Registration Dossier
Registration Dossier
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EC number: 220-135-0 | CAS number: 2638-94-0
Endpoint summary
Administrative data
Description of key information
The test substance showed no skin sensitisation potential in a LLNA.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A study was performed to assess the skin sensitisation potential of the test item using the murine local lymph node assay (LLNA). Groups of four mice were used in this study at three dosage levels and a vehicle control. Dosages were selected as follows: 10, 25 and 50% w/v in AOO (4:1 acetone/olive oil). Each group of mice was treated by daily application of 25 µL of each of one of these three concentrations, and vehicle control, to the dorsal surface of both ears for three consecutive days. The proliferative response of the lymph node cells (LNC) from the draining auricular lymph nodes was assessed five days following the initial application, by measurement of the incorporation of 3H-Thymidine by beta-scintillation counting of LNC suspensions. The response was expressed as radioactive disintegrations per minute per lymph node (dpm/node) and as the ratio of 3HTdR incorporation into LNC of test nodes relative to that recorded for control nodes (test/control ratio). The test substance is regarded as a sensitiser if at least one concentration of the chemical results in a three-fold greater increase in 3HTdR incorporation compared to control values.
In this study no signs of ill health or toxicity were observed. Bodyweight increases were recorded for all groups of mice over the period of the study. The test/control ratios obtained for 10, 25 and 50% w/v test item were 1.1, 1.3 and 1.1 respectively. As a test/control ratio of 3 or more was not recorded for any of the concentrations tested, the test item is not considered to have the potential to cause skin sensitization.
Responses to the positive control substances hexyl cinnamic aldehyde (HCA) and 2-Mercaptobenzothiazole (MBT), in contemporaneous studies demonstrate the reliability and sensitivity of this assay to detect skin sensitisers in this laboratory.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The test substance showed no skin sensitisation potential in a LLNA test. As a result the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EC) No 2017/776.
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