Registration Dossier
Registration Dossier
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EC number: 617-298-9 | CAS number: 82097-50-5
Endpoint summary
Administrative data
Description of key information
In a biodegradation screening study (OECD TG 301E), the activated sludge with a mixture of polyvalent bacteria and a secondary effluent of a sewage treatment plant of CH-4106 Therwil was exposed to 20 mg DOC/L of the substance for 28 days. Biodegradation of the test substance and reference substance measured as mg DOC/L and corrected by the blank control was calculated as 12 and 96% (DOC/DOC) respectively in 28 days. It is concluded that the test substance is not biodegradable under the test conditions.
Six standard guidelines followed and GLP complied studies are available for the biodegradation of the substance in water and sediment simulation tests endpoint. Three of these studies were performed in the freshwater-sediment system under aerobic conditions according to OECD TG 308 and/or EPA 162-4. The effect values of these aerobic studies were used as key values in a weight of evidence approach for the CSA. The geometric DT50 value (n=6) was determined to be 91.6 days at 20 ˚C. The major metabolites were identified to be M1, M2 and M3.
Seven aerobic studies and two aerobic/anaerobic studies are available for the biodegradation in soil: simulation tests endpoint. Five of them followed standard test guideline and complied with GLP. The effect values from two aerobic studies that followed standard test conditions (i.e. meet OECD, SETAC, OPPTS or JMAFF guideline requirements) were used in a weight of evidence approach for the CSA. The geometric DT50 value (n=4) was determined to be 54.5 days at 20 ˚C. The major metabolites were identified to be M1, M2 and M10.
Additional information
Studies required in Annex VII and some other studies required for higher tonnage are available. All the studies available have been included in the dossier. For the biodegradation in water and sediment : simulation tests endpoint, 6 studies are available (Dixon 2010&2012, Spare 1993a&b&c&d). For the biodegradation in soil endpoint, 9 studies are available (Hurst 2012&2013, Olson 1989&1990, Plücken 1985a&b&1986a&b&1989).
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