Registration Dossier
Registration Dossier
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EC number: 231-096-4 | CAS number: 7439-89-6
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:
There is very little evidence in humans and poor evidence in animal studies of sensitisation as a result of exposure to metallic iron. The widespread exposure to iron and its role in biological processes, together with the extensive use of dietary supplements shows that sensitisation is not a concern.
During contact with the skin, the metallic iron may oxidize. In the unlikely event that exposure time is long enough for any substantial oxidation to occur, this will not result in sensitization as it is shown by the negative outcome of the skin sensitisation study with iron oxides.
The very long history of apparent safe use and negative results with iron oxides, makes the requirement for a skin sensitization study with metallic iron redundant.
Migrated from Short description of key information:
There are no reports in the literature on skin sensitization with metallic iron. Based on the fact that human skin contact with iron has been widespread for a very long time, domestically as well as occupationally, without reports in the medical literature of skin sensitization due to this contact, the absence of skin sensitization can be assumed. So data waiving is justified on the basis of a very long history of apparently safe use. A history of safe use is also evident for iron oxides formed on the skin from metallic iron. Moreover, an experimental study is available that confirms the non-sensitizing nature of iron oxides.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
- Migrated from Short description of key information:
A series of inhalation studies with carbonyl iron (6 h/day, 5 days/week, 4 weeks) did not result in adverse effects that point to respiratory sensitisation.
Justification for classification or non-classification
Based on the fact that human skin contact with iron has been widespread for a very long time, domestically as well as occupationally, without reports in the medical literature of skin sensitization due to this contact, the absence of skin sensitization can be assumed. So non-classification is justified on a very long history of safe use. The inhalation studies with carbonyl iron (Section 7.2.2) show that there is no need either to classify metallic iron for respiratory sensitisation.
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