Registration Dossier
Registration Dossier
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EC number: 223-032-9 | CAS number: 3699-54-5
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:
In a GLP compliant study performed in accordance with OECD guideline 406 (based on the method described by Magnusson and Kligman), the skin sensitising properties of the substance were tested (Akzo Nobel/NOTOX, 1995).
The test concentrations (in distilled water) selected for the main study were based on the results of a preliminary study. In the main study, ten experimental animals were intradermally injected with a 25% concentration and epidermally exposed to a 50% concentration. Five control animals were similarly treated, but with omission of the test substance.
Approximately 24 hours before the epidermal induction exposure all animals were treated with 10% SDS. Two weeks after the epidermal application all animals were challenged with a 50%, 25% and 10% test substance concentration and the vehicle. No skin reactions were evident after the challenge exposure in the experimental and control animals.
No evidence was obtained that 1-(2-hydroxyethyl) imidazolidin-2-one had caused skin hypersensitivity in the guinea pig, since no responses were observed in the experimental animals in the challenge phase. This result leads to a sensitisation rate of 0 per cent.
Migrated from Short description of key information:
1-(2-hydroxyethyl) imidazolidin-2-one was not sensitising in a guinea pig maximisation test according to Magnusson and Kligman study.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
- Migrated from Short description of key information:
There are no data available concerning respiratory sensitisation.
Justification for classification or non-classification
Based on the results of the Magnusson and Kligman study, 1-(2-hydroxyethyl) imidazolidin-2-one does not need to be classified as sensitising according to Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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