Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

No skin sensitisation data were identified. However, exposure and availability considerations provide good support for the conclusion that a skin sensitisation study can be waived. Skin contact during production and/or use is expected to be very low and no general population exposure to palladium monoxide is anticipated. More critically, palladium monoxide is considered to be non-bioavailable following dermal exposure, as evidenced by transformation/dissolution test data, and thus unable to induce skin sensitisation. Finally, for animal welfare reasons, conducting new in vivo toxicity tests is considered a last resort. Consequently, no testing for skin sensitisation of palladium monoxide 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, the compound 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 palladium monoxide. But such effects are not expected, based on a lack of bioavailability 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).