Soybean oil, epoxidized

Endpoint summary

Additional information

A 48 hour static, acute toxicity study was performed according to the DIN-Vorschrift 38412-L15 (static procedure) guideline. Leuciscus idus were exposed for 48 hours to nominal concentrations of TK 11278. Based on nominal exposure concentrations the 48 hour LC50 was calculated to be 900 mg/L, the corresponding no-observed effect concentration (NOEC) was 580 mg/L (Rufli, 1988).

A 24 hour static, acute toxicity study was performed according to the OECD guideline 202 (1984).  Daphnia magna were exposed for 24 hours to nominal concentrations of TK 11278. Based on nominal exposure concentrations the 24 hour EC50 was observed to be >100 mg/L (the highest concentration tested), the corresponding no-observed effect concentration (NOEC) was 100 mg/L (Rufli, 1988).

A 24 hour static, tolerance study was conducted with Artemia salina as part of a research project. Artemia salina were exposed for 24 hours to the following nominal concentrations of epodixised soybean oil: 100, 1000 and 10000 mg/L. Based on nominal exposure concentrations the 24 hour TLm (median tolerance limit) was calculated to be 240 mg/L (Price et al).

A 72 hour growth inhibition toxicity study was performed according to the 87/302/EEC page 89-94 Algal Inhibition Test guideline. Scenedesmus subspicatuswas exposed for 72hours to nominal concentrations of TK 11278. Based on the initial measured exposure concentrations the 72 hour E_bC₅₀was calculated to be 8 mg/L (with 95% confidence limits of 5.4 to 11.6 mg/L), the corresponding no-observed effect concentration (NOEC) was 0.7 mg/L (Grade, 1993).

The water solubility of ESBO is estimated to be <0.02 µg/L, categorised as insoluble REACH, see section 4.8 for details. Ideally aquatic toxicity studies should not be conducted above the limit of water solubility, the study reported here tested nominal concentrations up to 1000 mg/L. According to Annexes VII and VIII a Daphnia, fish and algal studies are required unless there are mitigating factors such as the test substance is insoluble, this is the case for ESBO. Therefore, the Daphnia, fish and algal studies are

reported here for information only (this study was also reported in the OECD SIDS Initial Assessment Report for SIAM 22, 18 -21 April 2006), the endpoints will not be used for PNEC setting or in any risk assessment. The following summary is taken from the OECD SIDS Initial Assessment Report for SIAM 22, 18 -21 April 2006. Acute toxicity tests with fish (48 hr), as well as tests with both freshwater and marine crustacea (24 hr), and algae (72 hr) have been conducted with ESBO. Although the fish and invertebrate studies were conducted for shorter time periods than currently specified in the OECD guidelines, for the time periods examined there was no or minimal evidence of toxicity observed at the limit of water solubility. In the algae study with ESBO, on the basis of biomass, the median effective concentration was 72 h EbC50 > 8 mg/L and 72 h NOEC = 2.3 mg/L. Effects are not expected to be observed below the water solubility of these materials. Based on the physicochemical properties of the category members (very low water solubility, log Kow values >6.2, and readily biodegradable), the substances are unlikely to be bioavailable to aquatic organisms in acute aquatic testing. In preparation to conduct a chronic daphnia study it was demonstrated that there was no water soluble test substance detected above 0.05 mg EODA/L in a Water Accomodated Fraction (WAF) prepared from a loading of 100 mg/L. Therefore, considering the structure and low water solubility of EODA, it was concluded that the WAF is not likely to exert acute measurable effects on daphnids, and a chronic test would not be likely to provide meaningful, quantitative information on such effects. The option of conducting the chronic daphnia test with another member of the EOD family was considered, however similar results are expected from the WAF preparations for these poorly soluble substances. Further laboratory investigation of the chronic toxicity of this substance to aquatic organisms is therefore deemed not necessary.