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Ecotoxicological information

Long-term toxicity to fish

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Administrative data

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:
- Name of the substance on which testing is proposed to be carried out : Reaction mass of 2-hydroxyethyl laurate and ethylene dilaurate (EC 908-917-6)

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION
- Available GLP studies : not available
- Available non-GLP studies : not available
- Historical human/control data : not available
- (Q)SAR : No suitable QSAR data available.
- In vitro methods : No suitable in-vitro methods available.
- Weight of evidence : not available
- Grouping and read-across : No suitable source substances available with available chronic fish studies.
- Substance-tailored exposure driven testing: Not applicable
- Approaches in addition to above: not applicable
- Other reasons: 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 substance is poorly water soluble and information on long-term toxicity on fish must be provided in accordance with Column 2 of REACH Annex VIII and the “Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7b: Endpoint specific guidance”. A study according to OECD 210 is proposed since it should be regarded as the most suitable test guideline for addressing the information requirements related to fish long-term testing under REACH (Guidedance document Chapter R.7b, ECHA 2017).

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: The study should be conducted considering the OECD Guidance 23 for testing of poorly soluble and adsorptive substances.

Data source

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of hydroxyethyl laurate and ethylenedilaurate
EC Number:
908-917-6
Molecular formula:
C14H28O3 C26H50O4
IUPAC Name:
Reaction mass of hydroxyethyl laurate and ethylenedilaurate

Results and discussion

Applicant's summary and conclusion

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