Registration Dossier
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EC number: 270-472-2 | CAS number: 68441-68-9
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
No effects up to the limit of water solubility (OECD 203 & ISO 7346-1, D. rerio); read-across
Key value for chemical safety assessment
Additional information
One key study is available investigating the acute toxicity of Tetraesters of 2,2-bis(hydroxymethyl)propane-1,3-diol and decanoic and octanoic acid (CAS 68441-68-9) to fish. This study was conducted under semi-static conditions according to ISO guideline 7346-1 using Danio rerio as test organism, to which test concentrations of 1000, 3000 and 10000 mg/L (nominal) were applied. No mortality was observed in the 1000 and 3000 mg/L treatments. Mortality was observed in the 10000 mg/L treatment. However, since undissolved test material was not removed from the test vessels the observed toxicity may have been caused by physical interference rather than inherent properties of the substance itself. Therefore, the 96 h-LC50 was reported as > 3000 mg/L based on the nominal test concentration. Thus, no effects up to the limit of water solubility were observed.
This result is confirmed by supporting studies with two structurally related substances (in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5), which are characterized by similar ecotoxicological profiles and comparable structures. Read-across was performed to the source substances Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) and Fatty acids, C8-10. mixed esters with dipenaterythritol, isooctanoic acid, pentaerythritol and tripentaerythritol (CAS 189200-42-8), in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5.. This read-across is justified in detail within the analogue justification in IUCLID Section 13.
The study tested 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 guideline 203 and GLP. The model organism D. rerio was exposed to the nominal test item concentrations of 100 and 150 mg/L for 96 h under static conditions. The test solutions were prepared as oil-in-water dispersion solutions which were mixed continuously for 96 h. Analytical measurements of the substance using TOC analysis determined test concentrations of 0.696 and 0.704 mg/L, respectively. Undissolved test material was not removed from the test system. However, this is considered negligible, because no mortality was observed in any treatment and the control throughout the test period of 96 h. The reported LC50 (96 h) is > 0.704 mg/L (arithmetic mean). Thus, no effects up to the limit of water solubility (< 0.05 mg/L) were observed.
Based on the available results obtained for the target substance and the structurally related source substances (in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5), it can be concluded that Tetraesters of 2,2-bis(hydroxymethyl)propane-1,3-diol and decanoic and octanoic acid (CAS 68441-68-9) will not exhibit short-term effects to fish up to the limit of water solubility.
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