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EC number: 204-464-7
CAS number: 121-32-4
Ethylvanillin is not a skin sensitizer in a LLNA study performed in 2003 (CIT, 2003 - reliability 1) selected as a key study.
- Positive control results:at the
concentration of 25%, a moderate increase in cellularity and a
stimulation index exceeding the threshold value of 3 (SI=13.50) was
noted. The study was therefore considered valid.
No cutaneous reactions and no noteworthy
increase in ear thickness were observed in the animals at any of the
In the treated groups, no positive
lymphoproliferative response was noted and no dose-related increase in
the stimulation index was observed at the tested concentrations.
In a dermal sensitization study (Klein, 2003) with Ethylvanillin in acetone/olive oil (4/1), female CBA/J mice (4 animals per dose) were tested in LLNA, according to the guideline OECD 429 at doses: 0, 2.5, 5, 10, 25 and 50 %.
During the study, no cutaneous reactions (ears irritation) were observed, nor a positive lymphoproliferative response.
In absence of effect no EC3 value could be calculated.
Based on these results, Ethylvanillin is not sensitizing according to CLP 1272/2008/EC criteria.
Four studies were available for this endpoint. Two studies are reliable, one with reliability 1 and the other one with reliability 2 according to Klimisch scale. The two other studies are not reliable, one with reliability 3 and the other one with reliability 4. Among the two reliable studies, one was chosen as key study (CIT, 2003 - reliability 1), and the other one was selected as "supporting study". These two LLNA studies showed that Ethylvanillin is not sensitizing to skin.
Conclusion: Based on the two LLNA reliable studies ethylvanillin is not sensitizing to skin.
Based on the results obtained in two LLNA studies, ethylvanillin is not classified for skin sensitization, according to CLP 1272/2008/EC criteria.
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