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Long-term toxicity to fish

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Description of key information

No chronic test on fish is deemed necessary.

Key value for chemical safety assessment

Additional information

In Annex IX of Regulation (EC) No 1907/2006, it is laid down that long-term toxicity testing in 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 CLP-Regulation (EC) No 1272/2008 or is assessed to be a PBT or vPvB.

The hazard assessment of 2,2'-methyliminodiethanol reveals neither a need to classify the substance as dangerous to the environment, nor is it a PBT or vPvB substance.

Therefore, and for reasons of animal welfare, a long-term toxicity testing in fish is not provided.

Further, based on the obviously higher sensitivity of aquatic invertebrates to the test substance in the acute test (EC50 of 45 - 233 mg/L compared to the acute fish test LC50 of >1000 and <2200 mg/L) it is not to be expected, that a chronic test on fish will reveal any additional information on the chronic aquatic toxicity of the test substance.

Moreover, long-term toxicity testing is not triggered by the results of the exposure assessment and the risk characterization. The risk-characterisation ratios (RCR) do not indicate a risk for the environment (RCR < 1).

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