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Short-term toxicity to aquatic invertebrates

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Reference
Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-12-18 to 2012-12-21
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study, no deficiencies
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0.625 - 1.25 - 2.50 - 5.00 - 10.0 mg/L (dilution factor 2).
- Sampling method:
All test concentrations and the control were analytically verified by LC-MS/MS at the start of the exposure (0 h) and at the end of the exposure (48 h) as specified below.
Sampling at the start of the exposure (0 h) was carried out immediately before application.
At the end of the exposure (48 h), samples were taken directly from the test vessels.
- Sample storage conditions before analysis: All original samples were stored at room temperature until sample preparation. Prepared samples were stored at room temperature until analysis.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock solution (10.0 mg/L of the test item were weighed out) was freshly prepared with dilution water. Dispersion treatment was agitation
- Eluate: Dilution water
- Differential loading: 0.625 - 1.25 - 2.50 - 5.00 - 10.0 mg/L (dilution factor 2).
- Controls: Dilution water without test item tested under the same conditions as the test goups.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna (STRAUS)
- Strain: Clone 5
- Source: Institut für Wasser-, Boden- Lufthygiene (WaBoLu), further own breeding
- Age at study initiation (mean and range, SD): 2 to 24 h
- Method of breeding: In 2-3 L glass vessels with appr. 1.8 L culture medium, at 20 +/- 2 °C, in an incubator, 16 h illumination, illumination strength max. 20 µExm-2 x s-1
- Feeding during test: No feeding

ACCLIMATION
- Acclimation period: 2 h
- Acclimation conditions (same as test or not): Same as test
- Type and amount of food: No feeding
- Health during acclimation (any mortality observed): Healthy, no mortality observed

DILUTION WATER:
Dilution water ISO test water, according to OECD 202, Annex 3:
Component Concentration [mg/L]
KCl 5.76
NaHCO3 64.8
CaCl2  2 H2O 294
MgSO4  7 H2O 123
pH-value: 7.8  0.2




Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
No
Hardness:
Dilution water at test start: 246 (mg CaCO3/L)
Test temperature:
21.5 °C (Water)
pH:
Water Quality Parameters at the Start of the Exposure (0 h)
(measured in one additional replicate per concentration level and control)
Nominal concentration
of the test item
[mg/L] pH-Value


10.0 7.89
5.00 7.94
2.50 7.99
1.25 8.06
0.625 8.09
Control 7.87

Water Quality Parameters at the End of the Exposure (48 h)
(measured in all replicates)
Nominal concentration
of the test item
[mg/L] pH-Values
Replicates
1 2 3 4
10.0 7.64 7.66 7.67 7.67
5.00 7.66 7.65 7.68 7.66
2.50 7.69 7.66 7.67 7.68
1.25 7.70 7.70 7.69 7.70
0.625 7.72 7.72 7.70 7.70
Control 7.73 7.77 7.72 7.72
Dissolved oxygen:
Water Quality Parameters at the Start of the Exposure (0 h)
(measured in one additional replicate per concentration level and control)
Nominal concentration
of the test item
[mg/L] Dissolved O2-Concentration

[mg/L]
10.0 8.62
5.00 8.65
2.50 8.67
1.25 8.66
0.625 8.66
Control 8.52

Water Quality Parameters at the End of the Exposure (48 h)
(measured in all replicates)
Nominal concentration
of the test item
[mg/L] Dissolved O2 -Concentration [mg/L]
Replicates
1 2 3 4
10.0 7.33 7.73 7.91 7.53
5.00 7.86 8.10 8.30 8.26
2.50 7.95 8.00 8.14 8.19
1.25 8.20 8.32 8.26 8.26
0.625 8.23 8.19 8.26 8.31
Control 8.28 8.29 8.27 8.36
Salinity:
Not measured, freshwater
Nominal and measured concentrations:
please refer to "Any other information on materials and methods"
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass beakers, 50 mL
- Type (delete if not applicable): closed with parafilm
- Material, size, headspace, fill volume: Glass beakers (4 cm ID x 7 cm H), 50 mL
- Aeration: No
- Renewal rate of test solution (frequency/flow rate): static test
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): None


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: see above
- Conductivity: Dilution water at test start:632 µS/cm
- Culture medium different from test medium: Elendt M4 acc. to ELENDT (1990), modified to a total hardness of 160 to 180 mg CaCO3/L
- Intervals of water quality measurement: At test start and test end


OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16:8 light:dark cycle
- Light intensity: Diffuse light, illumination strength max. 20 µE x m-2 x s-1


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :
Immobility was determined in all groups after 24 h and 48 h.

TEST CONCENTRATIONS
- Range finding study:
Immobilisation Rates in the non GLP Preliminary Range Finding Test
(n = 20, divided into 2 replicates with 10 daphnids each)
Nominal
Test Item
Concentration
[mg/L] IMMOBILISATION [%]
24 h 48 h
Replicates Replicates
1 2 MV 1 2 MV
100 100 100 100 100 100 100
10 100 100 100 100 100 100
1 0 0 0 0 0 0
Control 0 0 0 0 0 0
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
5.76 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
is UVCB means 100% act. ingr.
Basis for effect:
mobility
Remarks on result:
other: 95% CI 5.07-8.66 mg/L
Details on results:
- Mortality of control: 0 %
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: No
Results with reference substance (positive control):
- Results with reference substance valid? Yes
- EC50/LC50: 1.60 (CI 1.40 - 1.80) mg/L
Reported statistics and error estimates:
EC10- and EC50-values were calculated by sigmoidal dose-response regression. The confidence intervals were calculated from the best-fit values, the standard error and the
t-distribution with the software GraphPad prism5. The concentration effect relationships are presented graphically.

Immobilisation Rates in the Definitive Test after 24 and 48 h of Exposure

                 (n = 20, divided into 4 replicates with 5 daphnids each)

Nominal

IMMOBILISATION [%]

test item

concentration

[mg/L]

active ingredient

[mg a.i./L]

24 h

48 h

Replicates

Replicates

1

2

3

4

MV

1

2

3

4

MV

10.0

6.10

100

80

80

80

85

100

100

100

100

100

  5.00

3.05

  40

  0

  0

  0

10

  40

    0

  20

    0

  15

  2.50

1.53

  20

  0

  0

  0

  5

  20

    0

    0

    0

    5

  1.25

0.763

    0

  0

  0

  0

  0

    0

    0

    0

    0

    0

  0.625

0.381

    0

  0

  0

  0

  0

    0

    0

    0

    0

    0

Control

    0

  0

  0

  0

  0

    0

    0

    0

    0

    0

Validity criteria fulfilled:
yes
Conclusions:
Based on the nominal concentrations of the test item Sodium methyl oleyl taurate, the 48-h EC50 for Daphnia magna was estimated to be 5.76 mg/L (95 % confidence limits: 5.07 – 8.66 mg/L). This corresponds to 3.51 mg a.i./L (95 % confidence limits: 3.09 – 5.28 mg a.i./L) based on the nominal concentrations of the active ingredient.
The NOEC after 48 h was 2.50 mg/L, which corresponds to 1.53 mg a.i./L. The LOEC after 48 h was 5.00 mg/L, which corresponds to 3.05 mg a.i./L.
Executive summary:

In the acute immobilisation test with Daphnia magna (STRAUS), the effects of the test item Sodium methyl oleyl taurate (batch number: DEB4003485) were determined according to OECD 202 (2004) from 2012-12-18 to 2012-12-21, with the definitive exposure phase from  2012-12-19 to 2012-12-21 at Dr.U.Noack-Laboratorien, Käthe-Paulus-Str.1, 31157 Sarstedt, Germany.

The study was conducted under static conditions over a period of 48 h with five concentration levels of the test item Sodium methyl oleyl taurate in the range of 0.625 to 10.0 mg/L, prepared with dilution water in a geometric series with a factor of 2. This corresponds to the nominal concentrations of the active ingredient in the range of 0.381 to 6.10 mg a.i./L. Twenty daphnids were exposed to each concentration level and the control.

The concentrations of the test item Sodium methyl oleyl taurate (C18:1-part) wereanalytically verified by LC-MS/MS at the start of the exposure (0 h) and at the end of the exposure (48 h) of all concentration levels and the control.
The measured concentrations of the test item at the start of the exposure (0 h) were in the range of 100 to 110 % of the nominal values. The measured concentrations of the test item at the end of the exposure (48 h) were in the range of 96 to 102 % of the nominal values, indicating
that the concentrations of the test item were successfully maintained for the duration of the test. The endpoints were based on the nominal concentrations of the test item Sodium methyl oleyl taurate and additionally given based on the nominal concentrations of the active ingredient (Table 1).

The water quality parameters (i.e. pH-values and dissolved oxygen concentrations), measured at the start (0 h) and the end of the exposure (48 h), were within the acceptable limits. The validity criteria of the test guideline were fulfilled.

IMPORTANT NOTE TO AVOID CONFUSION:

As the registration substance is a UVCB this means that the test item is 100% active ingredient.

EC10-, EC50- (with Confidence Interval), EC100-Values

                   (based on the nominal concentrations of the test item and the active ingredient)

Endpoints

Test

duration

[h]

Sodium methyl oleyl taurate

Nominal concentrations
of the test item

[mg/L]

EC10

(with 95 % confidence limits)

24

     4.99 (4.00 – 6.43)

  

48

     4.80 (3.35 – 8.20)

  

EC50

(with 95 % confidence limits)

24

     7.43 (6.39 – 8.37)

  

48

     5.76 (5.07 – 8.66)

  

EC100

24

> 10.0

48

   10.0

 

NOEC

48

     2.50

 

LOEC

48

     5.00

  

Description of key information

Based on the nominal concentrations of the test item Sodium methyl oleyl taurate, the 48-h EC50 for Daphnia magna was estimated to be 5.76 mg/L (95 % confidence limits: 5.07 – 8.66 mg/L). This corresponds to 3.51 mg a.i./L (95 % confidence limits: 3.09 – 5.28 mg a.i./L) based on the nominal concentrations of the active ingredient.

The NOEC after 48 h was 2.50 mg/L, which corresponds to 1.53 mg a.i./L. The LOEC after 48 h was 5.00 mg/L, which corresponds to 3.05 mg a.i./L.

Key value for chemical safety assessment

EC50/LC50 for freshwater invertebrates:
5.76 mg/L

Additional information