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Long-term toxicity to fish

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Description of key information

The test substance is not considered as hazardous for the environment. Therefore, a chronic test in fish is not provided.

Key value for chemical safety assessment

Additional information

The long-term toxicity to fish was estimated using the model ECOSAR v1.11 implemented in EPISuite v4.11 (chronic value = 327 mg/L). The substance was within the applicability of the estimation model; but as long-term prediction by the model has been developed based on a small data pool (training set: n < 5), the modeled results have a high uncertainty.

In addition, the ACR approach according to ECETOC (2003, Report no. 91) results in NOECs greater than 1 mg/L, based on the effect data of the acute toxicity study (BASF AG, 1987; report no. 10F0268/875180).

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. 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 the substance 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.  

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. 9, 10).  

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