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Toxic effects on sediment dwelling invertebrates can be excluded.
The chemical safety assessment according to Annex I of Regulation
(EC) No. 1907/2006 does not indicate the need to investigate further the
effects on sediment organisms. All polyol esters are ready
biodegradable, therefore chronic exposure of sediment organisms is
unlikely. Furthermore, the substance is not toxic to aquatic organisms
up to the limit of water solubility. In addition, available data
indicate, that the test substance is not bioaccumulative. Based on the
available information, toxicity to sediment organisms is not expected to
be of concern.
Distribution to the environmental compartments intrinsic
properties and fate
Since direct release of polyol esters to the aquatic system is not
anticipated, release to the aquatic compartment might occur via sewage
treatment plants only. According to the Guidance on information
requirements and chemical safety assessment, Chapter R7.b (ECHA, 2012)
once insoluble chemicals enter a standard STP, they will be extensively
removed in the primary settling tank and fat trap and thus, only limited
amounts will get in contact with activated sludge organisms.
Nevertheless, once this contact takes place, these substances are
expected to be removed from the water column to a significant degree by
adsorption to sewage sludge (Guidance on information requirements and
chemical safety assessment, Chapter R.7b, ECHA, 2012). Our substances of
concern is characterized by a log Koc value of > 5 (MCI method) and is
poorly water soluble (< 1 mg) and thus will undergo the same fate as
stated in the Guidance document. Furthermore, all polyol esters are
determined to be readily biodegradable and according to the Guidance on
information requirements and chemical safety assessment, Chapter R.7b,
readily biodegradable substances can be expected to undergo rapid and
ultimate degradation in most environments, including biological Sewage
Treatment Plants (STPs) (ECHA, 2012). Therefore, after passing through
conventional STPs, exposure, of these polyol esters into the
aqueous/sediment compartment are likely to be negligible.
Aquatic ecotoxicity data
Acute aquatic toxicity tests showed no adverse effects occurred in
the range of the water solubility of the substance (< 1 mg/L). The
obtained results indicate that all polyol esters are likely to show no
toxicity to sediment organisms as well.
The polyol esters have log Kow > 5 (KOWWIN v1.67) indicating a
potential for bioaccumulation. But due to the low water solubility,
rapid environmental biodegradation and metabolisation via enzymatic
hydrolysis, a relevant uptake and bioaccumulation in aquatic organisms
is not expected. After absorption, polyol esters are expected to be
enzymatically hydrolyzed by carboxylesterases yielding free fatty acid
and the free alcohol (e. g. pentaerythritol). From literature it is well
known, that these hydrolysis products will be metabolized and excreted
in fish effectively (Heymann, 1980; Lech & Bend, 1980; Lech & Melancon,
1980; Murphy & Lutenske, 1990). This is supported by low calculated BCF
values of 0.89 – 6.32 L/kg ww (BCFBAF v3.01, Arnot-Gobas, including
biotransformation, upper trophic). Please refer to IUCLID Section 5.3
for a detailed overview on bioaccumulation of the polyol esters
category. Thus, taking all information into account, the bioaccumulation
of this category member is assumed to be low.
Due to its readily biodegradable nature, extensive degradation of
this substance in conventional STPs will take place and only low
concentrations are expected to be released (if at all) into the
environment. Once present in the aquatic compartment, further
biodegradation will occur and, due to the high log Kow, low water
solubility and high adsorption potential, sediment organisms might be
exposed to polyol esters mainly via feed and contact with suspended
organic particles. After uptake by sediment species, extensive and fast
biotransformation of the substance by carboxylesterases into the free
fatty acid and the corresponding alcohol is expected. The supporting
BCF/BAF values estimated with the BCFBAF v3.01 program, Arnot-Gobas
model including biotransformation, also indicate that this substance
will not be bioaccumulative (all well below 2000). Furthermore, aquatic
toxicity data show that no effects occur up to the limit of water
solubility. Therefore, all polyol esters are unlikely to pose a risk for
sediment organisms in general and testing is thus omitted, hence
toxicity to sediment organisms is not expected to be of concern and thus
there is no need to investigate further the effects on sediment
In conclusion, due to a) the observed absence of toxicological
effects on aquatic organisms, b) the lack of chronic exposure and c)
the, acknowledged metabolisation of fatty acid esters, toxic effects on
sediment dwelling invertebrates can be excluded.
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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