Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study with analytical test item concentration verification

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): L4-Ligand

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
2ml of test solution was taken from each test vessel at the beginning and at the end of the test.

Test solutions

Vehicle:
no
Details on test solutions:
0.5032 g of the test substance was added in 5L test water at the loading rate of 100 mg/L. The mixtures was stirred (via magnetic stirrer) in the dark for 72h at 500rpm followed by filtration using a 0.45 μm nitrocellulose membrane.

Test organisms

Test organisms (species):
other: Gobiocypris rarus
Details on test organisms:
TEST ORGANISM
- Common name: Rare minnow
- Source: bred in Bioassay and Safety Assessment Lab, Shanghai Academy of Public Measurement, China
- Age at study initiation (mean and range, SD): about 4 month
- Length at study initiation (length definition, mean and SD): 2.3 +/- 0.1 cm
- Weight at study end (mean and range, SD): 0.22 +/- 0.03 g
- Fish were fed daily until 24 hours before the test was started

ACCLIMATION
- all fish were acclimatized for more than 14 days
- Conditions equivalent to housing
- Health during acclimation (any mortality observed): no mortality within 7 days before test initiation, no diseases were observed during the acclimation period
- Not medically treated before test

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h

Test conditions

Hardness:
Total hardness: 145 mg CaCO3/L
Dissolved oxygen concentration: >90% of ASV
Test temperature:
23.7 - 24.2 °C
pH:
8.4 - 8.6
Dissolved oxygen:
5.5 - 8.2 mg/L
Nominal and measured concentrations:
Nominal: 100 mg/L loading
Both the LOD2 and LOQ2 were well below the reported water solubility <0.1 mg/L.
Details on test conditions:
TEST SYSTEM
- Test vessel: 5L glass tanks containing 4L test solution
- Loading: about 0.5g fish/litre
- Feeding: none

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water, dechlorinated by activated carbon and sterilized by UV lamp, aerated continuously over 24h.

OTHER TEST CONDITIONS
- Photoperiod: 12 hours light : 12 hours dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :0, 24, 48, 72 and 96 hours after test initiation mortalities, abnormalities, pH , dissolved oxygen and temperature; at test end, body length and body weight of the test fish of the control group were measured.

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Details on results:
Measured concentration of 100 mg/L loading was below LOD2 (39.6 ng/mL). There was no acute toxicity of the saturated solution in the limit test.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
There were no mortalities and abnormalities observed in the fish of the control group and the treatment group during the test.