Registration Dossier

Ecotoxicological information

Long-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

No data available

Key value for chemical safety assessment

Additional information

According to Annex IX, Section 9.1.6, Column 2 of Regulation (EC) No 1907/2006, long-term toxicity tests for fish shall be proposed by the registrant if the result of the chemical safety assessment indicates the need to investigate further the effects of the substance and/or relevant degradation products on aquatic organisms. 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 dangerous according to CLP-Regulation (EC) No 1272/2008 and its second adaptation 286/2011 or is assessed to be a PBT or vPvB.  Acute toxicity data for the three trophic levels show that aquatic invertebrates (48-h EC50 = 4.57 mg/L) and algae (72-h ErC50 = 7.9 mg/L) have a similar sensitivity to DMDC, while fish is less sensitive (96-h LC50 = 22.4 mg/L).   Long-term toxicity data are available for aquatic invertebrates and algae; thus, the most sensitive trophic levels are covered. Considering the higher sensitivity of Daphnids and algae it is not expected, that further chronic testing on aquatic vertebrates would lead to NOEC/EC10 values of lower than 4.1 mg/L.  According to GHS, the substance is officially classified as Chronic Category 2. The self-classification based on the results of the short-term toxicity study on fish results in Chronic Category 3, while the available long-term toxicity data do not support a classification as chronically hazardous.  A long-term toxicity study with fish will not provide any relevant additional information.   In Annex XI, Section 3, it is laid down that testing 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).    Therefore, and for reasons of animal welfare, no long-term study on fish will be provided.