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Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017-08-08 to 2017-10-18
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:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
2004
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Sampling method: analytical samples taken from control and all test item concentrations at 0 hours (initial value) and 48 hours aged test solutions were analysed
- Fortified samples: a stock solution (1770 mg/L, purity not considered) and a dilution (1 mg/L) were prepared in acetonitrile/water (1:1, v/v) +0.1% acetic acid and used for fortification of recovery samples.
- Sample storage (before test): stored deep-frozen until analysis

Test solutions

Vehicle:
no
Details on test solutions:
- Stock solution of 15 mg/L. Lower test concentrations were prepared by dilution.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: straus, clone 5
- Feeding during test: no feeding during test
- Feeding of culture (before test): three times a week with single cell green algae
- Main test: freshly hatched daphnids less than 24 hours old were used

Study design

Test type:
static
Water media type:
freshwater
Remarks:
Elendt M4 medium
Limit test:
no
Total exposure duration:
48 h

Test conditions

Hardness:
250 mg/L CaCO3
Test temperature:
20.2 – 21.7 °C
pH:
7.28 – 8.03
Dissolved oxygen:
≥ 8.3 mg/L
Nominal and measured concentrations:
Nominal concentrations: 1.50, 0.500, 0.167, 0.0556 and 0.0185 mg/L and a control
Measured concentration (geometric mean based): 1.70, 0.515, 0.170, 0.0556, 0.0189 mg/L and not determined for the control
Details on test conditions:
TEST SYSTEM
- Test vessel: glass vessel
- Type: covered with a glass plate (to reduce evaporation)
- Material, size, headspace, fill volume: 100 mL capacity filled with 50mL of test solution
- No. of organisms: 20 daphnids per treatment group (4 replicates of 5 animals each)
- No. of treatment groups: 6 (5 dose rates of the test item and a control)

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M4
- Culture medium different from test medium: same as Elendt M4

OTHER TEST CONDITIONS
- Exposure to light: none

EFFECT PARAMETERS MEASURED: Immobilisation

RANGE-FINDING STUDY
- Test concentrations: control, 100, 10 and 1 mg/L
- Sampling points : after 24h and 48h of exposure
- Results used to determine the conditions for the definitive study:
-- After 24 h 95 % immobilisation was observed at 10.0 mg/L. 100 % of the daphnids were found to be immobile at the highest test item concentration of 100 mg/L.
-- After 48 hours 100 % immobilisation was observed at 10.0 mg/L and 100 mg/L test item.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate, tested at 1.00 and 2.00 mg/L with 20 test organisms per test concentration, at around the same time period as the study

Results and discussion

Effect concentrationsopen allclose all
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
0.114 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
0.056 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
see any other information on results
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Test concencentrations: 1 and 2 mg/L (20 organisms per test concentration)
- Relevant effect levels: EC50 (24h) is between 1 and 2 mg/L. The results are in accordance with the requirements of the OECD guideline 202.

Any other information on results incl. tables

Results non-GLP range finding test

After 48h

nominal test concentration (mg/L)
control 1 10 100
group 1 0 0 5 5
group 2 0 0 5 5
group 3 0 1 5 5
group 4 0 0 5 5
sum 0 1 20 20
% 0 5 100 100

Summary of biological results:

a) Results of the test, 24h values

 

nominal test item concentration [mg/L]

 

Control

0.0185

0.0556

0.167

0.500

1.50

immobilised daphnids after 24 h

Group 1

0

0

0

2

2

5

Group 2

0

0

1

1

3

5

Group 3

0

0

0

2

2

5

Group 4

0

0

1

2

5

5

Σ

0

0

2

7

12

20

%

0

0

10

35

60

100

b) Results of the test, 48h values

 

nominal test item concentration [mg/L]

 

Control

0.0185

0.0556

0.167

0.500

1.50

immobilised daphnids after 48 h

Group 1

0

0

0

4

5

5

Group 2

0

0

1

5

5

5

Group 3

0

0

0

4

5

5

Group 4

0

0

1

4

5

5

Σ

0

0

2

17

20

20

%

0

0

10

85

100

100

Determined concentration of test substance:

Test item

Sampling

Test item found

Test item concentration

measured

nominal [mg/L]

[h]

[mg/L]

% of nominal

[mg/L]

Control

0 fresh

< LOD

-

-

48aged

< LOD

-

-

0.0185

0 fresh

0.0187

101

0.0189

48 aged

0.0192

104

0.0556

0 fresh

0.0558

100

0.0556

48 aged

0.0564

101

0.167

0 fresh

0.175

105

0.170

48 aged

0.166

99

0.500

0 fresh

0.528

106

0.515

48 aged

0.498

100

1.50

0 fresh

1.60

107

1.70

48 aged

1.79

119

Effect concentrations:

nominal concentrations measured concentrations
24h 48h 24h 48h
NOEC 0.0556 0.0556 0.0556 0.0556
EC50 0.269 0.102 0.335 0.114
95% confidence limit of EC50 0.186-0395 0.079-0.132 0.225-0.475 0.090-0.139

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 48-hour EC50 for Daphnia magna is 0.114 mg/L (measured, geom. mean).
Executive summary:

The short-term toxicity to Daphnia magna was determined according to OECD 202 guideline with no deviations. The study was conducted under static conditions. The daphnids were exposed over a period of 48 hours to a nominal concentrations of 1.50, 0.500, 0.167, 0.0556 and 0.0185 mg/L and a control. This corresponds to 1.70, 0.515, 0.170, 0.0556, 0.0189 mg/L (geometric mean of measured concentrations).

The validity criteria were fulfilled.

The EC50 value was determined to be 0.114 mg/L (measured, geom. mean) and the NOEC 0.0556 mg/L.