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EC number: 204-464-7
CAS number: 121-32-4
Two reliable studies were available. One of them, done in accordance with the recognized guidelines, was selected as key study, and its summary is the following:
In a 96-h acute toxicity study (Brooke, 1984), fathead minnows (Pimephales promelas) were exposed to ethylvanillin at nominal concentrations of 0 (control); 12.5; 25; 50; 100 and 200 mg/L under flow through conditions.
The 96-h LC50 was 87.6 mg/L. 95% C.I. (Confidence Interval): 81.4 to 94.3 mg/L (based on measured concentrations).
Based on the criteria of the CLP regulation, ethylvanillin is considered as harmful for Pimephales promelas.
Although GLP were not mentioned and validity criteria not detailed, this toxicity study satisfies the guideline requirement and is therefore considered as reliable with restrictions.
Two studies were available. One of them, done in accordance with recognized guidelines, was selected as key study, and its summary is the following:
The 48 hours acute toxicity of ethylvanillin to Daphnia magna was studied under static conditions (ECT, 2017). Daphnids were exposed at nominal concentrations of 0, 4.27, 9.39, 20.7, 45.5 and 100 mg/L (nominal concentrations) or 0, 3.96, 8.58, 17.30, 41.6 and 95.6 mg/L (measured concentrations) for 48 hours.
The 48 hours EC50 was 26.2 mg/L (measured concentrations). The 48 hours EC10 based on immobilization was 12.7 mg/L.
Based on the results of this study, ethylvanillin is considered as harmful to Daphnia magna.
The other study (Palla, 1987) was assigned a reliability 3 according to Klimisch scale, because the study was poorly described and the study duration was only 24 hours. No analytical monitoring was done.
One study was available (ECT, 2017), with reliability 1, and was selected as key study. Its summary was the following:
In a 72 hours algae study, the acute toxicity of ethylvanillin was evaluated in the algal strain Pseudokirchneriella supcapitata using a 72-hour static test according to current EC and OECD guidelines, and GLP. The 72 -hour ErC50 (geometric mean) was > 100 mg/L. The 72-hour EyC50 (geometric mean) was 75.7 mg/L. The NOEC was 21.2 mg/L. The validity criteria were fulfilled. Based on this study, ethylvanillin is considered as not harmful to algae.
Toxicity to microorganisms:
Only one study was available (Schultz, 1997), with reliability 2, and was selected as key study. Its summary was the following:
In a study (Schultz, 1997), the acute toxicity of Tetrahymena pyriformis was studied under static conditions. Microorganisms were exposed to at least 5 concentrations of ethylvanillin. The 40-hour IC50 was 158.7 mg/L. Under these conditions, ethylvanillin is not considered harmful to microorganisms.
Long-term toxicity to aquatic invertebrates:
No data are available on ethylvanillin. A read-across was done with vanillin. One study (NIVA, 1996) with reliability 2 was available and its summary was the following:
The effect of vanillin on the reproduction of Daphnia magna was tested for 21 days according to the OECD guideline 202 and GLP (NIVA, 1996). Test solutions were renewed 3 times per week. A vanillin concentration of 100 mg/L resulted in a lethal effect starting at day 3. No lethality was observed at 56 mg/L and lower concentrations during 21 days exposure. Sublethal effects of vanillin included delayed occurence of the first brood, aborted broods and reduced number of live offspring. The EC50 for effects of reproduction (21 days) was estimated at 24 mg/L, the LOEC at 18 mg/L and the NOEC at 10 mg/L (all nominal concentrations). Since exposure concentrations were fluctuating, weigthed mean measured concentrations were calculated and this resulted in an EC50 for effects on reproduction of 16 mg/L, a NOEC of 5.9 mg/L and a LOEC of 10 mg/L.
The read-across justification is included in section 6.1.4 of the IUCLID.
Long-term toxicity to fish:
No data are available on ethylvanillin.
Annex XI, section 1.2 (weight of evidence) states that when a WoE provides adequate information for risk assesment (CSA) and hazard assessment (classification), testing on vertebrates shall be omitted.
According to the the WoE, a worst-case long-term NOEC/EC10 of 1.18 mg/L for fish is considered as the key value for the purposes of environmental classification and quantitative risk assessment.
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