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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:
2016/07/26-2017/12/11
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

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
Details on test material:
- Batch: 16021485
- Purity: 95.9%
- Colour: solid/greyish
- Expiry date: 2017-10-21
- Storage conditions: ambient (5-30 °C), dark, dry
Specific details on test material used for the study:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
-The test item has a low water solubility, therefore, the test item was applied as water accommodated fraction (WAF).
The WAF was used as application solution (~ 50 mL of the prepared solution was transferred to each test vessel).

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Sampling method: analytical samples taken at 0 hours (initial value) and 48 hours from aged test solutions were analysed from control and test item loading rate. Analyses on sampling point 24h were made but not reported on the Result Tables.
- Fortified samples: a stock solution (2000 mg/L, purity not considered) was prepared in acetonitrile. A dilution (10 mg/L) was prepared in acetonitrile. The stock solution and the 10 mg/L dilution was used for fortification of 0.03 mg/L and 60 mg/L recovery samples.
- Sample storage (before test): stored deep-frozen until analysis

Test solutions

Vehicle:
no

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:
other: Elendt M4
Limit test:
yes
Total exposure duration:
48 h

Test conditions

Hardness:
232 mg/L CaCO3
Test temperature:
20.0 – 21.8 °C
pH:
7.61 – 7.91
Dissolved oxygen:
≥ 8.4 mg/L
Nominal and measured concentrations:
Nominal concentration: 100 mg/L and a control
Measured concentration (geometric mean based): 4.31 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: 2 (1 dose rate 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, 1 and 0.1 mg/L
- Sampling points : after 24h and 48h of exposure
- Results used to determine the conditions for the definitive study:
-After 24 hours of exposure no immobilisation above the allowed control immobilisation was observed in the control and up to and including 100 mg/L.
-After 48 hours of exposure no immobilisation was observed in the control and up to and including 10.0 mg/L. 15 % immobilisation was observed at the highest test item loading rate of 100 mg/L.
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.:
> 4.31 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
NOEC
Effect conc.:
>= 4.31 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
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 below 1 mg/L. The results are in accordance with the requirements of the OECD guideline 202.

Any other information on results incl. tables

Summary of biological results:

a) Results of the test, 24h values

Nominal test item loading rate [mg/L]

Control

100

immobilised daphnids after 24 h

Group 1

0

0

Group 2

0

0

Group 3

0

0

Group 4

0

0

Σ

0

0

%

0

0

b) Results of the test, 48h values

Nominal item loading rate [mg/L]

Control

100

immobilised daphnids after 48 h

Group 1

0

0

Group 2

0

0

Group 3

0

0

Group 4

0

0

Σ

0

0

%

0

0

Determined concentration of test substance:

Test item loading rate

Test item

Sampling

Test item found

Test item concentration

nominal [mg/L]

Nominal
 [mg a.i./L]

[h]

[mg/L]

% of nominal

actual [mg/L]

Control

0

0 fresh

n.d.

-

-

24 aged

n.d.

-

48 aged

n.d.

-

100

100

0 fresh

33.2

33

4.31

24 aged

0.668

0.668

48 aged

0.456

0.456

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 48-hour EC50 for Daphnia magna is > 4.31 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, and it was a limit test. The daphnids were exposed over a period of 48 hours to a nominal concentration of 100 mg/L and a control. The measured concentration is 4.31 mg/L and for the control it was not determined.

The validity criteria were fulfilled.

The EC50 value was determined to be > 4.31 mg/L (measured, geom. mean).