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EC number: 204-464-7
CAS number: 121-32-4
Oral LD50 > 3160 mg/kgDermal LD 50 > 2000 mg/kg
a study (Hazleton, 1992), Sprague-Dawley rats (5M/5F/dose) received
ethylvanillin at different doses of 2000, 2510 and 3160 mg/kg in vehicle
were observed for 14 days.
signs: subdued behaviour and lethargy were noted at 15 min, 1, 2, 4
hours after treatment. All animals were
normal on day 2 for the 3 tested doses.
mortality was observed.
LD50 was higher than 3160
these conditions, ethylvanillin
is not classified as harmful by ingestion.
Four studies were
available. One with reliability 1 according to Klimish scale was
selected as the key study. In this key study (Lheritier -1992),
Sprague-Dawley rats (5M/5F/dose) received ethylvanillin at different
doses 2000, 2510 and 3160 mg/kg in vehicle carboxymethylcellulose (CMC).
Animals were observed for 14 days. Clinical signs: subdued behaviour and
lethargy were noted at 15 min, 1, 2, and 4 h after treatment. All
animals were normal on day 2 for the 3 tested concentrations.No
mortality was observed.
The LD50 was > 3160
mg/kg. Based on this value and according to the EU classification
criteria, ethylvanilline is not classified for oral acute toxicity.
Only one study was
available and selected as key study and has the reliability 1 according
In this acute dermal
toxicity study (Hazleton, 1992), groups of young Sprague-Dawley rats
(5/sex) were dermally exposed to ethylvanillin (assumed to be 100%)
moistened with purified water for 24 hours to 10% of body surface area
at dose of 2000 mg/kg bw. Animals then were observed for 14 days.
Dermal LD50 Combined >
2000 mg/kg bw. Neither mortality nor clinical signs were observed at
According to the EU
ethyvanilline is not classified for dermal
acute toxicity based on the dermal LD50 higher than 2000 mg/kg bw.
Based on available studies, ethylvanillin is
not classified for acute oral and dermal toxicity:
according to the directive 67/548/EC classification criteria.
according to the CLP 1272/2009/EC classification criteria.
on these same studies, since no adverse effect were observed, ethylvanillin
is not classified as STOT single exposure, according
to CLP 1272/2009/EC criteria.
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