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Long-term toxicity to aquatic invertebrates

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Description of key information

A long-term study on aquatic invertebrates is not provided.

Key value for chemical safety assessment

Additional information

In Annex IX of Regulation (EC) No 1907/2006, it is laid down that long-term testing to aquatic invertebrates shall be proposed by the registrant if the chemical safety assessment indicates the need to investigate further the effects on aquatic invertebrates.

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 methyldiethanolamine reveals neither a need to classify the substance as dangerous, nor is it a PBT or vPvB substance. Therefore a long-term study on aquatic invertebrates is not provided.

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).

A 96 -hour reproduction test on the marine copepod Acartia tonsa was performed (TNO Chemistry, 2002). The 96 -h NOEC was determined to be >= 100 mg/L. The 96 -h LC50 for parental mortality was > 100 mg/L. Although this study aimed to test the effect of MDEA on Acartia tonsa, there are several shortcomings of the test design to yield valid information on reproduction. A valid reproduction test should start with the exposure of newly hatched larvae, which should have sufficient time to reach adulthood and produce 2 to 3 broods of offspring in the control assays. As this study used 12 -d old females and information on the number of broods is missing, information regarding reproduction should not be considered in the risk assessment of MDEA. The data on mortality are discussed in IUCLID Ch. 6.1.3 Short-term toxicity to aquatic invertebrates.