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EC number: 210-519-6 | CAS number: 617-52-7
Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
Description of key information
Non-standard experimental data, risk assessment (PNEC derivation) bases on aquatic data and EPM
Key value for chemical safety assessment
- Short-term EC50 or LC50 for soil macroorganisms:
- 435 mg/kg soil dw
Additional information
- ECB European Chemicals Bureau (2003) Technical Guidance Document in support of Commission Directive 93/67/EEC on Risk Assessment for new notified substances, Commission Regulation (EC) No 1488/94 on Risk Assessment for existing substances and Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market, Part II, 328 p.
- ECHA European Chemicals Agency (2008) Guidance on information requirements and chemical safety assessment Chapter R.10: Characterisation of dose [concentration]-response for environment, 65 p & Chapter R.16: Environmental Exposure Estimation, 138 p.
- EMEA European Medicines Agency (2007) Guideline on Environmental Impact Assessment for Veterinary Medicinal Products in support of the VICH guidelines GL6 AND GL 38 - EMEA/CVMP/ERA/418282/2005-corr, 63 p.
- 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.
No experimental guideline study data on effects to soil macroorganisms are available. Testing for short-term toxicity to invertebrates, required in Annex IX, column 1, section 9.4.1 has been waived in accordance with column 2 restrictions.
Dijan et al. (1994) tested the nematocidal effect of the submission item Dimethyl itaconate (CAS 617-52-7). The experimental work is well documented in the publication, which meets generally accepted scientific standards. Therefore the study is considered conclusive and was rated „reliable with restrictions“, i.e. “Klimisch 2” according to the scale of Klimisch et al. (1997), because no standardized protocol was followed and no GLP quality assurance applied.
However terrestrial organisms, the test animals (Meloidogyne arenaria) were exposed 24 h to small amounts of aqueous test item solutions at several concentrations. Mortality was assessed on the basis of immobility after stimulation.
The LC50 was determined to be 2372 mg/L. In order to derive a value related to soil concentrations the EPM according to ECB (2003) as adopted by ECHA (2008) was employed. Employing the Equilibrium Partitioning Method (EPM) for conversion, 435 mg/kg soil dw results, when the Koc of 2.5 L/kg, the Henry constant of 0.02 (Pa·m³)/mol at 20 °C and for the conversion from soil wet weight to dry weight the factor of 1.333 according to EMEA (2007, p 31) were used.
Given the biodegradability of the submission item, this level is assumed to indicate no relevant nematoticidal effects in the environment.
In conclusion the available data give no indication for a relevant toxicity of the submission item to soil macroorganisms.
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