Registration Dossier
Registration Dossier
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EC number: 701-319-4 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
No relevant reproductive toxicity data were identified for platinum 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. Platinum dinitrate is a strong acid (pH<2.0) and exhibits skin corrosivity in vitro. Secondly, there are good-quality endpoint-specific data on another platinum (IV) species. In a combined repeated-dose and reproductive/developmental toxicity screening test, no adverse effects were observed at daily doses of hexahydroxyplatinic acid up to 1000 mg/kg bw/day. This supports the hypothesis that, even if testing were possible, platinum dinitrate would not be expected to cause any significant reproductive toxicity.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
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 human data were identified. However, consideration of the known toxicity and physico-chemical properties of this compound, as well as good-quality endpoint-specific data on another platinum (IV) species, provides good support for the conclusion that a reproductive toxicity study can be waived.
As platinum dinitrate is a strong acid and exhibits skin corrosivity in vitro, reproductive toxicity 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 platinum 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. Platinum dinitrate is a strong acid (pH<2.0) and exhibits skin corrosivity in vitro. Secondly, there are good-quality endpoint-specific data on another platinum (IV) species. In a combined repeated-dose and reproductive/developmental toxicity screening test, no adverse effects were observed at daily doses of hexhydroxyplatinic acid up to 1000 mg/kg bw/day. This supports the hypothesis that, even if testing were possible, platinum dinitrate would not be expected to cause any significant developmental toxicity.
Link to relevant study records
- Endpoint:
- developmental toxicity
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Reference
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 human data were identified. However, consideration of the known toxicity and physico-chemical properties of this compound, as well as good-quality endpoint-specific data on another platinum (IV) species, provides good support for the conclusion that a developmental toxicity study can be waived.
As platinum dinitrate is a strong acid and exhibits skin corrosivity in vitro, developmental toxicity/teratogenicitytesting by the oral route is not considered scientifically justified.
Toxicity to reproduction: other studies
Additional information
No data identified.
Mode of Action Analysis / Human Relevance Framework
No data identified.
Justification for classification or non-classification
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
