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Ecotoxicological information

Short-term toxicity to fish

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Link to relevant study record(s)

Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
July 3, 2019 to October 4, 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
version 1992
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Certificate dated 22 November 2017
Analytical monitoring:
yes
Details on sampling:
In order to verify the nominal and initial concentrations of the test item and maintenance of the concentrations during the ecotoxicological testing, chemical analysis in fish test solutions were performed according to the Analytical protocol FCBA Chimie n° 443-e version 2: Method for the chemical analysis of Molybdenum contained in the test item from fish ecotoxicology solutions by ICP/OES and the following protocol:
- at the beginnig of the test (T = 0h)
- at the end of the test (T = 96 h).
All the solutions (T0h) were analysed taken directly from the starting solutions without fish.
The final time was T2h instead of T96h for the concentration 100 mg/L because all the fish were dead after 2 hours of exposition.
T96h were measured for the control, 10 mg/L and 32 mg/L concentrations.
If the analyses were not carried out on time, the solutions were kept in refrigerator or freeze.
The measured concentraitons did not vary more than +/- 20% of nominal or initial measured concentration during the test.
Vehicle:
no
Details on test solutions:
According to the sponsor, the test item is poorly soluble in water. The dilution water was the fish test medium, a weakly saline adueous medium:
CaCl2, 2H2O = 294.0 mg/L
MgSO4, 7H2O = 123.2 mg/L
NaHCO3 = 63.0 mg/L
KCl = 5.5 mg/L
A solubilisation protocol was carried out before the experimentation. This method consisted in stirring each test item nominal concentration in the test medium during 24 hours at 20 +/- 2°C in the dark. The test solution was then filtered through a membrane filter (cellulose acetate filter, porosity size 0.45 µm): solutions obtained are named WAF (Water Accomodated Fraction).
Five concentrations (determined from a non-GLP preliminary test in a geometric serie was performed plus a control (test medium).
Based on the results of this preliminary test, the following test concentrations 10 - 18 - 32 - 58 and 100 mg test item/L were proposed for the definitive test.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
Danio rerio (Hamilton Buchanan) commonly named Zebra fish, of a length of 25 to 30 mm, free from any apparent malformations and diseases.
Every batch of fish received in the laboratory were held in the dilution water for a minimum time period of 12 days before testing.
Test type:
static
Water media type:
other: reconstituted test water
Remarks:
ISO medium
Limit test:
no
Total exposure duration:
96 h
Post exposure observation period:
The dead fish were reported every 24 hours, and removed as soon as possible. Fish is considered fdead if there is no visivble movement (e.g. gill movement) and if touching of the cuadal peduncle produces no reaction.
The visible abnormalities (loss of equilibrium, swimming behavior, respiratory function, pigmentation, etc...) were reported if need be. Observation at hree or six hours after the start of the test was done and checked if need be.
Temperature, pH and dissolved oxygen were measured every 24 hours in each aquarium during test duration.
Hardness:
CaCO3: 250 mg/L
Test temperature:
22.5 to 23.1°C
pH:
7.9
Dissolved oxygen:
9.1 mg/L
Nominal and measured concentrations:
10, 18, 32, 58 and 100 mg/L
Details on test conditions:
Light/dark cycle: 16h/8h
Reference substance (positive control):
yes
Remarks:
Potassium dichromate
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 58 - < 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
The results obtained for the test item on the toxicological endpoint 'mortality' give an LC50 (96h) between 58 and 100 mg/L, values expressed in nominal test item concentration.
All validity criteria were successful:
- Control mortality: 0 (validity ≤ 1 fish)
- Conditions: 22.8 - 23.5°C (validity: constant)
- Dissolved oxygen concentration: 91% (validity:> 60%)
- Concentrations maintaining: 1.6 to 2.2% (validity: +/- 20%)
Results with reference substance (positive control):
The toxic response obtained on the reference item K2Cr2O7 for the fish batch number 140519 gives an LC50 (24h) of 213.1 mg/L [185.0-249.5] in accordance with historical data obtained by the laboratory.
Sublethal observations / clinical signs:

Fish lethality:

 Nominal test item

concentrations

(mg/L)

 Number of fish

exposed at the start

Cumulative number of dead fish

at each observation time (%)          

     24h 48h  72h   96h
 Control  0 (0%)   0 (0%)  0 (0%)   0 (0%) 
 WAF 10  8  0 (0%)    0 (0%)   0 (0%)  0 (0%) 
 WAF 18  8   0 (0%)   0 (0%)  0 (0%)   0 (0%) 
 WAF 32  8  0 (0%)    0 (0%)  0 (0%)   0 (0%) 
 WAF 58  8   0 (0%)  0 (0%)    0 (0%)  0 (0%) 
 WAF 100  8  8 (100%)   8 (100%)   8 (100%)   8 (100%)
Validity criteria fulfilled:
yes
Conclusions:
The results obtained for the test item on the toxicological endpoint 'mortality' give an LC50 (96h) between 58 and 100 mg/L, values expressed in nominal test item concentration.

Description of key information

The results obtained for the test item in the experimental conditions of an OECD 203 test give an LC50 (96h) between 58 and 100 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
58 mg/L

Additional information