Registration Dossier
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EC number: 287-487-5 | CAS number: 85536-06-7
Long-term toxicity to fish
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 long-term toxicity to fish.
Key value for chemical safety assessment
Additional information
According to Regulation (EC) No. 1907/2006, Annex IX, Column 2, 9.1.6, long-term toxicity testing shall be proposed by the registrant if the chemical safety assessment according to Annex I indicates the need to investigate further the effects on aquatic organisms.
Glycerides, C8-18 (CAS No. 85536-06-7) is readily biodegradable and it has high potential for adsorption (log Koc values 0.42-14.2). 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). Besides being extensively biodegraded in STPs (due to its ready biodegradability), a significant degree of removal of this substance from the water column due to adsorption to sewage sludge can be expected (Guidance on information requirements and chemical safety assessment, Chapter R.7a (ECHA, 2012)). Therefore, after passing through conventional STPs, only low concentrations of these substances are likely to be (if at all) released into the environment.
Moreover, rapid metabolization of Glycerides, C8-C18 in aquatic organisms is expected. Enzymatic hydrolysis is expected to result in C8-18 fatty acids and glycerol as transformation products. Part of the free fatty acids will be re-esterified with glycerol and partial acyl glycerols to form triglycerides that will be stored as long-term energy reserves (Tocher, 2003). Glycerol is naturally present in animal and vegetable fats, rarely found in free state (mostly combined with fatty acids forming triglycerides) (ed. Knothe, van Gerpen and Krahl, 2005). If freely available in aquatic organisms, it will not bioaccumulate in view of its log Kow value of -1.76 (OECD SIDS, 2002). Especially in periods in which the energy demand is high (reproduction, migration, etc.), glycerides are mobilized from the storage sites as source of fatty acids. Fatty acid catabolism is the most important energy source in many species of fish, resulting in the release of acetyl CoA and NADH (through β-oxidation) and eventually, via the tricarboxylic cycle, the production of metabolic energy in the form of ATP. This fatty acid-catabolism pathway is the predominant source of energy related to growth, reproduction and development from egg to adult fish. A similar metabolic pathway is observed in mammals (see section 7.1.1 Basic toxicokinetics). According to the Guidance on information requirements and chemical safety assessment, Chapter R.7c (ECHA, 2012), even though ready biodegradability does not per se preclude bioaccumulation potential, generally (depending on exposure and uptake rates) ready biodegradable substances are likely to be rapidly metabolised, and therefore, concentrations stored in aquatic organisms will tend to be low. Considering the above information, low bioaccumulation potential of Glycerides, C8-C18 in aquatic organisms can be expected.
Based on the short term values, fish cannot be identified as the most sensitive organism. According to the Guidance on information requirements and chemical safety assessment, Chapter R7.b (ECHA, 2012), long-term toxicity testing on fish should only be conducted if it represents the most sensitive taxonomic group. The Guidance states that if invertebrates are likely to be more sensitive than fish and algae or the relative sensitivity of invertebrates cannot be predicted, long-term testing on Daphnia sp. should be preferred instead of fish. Considering this information, long-term toxicity testing on fish species is not deemed necessary.
A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within the 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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