Registration Dossier
Registration Dossier
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EC number: 231-177-4 | CAS number: 7440-69-9
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
According to Annexes VII, point 8.3 of Regulation No 1907/2006 information on skin sensitisation of substances shall be provided.
No published data or studies for determination the sensitisation properties of bismuth metal are available. A new study with this substance can hardly be conducted in accordance with the guideline, since elemental bismuth is only slightly soluble in water. However, based on the poor solubility of bismuth metal, sensitising properties are unlikely.
In addition, in an available guideline study with the more bioavailable substance, bismuth hydroxide nitrate oxide, the sensitising potential was determined in the LLNA in mice. 3 concentrations (10%, 25% and 50%) of the test item, a positive and a vehicle control were tested. Results show that bismuth hydroxide nitrate oxide does not reveal any sensitising properties. Therefore it can be considered that bismuth metal has no sensitising properties and should not be classified as such.
Migrated from Short description of key information:
Bismuth metal has no sensitising properties by read across.
Justification for classification or non-classification
No data about the sensitisation properties of bismuth metal are available. In an available guideline study with the more bioavailable substance, bismuth hydroxide nitrate oxide, the sensitising potential was determined in the LLNA in mice. Results show that bismuth hydroxide nitrate oxide does not reveal any sensitising properties and should not be classified and labelled according to regulation (EC) No.1272/2008.
Based on read across from this much more bioavailable substance, it can be considered that bismuth metal has no sensitising properties and should not be classified as such.
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.
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