Registration Dossier
Registration Dossier
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EC number: 219-169-9 | CAS number: 2379-81-9
Endpoint summary
Administrative data
Description of key information
Skin sensitising
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
No information on the "skin sensitisation" potential is available for the Target Substance. However data on Similar Substance 01 has been used for the assessment. More details about the substance similarity is reported in section 13.
The potential of the test item to cause skin sensitisation reactions following topical application to the skin of CBA/JN mice, was assessed using the LLNA:BrdU-ELISA method, according to the OECD Guideline for testing of chemicals No. 442b.
In the preliminary test, five concentrations [10 (maximum feasible concentration), 5, 2.5, 1 (2 only for Day 3 of study) and 0.5 % w/w in acetone:olive oil 4:1 (v/v)] were tested in the preliminary phase, in order to identify a non toxic and minimally irritant concentration and avoid false positive results.
No signs of toxicity (significant clinical signs or body weight losses) were observed at the tested concentrations.
According to the results of the irritation screening, the concentration of 10 % w/w was judged to be not irritant.
In the main assay, the test item was topically administered at the concentrations of 10, 5 and 2.5 % (w/w), in acetone:olive oil 4:1 (v/v).
No mortality nor clinical signswere recorded in any animal.
Changes in body weight observed during the study were within the expected range for this strain and age of animals.
A statistically significant increase in cell proliferation of draining lymph nodes was observed in the low, mid- and high dose groups [2.5, 5 and 10 % (w/w)], with Stimulation Indices of 1.93, 1.88 and 1.95, respectively.
The above results indicate that the test item may elicit a sensitisation response.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the OECD Guideline 442b, the substance can be classified as Skin sensitizer Category 1, when the SI index is > 1.6.
Under test condition, the substance was found to have an SI above the threshold set out in the guideline (between 1.88 and 1.9), therefore it is classified in Category 1.
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