Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
fish early-life stage toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
According to REACH Annex IX, 9.1.6. ‘Long-term toxicity testing on fish, (unless already provided as part of Annex VIII requirements)’ is a standard information requirement and cannot be generated otherwise. This is 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. The Fish Early Life Stage (FELS) toxicity test (OECD TG 210) is regarded as the most suitable test guideline for addressing the information requirements.

However, the registrant would like to point out, that the performance of a long-term toxicity study of ditolyl ether to fish is not needed as:

- The toxicity of ditolyl ether to freshwater aquatic organisms is documented by several acute aquatic studies in three trophic levels (fish, daphnid, algae) and long-term studies in two trophic levels (daphnid and algae). The results of the acute toxicity studies indicate that algae are the most sensitive species with an EC10 of 0.035 mg/L algae qualify as 75 times more sensitive than fish with 2.62 mg/L.

- In the chemical safety assessment of ditolyl ether no risk to the aquatic compartment is identified for all relevant uses (PEC/PNEC < 1), so that a refinement of the PNECaquatic is not required.

In addition, ECHA decision number SEV-D-2114341466-49-01/F in request 8 states: "If one of the DTE isomers is already found to meet the criteria for vPvB and/or PBT in accordance with REACH Annex XIII, this request does not need to be addressed." As the substance is classified vP, further testing of the Bioaccumulation in fish needs to take place as a first measure to establich a classification of B or vB properties of the substance. cf. section 5.3.1 of this dossier.
Depending upon the outcome and evaluation of the Bioaccumulation study, the registrant will potentially perform aquatic toxicity tests, following the tiered requirements as requested in the ECHA decision SEV-D-2114341466-49-01/F.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

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