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Ecotoxicological information

Long-term toxicity to fish

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Link to relevant study record(s)

Reference
Endpoint:
fish early-life stage toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:

Description of key information

Key value for chemical safety assessment

Additional information

No data are available describing the long-term toxicity of the registered substance to fish. A Fish, Early Life Stage Toxicity Test is currently ongoing. The final report is expected in July 2020. Until the results of this test are available, hazard assessment is based on the long-term Daphnia result. 

 

Long-term fish data are waived until the results of the FELS test are available, for the following reasons:

 

In accordance with Column 2 of REACH Annex X, there is no need to further investigate the effects of this substance in a long-term aquatic toxicity to fish study because, as indicated in guidance R.7.8.4.3 (ECHA 2016), the quantitative chemical safety assessment (conducted according to Annex I of REACH) indicates that the Risk Characterisation Ratio is below 1 and therefore the risk is already adequately controlled and further testing is not justifiable.

 

Based on the short-term aquatic data set, no effects were seen in any trophic level at the limit of solubility of the substance.

 

Long-term invertebrate toxicity tests are available with the registered substance. The results from these tests have been used to derive PNECs; there is no indication that fish would be significantly more sensitive than invertebrates, as indicated by the short-term data.

 

A PNEC has been derived for the purpose of chemical safety assessment. An assessment factor of 100 was applied to derive the freshwater PNEC, based on long-term invertebrate data. For a narcotic chemical without a specific mode of toxic action, it is unlikely that the aquatic PNEC would be significantly over-estimated using this method.

 

Overall it is concluded that the risk characterisation conclusion is sufficiently conservative in respect of any uncertainties until further in vivo testing with fish is available.

 

Details on how the PNEC and the risk characterisation ratio have been derived can be found in IUCLID Section 6.0 and Chapters 9 and 10 of the Chemical Safety Report, respectively.