Registration Dossier
Registration Dossier
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EC number: 410-560-1 | CAS number: 153519-44-9 CGL 400
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:
Procedure and observations
To assess the allergenic potential of the test article in albino guinea pigs, the Maximization-Test (OECD guideline 406) was used (Ciba 1991e). Ten animals per sex and dose were used. The concentration for the intradermal injections was selected on account of the solubility of the test article; the dose level for the epidermal applications were selected on account of the primary irritation potential of the test article and with regard to nonspecific reactions in adjuvant treated animals. After intradermal and epicutaneous induction, the animals were challenged epicutaneous with a 3% paste of the substance in vaseline. Evaluation and scoring of the reactions followed after 24h and 48h. Positive controls were performed with potassium dichromate.
None of the animals showed erythema or oedema after treatment with the test article. Neither toxic symptoms nor deaths occurred in the control and test groups. Because the simultaneously treated positive control group showed a lower incidence of positive animals than expected, a second challenge was performed to confirm the negative results in the test group. No animal showed a positive reaction.
Discussion
Multiple application of the test substance onto skin did not cause an allergic reaction. The test article is, therefore, regarded as non-sensitizer.
Migrated from Short description of key information:
To assess the allergenic potential of the test article in albino guinea pigs the Maximization-Test (OECD guideline 406) was used. None of the animals showed erythema or oedema after repeated treatment with the test article. Therefore, the test substance is considered to be a non-sensitizer.
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for skin sensitization under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).
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