Registration Dossier
Registration Dossier
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EC number: 632-619-2 | CAS number: 881685-58-1
Endpoint summary
Administrative data
Description of key information
In a biodegradation screening study (OECD TG 301 F), after 28 days of exposure of activated sludge to 102 mg/L of the substance, no biodegradation was observed. Based on the result, the substance is considered to be not readily biodegradable.
Two GLP compliant simulation studies on biodegradation in water and sediment are available. One study that represents the direct biodegradation of the substance in the water-sediment system was included as the key study. Its effect values were used as key values in a weight of evidence approach. This study followed OECD TG 308, EPA 162-3 and EPA 162-4 guidelines. The geomean DT50 value of the substance in freshwater-sediment under aerobic conditions in two different freshwater systems (river and pond) was determined to be > 1 year. The second study used an outdoor freshwater-sediment microcosm with a representative community of macrophytes and macroinvertebrates. There was no standard guideline available for this type of study. But the study considered OECD TG 308, EPA 162-3 and EPA 162-4 guidelines. This type of study is not designed to represent the degradation process alone and thus cannot be considered to yield a degradation half-life that can be used for the CSA according to ECHA Guideline on Information requirements and chemical safety assessment, Chapter R.7b: Endpoint specific guidance. Therefore, this study is selected as a supporting study. The DT50 values for the water column and the total system were determined to be 3.5 days and 21.2 days in this study, respectively.
Four aerobic studies and one aerobic/anaerobic study are available for biodegradation in soil: simulation tests endpoint. They all followed standard test guidelines (OECD TG 307 and EPA 162 -1) and complied with GLP. The effect values from all four aerobic studies were used in a weight of evidence approach for the CSA. The geometric DT50 value (n = 12) was determined to be 227 days at 20 ˚C. In the aerobic/anaerobic study, only the DT50 value under anaerobic conditions is reported. Therefore, this study is included as a supporting study. The DT50 value was determined to be >> 1 year (aerobic phase excluded).
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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