Registration Dossier
Registration Dossier
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EC number: 285-550-1 | CAS number: 85116-97-8
Sediment toxicity
Administrative data
Link to relevant study record(s)
Description of key information
The assessment of the sediment toxicity should be based on the outcome of aquatic toxicity testing. New studies with the registered substance will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. Thus, the strategy of sediment toxicity will be evaluated later when all aquatic toxicity studies are available.
For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.
Key value for chemical safety assessment
Additional information
The assessment of the sediment toxicity should be based on the outcome of aquatic toxicity testing. New studies with the registered substance will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. Thus, the strategy of sediment toxicity will be evaluated later when all aquatic toxicity studies are available.
For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.
No experimental data evaluating the toxicity to sediment organisms are available for Fatty acids, C16-18, esters with diethylene glycol (CAS 85116-97-8). Only negligible releases into surface waters from sewage treatment plants are expected to take place due to: a) the ready biodegradability and b) the high adsorption properties of this substance, resulting in an effective removal in sewage treatment plants. 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 Fatty acids, C16-18, esters with diethylene glycol is not bioaccumulative. Based on the available information, toxicity to sediment organisms is not expected to be of concern.
Intrinsic properties and fate
Fatty acids, C16-18, esters with diethylene glycol is readily biodegradable. 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, 2016). Therefore, after passing through conventional STPs, only low concentrations of the substance is likely to be (if at all) released into the environment.
Furthermore, the substance exhibits a log Koc value of ≥ 3.27and is poorly water soluble (< 1 µg/L at 20 °C, pH=6.3 (OECD 105)). The Guidance on information requirements and chemical safety assessment, Chapter R7.b (ECHA, 2016) states that 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.7a, (ECHA, 2014a)) and the rest will be extensively biodegraded (due to ready biodegradability). Thus, discharged concentrations of these substances into the aqueous/sediment compartment are likely to be negligible.
Considering this one can assume that the availability of Fatty acids, C16-18, esters with diethylene glycol in the sediment environment is very low, which reduces the probability of chronic exposure of sediment organisms in general.
Aquatic ecotoxicity data
Available acute data with fish, aquatic invertebrates and algae as well as chronic data from aquatic algae showed that no adverse effects occurred in the range of the water solubility (< 1 µg/L at 20 °C, pH=6.3 (OECD 105)). Moreover, no toxic effects on activated sludge microorganisms were observed. The results obtained indicate that the substance is likely to show no toxicity to sediment organisms as well. It is not expected that results from additional studies with sediment organisms will lie out of the overall ecotoxicological profile of the substance.
Metabolism/Bioaccumulation
After absorption, Fatty acids, C16-18, esters with diethylene glycol (CAS 85116-97-8) is expected to be enzymatically hydrolyzed by carboxylesterases yielding the corresponding alcohol and fatty acid. QSAR estimations using BCFBAF v3.01 support the expected low potential for bioaccumulation of this substance. When including biotransformation, BCF and BAF values of 0.893 - 69.79 and 0.903 - 69.93 L/kg, respectively were obtained (Arnot-Gobas estimate, including biotransformation, upper trophic). The metabolism/low potential for bioaccumulation of the hydrolysis products is well established and not of concern in terms of bioaccumulation (for further information see chapter 5.3 of the technical dossier). Summarizing, Fatty acids, C16-18, esters with diethylene glycol is expected to have a low potential for bioaccumulation.
Conclusion
Due to its readily biodegradable nature, extensive degradation of the 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, the substance will be bioavailable to sediment organisms 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 corresponding fatty acid and alcohol are 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, all available aquatic toxicity data show that no effects occur up to the limit of water solubility. Therefore, Fatty acids, C16-18, esters with diethylene glycol is unlikely to pose a risk for sediment organisms and testing is thus omitted.
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.
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