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Long-term toxicity to fish

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Description of key information

The chemical safety assessment according to Annex I of Regulation (EC) No. 1907/2006 does not indicate the need to investigate further the long-term toxicity to fish.

Key value for chemical safety assessment

Additional information

According to Annex IX of Regulation (EC) No 1907/2006 long-term toxicity tests on fish do not need to be conducted if the chemical safety assessment of a substance indicates the no need for a further investigation of 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 of2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 78-16-0)indicates no need to either classify the as dangerous to the environment, nor is the substance a PBT or vPvB substance.

Experimental data on the long-term toxicity of 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 78-16-0) are not available. However the available data on acute and chronic toxicity of the TMP esters group indicates no potential for toxicity to aquatic organisms up to the limit of water solubility (< 0.05 mg/L). Furthermore due to the expected environmental fate of 2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate (CAS 78-16-0) and the low bioaccumulation potential a chronic exposure of aquatic organisms and long-term toxicity is not likely. The substance is readily biodegradable and thus a distribution of the substance to natural waters is not expected due to an ultimate degradation in sewage treatment plants. Furthermore the BCF/BAF values calculated for the substance indicate a low potential for bioaccumulation.

Thus no long-term toxicity tests on fish are provided.