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EC number: 204-464-7
CAS number: 121-32-4
- 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.
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 %.
the study, no cutaneous reactions (ears irritation) were observed, nor a
positive lymphoproliferative response.
absence of effect no EC3 value could be calculated.
on these results, Ethylvanillin is not sensitizing, according to
67/548/EC directive and CLP 1272/2008/EC criteria.
Four studies were
available for this endpoint, two studies with reliability 2 according to
Klimisch scale and two with reliability 3. Among the two reliable
studies, one was chosen as key study (CIT, 2003), and another one was
selected as "supporting study". These two LLNA studies showed that
Ethylvanillin is not sensitizing.
Based on the results obtained in two LLNA studies,
ethylvanillin is not classified for skin sensitization, according to the
directive 67/548/EC and CLP 1272/2008/EC criteria.
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