Registration Dossier
Registration Dossier
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EC number: 274-765-6 | CAS number: 70693-39-9
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- fish early-life stage toxicity
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Description of key information
The hazard assessment is based on the current data available. A study on long-term toxicity to fish (OECD 210) is requested for the registered substance based on the ECHA decision on a compliance check (decision number CCH-D-2114588821-38-01/F). The long-term toxicity study on fish could not be finalised until now due to the reasons explained in the document ‘CRO statement for Long-term fish toxicity test (OECD 210) with EC 274-765-6’ (attached to the Endpoint Summary of IUCLID Section 6.1.2) showing in addition all dates from order to final report scheduled. The finalised study will be submitted later based on ECHA decision number CCH-D-2114588821-38-01/F. The aquatic toxicity will be re-evaluated in the update of this dossier as soon as the final long-term fish toxicity study will be available.
Key value for chemical safety assessment
Additional information
The hazard assessment is based on the current data available. A study on long-term toxicity to fish (OECD 210) is requested for the registered substance based on the ECHA decision on a compliance check (decision number CCH-D-2114588821-38-01/F). The long-term toxicity study on fish could not be finalised until now due to the reasons explained in the document ‘CRO statement for Long-term fish toxicity test (OECD 210) with EC 274-765-6’ (attached to the Endpoint Summary of IUCLID Section 6.1.2) showing in addition all dates from order to final report scheduled. The finalised study will be submitted later based on ECHA decision number CCH-D-2114588821-38-01/F. The aquatic toxicity will be re-evaluated in the update of this dossier as soon as the final long-term fish toxicity study will be available.
There are no long-term fish studies available for Monopentaerythritol tetraesters and dipentaerythritol hexaesters of valeric, heptanoic and nonanoic acids. 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. Thus, in accordance to Annex IX, column 2 no further long-term toxicity test to fish is proposed. Available short-term studies for fish, aquatic invertebrates and algae, all indicate no potential for aquatic toxicity. Moreover, no chronic effects were recorded in the long-term toxicity to invertebrates study up to the limit of water solubility. As there was no sign that fish are more sensitive compared to aquatic invertebrates in the available short- and long-term tests, it cannot be expected that a long-term test with fish will generate different results. Thus, based on the above mentioned results, it can be excluded that the target substance will exhibit chronic toxicity to fish up to the limit of water solubility. Hence due to animal welfare reasons and to avoid unnecessary vertebrate tests, no further long-term test with fish was proposed.
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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