Registration Dossier

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:
From 2018-04-12 to 2018-08-30
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)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, protected from light, original container

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations:
* 0 mg/L of test item (control)
* 100 mg/L of test item

- Sampling method: sampling done at the start of the exposure (0 hours) of the fresh media (control and limit concentration) after preparation of the limit concentration and at the end of the exposure (48 hours) of the old media (control and limit concentration), directly from the test vessels.

- Sample storage conditions before analysis: at 6 +/- 2°C until the start of the analysis, if necessary

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A limit concentration (100 mg/L of the test item were weighed out) was freshly prepared with dilution water prior to the start of the exposure (at 0 hours). The test solution was agitated until it was visually clear.

- Controls: dilution water without test item, incubated under the same conditions as the test groups).

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnid
- Strain/clone: STRAUSS
- Source: Institut für Wasser-, Boden- und Lufthygiene (WaBoLu), 14195 Berlin, Germany
- Age of parental stock (mean and range, SD): less than 24 hours (at test initiation)
- Feeding during test: no
- Acclimation period: No acclimatation period as the daphnids were cultured under the same conditions as the test replicates.


Study design

Test type:
static
Water media type:
other: medium Elendt M4 according to OECD 202, Annex 3 (2004)
Limit test:
yes
Total exposure duration:
48 h

Test conditions

Hardness:
271 mg CaCo3/L (8 hours, in dilution water)
Test temperature:
18 - 22°C ± 1°C
pH:
Fresh media at start of exposure: 7.55 - 7.62 (100 mg/L - control)
Dilution water at start of exposure: 7.62
Dissolved oxygen:
Fresh media at start of exposure: 8.89 mg/L - 9.33 mg/L (100 mg/L - control)
Dilution water at start of exposure: 9.33 mg/L
Old media at end of exposure: .8.33 mg/L - 8.76 mg/L (100 mg/L - control)
Nominal and measured concentrations:
Nominal concentration : 100 mg/L of test item
Measured concentrations at start of exposure: 96.2 %
Measured concentration at end of exposure: 90.6%
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass beakers (4 (ID) x 7 (H) cm), 50 mL capacity
- Type : closed with watch glasses
- Material, size, headspace, fill volume: 50 mL glass beaker, filled at 20 mL
- Aeration: no

- Renewal rate of test solution (frequency/flow rate): no renewal
- No. of organisms per vessel: 5 daphnids
- No. of vessels per concentration (replicates): 4 replicates
- No. of vessels per control (replicates): 4 replicates


OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light, 8 hours darkness
- Light intensity: Diffuse light, maximum of 1500 lx

RANGE-FINDING STUDY
- Test concentrations:
* 0 mg/l of test item (control)
* 1.00 mg/l of test item
* 10.0 mg/l of test item
* 100 mg/l of test item

- Results used to determine the conditions for the definitive study: Immobilization rates were used to determine the conditions for the definitive study
Reference substance (positive control):
yes
Remarks:
potassium dichromate (K2Cr2O7)

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
EC10
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Key result
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC10
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: non observed
- Mortality of control: No mortality observed
Results with reference substance (positive control):
- Results with reference substance valid? yes
- ECx: EC50 at 2.07 mg/L
- Other: 95% confidence limits: 1.22 - 3.66 mg/L
Reported statistics and error estimates:
No statistical analysis was preformed

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
In the limit concentration of 100 mg/L of the test item, no effects on Daphnia magna were observed.
Based on the nominal concentrations of the test item, the 48 hours-EC10 / 50 / 100 for Daphnia magna was > 100 mg/L.

Executive summary:

In the acute immobilization test with Daphnia magna (STRAUS), the effects of the test item were determined at the test facility according to OECD 202 (2004) from 2018-06-12 to 2018-06-14.

A concentration of 100 mg/L was tested in a limit test under static conditions over a period of 48 hours. The limit concentration of 100 mg test item/L was blue and visually clearly dissolved at the start of the exposure, while the control was colourless and visually clear throughout the exposure. After 24 hours and at the end of the exposure interval a slight sedimentation of the test item was observed.

Twenty daphnids, divided into 4 replicates with 5 daphnids each, were exposed to the limit concentration and the control.

The concentrations of the test item were analytically verified via photometric analysis at a wavelength of 662 nm in the fresh media at the start of the exposure (0 hours) and in the old media at the end of the exposure (48 hours) in the limit concentration and in the control.

The measured concentration of the test item in fresh medium at the start of the exposure (0 hours) was 96% of the nominal value of the limit concentration. At the end of the exposure period (48 hours), the measured test item concentration in the old media was 91% of the nominal value of the limit concentration. Since the measured concentration of the test item did remain stable within ± 20% of the nominal concentration throughout the exposure period, the nominal concentration was used for evaluation.

No effects were found at the limit concentration of 100 mg/L of the test item in Elendt M4 medium.

The validity criteria of the test guideline were fulfilled.