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EC number: 290-836-4
CAS number: 90268-36-3
Guidance on information requirements and chemical safety assessment,
Chapter R.7C: Endpoint specific guidance (November 2014), section R.
220.127.116.11, 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.
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.
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.
be conservative, the more
from the equilibrium partioning method was used for the risk assessment
and the result from this read across study was not used for the risk
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.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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