Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 21-25, 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 203 (Fish, Acute Toxicity 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: cool, dark, well-ventilated space at less than 15 degrees C, with container tightly closed
- Solubility and stability of the test substance in the solvent/vehicle: forms highly viscous solution or gel when mixed with water

Sampling and analysis

Analytical monitoring:
no

Test solutions

Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: About 100 mg of test substance was weighed and added to Cu-reduced dilution water. This solution was stirred for 2 hrs at room temperature. This stock solution served as the highest test concentration.

Test organisms

Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish
- Source: test facility bred
- Length at study initiation (length definition, mean, range and SD): 2.0 +/- 1.0 cm
- Weight at study initiation (mean and range, SD): 0.075 g, 0.069-0.081 g, 0.005 g

ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food during acclimation: live brine shrimp ad libitum
- Feeding frequency during acclimation: daily
- Health during acclimation (any mortality observed): less than 5% the week preceeding the study

FEEDING DURING TEST: No

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h

Test conditions

Hardness:
1.2 mmol/L
Test temperature:
22.8-23.7 degrees C
pH:
8.08-8.46
Dissolved oxygen:
97-104%
Conductivity:
271 uS/cm
Nominal and measured concentrations:
Nominal: 0. 6.25, 12.50, 25.00, 50.00, 100.00 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: full glass aquaria
- Material, size, headspace, fill volume: glass, 3.0 L size, 2.0 L fill volulme
- Aeration: yes
- Renewal rate of test solution (frequency/flow rate): 48 hrs
- No. of organisms per vessel: 7
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
- Biomass loading rate: 0.263 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Cu-reduced dilution water
- Total organic carbon: 0.5321 mg/L
- Metals: 1.2 mmol/L
- Chlorine: < 0.02 mg/L
- Alkalinity: 1.8 mmol/L
- Ca/mg ratio: 1.0/0.2 mmol/L
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12/12


EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality and abnormal behaviour at 24, 48, 72, and 96 hrs

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
- Range finding study: yes
- Test concentrations: 1.0, 10.0, and 100 mg/L
- Results used to determine the conditions for the definitive study: 100% mortality was observed at the 100 mg/L concentration. No effects were seen at the two lower concentrations. Thus the range 0-100 mg/L was suitable.

Results and discussion

Effect concentrations
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
34.77 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
- Behavioural abnormalities: None
- Mortality of control: None

Any other information on results incl. tables

Fish Survival

Concentration (mg/L)

24 hrs

48 hrs

72 hrs

96 hrs

0

7

7

7

7

6.25

7

7

7

7

12.50

7

7

7

7

25.00

7

7

7

7

50.00

0

0

0

0

100.00

0

0

0

0

Applicant's summary and conclusion

Validity criteria fulfilled:
no
Conclusions:
The 96-hr LC50 for fish was 34.77 mg/L.
Executive summary:

The toxicity of the test substance to fish was determined in a OECD Guideline 203 test. Groups of 7 fish were exposed to concentrations of 0. 6.25, 12.50, 25.00, 50.00, and 100.00 mg/L for 96 hrs. Chemical analysis was not done due to difficulties analyzing the test substance. All animals in the 100 mg/L group died within 3 hrs. At the 24 hr observation, all animals in the 50.00 mg/L group had died. No other animals died during the study. The 96-hr LC50 for fish was 34.77 mg/L.