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:
August 23-25, 2017
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)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: granular
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Mitsubishi-Chemical Foods Corporation; 6912911B
- Expiration date of the lot/batch: September 11, 2018
- Purity test date: June 27, 2017

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: below 15 degrees C in a cool, dark, well-ventilated space with container tightly closed

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 200 mg of test substance was added to 2 L of dilution water. This was stirred for 2 hrs at room temperature. Another stock solution was prepared for renewal at 24 hrs in a similar manner. The stock solution served as the highest concentration. Additional test concentration were prepared by successive dilutions of the stock solution.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Source: German Federal Environmental Agency, Institut fur Wasser-, Boden- und Lufthygiene
- Age of parental stock (mean and range, SD): 3 weeks
- Feeding during test: No


ACCLIMATION
- Acclimation period: 4-24 hrs
- Acclimation conditions (same as test or not): yes
- Type and amount of food: algal suspension and ArtemioFluid
- Feeding frequency: daily


METHOD FOR PREPARATION AND COLLECTION OF EARLY INSTARS OR OTHER LIFE STAGES: newborns were seperated by sieving and transferred with a bore Pasteur pipette

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h

Test conditions

Hardness:
140-250 mg/L CaCO3
Test temperature:
20.8 degrees C
pH:
7.62-8.34
Dissolved oxygen:
3-9 mg/L
Nominal and measured concentrations:
Nominal: 0, 6.25, 12.5, 25.0, 50.0, 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beakers
- Type (delete if not applicable): open - covered with glass panes to prevent evaporation but allow gas exchange
- Material, size, headspace, fill volume: glass, 50 mL fill volume
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): 24 hrs
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 5
- No. of vessels per vehicle control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: purified drinking water, Cu-reduced


OTHER TEST CONDITIONS
- Photoperiod: 16 hrs light/8 hrs dark
- Light intensity: 814-823 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): immobilization, 0, 24, and 48 hrs


RANGE-FINDING STUDY
- Test concentrations: 1.0, 10.0, 100 mg/L
- Results used to determine the conditions for the definitive study: In both the 1.0 and 10.0 mg/L concentrations, one daphnid died. At the 100 mg/L concentration, two daphnids died. As the observed effects were not statistically significant, a test range of 0-100 mg/L was considered appropriate.
Reference substance (positive control):
yes
Remarks:
Test sensitivity of the test organism is regularly tested using K2Cr2O7.

Results and discussion

Effect concentrations
Key result
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Details on results:
- Behavioural abnormalities: one daphnid in the 100 mg/L concentration was immobilized
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Relevant effect levels: 5% immobilization at 0.90 mg/L, 50% immobilization at 1.35 mg/L, 75% immobilization at 2.00 mg/L
- Limit test: no
- Dose-response test: yes
- ECx: EC50 = 1.435 mg/L
Reported statistics and error estimates:
No statistics were calculated as the LC50 could not be calculated.

Any other information on results incl. tables

Daphnid Immobilization

Concentration (mg/L)

Total Daphnids

Mobile

Immobile

% Immobility

0

20

20

0

0.0

6.25

20

20

0

0.0

12.5

20

20

0

0.0

25.0

20

20

0

0.0

50.0

20

20

0

0.0

100

20

19

1

5.0

 

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 48-hr LC50 > 100 mg/L.
Executive summary:

The toxicity of the test substance to aquatic invertebrates was determined in an OECD Guideline 202 test. Daphnids were exposed to test concentrations of 0, 6.25, 12.5, 25.0, 50.0, and 100 mg/L, with renewal at 24 hrs. Due to difficulties in analyzing the test substance, analytical concentrations were not determined. Rather, nominal concentrations were reported. Only one daphnid was immobilized at the 100 mg/L concentration. At all other concentrations, no daphnids showed immobility. The LC50 > 100 mg/L.