A mixture of cis- and trans-cyclohexadec-8-en-1-one

Long-term toxicity to fish

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: Mixture of cis- and trans-cyclohexadec-8-en-1-one

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 weight 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 according to OECD guideline 203, an LC50 (96 h) of 0.75 mg/L was observed. In the short-term toxicity test to Daphnia according to OECD guideline 202, the EC50 value was 275 µg/L based on mobility effects. In the toxicity to aquatic algae test according to OECD guideline 201, the EC50-values for inhibition of growth rate (ErC50) and yield (EyC50) after 72 hours were 470 µg/L and 122 µg/L, respectively. The EC10-values for inhibition of growth rate (ErC10) and yield (EyC10) after 72 hours were 119 µg/L and 25.3 µg/L, respectively. The NOEC-values for both inhibition of growth rate and yield after 72 hours were 28.4 µg/L. The EC50 (3h) of the test item to the respiration of microorganisms was determined to be above 10000 mg/L. In the long-term toxicity to aquatic intervertebrates test according to OECD guideline 211, the values of 21d-NOEC (reproduction and mortality) were determined to be above 0.0141 mg/L based on the mean measured concentrations. Based on the obtained short-term data, it can be stated that there is evidence for a potential long-term aquatic toxicity of the test substance. 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 intends to conduct a standard OECD 210 study based on the results of the pre-tests, which has to be performed beforehand.
The current testing proposal will be submitted under EU REACH to address 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.

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Test material

Test material information

Constituent 1

Reference substance name:

A mixture of cis- and trans-cyclohexadec-8-en-1-one

EC Number:

401-700-2

EC Name:

A mixture of cis- and trans-cyclohexadec-8-en-1-one

Cas Number:

3100-36-5

Molecular formula:

C16H28O

IUPAC Name:

(8E)-cyclohexadec-8-en-1-one; (8Z)-cyclohexadec-8-en-1-one