Registration Dossier
Registration Dossier
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EC number: 606-423-2 | CAS number: 200295-52-9
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:
An LLNA according to OECD TG 429 was performed on 6 female NMRI mice per dose group using substance formulations in methyl ethyl ketone of 0 % (vehicle control), 3 %, 10 % and 30 % (due to the solubility of the test item the highest feasible concentration was 30%). The assay was conducted as IMDS-modification (Integrated Model for the Differentiation of Skin Reactions), which allows for discrimination of the irritant potential by comparing the specific immune reaction induced by the test substance in the draining lymph nodes (LN cell counts) to the immediate non-specific acute skin reaction (ear swelling / ear weight).
With respect to a specific immune reaction, the "positive level" for cell counts, which is 1.4, has not been exceeded in any dose group. Compared to vehicle treated animals there was a slight statistical significant increase at the highest dose level (30 % concentration) for the weights of the draining lymph nodes. An increase in this parameter could point to an irritant property of the test item. The "positive level" of ear swelling which is 2 x 10 exp-2 mm increase, i.e. about 10 % of the control values, has not been reached or exceeded in any dose group. No substance specific effects were determined for ear weights either.
In conclusion, the study results did not reveal an indication for a skin sensitizing potential up to and including a 30 % concentration of the substance, and also no conclusive indications for an irritant potential were found. 30 % turned out to be the NOEL in this study with respect to skin sensitization.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to Regulation (EC) No 1272/2008, Annex I, no classification is warranted for skin sensitization.
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