Registration Dossier

Administrative data

Description of key information

No relevant repeated dose toxicity data were identified for palladium dinitrate. However, good support for the conclusion that a repeated dose toxicity study can be waived comes from two sources. Firstly, a consideration of the known toxicity and physico-chemical properties of this compound. Palladium dinitrate is a strong acid (pH<2.0) and exhibits skin corrosivity in vitro. Secondly, there are good-quality endpoint-specific data on another palladium (II) species. In a combined repeated-dose and reproductive/developmental toxicity screening test, no adverse effects were observed at daily doses of palladium(II) dihydroxide up to 1000 mg/kg bw/day. This supports the hypothesis that, even if testing were possible, palladium dinitrate would not be expected to cause any significant systemic toxicity.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
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

Additional information

No relevant human data were identified. However, consideration of the known toxicity and physico-chemical properties of this compound, as well as endpoint-specific data on another palladium (II) species, provides good support for the conclusion that a repeated dose toxicity study can be waived.

As palladium dinitrate is a strong acid and exhibits skin corrosivity in vitro, repeated dose testing by the oral route is not considered scientifically justified.

Justification for classification or non-classification