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Long-term toxicity to aquatic invertebrates

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In Annex IX of Regulation (EC) No 1907/2006, it is laid down that chronic tests 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 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. Therefore, a chronic test in aquatic invertebrates is not provided. As the substance hydrolyses forming methanol and formic acid chronic test data on one of the products of hydrolysis (formic acid) are given additionally as supporting evidence to emphasise the low hazard potential of methyl formate without using the data for derivation of PNEC. Hydrolysis product formic acid/formate The chronic test with formic acid using Daphnia magna as test species was performed according to OECD TG 211. The NOEC based on reproduction and growth was determined to be 100 mg/L, indicating no adverse long-term effects (BASF AG, 2007). No chronic toxicity data exist for methanol as the other product of hydrolysis. Based on its available acute toxicity data (LC/EC50values for fish, invertebrates, algae and microorganisms: > 1000 mg/L; OECD SIDS, 2004), long-term toxicity is not to be expected. Hydrolysis product methanol In an early-life-stage bioassay conducted with Oryzias latipes (Gonzales-Doncel et al., 2008), NOECs range between 7900 - 15800 mg/L. Although this in-vitro study was not conducted according to current standard guidelines, the results give a clear indication of the low hazard potential (acute and long-term) of methanol to aquatic organisms.