Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Long-term toxicity to fish
Administrative data
- Endpoint:
- fish early-life stage toxicity
- Type of information:
- experimental study planned
- Study period:
- The test will be conducted after a decision on the requirement to carry out the proposed test has been taken.
- Justification for type of information:
- TESTING PROPOSAL ON VERTEBRATE ANIMALS
NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Esterification products of fatty acids, C18 (unsaturated) alkyl and adipic acid with pentaerythritol
CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION :
- Available GLP studies: No GLP-studies available
- Available non-GLP studies: No non-GLP studies available
- Historical human/control data: not relevant
- (Q)SAR: An EC10 (28 d) of 7.22 E-29 mg/L is predicted as the lowest chronic value. As the substance is a UVCB, three known main constituents were used for calculation. The lowest obtained chronic toxicity value is given. The result is not reliable, since the log Kow of the constituents is above the cut-off for the prediction models (see EPIsuite v4.11 calculation with Esterification products of fatty acids, C18 (unsaturated) alkyl and adipic acid with pentaerythritol).
- In vitro methods: not applicable
- Weight of evidence: no suitable data available, i.e. read-across
- Grouping and read-across: The substance is member of the FEUC PFAEm&b category. Suitable read-across data are not available within the PFAEm&b group.
- Substance-tailored exposure driven testing: not applicable
- Approaches in addition to above: not applicable
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Esterification products of fatty acids, C18 (unsaturated) alkyl and adipic acid with pentaerythritol
- Molecular formula:
- not applicable
- IUPAC Name:
- Esterification products of fatty acids, C18 (unsaturated) alkyl and adipic acid with pentaerythritol
- Test material form:
- liquid
Constituent 1
Sampling and analysis
- Analytical monitoring:
- yes
Results and discussion
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
