Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

No relevant reproductive toxicity data were identified for palladium dinitrate. However, good support for the conclusion that a reproduction 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 reproductive toxicity.

Link to relevant study records
Reference
Endpoint:
screening for reproductive / developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

No relevant data in humans were identified. However, consideration of the known toxicity and physico-chemical properties of this compound provides good support for the conclusion that a reproductive 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.

Effects on developmental toxicity

Description of key information

No relevant developmental toxicity/teratogenicity data were identified for palladium dinitrate. However, good support for the conclusion that a developmental 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 developmental toxicity.

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

No relevant data in humans were identified. However, consideration of the known toxicity and physico-chemical properties of this compound provides good support for the conclusion that a developmental 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.

Toxicity to reproduction: other studies

Additional information

No data identified.

Justification for classification or non-classification

Additional information