Registration Dossier
Registration Dossier
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EC number: 943-011-4 | CAS number: -
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. Pursuant to ECHA decision on a compliance check CCH-D-2114546451-53-01/F new studies with the registered substance are ongoing but will be finalized after the deadline 19 Oct 2022. Please see attached document (chapter 13) explaining the delay of the final studies. The finalised studies will be reported in an updated dossier as soon as they become available, and the hazard assessment will be re-evaluated accordingly. 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.
The current hazard assessment is based on the data presently available.
Key value for chemical safety assessment
Additional information
The assessment of the sediment toxicity should be based on the outcome of aquatic toxicity testing. Pursuant to ECHA decision on a compliance check CCH-D-2114546451-53-01/F new studies with the registered substance are ongoing but will be finalized after the deadline 19 Oct 2022. Please see attached document (chapter 13) explaining the delay of the final studies. The finalised studies will be reported in an updated dossier as soon as they become available, and the hazard assessment will be re-evaluated accordingly. 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.
The current hazard assessment is based on the data presently available.
No experimental data evaluating the toxicity to sediment organisms are available. Since the substance is readily biodegradable, 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 substance is not bioaccumlative. Based on the available information, toxicity to sediment organisms is not expected to be of concern.
Intrinsic properties and fate
The substance is readily biodegradable based on data from accepted OECD guidance. 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, 2014). Therefore, after passing through conventional STPs, only low concentrations of these substances are likely to be (if at all) released into the environment.
Furthermore, the diester components of Octadecanoic acid, monoester with 1,2-propanediol (CAS 1323-39-3) and Palmitic acid, monoester with propane-1,2-diol (CAS 29013-28-3) exhibit a log Koc of > 5 (MCI) and the substance is poorly water soluble (< 0.1 mg/L). The Guidance on information requirements and chemical safety assessment, Chapter R7.b (ECHA, 2014) 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, 2014)) 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 the substance in the sediment environment is very low, which reduces the probability of chronic exposure of sediment organisms in general.
Aquatic ecotoxicity data
Aquatic toxicity tests of the substance to fish, invertebrates, algae and microorganisms showed no adverse effects occurred up to the limit of water solubility. The obtained results indicate that it is likely that there is no toxicity to sediment organisms as well.
Metabolisms/Bioaccumulation
After absorption glycol esters are expected to be enzymatically hydrolyzed by carboxylesterases yielding the corresponding alcohol and fatty acid. The substance is characterized by a high log Kow 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. Enzymatic breakdown will initially lead to the free fatty acid and the free glycol alcohol (e. g. propylene glycol). 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). Thus, taking all information into account, the bioaccumulation of the substance is assumed to be low.
Conclusion
Due to its readily biodegradable nature, extensive degradation 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 by carboxylesterases into the free fatty acid and the corresponding alcohol is expected. Furthermore, aquatic toxicity data show that no effects occur up to the limit of water solubility. Therefore, the substance is unlikely to pose a risk for sediment organisms.
A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within CSR.
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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