Registration Dossier

Ecotoxicological information

Long-term toxicity to fish

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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.