is required to be dermally bioavailable in order to induce skin sensitisation, ruthenium is considered incapable of inducing skin sensitisation. Finally, for animal welfare reasons, conducting new in vivo toxicity tests is considered a last resort. Consequently, no testing (in vitro or in vivo) for skin sensitisation of ruthenium is considered justified.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
No respiratory tract sensitisation data are available. A new study was not conducted as no standard and validated test method is available and it is not a REACH Standard Information Requirement. Further, ruthenium 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.
Justification for classification or non-classification
No skin or respiratory tract sensitisation data are available for ruthenium. However, such effects are not expected, based on a lack of (bio)availability by the dermal and inhalation routes. As such, there is no evidence to classify it as a skin or respiratory sensitiser according to EU CLP criteria (EC 1272/2008).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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