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EC number: 212-133-3
CAS number: 764-99-8
No data available
JUSTIFICATION FOR DATA WAIVING[Specific explanation in addition to field 'Justification for data waiving']In Annex IX, Section 9.1.6, Column 2 of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity testing on fish shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on fish. According to Annex I of this regulation, the chemical safety assessment triggers further action when the substance or the preparation meets the criteria for classification as hazardous according to CLP-Regulation (EC) No 1272/2008 and its second adaptation 286/2011 or is assessed to be a PBT or vPvB. The hazard assessment of the substance reveals neither a need to classify the substance as dangerous to the environment, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may be hazardous to the environment. 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.18.104.22.168, 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 aquatic invertebrates and algae are the more sensitive trophic levels. A detailed description of this approach is given in the attached justification document: 764-99-8_Waiver_Long-term Fish_2022-03-21.pdf
In conclusion, and for reasons of animal welfare, a chronic test in 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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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