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Ecotoxicological information

Short-term toxicity to fish

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Description of key information

Most sensitive aquatic organism group for short-term effects, submission item considered “moderately toxic”

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
3.2 mg/L

Additional information

On the basis of the available data, fish were found to be the most sensitive aquatic organism group for short-term exposure.

The short-term secondary consumer ecotoxicity of the submission item Dimethyl itaconate (CAS 617-52-7) to zebra fish embryos (Danio rerio) was measured in a GLP-compliant study using the “Fish Embryo Acute Toxicity (FET) Test” compliant with the OECD TG 236 (2013) protocol (Peither 2015, Harlan Laboratories Report no. D91884). The validity criteria were met and the experiment can be considered relevant and adequate for the endpoint. Therefore it is deemed conclusive and was rated “reliable without restrictions“, i.e. “Klimisch 1” according to the scale of Klimisch et al. (1997).

Newly fertilized eggs of zebra fish were exposed to aqueous test media containing the test item at nominal concentrations of 0.46, 1.0, 2.2, 4.6, and 10 mg/L under static conditions for the test period of 96 hours. Additionally, a control and the positive control 3,4-dichloroaniline at the nominal concentration of 4.0 mg/L were tested in parallel. The measured concentrations of the test item in the test media were between 67 and 77 % of the nominal values at the start of the test. During the test period of 96 hours, the test concentrations slightly decreased to 72 to 91 % of the initially measured concentrations, i.e. 54 to 69 % of nominal. The mean measured concentrations were calculated as the geometric mean over all measurements per test concentration: Geometric mean measured 0.31, 0.60, 1.5, 3.0 and 7.2 mg test item/L, i.e. 67, 60, 68, 65 and 72 % of the nominal values, respectively. Thus the results were related to the geometric mean measured concentrations of the test item. The slight losses of the test item are deemed likely being caused by microbial biodegradation and to a minor degree due to volatilization into the small headspaces. The test was conducted in disposable multiwell test plates. At the start of the test, 20 viable, pre-selected eggs were transferred to the test wells of each treatment. The eggs were observed on toxic effects on the development of the embryos and larvae. Apical observations (coagulation of embryos, lack of somite formation, non-detachment of the tail, and lack of heartbeat) were recorded as indicators of lethality.

Summarizing the results from the different test parameters assessed, the NOEC for embryos and larvae of zebra fish was determined to be 1.5 mg/L, since no adverse effects of the test item on development of larvae, hatching success, and mortality were determined.

The LOEC was determined to be 3.0 mg/L due to distinct adverse effects on hatching success, development rate, and mortality of the embryos and larvae. The 96-hours LC50 for embryos and larvae was calculated to be 3.2 mg/L (the 95% confidence limits could not be determined). The 96-hours LC100 was assigned to the test concentration 7.2 mg/L and the 96-hours LC0 to 1.5 mg/L.

This places the test item in the “moderately toxic” acute toxicity class according to the scheme of (U.S. EPA 1994, p 10). On the basis of this study alone no classification is indicated according to CLP (5th ATP of Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the EU.

  • Klimisch HJ, Andreae M, Tillmann U (1997). A Systematic Approach for Evaluating the Quality of Experimental Toxicological and Ecotoxicological Data. DOI 10.1006/rtph.1996.1076 PMID 9056496 Regul Toxicol Pharmacol 25:1-5.
  • U.S. EPA United States Environmental Protection Agency (1994). Pesticide Reregistration Rejection Rate Analysis, Ecological Effects. Self-published EPA, Office of Prevention, Pesticides and Toxic Substances (OPPTS), Washington, DC, U.S.A., document number 738-R-94-035. 188 p.