Registration Dossier
Registration Dossier
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EC number: 610-916-8 | CAS number: 5294-61-1
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:
Key study: The skin sensitisation test following dermal exposure was performed according to OECD Guideline 429 and EU method B.42, following the Principles of GLP. Based on the preliminary results, three groups (four animals in each) received the test substance formulated in PG at 50, 25 and 10 % (w/v) concentrations. No mortality or signs of systemic toxicity were observed during the study. Minimal amount of test item precipitate was observed on the ears of the animals in the 50 % (w/v) dose group on Days 3-5. No treatment related effects were observed on the body weight changes of the experimental animals. The stimulation index values were 4.2, 2.3 and 1.7 at concentrations of 50, 25 and 10 % (w/v), respectively. The calculated EC3 value was 34.2 % (w/v). All validity criteria were fulfilled. In conclusion, the test item was shown to have sensitisation potential (sensitizer) in the Local Lymph Node Assay.
Migrated from Short description of key information:
Key study: Test method according to OECD Guideline 429. GLP study. The test item was shown to have sensitisation potential (sensitizer) in the Local Lymph Node Assay. The stimulation index values were 4.2, 2.3 and 1.7 at concentrations of 50, 25 and 10 % (w/v), respectively. The calculated EC3 value was 34.2 % (w/v).
Justification for selection of skin sensitisation endpoint:
Only one study available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available results, the substance is classified as Skin Sensitizer Category 1B, H317 according to CLP Regulation (EC) no. 1272/2008.
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