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Toxicity to soil macroorganisms except arthropods

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Description of key information

NOEC =1000 mg/kg for Eisenia fetida (OECD 222), read across

Key value for chemical safety assessment

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Since no studies investigating the toxicity towards microorganisms of Fatty acids, C14-18 and C16-18-unsatd., mixed esters with castor oil, castor oil Fatty acids, 2-ethylhexanoic acid and 2,2-bis(hydroxymethyl)-1-butanol (CAS No. 92113-48-9) are available for this endpoint, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across to the structurally similar analogue substances 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS No. 78-16-0) and 2-ethyl-2-(((1-oxoisooctadecyl)oxy)methyl)-1,3-propanediyl bis (isooctadecanoate) (CAS No. 68541-50-4) was conducted. This read-across is justified in detail in the overall summary (IUCLID chapter 6.3) and within the analogue justification in IUCLID Section 13. The read across is justified based on common breakdown products, similar physico-chemical properties, environmental fate, toxicological and ecotoxicological properties.

The long-term toxicity of the read-across substance 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS No. 78-16-0) was tested according to OECD guideline 222. The test was conducted with artificial soil that was mixed with the test substance. Earthworms of the species Eisenia fetida were exposed to the test substance for 28 days and then removed from the test substrate. The survival rate and growth (body weight) of the specimen were determined. After another 28 days the hatched juveniles were collected from the test substrate and the reproduction rate was recorded. Mortality or a decrease in body weight of the adult earthworms was not observed. Thus a NOEC of 1000 mg/kg soil based on mortality was reported. A NOEC = 1000 mg/kg soil based on the reproduction rate was determined.

The long-term toxicity of the read-across substance2-ethyl-2-(((1-oxoisooctadecyl)oxy)methyl)-1,3-propanediyl bis (isooctadecanoate) (CAS 68541-50-4) was tested according to OECD guideline 222. The test was conducted with artificial soil that was mixed with the test substance. Earthworms of the species Eisenia fetida were exposed to the test substance for 28 days and then removed from the test substrate. The survival rate and growth (body weight) of the specimen were determined. After another 28 days the hatched juveniles were collected from the test substrate and the reproduction rate was recorded. Mortality or a decrease in body weight of the adult earthworms was not observed. Thus a NOEC of 1000 mg/kg soil based on mortality and a NOEC = 1000 mg/kg soil based on the reproduction rate was determined.