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EC number: 947-899-4
CAS number: -
No effects up to the limit of water solubility; read-across.
No study investigating the toxicity of fatty acids C18-C22 (even
numbered), tetraesters with pentaerythritol to aquatic algae is
available. Therefore, in accordance to Regulation (EC) No. 1907/2006
Annex XI, 1.5 a read-across to the structurally related source
bis(isooctadecanoate) (CAS 62125-22-8) and fatty acids, C16-18 and
C18-unsatd., tetraesters with pentaerythritol (CAS 68604-44-4) is
Based on the high degree of similarity between the structural and
physico-chemical properties of the target and source substances, the
source substances are considered as suitable representative for the
evaluation of the short-term toxicity of the target substance to aquatic
invertebrates. The read-across approach is justified in detail within
the analogue justification in IUCLID section 13.
A study investigating the toxicity to aquatic algae and
cyanobacteria of 2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl
bis(isooctadecanoate) (CAS 62125-22-8) is available. The study was
performed according to OECD 201. The green algae Pseudokirchneriella
subcapitata was exposed under static conditions to nominal concentration
of 100, 180, 320, 560 and 1000 mg/L. The test solution was prepared as
water accommodated fraction (WAF) by adding the appropriate amount of
test substance with subsequent stirring followed by settling. After the
test duration of 72 h an EL50 > 1000 mg/L (nominal) based on growth rate
was determined, the EL10 ranged from > 180 - < 320 mg/L. It can hence be
concluded that the test substance will not exhibit effects to aquatic
algae up to the limit of water solubility.
The second study investigated the toxicity of fatty acids, C16-18
and C18-unsatd., tetraesters with pentaerythritol (CAS 68604-44-4) to
aquatic algae and cyanobacteria. The limit study was performed according
to OECD 201. A water accommodated fraction (WAF) was prepared. The green
algae Desmodesmus subspicatus was exposed to a nominal concentration of
100 mg/L. The test solution was prepared by adding the appropriate
amount of test substance with subsequent stirring followed by
filtration. No effect on growth rate and biomass of Desmodesmus
subspicatus up to the limit of water solubility was observed resulting
in an EL50 > 100 mg/L (nominal) and a NOELR of ≥ 100 mg/L (nominal),
respectively for growth rate and biomass.
In addition, aquatic toxicity of the substance is unlikely to
occur due to the low bioavailability of the substance in water. Due to
the high potential for adsorption, the substance can be effectively
removed in conventional sewage treatment plants (STPs) by sorption to
biomass. The low water solubility (< 0.518 mg/L at 20 °C, OECD 105) and
high estimated log Kow (> 10, QSAR, VEGA 1.1.3) indicate that the
substance is highly lipophilic. If released into the aquatic
environment, the substance undergoes extensive sorption on organic
matter. Thus, the bioavailability in the water column is reduced
rapidly. Furthermore, as the substance has a high molecular weight of
1370.31 – 1426.42 g/mol, it is unlikely that it is readily absorbed, due
to the steric hindrance of crossing biological membranes.
Based on the available results from 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, a low bioavailability of the substance in water
and a steric hindrance of crossing biological membranes, it can be
concluded that fatty acids C18-C22 (even numbered), tetraesters with
pentaerythritol will not exhibit effects to aquatic algae up to the
limit of water solubility.
Hsieh, A. and Perkins, E. G. (1976). Nutrition and Metabolic
Studies of Methyl Ester of Dimer Fatty Acids in the Rat. Lipids,
Lipinski et al. (2001). Experimental and computational approaches
to estimate solubility and permeability in drug discovery and
development settings. Adv. Drug Del. Rev. 46: 3-26.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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