Registration Dossier
Registration Dossier
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EC number: 604-617-1 | CAS number: 147993-66-6
Endpoint summary
Administrative data
Description of key information
Additional information
The Guidance on information requirements and chemical safety assessment, Chapter R.7C: Endpoint specific guidance (November 2014), section R. 7.11.6.3, Table R.7.11-2, page 145, specifies the information needed to waive the terrestrial studies based on soil hazard categories.
The log Pow of the registered substance is <3. Therefore, accumulation and persistence of the registered substance in soil and organisms is very unlikely. A PNEC soil was calculated using the aquatic PNEC and the equilibrium partitioning method. Based on these characteristics, the registered substance is not expected to cause adverse effects on terrestrial organisms and consequently terrestrial toxicity tests are not needed.
Nevertheless, a read across earthworm reproduction study is available from the diester group (CAS 29857 -13 -4). This study was added to this dossier to demonstrate that the sulfosuccinates do not cause high toxicity in terrestrial organisms. In the Klimisch 1 GLP study from Straube (2016) the chronic toxicity of Butanedioic acid, sulfo-, 1,4-diisodecyl ester, sodium salt on earthworms (Eisenia fetida) reproduction and growth in artificial soil was determined in an 56 day test according to OECD 222. The test was performed with Control, 1.3, 13, 26, 52 and 104 mg a.i./kg soil dry weight. The biological results are based on nominal concentrations since the analysis of the stock solution confirmed correct preparation of this solution and the preparation and application of the application solutions was checked and documented by weighing.
Eight replicates with 10 worms each were set up for the control and 4 replicates for each test group. After 28 days 0, 0, 0, 0, 0, 0 and 0% mortality was observed in the control and at nominal test concentrations of 1.3, 13, 26, 52 and 104 mg a.i./kg soil dry weight, respectively.
The reproduction per pre replicate container with 10 adult worms was 190, 165, 171, 150, 170, and 170 living offspring per container (10 worms) control and at nominal test concentrations of 1.3, 13, 26, 52 and 104 mg a.i./kg soil dry weight, respectively. The overall NOEC for reproduction, mortality, growth and food consumption was equal or greater than the highest test concentration, i.e. >= 104 mg/ kg dw.
To be conservative, the more conservative result from the equilibrium partioning method was used for the risk assessment and the result from this study was not used for the risk assessment. However, this read across chronic earthworm study supports that the substance in not expected to cause relevant toxicity to the terrestrial compartment. Therefore, further terrestrial studies are not needed.
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