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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 short-term toxicity of fatty acids
C18-C22 (even numbered), tetraesters with pentaerythritol to fish 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 pentaerythritol tetraoleate
(CAS 19321-40-5) is applied.
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 to be suitable representatives for the
evaluation of the short-term toxicity of the target substance to fish.
The read-across approach is justified in detail within the analogue
justification in IUCLID section 13.
The first study investigated the short-term toxicity
bis(isooctadecanoate) (CAS 62125-22-8) to freshwater fish according to
OECD 203 under semi-static conditions using Danio rerio as test
organism. Nominal concentrations of 10, 18, 32, 56 and 100 mg/L were
applied. A stock solution was prepared daily and diluted appropriately.
No mortalities occurred after the test duration of 96 hours resulting in
an LC50 of > 100 mg/L.
Short-term toxicity of pentaerytritol tetraoleate (CAS 19321-40-5)
to freshwater fish was investigated in the second study. This study was
conducted according to OECD 203 under static conditions using Cyprinus
carpio as a test organism. A nominal test concentration of 100 mg/L was
applied by preparing a stock solution in acetone. Blank and solvent
controls were also tested. No mortalities occurred after the test
duration of 96 hours resulting in an LC50 of > 100 mg/L.
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. The relevant route of uptake of the substance in aquatic
organisms is expected to be predominantly by ingestion of particle bound
substance. However, 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. Following the
‘rule of 5’ (Lipinski et al., 2001), developed to identify drug
candidates with poor oral absorption based on criteria regarding
partitioning (log Kow > 5) and molecular weight (> 500 g/mol), the
substance is considered to be poorly absorbed after oral uptake (Hsieh &
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 short-term effects to fish 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,
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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