Registration Dossier
Registration Dossier
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EC number: 231-116-1 | CAS number: 7440-06-4
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
No relevant reproductive toxicity data were identified.
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 or laboratory animal reproductive toxicity data were identified. However, availability considerations provide good support for the conclusion that a reproductive toxicity study can be waived.
Platinum is considered to be non-bioavailable following oral and dermal exposure, as evidenced by transformation/dissolution and bio-elution test data.
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. Further, bio-elution test data indicates lack of bioavailability in lung fluid.
Since a chemical is required to be bioavailable in order to induce reproductive toxicity, platinum is not considered to pose a toxicity hazard to reproduction. Finally, for animal welfare reasons, conducting new in vivo toxicity tests is considered a last resort. Consequently, no testing for reproductive toxicity of platinum is considered justified.
Effects on developmental toxicity
Description of key information
No relevant developmental toxicity data were identified.
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 developmental toxicity data were identified.
Toxicity to reproduction: other studies
Description of key information
No data identified.
Additional information
No relevant human or laboratory animal developmental toxicity data were identified. However, availability considerations provide good support for the conclusion that a developmental toxicity study can be waived.
Platinum is considered to be non-bioavailable following oral and dermal exposure, as evidenced by transformation/dissolution and bio-elution test data.
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. Further, bio-elution test data indicates lack of bioavailability in lung fluid.
Since a substance is required to be bioavailable in order to induce reproductive/developmental toxicity, platinum is not considered to pose a toxicity hazard to development. Finally, for animal welfare reasons, conducting new in vivo toxicity tests is considered a last resort. Consequently, no testing for developmental toxicity of platinum is considered justified.
Mode of Action Analysis / Human Relevance Framework
No data identified.
Justification for classification or non-classification
No reproductive toxicity data are available for platinum. However, such effects are not expected, based on a lack of bioavailability following exposure via the oral, dermal and inhalation routes. As such, there is no evidence to classify it for reproductive toxicity according to EU CLP criteria (EC 1272/2008).
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.
