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Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
This study was conducted between 01 August 2016 and 18 August 2016
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:
1992
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
Ec No. 440/2008
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
Water samples were taken from the control and 62 mg/L test vessel at 0 and 72 hours from fresh media and at 24 and 96 hours from old media for quantitative analysis. The samples were stored frozen prior to analysis.
Duplicate samples and samples at 24 (fresh media), 48 (old and fresh media) and 72 hours (old media) were taken and stored frozen for further analysis if necessary
Vehicle:
no
Details on test solutions:
A nominal amount of test item (1550 mg) was dissolved in test water and the volume adjusted to 500 mL to give the 3100 mg/L stock solution, from which a dilution was made to give the test concentration of 62 mg/L.
The stock solution was inverted several times and the test concentration was stirred with a flat bladed mixer for approximately 1 minute, to ensure adequate mixing and homogeneity.
The concentration and stability of the test item in the test preparations were verified by chemical analysis at 0, 24, 72 and 96 hours
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow Trout
- Strain: Not applicable
- Source: Brow Well Fisheries Limited, Hebden, near Skipton, Yorkshire, UK
- Age at study initiation (mean and range, SD): Juvenile
- Length at study initiation (length definition, mean, range and SD): 5.4 cm (sd=0.2)
- Weight at study initiation (mean and range, SD): 1.3 g (sd=0.2)
- Method of breeding: Not reported
- Maintenance of the brood fish: not reported

ACCLIMATION
- Acclimation period: 7 days
- Acclimation conditions (same as test or not): test conditions
- Type and amount of food during acclimation: commercial trout pellets
- Feeding frequency during acclimation: not reported
- Health during acclimation (any mortality observed): good, 1 mortality

Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Remarks on exposure duration:
photoperiod of 16 hours light and 8 hours darkness with 20 minute dawn and dusk transition periods for a period of 96 hours.
Post exposure observation period:
none
Hardness:
140 mg/L as CaCO3
Test temperature:
14”C
pH:
7.8 - 9.0
Dissolved oxygen:
8.7 mg O2/L
Salinity:
not applicable
Conductivity:
Not reported
Nominal and measured concentrations:
Analysis of the test preparations at 0, 24, 72 and 96 hours showed measured test concentrations to be near nominal and so it was considered justifiable to estimate the LC50 value in terms of the nominal test concentration only.
Details on test conditions:
Experimental Design and Study Conduct

Definitive Test
In accordance with the recommendations of REACh, the test was conducted according to the threshold approach recommended by ECHA. Using this approach the lowest EC50 value from either the Algal Growth Inhibition study or Acute Toxicity to Daphnia magna study is set as the threshold concentration and a “Limit test” is conducted at this threshold concentration. If no mortalities are observed this indicates that fish are not the most sensitive species and that the LC50 is greater than the threshold concentration. The EC50 value obtained from the Algal Growth Inhibition study (Envigo Study Number LX80SB) was the lower of these two EC50 values and hence the test was conducted at a single concentration of 62 mg/L.

Experimental Preparation
A nominal amount of test item (1550 mg) was dissolved in test water and the volume adjusted to 500 mL to give the 3100 mg/L stock solution, from which a dilution was made to give the test concentration of 62 mg/L.
The stock solution was inverted several times and the test concentration was stirred with a flat bladed mixer for approximately 1 minute, to ensure adequate mixing and homogeneity.
The concentration and stability of the test item in the test preparations were verified by chemical analysis at 0, 24, 72 and 96 hours.

Exposure Conditions
In the definitive test, 25 to 30 liter glass exposure vessels containing 20 liters of test media were used for each control and test concentration. At the start of the test seven fish were placed in each test vessel at random, in the test preparations. The test vessels were then covered to reduce evaporation and maintained at 14”C in a temperature controlled room with a photoperiod of 16 hours light and 8 hours darkness with 20 minute dawn and dusk transition periods for a period of 96 hours. The test vessels were aerated via narrow bore glass tubes. The fish were not individually identified and received no food during exposure.
The control group was maintained under identical conditions but not exposed to the test item.
A semi-static test regime was employed in the test involving a daily renewal of the test preparations to prevent the build up of nitrogenous waste products.
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 62 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
>= 62 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
Definitive Test

Verification of Test Concentrations
Analysis of the test preparations at 0, 24, 72 and 96 hours showed measured test concentrations to be near nominal and so it was considered justifiable to estimate the LC50 value in terms of the nominal test concentration only.

Mortality Data

There were no mortalities in 7 fish exposed to a test concentration of 62 mg/L for a period of 96 hours. Inspection of the mortality data gave the following results:

Time (h) LC50 (mg/L)
96 >62

Sub-Lethal Effects
There were no sub-lethal effects of exposure observed in 7 fish exposed to a test concentration of 62 mg/L for a period of 96 hours.

Validation Criteria
The test was considered to be valid given that none of the control fish died or showed signs of stress during the test and that the oxygen concentration at the end of the test was equal to or greater than 60% of ASV (6.1 mg O2/L) in the control and test vessels.

Water Quality Criteria
Temperature was maintained at 14”C throughout the test. While there were no treatment related differences for oxygen concentration, the pH in the test concentration was significantly higher than that of the control.

Observations on Test Item Solubility
At the start and throughout the test the control and 62 mg/L test concentration were observed to be clear colorless solutions.
Results with reference substance (positive control):
Not applicable
Reported statistics and error estimates:
Not applicable
Validity criteria fulfilled:
yes
Conclusions:
The acute toxicity of the test item to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated and based on the nominal test concentrations gave a 96-Hour LC50 of greater than 62 mg/L. The No Observed Effect Concentration was 62 mg/L.
Executive summary:

A study was performed to assess the acute toxicity of the test item to rainbow trout (Oncorhynchus mykiss).  The method followed was designed to be compatible with the OECD Guidelines for Testing of Chemicals (1992) No 203, "Fish, Acute Toxicity Test" referenced as Method C.1 of Commission Regulation (EC) No. 440/2008.

Methods

In accordance with the recommendations of REACh, the test was conducted according to the threshold approach recommended by ECHA.  Using this approach the lowest EC50 value from either the Algal Growth Inhibition study or Acute Toxicity to Daphnia magna study is set as the threshold concentration and a “Limit test” is conducted at this threshold concentration.  If no mortalities are observed this indicates that fish are not the most sensitive species and that the LC50 is greater than the threshold concentration. The EC50 value obtained from the Algal Growth Inhibition study (Envigo Study Number LX80SB) was the lower of these two EC50 values and hence the test was conducted at a single concentration of 62 mg/L.

Seven fish were exposed to an aqueous solution of the test item, at a single concentration of 62 mg/L for a period of 96 hours at a temperature of 14 C under semi-static test conditions.  The number of mortalities and any sub-lethal effects of exposure in each test and control vessel were determined 1, 3 and 6 hours after the start of exposure and then daily throughout the test until termination after 96 hours.

Results

Analysis of the test preparations at 0, 24, 72 and 96 hours showed measured test concentrations to be near nominal and so the results are based on nominal test concentrations only.

Exposure of rainbow trout (Oncorhynchus mykiss) to the test item gave LC50 values of greater than 62 mg/L. The No Observed Effect Concentration was 62 mg/L.

Description of key information

The acute toxicity of Aradur 1019 to fish was determined according to OECD test guideline 203.

The results is reported to be LC50 (96h) > 62 mg/l

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
62 mg/L

Additional information