Registration Dossier
Registration Dossier
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EC number: 211-765-7 | CAS number: 693-98-1
Endpoint summary
Administrative data
Description of key information
2 -Methylimidazole was not a skin sensitiser in a local lymph node assay in the mouse.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitising properties of 2-methylimidazole were determined in a GLP study according to OECD guideline 429 (Local Lymph Node Assay (LLNA)) and EU method B.42 (BASF SE, 2012). For this purpose, three groups of 5 female mice each were treated with increasing concentrations of 2-methylimidazole (10%, 25% and 50% in vehicle, respectively) applied on the dorsum of both ears (25 µL per ear) for three consecutive days. Three days after the last treatment, all animals received an intravenous injection of 3H-methyl Thymidine (3HTdR). Five hours later, the 3HTdR incorporation in the draining auricular lymph nodes was determined. The results were compared with those of a control group which was treated with the vehicle (ethanol:sterile water, 7:3 v/v). A positive control group treated with α-hexyl cinnamaldehyde (up to 25% HCA solution in acetone:olive oil, 4:1 v/v) was included in the report as a reliability check.
No signs of systemic toxicity or local skin irritation were observed.
Stimulation indices (SIs) of 1.02, 1.07 and 1.14 were calculated in response to a 10%, 25% and 50% 2-methylimidazole concentration, respectively. Since the SIs were lower than 3 at all concentrations the results indicted that 2-methylimidazole should not be considered a skin sensitiser (a SI of 3 is the limiting value required for classification as a skin sensitiser).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results of the skin sensitisation study, 2-methylimidazole does not need to be classified according to the Regulation (EC) No. 1272/2008.
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