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EC number: 947-899-4
CAS number: -
Since the chemical safety assessment according to Annex I of
Regulation (EC) No 1907/2006 does not indicate the need to further
investigate the long-term toxicity to fish no further long-term toxicity
test to fish is proposed, in accordance with Annex IX, column 2.
There are no experimental studies available, in which the
long-term toxicity of the target substance fatty acids C18-C22 (even
numbered), tetraesters with pentaerythritol to fish was assessed.
All the available studies for short-term aquatic toxicity to fish,
daphnids and algae indicate no potential for acute aquatic toxicity.
Furthermore, the short-term toxicity studies provide no indication that
aquatic invertebrates are less sensitive than fish. Therefore, a
long-term test with fish is not expected to generate significantly
Additional data for long-term aquatic toxicity are available for
aquatic invertebrates. In accordance to Regulation (EC) No. 1907/2006
Annex XI, 1.5 a read-across to the structurally related source
substances fatty acids, C16-18 and C18-unsaturated, esters with
pentaerythritol (CAS 85711-45-1) and decanoic acid, mixed esters with
heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS
71010-76-9) is applied. No long-term effects to aquatic invertebrates
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 &
Thus, the chemical safety assessment according to Annex I of
Regulation (EC) No 1907/2006 does not indicate the need to investigate
further the long-term toxicity to fish. In accordance with Annex IX,
column 2 and for animal welfare reasons, no further long-term toxicity
test to fish is therefore proposed.
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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