Registration Dossier
Registration Dossier
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EC number: 429-900-5 | CAS number: 82356-51-2
Endpoint summary
Administrative data
Description of key information
Three key studies are available to determine the terrestrial toxicity of the registered substance.
The first study was performed to assess the acute toxicity of the registered substance to the earthworm (Eisenia fetida) in an artificial soil, according to OECD Guideline 207 and EEC Commission Directive 87/302/EEC. The 14d-LC50 value based on the mortalities of earthworms was determined to be 250 mg/Kg (95% confidence limits = 240 -260 mg/Kg).
The second study was performed to assess the effects of the registered substance on seedling emergence and growth on three different species: oat (Avena sativa), soybean (Glycine max) and tomato (Lycopersicon esculentum), according to OECD Guideline 208 part A. This original guideline is considered as an acute test, when only three plant species are used in the test (http://echa.europa.eu/documents/10162/13628/evaluation_report_2012_en.pdf see pp 34-35). The 25d-EC50 to oat, the 26d-EC50 to soybean and the 28d-EC50 to tomato, based on percent emergence and shoot weight, were determined to be greater than the maximum rate tested 1100 mg/Kg. The highest concentration without observed effect (NOEC) were determined to be 117 mg/Kg for shoot weight of oat and 1100 mg/Kg for percent emergence and shoot weight of soybean and tomato. Necrosis in solvent controls and a poor dose-effect relationship for shoot weights were observed for oat and tomato. Therefore, the results with these two species must be taken into account with caution.
The third study was performed to assess the long-term effect of the registered substance after a single exposure, on nitrogen transformation activity of soil microorganisms, according to OECD guidelines 216 and EPPO 1994. The substance showed no significant effect on the nitrogen transformation activity of soil microorganisms at a test concentration of 1000 mg/Kg over a 28 -day period (NOEC >= 1000 mg/Kg) and therefore can be considered to have no long-term effect on nitrogen transformation in soil.
Even if the plant study available is considered as an acute test (based on number of tested species), the NOEC value is the lowest, so it’s justified to use it for PNEC derivation. As a long-term toxicity test on microorganisms is available (OECD 216; NOEC >= 1000 mg/kg on soil microorganisms) showing a NOEC value greater than the NOEC plant, an assessment factor of 50 is used. Therefore, the PNEC soil is equal to 117/50 = 2.34 mg/kg dw.
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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