Registration Dossier
Registration Dossier
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EC number: 276-657-4 | CAS number: 72428-99-0
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Additional information:
Equivocal and/or inconsistent results were obtained from several LLNA studies indicating that the test method allows no reliable conclusion on the possible skin sensitizing properties of the test item. In particular a negative result (SI: <3) was observed in a reduced LLNA, a negative result (SI: <3) in combination with a tendency to a dose response relationship was observed in a full LLNA, and a slightly positive result (SI max: 3.46 at mid dose) combined with a missing dose response relationship was observed in another full LLNA.
However in a higher tier study in guinea pigs according to OECD TG No. 406 a clear negative result was achieved. In this study no cutaneous reaction attributable to allergy was recorded in any animal of the treatment group after the challenge phase.
Based on thesedata the LLNA results were considered to be inappropriate for a final conclusion on the possible skin sensitizing properties of the test item. But because a clear negative result was achieved in the higher tier test in guinea pigs the test item was considered not to be a skin sensitizer.
Migrated from Short description of key information:
The test item revealed negative results when tested for its possible skin sensitizing activity in guinea pigs according to OECD TG No. 406.
Justification for selection of skin sensitisation endpoint:
Higher tier test method
Justification for classification or non-classification
Due to the equivocal results obtained from several LLNA studies preference was given to a higher tier test according to OECD TG No. 406. In this study the test item didn’t cause any sensitizing effects and thus the test item does not have to be classified regarding skin sensitization according to the criteria laid down in Directive 67/548/EEC and in 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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