Registration Dossier
Registration Dossier
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EC number: 823-780-1 | CAS number: 1034820-43-3
Endpoint summary
Administrative data
Description of key information
Non-skin sensitiser
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitisation potential of the substance was evaluated by taking into consideration experimental data on Similar Substance 01. Justification for Read Across is given in Section 13 of IUCLID.
Similar Substance 01 was evaluated for its skin sensitisation potential in the Maurer optimisation test according to the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), of the US Association of Food and Drug Officials (AFDO). During the induction period (days 0 -19) ten male and ten female guinea pigs were subjected to intradermal injections with 0.1 % of substance in polyethylene glycol:saline (70:30). After one week the animals were subjected to intradermal injections with 0.1 % of substance with adjuvant (ratio 1:1) for two weeks. The animals were later challenged with intradermal injections of 0.1 % of substance in polyethylene glycol:saline (70:30). After 24 hrs the skin reactions were assessed and the skin-fold thickness of the erythemateous reaction and the individual "reaction volume was determined. Skin sensitization was defined to occur of the challenge reaction whenever the reaction volume exceeded the mean value + one SD of the pre-sensitization responses. Only 2 out of 20 test group animals presented skin reactions while one out of 20 animals in the negative control group had a positive reaction.
The analogue substance is considered as a non-skin sensitiser.
The in-vivo skin sensitization test OECD 429 (Local Lymph Node Assay) with the incorporation of 3H-methyl thymidine radionuclide was carried out on the test item. In the pilot experiment, the following concentrations of the test item were used: 100%, 50% and 5%. For 50% and 5% concentrations the vehicle DAE433 was used. Based on the results, the following levels were selected for the main study: 100%, 50% and 5%.
In the main study, the contact allergenic potential of the test item was evaluated after topical application to female BALB/c mice. Mice were exposed to the three selected concentrations of the test item for 3 consecutive days.The positive control item was Dinitrochlorobenzene (DNCB) in vehice DAE 433.
Primary proliferation of the lymphocytes in the lymph node draining the site of application was evaluated using radioactive labelling proliferating cells. The ratio of the proliferation in treated groups to that in vehicular controls, termed the Stimulation Index (SI), was determined. The evaluation of ear weight was performed for elimination of false positive findings with certain skin irritants.
There were no mortalities. The animals exposed to 100%, 50% and 5% test item showed no skin reactions and no other negative clinical symptoms of intoxication throughout the experiment. Nevertheless, statistically significant increased ear weight at the 50% and % dose level was recorded compared to the negative control, but without dose-response relationship.
The values of SI for the test groups trated with the test item were below the threshold, SI is < 3 [100% (1.33), 50% (1.45) and 5% (1.42)] but the value of disintegrations per minute (DPM) for all test item groups is statistically signicantly increased compared to negative control (without dose-response relationship).
The positive control item, DNCB, as a known contact allergen (0.5%(w/v)) elicited the expected reaction pattern with a significant increase in the SI (9.76) and ear weight. Appropriate performance of the assay in the test laboratory was therefore demonstrated.
Under the given conditions, the test item is not considered a sensitizer in the LLNA assay in mice.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No criteria for the classification or non-classification are mentioned in the CLP Regulation regarding the Maurer optimisation test. However, the results of the test group are comparable to the results of the negative/control group. Two out of 20 and one out of 20 animals in the test and negative control group respectively presented positive skin reactions.
Regarding the in vivo LLNA assay (OECD 429) the susbtance is considered a skin sensitizer if the stimulation index (SI) is > 3. By considering the assay performed on the test item, the SI remains below the threshold for each tested concentration (100%, 50% and 5% test item).
The substance is not classified for skin sensitisation according to the CLP Regulation (EC) No.1272/2008.
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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