Dodecanoic acid, 2,2-dimethyl-3-oxopropyl ester

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

fish early-life stage toxicity

Type of information:

experimental study planned

Study period:

The study will be performed in 2021 or in the following years depending on ECHA decision.

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: 2,2-dimethyl-3-oxopropyl dodecanoate

CONSIDERATIONS THAT THE GENERAL ADAPTATION POSSIBILITIES OF ANNEX XI OF THE REACH REGULATION ARE NOT ADEQUATE TO GENERATE THE NECESSARY INFORMATION:
- Available GLP studies: There are no GLP studies available for this substance covering the endpoint of long-term toxicity to fish.
- Available non-GLP studies: There are no non-GLP studies available for this substance covering the endpoint of long-term toxicity to fish.
- (Q)SAR: QSAR approaches are currently not well fitted-for-purpose for long-term toxicity to fish and consequently no firm recommendations can be made concerning their routine use in a testing strategy in this area (ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R 7a: Endpoint specific guidance, 2017).
- In vitro methods: There are no in vitro methods available to fully cover the endpoint of long-term toxicity to fish.
- Weight of evidence: There is no weigh of evidence information available to cover the endpoint of long-term toxicity to fish.
- Grouping and read-across: : There are no substances which apply for read-across addressing long-term toxicity to fish.

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 fully registered according to REACH Annex IX. Therefore, one long-term toxicity test to fish is legally required. The test substance has been tested in a series of short-term aquatic tests. In the short-term toxicity to fish test no mortalities were observed at the water solubility limit (1 mg/L), thus, the EC50 was determined to be greater than 1 mg/L. In the short-term toxicity test to Daphnia a dose-responce was observed and the EC50 was extrapolated to be 1.02 mg/L, a little bit above the water solubility. In the toxicity to aquatic algae test, an EC50 greater than 1 mg/L was also determined as only slight inhibition on the growth rate of the algae was observed at the water solubility limit. Based on the obtained short-term data, it can be stated that the test substance falls in the category of "difficult to test substances which do not reach equilibrium in during short-term exposure", thus, all adaption options from Annex IX are not applicable for the substance and the basic fish early life-stage study design is proposed.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
The registrant indends to conduct a standard OECD 210 study based on the results of the pre-tests, which would have to be performed beforehand.
The current testing proposal will be submitted both under EU REACH and UK REACH to adress the data gap in the study requirements.
The registrant requests the Authority to take into account that CROs are currently fully booked with regard to long-term fish tests and that a pre-test incl. method development would need to be performed, when setting the deadline for submission of the test results.

Qualifier:

according to guideline

Guideline:

OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)

Water media type:

freshwater

Description of key information

A testing proposal on the endpoint "Long-term toxicity to fish" has been submitted and after finalisation of the formalities, such a test will be performed with the test substance and included in a future dossier update.