Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

No relevant repeated dose toxicity data were identified.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Mode of Action Analysis / Human Relevance Framework

No data identified.

Additional information

No relevant human or laboratory animal repeated dose toxicity data were identified for ruthenium metal. However, exposure and availability considerations provide good support for the conclusion that a repeated dose toxicity study 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 systemic toxicity following repeated exposure, ruthenium is not considered to pose a systemic toxicity hazard. Finally, for animal welfare reasons, conducting new in vivo toxicity tests is considered as a last resort. Consequently, no testing for repeated dose toxicity of ruthenium is considered justified.

Justification for classification or non-classification

No repeated dose toxicity 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 as STOT-RE according to EU CLP criteria (EC 1272/2008).