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
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: flakes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Mitsubishi-Chemical Food Corporation; 63281211
- Expiration date of the lot/batch: March 27, 2018
- Purity test date: May 30, 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
- Solubility and stability of the test substance in the solvent/vehicle: forms viscous solution or gel with water

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations: all
- Sample storage conditions before analysis: -25 degrees C

Test solutions

Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test solutions were prepared by adding 100.5 mg of test substance to 1 L dilution water. After 24 hrs, 100.3 mg test substance was added to an additional 1 L of dilution water. This was ultrasonicated fro 2 hrs, and stirred for 72 hrs at room temperature. It was then filtered through a 0.22 um PES bottle top filter. This stock concentration was used as the hightest test concentration, and was diluted for the further tests.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Justification for species other than prescribed by test guideline:
- 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: 1 week
- 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: Separated by sieving and transported 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

Test temperature:
18-22 degrees C
pH:
7.13-8.19
Dissolved oxygen:
7.3-9.2 mg/L
Nominal and measured concentrations:
Nominal: 0, 6.25, 12.5, 25.0, 50.0, and 100 mg/L (due to difficulties analyzing the test substance, only nominal concentrations were reported)
Details on test conditions:
TEST SYSTEM
- Test vessel: glass beakers
- Type (delete if not applicable): closed by covering with glass panes
- Material, size, headspace, fill volume: glass, 50 mL fill volume
- Aeration: No, glass panes over the top of the vessel
- Renewal rate of test solution (frequency/flow rate): one renewal at 24 hrs
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4


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


OTHER TEST CONDITIONS
- Photoperiod: 16 hrs light/8 hrs dark
- Light intensity: 807-813 lx

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): immobility daily


RANGE-FINDING STUDY
- Test concentrations: First study - 1.0, 10.0, and 100 mg/L; second study - 0.1, 1.0, and 10 mg/L
- Results used to determine the conditions for the definitive study: In the first range-finding study, 45% of the daphnids in the 1.0 mg/L concentration died, but only 10% of daphnids at the higher concentrations died. In the second range-finding study, no daphnids died, thus it was decided that in the first range-finding study either the test solutions were improperly made, or the daphnids were not in good condition at the start of the test. The decision was then made to test at the higher concentrations in the first test.

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: only one daphnid in the 100 mg/L test concentration was immobilized
- Other biological observations: no significant signs of disease or stress were noted
- Mortality of control: 0

Any other information on results incl. tables

Immobilization of Daphnids after 48 hrs Exposure

Concentration (mg/L)

Total Daphnids

Mobile

Immobile

% Immobility

0

20

20

0

0

6.25

20

20

0

0

12.5

20

20

0

0

25.0

20

20

0

0

50.0

20

20

0

0

100.0

20

19

1

5

 

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 48-hr LOEC for Daphnia magna was > 100 mg/L.
Executive summary:

The toxicity of the test substance to aquatic invertebrates was determined in an OECD Guideline 202 study. 20 daphnids (5 animals x 4 replicates) were exposed to concentrations of 0, 6.25, 12.5, 25.0, 50.0, and 100 mg/L for 48 hrs. Only one daphnid in the 100 mg/L group died. Due to difficulties with analysis of the test substance, only nominal concentrations were reported. The LOEC was > 100 mg/L.