[No public or meaningful name is available]

Long-term toxicity to fish

Description of key information

Testing is not technically feasible.  For the purpose of hazard assessment, and the exposure assessment and risk characterisation,  PNECs for representative hydrocarbon blocks were calculated with a modelling tool (PETRORISK, see CSR sections 9&10). The classification of the substance was derived based on the short-term toxicity results.

Additional information

This UVCB substance is a complex mixture of hydrocarbons. As it is also poorly water soluble and partly volatile substance, the testing is not technically feasible. Therefore, the long-term testing was not considered scientifically justified, and the read-across data on fossil fuels with similar composition was used as supporting study for this endpoint. For the purpose of hazard assessment, exposure assessment and risk characterisation, PNECs for representative hydrocarbon blocks were calculated with a modelling tool (PETRORISK, see CSR sections 9&10). No single value was possible to be selected for CSA.

The study by Mos L. et al. (2007) was used as a supporting study to evaluate the long-term toxicity of fossil fuels to fish. The read-across approach was justified because the fate and ecotoxicological properties of renewable diesel are considered similar to fossil diesel fuels based on the similar composition and physical-chemical properties. The aim of this study was to examine the sublethal and lethal effects of 14 –day exposure of Ultra Low Fuel (ULS) Diesel No. 2 (CAS 68476-34-6) to rainbow trout (Oncohynchus mykiss). The study was conducted with similar method to OECD 204.

The parameters assessed during the tests were growth and survival and based on these results toxicity thresholds were determined. In addition to toxicity tests, this study also evaluated gene expression changes in test animals by conducting microarray tests.

The test indicated low toxic effect on rainbow trout at doses ≤8 mg/L, as evidenced by no significant effects on survival and growth rates. Diesel doses of 40 mg/L were associated with a gradual increase in mortality over the duration of the test, and exposures of > 200 mg/L of diesel resulted in 100 % mortality of rainbow trout. EC20 and EC50 values were determined as > 40 mg/L for growth and 26.7 mg/L and 44.8 mg/L for survival, respectively.

The classification of the substance was derived based on the short-term toxicity results, because these results presented higher toxicity response than the above long-term study results. Based on the biodegradation water screening study, this substance is not readily biodegradable in water. In conclusion, CSA does not indicate the need for further long-term testing since there is enough data to classify this substance as Aquatic Chronic Cat 3.