Registration Dossier
Registration Dossier
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EC number: 227-105-6 | CAS number: 5657-17-0
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 skin sensitisation studies on ED2A-H2 is available. However the structural analogue, (H)EDTA and its various Na salts, are expected to exhibit similar properties and therefore studies using EDTA-Na2H2 and EDTA-Na3H have been used for read across. (For read-across justification also refer to Section 13). In the OECD 406 guideline study with EDTA-Na2H2 3/10 guinea pigs showed a patch erythema after the first challenge and 1/10 after the second challenge. The reports on humans are conflicting and in case of the positive results it cannot be ruled out that the reactions reflected irritation rather than sensitisation. However, overall these results do not warrant a labeling according to EU or GHS critieria, which was also confirmed by the independent evaluation of the MAK Commission for the Investigation of Health Hazards of Chemical Compounds in the work area with regard to EDTA (MAK, 46. Lieferung, 2009).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Because ED2A-H2 is not considered to be a skin sensitiser it is not expected that it would be a respiratory sensitiser as all respiratory sensitisers tested have shown skin sensitising properties in skin sensitisation tests.
Justification for classification or non-classification
The available information indicate that the substance should not be classified as skin sensitising or respiratory sensitising according to Regulation 1272/2008/EC (CLP).
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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