Registration Dossier

Diss Factsheets

Administrative data

Description of key information

No relevant acute oral, dermal or inhalation toxicity data were identified.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No relevant human or laboratory animal acute toxicity data were identified for ruthenium metal. However, exposure and availability considerations provide good support for the conclusion that acute toxicity studies 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. Moreover, skin contact during production and/or use is expected to be negligible.

 

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 substance is required to be bioavailable in order to induce systemic toxicity following acute exposure, ruthenium is not considered to pose an acute toxicity hazard. Finally, for animal welfare reasons, conducting new in vivo toxicity tests is considered a last resort. Consequently, no testing for acute toxicity of ruthenium is considered justified.

Justification for classification or non-classification

No acute 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 for acute toxicity according to EU CLP criteria (EC 1272/2008).