Registration Dossier
Registration Dossier
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EC number: 430-750-8 | CAS number: -
Endpoint summary
Administrative data
Description of key information
The test item Urea 4 revealed no sensitising properties in a guinea pig maximisation test of Magnusson and Kligman according to EU method B.6 and OECD Guideline 406.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
An in vitro or in chemico skin sensitisation study was not conducted because adequate data from an in vivo skin sensitisation study are available.
The test item Urea 4 was assessed for its skin sensitising properties using the guinea pig maximisation test of Magnusson and Kligman according to EU method B.6 and OECD Guideline 406. During the induction phase the guinea pigs were intradermally injected with a suspension of the test item and topically treated with 2 g of the test item moistened with CMC 1%. Following a latency period of 14 days the animals were challenged with another topical application of the test item (2 g moistened with CMC 1% (100% Urea 4)), exposed to the flank.
The grade of skin reactions of treated animals was compared to controls (control animals were treated with isotonic saline during the induction phase and during challenge phase) The sensitisation rate after application of the test item was 0%. Under the test conditions the test item showed no sensitising properties. Additionally, no other signs of toxicity were observed. All animals showed normal food intake and weight gain.
Justification for selection of skin sensitisation endpoint:
GLP and guideline conform study
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
Based on the available results, the test substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the eighteenth time in Regulation (EU) 2022/692.
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