Registration Dossier
Registration Dossier
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EC number: 700-518-3 | CAS number: 38233-76-0
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A Local Lymph Node Assay (LLNA) was conducted (Huntingdon Life Sciences, 2011) in mice to predict the potential of ETD to cause skin sensitisation. The study was conducted according to OECD test guideline 429 and EU test method B42, and in compliance with GLP.
Following a preliminary investigation (2 concentrations, 2 mice per concentration), the main study comprised a negative control group (vehicle only, acetone:olive oil, 4:1), three treated groups (ETD as supplied, ETD at 25% in vehicle, and ETD at 50% in vehicle), and a positive control group (treated with Hexyl Cinnamic Aldehyde); each group comprised of four female mice.
The Stimulation Indices (SI, test/control ratios) obtained for 25%, 50%, and 100% (as supplied) ETD were 5.8, 6.8, and 7.2, respectively. Due to the dose responses obtained, it was not possible to extrapolate an EC3 value; the EC3 value must be lower than the lowest concentration tested (25% ETD, v/v).
Migrated from Short description of key information:
Skin sensitisation, LLNA, Mice: Predicted sensitising.
Justification for classification or non-classification
The LLNA study noted above concluded that ETD has the potential to cause skin sensitisation. An accurate value for the EC3 could not be determined on the basis of the available study due to the dose response observed, and so it is not possible to determine the sub-category according to tables 3.4.3 and 3.4.4 of the second ATP to the CLP regulation (Commision Regulation (EU) No 286/2011), and so ETD should be classified as Category 1 for skin sensitisation. The resulting hazard statement is "H317: May cause an allergic skin reaction".
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