Registration Dossier
Registration Dossier
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EC number: 279-919-6 | CAS number: 82205-20-7
Endpoint summary
Administrative data
Description of key information
The potential of the source substance (87.9% purity) to cause skin sensitisation reactions following topical application to the skin of CBA/JN mice, was assessed using the LLNA: BrdU-ELISA method (OECD 442B). An increase in cell proliferation of draining lymph nodes was observed in the high, medium and low dose groups, indicating that the test item may elicit a sensitisation response.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
No data is available for the target substance. Thus, available data from the source substance was used in a read-across approach. Details on the read-across rational are provided in section 13.
The potential of the source substance (87.9% purity) to cause skin sensitisation reactions following topical application to the skin of CBA/JN mice, was assessed using the LLNA: BrdU-ELISA method (OECD 442B). Based on the results from a preliminary test the test item was topically administered at concentrations of 50, 25 and 10% w/w, in acetone:olive oil 4:1 (v/v) in the main assay. No mortality nor clinical signs were recorded in any animal. Changes in body weight observed during the study were within the expected range for this strain and age of animals. An increase in cell proliferation of draining lymph nodes was observed in the high, medium and low dose groups with Stimulation Indices of 3.07, 4.77 and 4.64, respectively. Dunnett’s test showed a statistically significant difference (p < 0.01) between medium and low dose groups and negative control group, indicating that the test item may elicit a sensitisation response.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In a dermal sensitization study according to OECD 442B, female mice were tested positive for the source substance. Based on the results from the read-across partner, classification of the target substance is warranted (Skin Sens. 1, H317). Subcategorization into 1A/1B is not possible as the EC3 value could not be determined as the stimulation indices of all concentrations were above 3.
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