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Long-term toxicity to fish

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Reference
Endpoint:
fish early-life stage toxicity
Type of information:
experimental study planned
Justification for type of information:
TESTING PROPOSAL ON VERTEBRATE ANIMALS

NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Isononanoic acid, C16-18 (even numbered)-alkyl esters / 111937-03-2 / 601-141-6

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION [please address all points below]:
- Available GLP studies: No GLP-studies available
- Available non-GLP studies: No non-GLP-studies available
- Historical human data: Not relevant
- (Q)SAR: No valid QSAR methods available to reliably estimate the long-term toxicity to fish for Isononanoic acid, C16-18 (even numbered)-alkyl esters.
- In vitro methods: Not applicable.
- Weight of evidence: No data for weight of evidence approach available.
- Grouping and read-across: The substance is member of the Long Chain Aliphatic Esters (LCAE) Category. No study investigating the long-term toxicity to fish is available for any of the members. Thus, predicting the long-term toxicity to fish based on a read-across is not possible. The data generated in the proposed study will be used as source information to perform read-across within the LCAE category, in order to prevent unnecessary vertebrate animal testing while fulfilling the information requirements.
- Substance-tailored exposure driven testing: Not applicable
- Approaches in addition to above: Not applicable

CONSIDERATIONS THAT THE SPECIFIC ADAPTATION POSSIBILITIES OF ANNEXES VI TO X (AND COLUMN 2 THEREOF) OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- The specific adaptation possibilities of ANNEX IX are not adequate to generate the necessary information, consequently there is a data gap regarding the long term toxicity to fish. Long-term toxicity testing to fish is a standard information requirement in Annex IX to REACH (Annex IX, Section 9.1.6). Additionally the substance is poorly water soluble (< 0.05 mg/L). For hydrophobic or poorly water soluble (e.g. water solubility below 1 mg/L or below the detection limit of the analytical method of the test substance), long-term tests shall be considered (REACH Annex VIII , Section 9.1.3, Column 2).

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: Due to the low solubility of the substance in water the OECD GD 23 and ECHA Guidance, Chapter R7b, Table R.7.8-3 relating to the aquatic toxicity testing of difficult substances will be consulted, so that the most appropriate design of the study will be chosen.
Qualifier:
according to guideline
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

Description of key information

There are no studies investigating the long-term toxicity of Isononanoic acid, C16-18 (even numbered)-alkyl esters (CAS 111937-03-2) to fish available. Hence, the available data is not sufficient to conclude on the accurate chronic environmental classification and the hazard assessment. A study investigating the long-term toxicity to fish is proposed which will provide valuable new information on the aquatic toxicity of Isononanoic acid, C16-18 (even numbered)-alkyl esters (CAS 111937-03-2).


 


 


 

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