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Long-term toxicity to fish

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For 2-dimethylaminoethyl methacrylate, a GLP OECD Guideline 204 study on prolonged toxicity to fish is reported. After 14 days of exposure in a semi-static system a LC50 of 5.26 mg/L was measured. The LC0 after 14 days was determined at 2.96 mg/L. However, according to Annex IX long-term toxicity tests on fish shall provide information about one of the following parameters: a) early-life stage toxicity; b) short-term toxicity on embryo and sac-fry stages or c) juvenile growth inhibition. Thus, the present prolonged study cannot be taken into account for a long-term toxicity assessment; therefore, the result of this study can just be used for a pre-evaluation of the long-term toxicity of the test substance. Furthermore, analytical monitoring showed that a major part of the test substance was degraded within 24 hours. Investigations on abiotic degradation showed that over time the substance will hydrolyse under environmental conditions into methacrylic acid (CAS# 79-41-4) and 2-dimethylamino ethanol (CAS# 108-01-0). Therefore, the mortality was probably caused by degradation products too. An investigation on long-term toxicity is just reported for methacrylic acid. The result of this OECD Guideline 210 study showed a NOEC of 10 mg/L.

In addition, in Annex IX of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity to 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 dangerous according to Directive 67/548/EEC or Directive 1999/45/EC or is assessed to be a PBT or vPvB.

The hazard assessment of 2-dimethylaminoethyl methacrylate 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. Therefore, and for reasons of animal welfare, a long-term toxicity study in fish is not provided.