Registration Dossier
Registration Dossier
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EC number: 215-716-0 | CAS number: 1345-07-9
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:
The skin sensitization potential of dibismuth trisulfide was determined in the Local Lymph Node Assay (LLNA) according to OECD guideline 429. Individual approach was used in this test. Selection of test item concentrations based on the results of a formulation evaluation and also results of preliminary irritation/toxicity tests according to the relevant guidelines [1-3]. Based on the results the maximum attainable concentration of 100 % (i. e. 1 g test item/mL formulation) and concentrations of 50 % and 25 %. The formulations were suspensions and homogenous enough while applied on the ears of animals. In the main test, 30 female CBA/Ca mice were allocated to six groups of five animals each: - three groups received Dibismuth trisulfide at 100 %, 50 % or 25 %, - the negative control group received the vehicle of the test item (DMSO) only, - the positive control group received 25 % α-Hexylcinnamaldehyde (HCA), - the negative control group for the positive control group received Acetone: Olive oil 4:1 (v/v) mixture (AOO) only. Each substance was applied on the external surface of each ear (25 μL/ear) of the animals for three consecutive days (Day 1, 2 and 3). There was no treatment on Days 4, 5 and 6. No mortality, significant, treatment related effect on the body weights or any other sign of systemic toxicity was observed in any treatment group. No visible sign of irritation or any other local effect was observed in any treatment group.
Migrated from Short description of key information:
Under the conditions of the present Local Lymph Node Assay, dibismuth trisulfide tested at the maximum attainable concentration of 100 %
(i.e. 1 g/mL) and at concentrations of 50 % and 25% as suspension in a suitable vehicle (Dimethyl sulfoxide) was shown to have no sensitization
potential.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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