Registration Dossier
Registration Dossier
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EC number: 943-670-8 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Skin sensitiser.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
No tests are available for disperse blue 73, therefore one available test on similar substance 1 was used for the assessement. The test article was investigated for possible allergenic potential to the skin of 15 (10 test and 5 control) male albino guinea pigs based on the Guinea-Pig Maximisation Test, of OECD guideline 406 "Skin Sensitisation" (1992) and EU method B.6. "Acute Toxicity-Skin Sensitisation" (1996).
The intradermal induction of sensitization in the test group was performed in the nuchal region with a 1 % dilution of the test article in PEG 400 and in an emulsion of Freund's Complete Adjuvant (FCA) / physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test article at 50 % in PEG 400 one week after the intradermal induction and following pretreatment of the test areas with 10 % Sodium-Lauryl-Sulfate (SLS) approximately 23 hours prior to application of the test article. The animals of the control group were intradermally induced with PEG 400 and FCA / physiological saline and epidermally induced with PEG 400 under occlusion following pretreatment with 10 % SLS.
No mortality occurred. No toxic symptoms were evident in the guinea pigs of the control or test group. All test animals showed moderate/confluent to intense erythema and swelling after challenge treatment with the test article formulation.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the CLP Regulation (EC 1272/2008), Annex I, Part 3, Table 3.4.3, a test substance is assigned to Category 1A based on this criteria: "≥ 60 % responding at > 0,1 % to ≤ 1 % intradermal induction dose," in the guinea pig maximisation test.
All animals exposed to 1 % intradermal induction dose showed response to test substance. Since this result fulfils the above criteria for classification, test substance is classified in category 1A (H317) as skin sensitiser in the CLP Regulation (EC 1272/2008).
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