Registration Dossier
Registration Dossier
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EC number: 415-510-2 | CAS number: 145703-76-0
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation was tested on guinea pigs in maximisation test by intradermal and epidermal exposure. Type and incidence of findings were similar in the experimental and the control group. There were no histopathological differences between the skin areas treated with 50 % test substance concentration and vehicle. By comparing the responses in test animals and control animals, few positive reactions were seen at concentrations tested (50 %, 25 % and 10 %). However, the number of positive responses was far below the threshold for classification according to the CLP Regulation (EC 1272/2008). No symptoms of systemic toxicity were seen in animals and no mortality occurred except one animal dead without previously showing adverse clinical signs. At necropsy it was found with clotted blood in the abdominal cavity.
Under test conditions, during the observation period, the substance appeared as non-sensitising and did not induce systemic toxicity.
Migrated from Short description of key information:
The substance is not sensitising in guinea pig maximisation test.
Justification for selection of skin sensitisation endpoint:
The study is reliable and representative.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The substance is not classified according to the CLP Regulation (EC 1272/2008). In the guinea pig maximisation test (adjuvant type), a positive response in less than the threshold of 30 % of the treated animals was found upon intradermal induction of the test substance at concentrations of 1 % or 2 % w/w. The assessment was done 24 and 48 h after the first and the second challenge. Therefore, the substance may not be attributed to a sensitising category and the result is considered as negative.
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