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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Ecotoxicological information

Toxicity to aquatic plants other than algae

Administrative data

Endpoint:
toxicity to aquatic plants other than algae
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report date:
2018

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 221 (Lemna sp. Growth Inhibition Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyldimethyl[2-[(2-methyl-1-oxoallyl)oxy]ethyl]ammonium ethyl sulphate
EC Number:
236-195-6
EC Name:
Ethyldimethyl[2-[(2-methyl-1-oxoallyl)oxy]ethyl]ammonium ethyl sulphate
Cas Number:
13223-03-5
Molecular formula:
C10H20NO2.C2H5O4S
IUPAC Name:
ethyldimethyl{2-[(2-methylprop-2-enoyl)oxy]ethyl}azanium ethyl sulfate

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
All test item concentrations and the control were analytically verified via LC-MS/MS at the start (0 day) and at the end of the exposure (7 days) and on every renewal day. Freshly prepared and old media were analyzed. At the start samples were taken from the freshly prepared dilution levels. At the end samples were taken from pooled replicates and analyzed immediately. Details of the analytical method are given in section 13. The samples were analyzed with an LC-MS/MS method. The method was implemented under non-GLP but documented in the raw data and validated according to Annex 1. The method validation was not part of this GLP study.

Test solutions

Vehicle:
no
Details on test solutions:
A stock solution with a nominal test item concentration of 500 mg/L was freshly prepared with dilution water (see Table 3) and agitated until the solution was visually clear. The stock solution was freshly prepared on each renewal day. 5 concentrations were tested in a geometrical series with a dilution factor of 3.2: 4.77 - 15.3 - 48.8 - 156 - 500 mg Quat 311/L, corresponding to the following corrected nominal concentrations of the test item (concentration of the main component): 4.67 - 15.0 - 47. 7 - 153 - 489 mg/L.
The concentrations are based on the results of a preliminary range finding test

Test organisms

Test organisms (species):
Lemna gibba
Details on test organisms:
TEST ORGANISM
- Common name: Duckweed
- Strain: not indicated
- Source (laboratory, culture collection): EUROFINS-GAB GMBH, Eutinger Str. 24, D-75223 Niefernöschelbronn, Germany
- Age of inoculum (at test initiation): not applicable
- Method of cultivation: in house culture

ACCLIMATION
- Acclimation period: not applicable
- Culturing media and conditions (same as test or not): yes
- Any deformed or abnormal cells observed: no

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
7 d

Test conditions

Test temperature:
23.7 - 25.7
pH:
7.53 - 8.59
Nominal and measured concentrations:
Nominal: control, 4.67, 15, 47.7, 153, 489 mg/L
TWA: < LOQ, 2.23, 6.38, 23.0, 126, 439 mg/L
As the analytical determined test concentrations were above +/-20 % of the nominal test concentrations, all biological results were referred to the time weightes average (TWA) concentrations.
Details on test conditions:
TEST SYSTEM
- Incubation chamber used: not indicated
- Test vessel: crystalizing glass dishes
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: glass, 900 ml (nominal), filled with 500 ml medium
- Aeration: no
- Agitation: no
- Renewal rate of test solution (frequency/flow rate): daily
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates):6


GROWTH MEDIUM
- Standard medium used: yes


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: 20> AAP-medium; according to OECD 221
- Culture medium different from test medium: no
- Intervals of water quality measurement: daily

OTHER TEST CONDITIONS
- Sterile test conditions: no
- Adjustment of pH: no
- Photoperiod: continuous
- Light intensity and quality: 1100 - 4440 lux (fluorescent)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : frond number (after 3 5 and 7 days), dry weight at test end.
- Determination of frond number: yes
- Determination of biomass: yes

- Determination of frond area:
- Other:

RANGE-FINDING STUDY
- Test concentrations:
- Results used to determine the conditions for the definitive study:
Reference substance (positive control):
yes
Remarks:
3,5-dichlorophenol

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
7 d
Dose descriptor:
EC50
Effect conc.:
320 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
frond number
Key result
Duration:
7 d
Dose descriptor:
EC50
Effect conc.:
478 mg/L
Nominal / measured:
meas. (TWA)
Conc. based on:
test mat.
Basis for effect:
other: dry weight
Results with reference substance (positive control):
ErC50: 7.68 mg/L (frond number)
ErC50: > 8 mg/L (dry weight)
Reported statistics and error estimates:
EC10-, EC20- and ECso-values (0 - 7 d) of the growth rate and yield (frond number and dry weight) inhibition were calculated by third order polynomial regression. Calculations of the confidence intervals of EC10-, EC20- and ECso-values were carried out from the best fit values, the standard error and the t-distribution with the software GraphPad Prism.

The data for the tables in this report were computer-generated and rounded for presentation from the fully derived data. Consequently, if calculated manually based on the given data, minor deviations
may occur from these figures. Calculations were carried out using the following software:
- Excel, MICROSOFT CORPORATION
- SigmaPlot, SPSS INC.
- GraphPad Prism, GRAPHPAD SOFTWARE, INC.

Applicant's summary and conclusion