Registration Dossier
Registration Dossier
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EC number: 203-680-9 | CAS number: 109-55-7
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
The substance is not considered as hazardous for the environment. Therefore, a chronic test in fish is not provided.
Key value for chemical safety assessment
Additional information
In Annex XI Section 3, it is laid down that testing in accordance with sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX may be omitted, based on the exposure scenario(s) developed in the Chemical Safety Report (“Substance-Tailored Exposure-Driven Testing”). In accordance with Annex XI Section 3, it can be demonstrated in the risk assessment that the manufacture and the use of the substance do not pose an unacceptable risk for all environmental compartments as the risk characterization ratios (RCRs) of the chemical safety assessment are below 1 for all compartments (see Chemical Safety Report Ch. 9, 10).
Considering the possibility for the prediction of relative species sensitivities according to the REACH Guidance Document R.7b (ECHA, June 2017, v4.0), chapter R.7.8.5.3, further testing on fish would not contribute to improve the current knowledge of the substance and/or its associated risk when released to the aquatic compartment. This conclusion is based on reliable and valid short-term (fish, aquatic invertebrates, algae) and long-term (aquatic invertebrates, algae) data which clearly demonstrate that fish is not the most sensitive trophic level. A detailed description of this approach is given in the attached justification document: 109-55-7_Waiver_Long-term Fish_2022-06-15.pdf.
Therefore, and for reasons of animal welfare, a long-term toxicity test on fish is not provided.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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