Thymol

Long-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

fish early-life stage toxicity

Type of information:

experimental study planned

Justification for type of information:

CONDITIONAL TESTING PROPOSAL ON VERTEBRATE ANIMALS

A testing proposal for Annex IX Long Term Fish specified in 9.1.6 is included in the dossier based on BoA decisions A-010-2018 and A-011-2018. The BoA in A-011/2018 came to the conclusion that registrants are required to propose long-term fish testing under Annex IX in any case, and that registrants may be required to perform / shall propose (under column 2) longer term fish toxicity tests that go beyond those described in Annex IX, column 1. According to the BoA, Annex IX (section 9.1, column 2) does not allow registrants to omit information on long term toxicity to fish under column 1. Rather, according to the BoA, Annex IX requires registrants to submit information on a further study than one of the three listed in Column 1 of Section 9.1.6. of Annex IX, if the chemical safety assessment indicates that it is necessary to investigate the effects of a substance on aquatic organisms beyond what any one of those three Column 1 studies would do.
Our CSA demonstrates PEC/PNEC values of < 1 in all cases. In conclusion, further testing is not warranted. However, a long-term fish study (OECD 210) is nevertheless proposed based on the BoA decision. As the BoA decision A-010-2018 is currently being challenged before the General Court (T-656/20), we respectfully request ECHA to suspend any decision on the testing proposal and to first await the decision of the General Court in the aforementioned case. Vertebrate studies should always be the last resort to generate information. In this regard, reference is made to Para. 132 of C-471/18 P:
“It follows from those general provisions, which are to be construed in the light of recital 47 of the REACH Regulation, according to which it is necessary to replace, reduce or refine testing on vertebrate animals’, that a registrant has, generally and therefore especially where ECHA issues it with a decision asking it to complete its registration dossier with a study involving animal testing, not simply the possibility but the obligation to generate information obtained by means other than animal testing ‘whenever possible’ and to undertake such testing ‘only as a last resort’.”
Case T-656/20 is still ongoing and the decision if long-term fish tests must always be performed is, thus, still not finally decided. In conclusion, LANXESS requests ECHA to not issue any draft decision until the BoA decision’s in case A-010-2018 is upheld by the General Court in case T-656/20, also taking animal-welfare considerations into account.


NON-CONFIDENTIAL NAME OF SUBSTANCE:
- Name of the substance on which testing is proposed to be carried out: Thymol

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 regarding chronic toxicity to fish with the test substance thymol are available.
- Available non-GLP studies: No non-GLP studies regarding chronic toxicity to fish with the test substance thymol are available.
- Historical human/control data: No historical human/control data regarding chronic toxicity to fish with the test substance thymol could be retrieved.
- (Q)SAR: QSAR modelling is not sufficient as only information to cover this endpoint. In addition, QSAR is not recommended for chronic toxicity.
- In vitro methods: not applicable
- Weight of evidence: No data sufficient for a weight of evidence approach could be retrieved.
- Grouping and read-across: Only one study on long-term toxicity to fish, an OECD 212 with deviations, was found for a potential read-across analogue substance: p-thymol. The study and the read-across dataset was concluded to be not sufficient to meet the requirements of RAAF.
- 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:
- Please refer to first section of this testing proposal.
Additional information: Literature searches have been performed in 2018 und 2020 to find valid data on long-term toxicity to fish for the registered substance. No information sufficient to cover the endpoint could be retrieved.

FURTHER INFORMATION ON TESTING PROPOSAL IN ADDITION TO INFORMATION PROVIDED IN THE MATERIALS AND METHODS SECTION:
- Details on study design / methodology proposed: not relevant

Qualifier:

according to guideline

Guideline:

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

Description of key information

A conditional testing proposal has been submitted for a long-term toxicity study to fish (OECD 210) with the registered substance according to Annex IX, Section 9.1.6. of the REACH Regulation.