Registration Dossier
Registration Dossier
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EC number: 932-833-9 | CAS number: -
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:
No data are available on skin sensitisation potential of the reaction mass of ammonium iron (III) citrate and ammonium sulfate.
Due to the ubiquitous nature of the constituents of the registered substance and the intrinsic mechanisms in place for the regulation of citrate and iron homeostasis, further testing would be unjustified. Additional information on basis of read across approach and justification for data waiving is given in an expert report (Peter Fisk Associates, 2012) attached in Section 13 of the IUCLID dossier.
The other non-citrate chemical species that are part of the registered substance are ammonium and ammonium sulfate for which no data is included in the present data set. The ammonium and ammonium sulfate are not expected to contribute to the sensitisation potential of the registered substance, and a disseminated REACH dossier for ammonium sulfate is available via the ECHA website which includes confidential company data as a key study for the sensitisation endpoint. The reported, reliable study conducted according to an appropriate protocol, reports no sensitisation potential of ammonium sulfate to the skin of guinea pig.
Migrated from Short description of key information:
No data are available for skin sensitisation potential of the reaction mass of ammonium iron (III) citrate and ammonium sulfate.
The ubiquitous nature of iron and citrate in the environment and their importance in biological processes, and their homeostasis being under strict control make further testing counterintuitive.
Justification for classification or non-classification
Based on the available information and the ubiquitous nature of the consituent ions of the registered substance, no classification is proposed for sensitisation of the reaction mass of ammonium iron (III) citrate and ammonium sulfate in accordance with current regulation (EC 1272/2008).
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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