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EC number: 201-089-0 | CAS number: 78-16-0
Sediment toxicity
Administrative data
Link to relevant study record(s)
Description of key information
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.
Key value for chemical safety assessment
Additional information
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.
Experimental data on the toxicity of 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 78-16-0) to sediment organisms are not available.
Short-term toxicity test on aquatic organisms show that the substance is not acutely toxic to aquatic organisms up to the limit of water solubility. Due to the ready biodegradability of the substance a chronic exposure of sediment organisms is not likely. Furthermore the substance is not expected to be bioaccumulative. Thus, toxicity to sediment organisms is not expected to be of concern.
Distribution to the environmental compartments,intrinsic properties and fate
Since direct release of 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 78-16-0) 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 substance of concern is characterized by a log Koc value of > 4.36.31 (MCI; KOCWIN v2.00; Blum, 2011)and is poorly water soluble(< 0.05 mg/L; Frischmann, 2012)and thus will undergo the same fate as stated in the Guidance document. Furthermore, 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 78-16-0) is readily biodegradable (85.3% (ThCO2) after 29 d (OECD 301 B) 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
The substance is not acutely toxic to aquatic organisms (e.g. fish, aquatic invertebrates, algae and microorganisms) in the range of the water solubility of the substance (< 0.05 mg/L; Frischmann, 2012). Therefore an acute toxicity of the substance to sediment organisms is not expected.
Metabolisms/Bioaccumulation
After uptake,2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 78-16-0)is expected to be enzymatically hydrolyzed by carboxylesterases to the corresponding alcohol and fatty acid. The test substance has a log Kow of 9.17 (KOWWIN v1.68; Blum, 2011) indicating a potential for bioaccumulation. But due to the low water solubility, rapid environmental biodegradation and metabolism via enzymatic hydrolysis, a relevant uptake and bioaccumulation in aquatic organisms is not expected.After absorption, 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 78-16-0) is expected to be enzymatically hydrolyzed by carboxylesterasesto the fatty acid and the alcohol. From literature it is well known, that these hydrolysis products will be effectively metabolised and excreted by fish (Heymann, 1980; Lech & Bend, 1980; Lech & Melancon, 1980; Murphy & Lutenske, 1990). The low bioaccumulation potential of the substance is also indicated by low calculated BCF values of 1.044 L/kg ww (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic; Blum, 2011). Please refer to IUCLID Section 5.3 for a detailed overview on bioaccumulation of the TMP esters group members.
Conclusion
The substance is readily biodegradable and thus will be largely removed by degradation in conventions sewage treatment plants. Furthermore due to the low water solubility and high adsorption potential concentrations in the water column are presumably low. Thus a release of the substance in the environment via a STP effluent is unlikely. However, when discharged to the aquatic environment only low concentrations are expected and a rapid degradation is anticipated. Due to the physic-chemical properties of the substance an adsorption of the substance to sediment particles is possible. Sediment organisms may take the substance up by ingestion of food particles. When ingested by organisms the substance will be metabolised via enzymatic hydrolysis in free fatty acids and the free glycol alcohols. Since the substance is expected to be easily metabolised a bioaccumulation is not likely. Furthermore BCF/BAF values calculated for the single components of the substance indicate a low bioaccumulation potential (BCF/BAF = 1.044 L/kg; SRC BCFBAF v3.01 Arnot Gobas, upper trophic level; Blum, 2011). According to short-term toxicity studies the substance is not acutely toxic to aquatic organisms up to the limit of water solubility. Thus 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 78-16-0) is unlikely to pose a risk for sediment organisms,hence toxicity to sediment organisms is not expected to be of concern and thus there is no need toto investigate further the effects on sediment organisms.
A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within CSR
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