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

Endpoint summary

Additional information

TS-ED 532 was tested in a number of acute aquatic toxicity studies. In zebra fish, the LC50 was estimated to be >0.28 to <0.73 mg/L. NOEC was estimated to 0.28 mg/L. Due to the low water solubility of TS-ED 532, the effect observed was considered to be a physical effect rather than a toxic effect due to partitioning of TS-ED 532 onto the gills of the fish. NOEC was several magnitudes higher than the estimated solubility and TS-ED 532 is considered to be non-toxic within the solubility range. InDaphnia magna, acute effects of TS-Ed 532 were observed at all test concentrations from 0.08 to 180 mg/L at 48 h. The EC50 value (48 h) was 0.92 mg/L which is several magnitudes higher than the estimated solubility. TS-ED 532 is not considered to be systemically toxic within the solubility range based on the idea that the effects on mobility were a physical effect of the non-dissolved TS-ED 532 rather than a systemic effect. In algae, TS-ED 352 did not significantly inhibit the growth rate of Pseudokirchneriella subcapitata at 2.5 and 5 mg/L and thus did not have any effects within the solubility range. The EC50 was estimated to be 106 mg/L. Overall, TS-ED 532 was tested as an emulsion because of its very low aqueous solubility. Measured concentrations were lower than the nominal test concentrations. The effects observed are considered a physical effect of TS-ED 532 rather than manifestations of systemic toxicity. There were no signs of systemic toxicity at the limit of water solubility.  

 

TS-ED 532 was tested in a number of long-term aquatic toxicity studies. Due to the very low water solubility of TS-ED 532, the studies were conducted with radiolabelled TS-ED 532 using concentrations in the range of 60-90 µg/L. According to preliminary studies 70 µg/L was the highest concentration of TS-ED 532 to be dissolved in the test medium. TS-ED 532was tested for chronic toxicity including endocrine disrupting effectson zebra fish (OECD 210 “Fish, Early-Life Stage Toxicity Test”)at0 (control); 10; 16; 27; 43 and 70 μg/Lradiolabelled TS-ED 532(mean actual concentrations of 0; 7.8; 12.7; 21.1; 32.1 and 50.6μg/L). NOEC was determined to be 50.6 μg/ forembryonic 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 32.1μg/L. There was no effecton the sex ratio. In another study, TS-ED 532 was tested for potential endocrine disrupting effects on adult zebra fish (OECD 230 “21-day Fish Assay: A Short-Term Screening for Oestrogenic and Androgenic Activity, and Aromatase Inhibition”) 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). No significant changes in the VTG levels were observed in adult females or males when exposed to TS-ED 532. LOEC was estimated to ≥46.7 μg/L. 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.

 

In another study, TS-ED 532 was tested for inhibitory effects on the reproduction of the freshwater crustacean Daphniamagnausing concentrations of 10; 16; 27; 43 and 70 µg/L radiolabelled TS-ED 532.The production of offspring was uniform in both controls compared with the individual test concentrations, and therefore, the NOEC (21 days) was estimated to be≥70 µg/L and the EC10 as well as EC50 are estimated to be >70 µg/L.Overall, TS-ED 532 did not show chronic toxicity or reproductive toxicity, including endocrine disrupting effects, in the solubility range of 60-90 µg/L, using radiolabelled TS-ED 532.