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Ecotoxicological information

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:
From February 27 to March 01, 2018
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Qualifier:
according to guideline
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
updated 13th April 2004
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
Samples were taken from the test item treated groups and from the control group, 4 x 1 ml at the start and 4 x 1 ml at the end of the study.
Vehicle:
no
Details on test solutions:
An appropriate amount of test item was dispersed in RO-water in order to obtain the concentration of 10000 mg/l. The dispersions of subsequent lower concentrations were prepared by appropriate diluting of the stock dispersion.
Thereafter, the appropriate amounts of the RO-water stock solutions were dispersed in the dilution water (ISO medium) in order to obtain the concentrations.
Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Sourcen: laboratory of Hydrobiology (Central Agricultural Office, Directorate of Plant-, and Soil Protection).
- Breeding: the Daphnia are bred in the testing laboratory.
- Age of animals: less than 24 h old at the beginning of the test.
- Sex: female.
- Feeding during test: Daphnia will not be fed during the test.
- Animal health: apparently healthy animals will be used in this test with a known history (breeding method, pre-treatment).
- Food and Feeding: the Daphnia are fed with concentrated algal suspension of Raphidocelis subcapitata during the holding.

ACCLIMATION
- Acclimation period: brood daphnids were maintained in dilution water at the test temperature for at least 48 hours prior to the start of the test.
- Acclimation conditions: test animals were bred under similar (or the same) conditions as that used during the exposure period (holding water, temperature, background colour etc.), therefore additional acclimatisation before the test was not necessary.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Test temperature:
20.0 - 21.1 °C
pH:
7.89 - 8.16
Dissolved oxygen:
8.19 – 8.68 mg/l
Nominal and measured concentrations:
Nominal 6.25, 12.5, 25.0, 50.0 and 100.0 mg/l
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beaker; volume app. 50 ml with approx.40 ml control or test solution.
- No. of organisms per vessel: 5 animals.
- No. of vessels per concentration: 4 replicates.
- Biomass loading rate: at least 4 ml test solution/animal.

TEST MEDIUM / WATER PARAMETERS
- Preparation of dilution water: reconstituted water (ISO medium, according to OECD 202).

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light (artificial illumination) and 8 hours darkness.
- Light intensity: 851 lux at the start of the test.

EFFECT PARAMETERS MEASURED
The immobility or mortality of the Daphnia was determined by visual observation after 24 and 48 hours of exposure. Those animals not able to swim within 15 seconds after gentle agitation of the test beaker are considered to be immobile.

RANGE-FINDING STUDY
- Test: in order to select appropriate test concentrations for use in the definitive test, three non-GLP preliminary range-finding tests were conducted.
- No. of organisms per vessel: 10 daphnids (divided into 2 replicates) in each test concentration.
- Exposure period: 48 hours.
- Concentration: 0.1, 1.0, 10 and 100 mg/l.
- Test solutions: first preliminary test test item was dispersed in dilution water (ISO medium) in order to obtain the concentration of 100 mg/l. In the second preliminary test a test item stock solution was prepared first in RO-water, in order to obtain the concentration of 1000 mg/l. In the third preliminary test a test item stock solution was prepared in RO-water, in order to obtain the concentration of 10000 mg/l. In the first and second preliminary tests precipitation was observed (also on the bottom of the vessels), a third experiment was run. In the third pre-test floating precipitations in the water phase and on the bottom of the vessel were observed and this did not cause any phisical effect on daphnid.

VALIDITY OF THE TEST
- The immobilisation rate of the introduced Daphnia must not exceed 10 % in the control group.
- The dissolved oxygen concentration at the end of the test must be ≥ 3 mg/l in control and test vessels.
Reference substance (positive control):
yes
Remarks:
potassium dichromate
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
MAIN STUDY
No immobilization or any abnormal behaviour of test animals was observed in the control group and in the test concentrations of 12.5, 25.0 and 100 mg/l groups after 48 hours of exposure. After 24 and 48 hours in the 6.25 mg/l treated group 5 % immobilization was observed and after 48 hours in the 6.25 and in the 50.0 mg/l groups 5 % immobilization was observed.
After 24 hours precipitation was observed in the test vessels (in each concentration) but the test item concentrations was not influenced by this phenomenon (based on the analytical measurements).

MEASURED CONCENTRATIONS
The measured concentration of the test item in the test solutions was between 92 and 103 % of the nominal value at the start and between 89 and 120 % of the nominal values at the end of the test. There is evidence that the concentrations of the tested substance were maintained within ± 20 % of the nominal concentrations throughout the test. Therefore the analysis of the results was based on the nominal concentrations values.

RANGE-FINDING STUDY
First preliminary test: immobilization of 0, 20, 30 and 40 % at 0.1, 1.0, 10 and 100 mg/l, respectively.
Second preliminary test: immobilization of 0, 0, 10 and 60 % at 0.1, 1.0, 10 and 100 mg/l, respectively.
Third preliminary test: immobilization of 0, 0, 40 and 10 % at 0.1, 1.0, 10 and 100 mg/l, respectively.

Immobilization of the test animals

Nominal concentration [mg/l] Replicate Number of treated animals Number of immobilized animals
24 h 48 h
Control 1 5 0 0
2 5 0 0
3 5 0 0
4 5 0 0
6.25 1 5 0 0
2 5 0 0
3 5 0 0
4 5 1 1
12.5 1 5 0 0
2 5 0 0
3 5 0 0
4 5 0 0
25 1 5 0 0
2 5 0 0
3 5 0 0
4 5 0 0
50 1 5 0 1
2 5 0 0
3 5 0 0
4 5 0 0
100 1 5 0 0
2 5 0 0
3 5 0 0
4 5 0 0

MEASURED CONCENTRATIONS

Nominal Concentration, mg/l Start End
Measured concentrations, mg/l % of the nominal Measured concentrations, mg/l % of the nominal
6.25 5.77 92 5.570 89
12.5 12.47 100 12.57 101
25 25.34 101 26.61 106
50 50.91 102 55.70 111
100 103.2 103 119.9 120

TEST CONDITIONS

Temperatures measured during the experiment

Nominal concentration [mg/l] Replicate Temperature[°C]
0h 48h
Control 1 20.9 20.9
2 20.9
3 21.0
4 21.0
6.25 1 21 21.0
2 21.0
3 20.9
4 21.0
12.5 1 21 21.1
2 20.9
3 20.9
4 21.0
25 1 21.1 21.0
2 21.0
3 20.9
4 21.0
50 1 20 20.9
2 20.9
3 20.9
4 21.0
100 1 20 21.0
2 21.0
3 21.0
4 21.0

Dissolved Oxygen Concentrations measured during the experiment

Nominal concentration [mg/l] Replicate Dissolved Oxygen Concentration [mg/l]
0h 48h
Control 1 8.68 8.33
2 8.22
3 8.19
4 8.25
6.25 1 8.5 8.34
2 8.33
3 8.33
4 8.3
12.5 1 8.46 8.31
2 8.25
3 8.30
4 8.42
25 1 8.45 8.42
2 8.39
3 8.43
4 8.48
50 1 8.45 8.38
2 8.42
3 8.41
4 8.42
100 1 8.41 8.31
2 8.33
3 8.34
4 8.39

pH-values measured during the experiment

Nominal concentration [mg/l] Replicate pH
0h 48h
Control 1 7.89 7.97
2 8.02
3 8.03
4 8.07
6.25 1 7.97 8.08
2 8.09
3 8.10
4 8.07
12.5 1 7.97 8.08
2 8.10
3 8.08
4 8.13
25 1 7.96 8.16
2 8.15
3 8.16
4 8.16
50 1 7.95 8.15
2 8.15
3 8.14
4 8.13
100 1 7.9 8.12
2 8.11
3 8.12
4 8.13
Validity criteria fulfilled:
yes
Remarks:
immobilisation was not observed in the control group and the dissolved oxygen concentration at the end of the test in control and test vessels was in the range of 8.19- 8.48 mg/l
Conclusions:
EC50 (48h) > 100 mg/l (nominal)
Executive summary:

Acute toxicity of the test item was assessed on Daphnia magna in a 48-hour Acute Immobilisation Test. Young Daphnia were exposed to aqueous test media containing the test item for 48 hours in a static test. A full test was performed in which the test animals were exposed to aqueous test media containing the test item for 48 hours at the nominal concentrations of 6.25, 12.5, 25.0, 50.0 and 100.0 mg/l in the test medium plus a control.

The quantification of the test item was performed by a previously validated analytical method. Samples were taken from the test concentrations and from the control at the start and at the end of the test and analysed by HPLC-UV. The measured exposure concentrations were between 92-103 % at the start of the test and between 89-120 % of the nominal at the end of the test therefore, biological results are based on the nominal concentrations.

The immobilisation of the test animals was recorded 24 and 48 hours after test start. Environmental conditions were recorded. All measured values remained within the acceptable ranges.

There was 5 % immobilisation in the test concentrations of 6.25 and 50. 0 mg/l and there was no immobilization in the control group and in the concentrations of 12.5, 25.0 and 100.0 mg/l. In addition to immobility, no abnormal behaviour or appearance of test animals was detected.

Conclusion

EC50 (48h) > 100 mg/l (nominal)

Description of key information

Not harmful/toxic to aquatic invertebrates

Key value for chemical safety assessment

Additional information

Acute toxicity of the test item was assessed o nDaphnia magna in a 48-hour Acute Immobilisation Test, according to the OECD guideline 202. Young Daphnia were exposed to aqueous test media containing the test item for 48 hours in a static test. A full test was performed in which the test animals were exposed to aqueous test media containing the test item for 48 hours at the nominal concentrations of 6.25, 12.5, 25.0, 50.0 and 100.0 mg/l in the test medium plus a control. The quantification of the test item was performed by a previously validated analytical method. The measured exposure concentrations were between 92-103 % at the start of the test and between 89-120 % of the nominal at the end of the test therefore, biological results are based on the nominal concentrations.

There was 5 % immobilisation in the test concentrations of 6.25 and 50. 0 mg/l and there was no immobilization in the control group and in the concentrations of 12.5, 25.0 and 100.0 mg/l. In addition to immobility, no abnormal behaviour or appearance of test animals was detected.