Registration Dossier
Registration Dossier
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EC number: 824-774-1 | CAS number: 148124-40-7
Endpoint summary
Administrative data
Description of key information
The test item EDTA-Fe(OH)K2 is not considered to be irritating to the skin or eyes. A study for respiratory irritation is not available; however, an acute inhalation study (Haferkorn, 2008) with EDTA-FeNa does not give any indication that the test substance EDTA-Fe(OH)K2 should be regarded as a respiratory irritant.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
The key studies with EDTA-FeK (recently performed according to current guidelines and GLP) did not result in skin or eye irritation in vitro; studies with EDTA-FeNa showed slight irritation effects but do not require classification.
Justification for selection of skin irritation / corrosion endpoint:
For EDTA-FeK only an in vitro skin irritation study was carried out based on the absence of skin irritation for the read across substance EDTA-FeNa (see also section 13); based on this no skin irritation is expected for EDTA-Fe(OH)K2 either.
Justification for selection of eye irritation endpoint:
For EDTA-FeK only an in vitro eye irritation study was carried out based on the absence of eye irritation for the read across substance EDTA-FeNa (see also section 13)
Justification for classification or non-classification
Key studies with the test substance and the read across substance EDTA-FeNa did not show irritation. Therefore classification for irritation/corrosion is not warranted.
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