Tetraesters of pentaerythritol with 2-ethylhexanoic acid and heptanoic acid and nonanoic acid

Toxicity to soil macroorganisms except arthropods

Description of key information

NOEC (56 d) ≥ 1000 mg/kg soil dw based on reproduction (OECD 222); read-across
NOEC (14 d) ≥ 1000 mg/kg soil dw based on mortality (OECD 207); read-across

Additional information

Since no studies investigating the toxicity of Tetraesters of pentaerythritol with 2-ethylhexanoic acid, heptanoic acid and nonanoic acid (EC 806-879-4) to soil macroorganisms are available for this endpoint, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across to the structurally related source substances Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) and 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 78-16-0).

The target substance is characterized as a tetraester of pentaerythritol and different fatty acids (C7, C9 and 2-ethylhexanoic acid). Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) is a tetraester of C5/C7/C9/C10 with pentaerythritol. 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 78-16-0) in a triester of trimethylolpropane and linear C7 fatty acids. Using both substances for the prediction of terrestrial toxicity of the target substance is reliable since the endpoint is covered by interpolation. This read-across is justified in detail in the overall summary (IUCLID Section 6.3) and within the analogue justification in IUCLID Section 13. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) read-across substance was used for the assessment.

 

The first study with the source substance Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) was conducted according to OECD 207 under GLP conditions (Kelley, 2013). Eisenia fetida was exposed to a test concentration of 1000 mg/kg dw in artificial soil for 14 d. Mortality was recorded at the end of the study. 100% survival was observed in both the control group and treatment group resulting in a NOEC (14 d) for mortality of ≥ 1000 mg/kg dw.

The second study with the source substance 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 78-16-0) was performed according to OECD 222 (GLP). The effect of the test substance on earthworm survival, growth and reproduction was tested in accordance with GLP provisions (Eisner, 2013). 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 d and then removed from the test substrate. The survival rate and growth (body weight) of the specimen were determined. After another 28 d 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 (28 d) ≥ 1000 mg/kg soil based on mortality was reported. A NOEC (56 d) ≥ 1000 mg/kg soil based on the reproduction rate was determined.

Based on the result from two structurally related source substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile and comparable structure, no effects on earthworms are expected for Tetraesters of pentaerythritol with 2-ethylhexanoic acid, heptanoic acid and nonanoic acid (EC 806-879-4).