Registration Dossier
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EC number: 270-472-2 | CAS number: 68441-68-9
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
Experimental data on the long-term toxicity to fish are not available. The chemical safety assessment according to Annex I of Regulation (EC) No. 1907/2006 does not indicate the need to further investigate the long-term toxicity to fish. Thus, no further long-term toxicity test to fish is proposed, in accordance with Annex VIII, 9.1.3, column 2.
According to the Guidance on information requirements and chemical safety assessment Chapter R.7b: Endpoint specific guidance, R.7.8.5.3 (ECHA, 2017), long-term testing of fish should only be conducted if fish represent the most sensitive taxonomic group. The Guidance states that if aquatic 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.
The available experimental studies on the short-term aquatic toxicity of Tetraesters of 2,2-bis(hydroxymethyl)propane-1,3-diol and decanoic and octanoic acid (CAS 68441-68-9) do not show any acute toxic effects up to the limit of water solubility on all three trophic levels. Since fish cannot be identified as the most sensitive organism, long-term studies were compiled for aquatic invertebrates and algae. The long term data on the reproduction of daphnia and inhibition of algae growth do not show any adverse effects up to the limit of water solubility. Thus, there is no indication that fish are the most sensitive species in the short term tests and it cannot be expected that a long-term test with fish will generate different results than the existing long-term test with invertebrates. Therefore, a further long-term test with vertebrates, i.e. fish, is not considered necessary for the assessment of the long-term hazard of Decanoic acid, mixed esters with octanoic acid and pentaerythritol (CAS 68441-68-9) based on the available data as well as for animal welfare. In addition, it is not likely that aquatic organisms will be exposed to the test substance since it is readily biodegradableand will ultimately be degraded in most environments, including sewage treatment plants.
Therefore, it can be concluded that chronic exposure of of Tetraesters of 2,2-bis(hydroxymethyl)propane-1,3-diol and decanoic and octanoic acid (CAS 68441-68-9) to fish is unlikely and that it presumably does not pose a higher risk to fish than it does to daphnia.
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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