Reaction mass of 1,3-diacetoxypropan-2-yl 12-acetoxyoctadecanoate and 2,3-diacetoxypropyl 12-acetoxyoctadecanoate

Long-term toxicity to fish

Description of key information

TS-ED 532 was tested for chronic toxicity including endocrine disrupting effects on zebra fish (Danio rerio) according to the OECD 210 (Fish, Early-Life Stage Toxicity Test) test guideline. TS-ED 532 was tested at 0 (control); 10; 16; 27; 43 and 70 μg/L. (mean actual concentrations of 0; 7.8; 12.7; 21.1; 32.1 and 50.6 μg/L. using liquid scintillation counting). NOEC was determined to be 50.6 μg/L for embryonic development, hatching, behaviour, growth, survival and change in the sex ratio, LOEC was > 50.6 μg/L. A NOEC for potential endocrine disrupting effects (vitellogenin (VTG)) was determined to be 32.1, LOEC was 50.6 μg/L
In another study, TS-ED 532 was tested for potential endocrine disrupting effects on adult zebra fish (Danio rerio) in accordance with  OECD Guideline No. 230 “21-day Fish Assay: A Short-Term Screening for Oestrogenic and Androgenic Activity, and Aromatase Inhibition”. TS-ED 532 was tested at 0 (control); 10; 16; 27; 43 and 70 μg/L. (mean actual concentrations of 0; 7.55; 12.3; 21.7; 29.9 and 46.7 μg/L. using liquid scintillation counting). No significant effects were observed on the effect parameters measured and LOEC was estimated to ≥46.7 μg/L. No significant changes in the VTG levels were observed in adult females or males when exposed to TS-ED 532. 
Based on the fact that TS-ED 532 does not cause any effect on the population relevant endpoint ‘change in sex ratio’ and does not cause any significant change in the VTG levels when exposed to adult stages of fish, it is concluded that TS-ED 532 does not cause endocrine disrupting effects in fish.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

50.6 µg/L

Additional information

TS-ED 532 was tested for chronic toxicity including endocrine disrupting effects on zebra fish (Danio rerio) according to the OECD 210 (Fish, Early-Life Stage Toxicity Test) test guideline. TS-ED 532 was tested at 0 (control); 10; 16; 27; 43 and 70 μg/L. (mean actual concentrations of 0; 7.8; 12.7; 21.1; 32.1 and 50.6 μg/L. using liquid scintillation counting). A NOEC and LOEC were determined to be 50.6 μg/L and > 50.6μg/L respectively

for embryonic development, hatching, behaviour, growth, survival and change in the sex ratio. A NOEC for potential endocrine disrupting effects (vitellogenin (VTG)) was determined to be 32.1 μg/L and a LOEC was determined to be 50.6 μg/L.

In another study, TS-ED 532 was tested for potential endocrine disrupting effects on adult zebra fish (Danio rerio) in accordance with OECD Guideline No. 230 “21-day Fish Assay: A Short-Term Screening for Oestrogenic and Androgenic Activity, and Aromatase Inhibition”. TS-ED 532 was tested at 0 (control); 10; 16; 27; 43 and 70 μg/L. (mean actual concentrations of 0; 7.55; 12.3; 21.7; 29.9 and 46.7 μg/L. using liquid scintillation counting). No significant effects were observed on the effect parameters measured and LOEC was estimated to ≥46.7 μg/L. No significant changes in the VTG levels were observed in adult females or males when exposed to TS-ED 532.

Overall, TS-ED 532 was found not to have an effect on the embryonic development, hatching, behaviour, growth, survival and on the population relevant endpoint change in the sex ratio at 50.6 ug/L (the highest tested level) using the OECD draft Guideline ‘Fish Sexual Development Test’. The NOEC value was thus 50.6 ug/L and LOEC > 50.6 ug/L. Significant effects were, however, observed on the effect parameter VTG. The observed effect was a statistically significant decrease in the female VTG level. Vitellogenin is the precursor of yolk proteins, which is produced in the liver under estrogenic control and the observed decrease in the VTG level among the females may indicate a potential endocrine effect caused by the exposure of TS-ED 532. The background level of VTG in newly sexual mature fish is lower than in adult stages and it was therefore decided to perform a VTG study in adult stages using the OECD Test Guideline no. 230 ‘Fish Screening Assay. In this test no significant change in the VTG level was obtained.

Based on the fact that TS-ED 532 does not cause any effect on the population relevant endpoint ‘change in sex ratio’ and does not cause any significant change in the VTG levels when exposed to adult stages of fish, it is concluded that TS-ED 532 does not cause endocrine disrupting effects in fish.