Registration Dossier
Registration Dossier
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EC number: 256-032-2 | CAS number: 42978-66-5
Long-term toxicity to fish
Administrative data
Link to relevant study record(s)
Description of key information
No data on the long term toxicity of TPGDA on fish are available.
Key value for chemical safety assessment
Additional information
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. 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. 10). In addition, the substance is not classifies as a PBT or vPvB substance (see IUCLID Ch. 2.3). 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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