Registration Dossier
Registration Dossier
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EC number: 430-010-4 | CAS number: 12160-44-0
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
In a GLP compliant sensitisation study, performed according to OECD guideline No. 406, Dunkin-Hartley guinea pigs were treated with potassium ferrite in order to evaluate its sensitizing properties (Huntingdon Life Sciences, 1997). Twenty male animals were treated with potassium ferrite in water and 10 male control animals only with the vehicle. Based on the results of a preliminary study and in compliance with the OECD 406 guideline the following dose levels were used: Intradermal injection: 0.25% w/v in dist. water for irrigation, topical application: 10% w/v in distilled water; challenge application: 7.5% and 3.75% w/v in distilled water. No signs of ill health or toxicity were recorded. After induction, the following dermal reactions were observed: Necrosis was recorded at sites receiving Freund's Complete Adjuvant (50:50 with water) in test and control animals. Slight irritation was seen in test animals at sites receiving 0.25% w/v potassium ferrite in water for irrigation. No irritation was observed in control animals. Slight erythema was observed in test animals following topical application of 10% w/v potassium ferrite in distilled water. Slight erythema was also seen in the control animals. Following challenge, marked dermal reactions were seen in nine of the twenty test animals compared to none in the controls. No dermal reactions were seen in eight test animals. The remaining three animals gave inconclusive responses.
Migrated from Short description of key information:
The test substance is a skin sensitiser.
Justification for classification or non-classification
Based on the findings in the skin sensitisation study, the test substance has to be classified as Xi; R43 according to Directive 67/548/EEC and as Cat1B:H317 according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 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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