Registration Dossier
Registration Dossier
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EC number: 215-385-2 | CAS number: 1324-76-1
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:
A Local Lymph Node Assay study was performed to determine the skin sensitizing potential of test article in the local lymph node assay in mice. The study employed the alternative method of the lymph node weight and lymph node cell count to assess proliferation.This method has the advantage of (i) more simplistic experimental work, (ii) less variability, (iii) better reproducibility, (iv) faster results, (v) reduced costs.
Treatment with test article atconcentrations of 5%, 10% or 25% did not reveal statistical significantly increased values for lymph nodecell count. The stimulation indices of the lymph node cell count did not exceed the threshold level of 1.4. Hence, the test item is classified as not sensitizing. No signs of local or systemic intolerance were recorded. The animal body weight was not affected by the treatment. Based on the results of this study, test article at concentrations of 5%, 10% or 25% (w/w) did not reveal any sensitising properties in the local lymph node assay.
Migrated from Short description of key information:
Test article at concentrations of 5%, 10% or 25% (w/w) cannot cause any skin sensitizing response in the local lymph node assay.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data, test article cannot reveal any skin sensitizing properties in local lymph node assay and should not be classified according to CLP(Regulation EC No. 1272/2008).
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