Registration Dossier

Administrative data

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
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)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
no
Details on test solutions:
Test solutions were prepared by directly dissolving appropriate amount of test substance in dilution medium and then facilitating its dispersion by stirring for 30 min.
The test substance amount was calculated based on the purity of test substance (94.8%) converted into 100% active ingredient.
Fish to be used in the test were held for at least 7 days in water of the quality and temperature to be used in the test.

Test organisms

Test organisms (species):
other: Gobiocypris rarus
Details on test organisms:
The test species of Rare minnow, Gobiocypris rarus were bred by the test institute. A population of a single stock was used in the test.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Post exposure observation period:
no

Test conditions

Hardness:
156 - 165 mg (CaCO3)/L
Test temperature:
23.0 - 23.1 °C
pH:
7.68 - 7.77
Dissolved oxygen:
77 % to 95 % of the air saturation; No aeration
Nominal and measured concentrations:
nominal: 100 mg/L
measured: 104 m g/L
Details on test conditions:
TEST SYSTEM
- Test vessel: volume 3 L
- Aeration: no
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 3
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): 1
Reference substance (positive control):
yes

Results and discussion

Effect concentrations
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
100 ng/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Results with reference substance (positive control):
Potassium dichromate LC50 24 hours: 282 mg/L

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The LC50 of the test item is greater than 100 mg/L
Executive summary:

Under static conditions,the acute toxicity ofthetest substanceofSanolin Lave Blue A dry to Rare minnow (Gobiocypris rarus)was conductedaccording to:“The guidelines for the testing of chemicals” (HJ/T 153-2004),“The Guidelines for the Testing of Chemicals, Effects on Biotoc Systems”(the 2nd edition)(2013); and with reference to Procedure 203 of theGuidelines for Testing of Chemicalsof the OECD:Fish, Acute Toxicity Test” (1992).

A range-finding test and then a limit test were performed respectively. Nominal concentrations of 1.0, 10.0 and 100mg/Lwere used in the range-finding test, while the nominal concentration of100mg/L was used in the limit test. Water samples taken from the control and the treatments in the limit test were analysed.The mean of the measured concentrations was 104 mg/L,ranging from 101 mg/L to 108 mg/L during the test period. The analytical results showed that the measured concentration of the test substance was consistent in the test medium throughout the 96-hour test period (deviation within 20%). Thus a static procedure was reasonable.

Five fish per treatment with no replication were tested in the range-finding test while three replicates of seven fish each were tested in the control and limit concentration of the limit test.The test fishes were exposed for 96 hours to the test solution.

During thetestperiod, the pH valuesof the control mediums and test mediums were between 7.68 and 7.77, the Dissolved Oxygen (DO) values varied from 77 % to 95 % of the air saturationat the test temperature; the total hardness was in the range of 156 mg (CaCO3)/L to 165 mg (CaCO3)/L; the temperature of the test mediums was maintained in the range of 23.0 ºC to 23.1 ºC and all fishes in the control group were normal. With the same conditions, K2Cr2O7was used as the positive control substance, and the resulting 24 h-LC50was 282mg/L.So the study met the acceptability criteria prescribed by the protocol and Test Guidelines (The mortality of control ≤ 10%; pH:6.0~8.5; dissolved oxygen concentration: >60% of the air saturation value; temperature: (23±2) ºC;24 h-LC50ofK2Cr2O7in the range of 200mg/L to 400 mg/L). Thus the test was considered valid.

During the test period, all fish in the control groups and treated groupswere alive and appeared normal. The results showed that undervalidstatic conditions, the 96 h-LC50of test substanceto fish (Rare minnow,Gobiocypris rarus)was greater than the nominal concentration of 100mg/L(measured concentration 104 mg/L), while the maximum concentration causing no mortality (96 h-LC0) was equal to the nominal concentration of 100mg/L(measured concentration 104 mg/L). i.e.:

96 h-LC50>100mg/L(measured concentration104 mg/L);

96 h-LC0=100mg/L (measured concentration 104 mg/L).