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Ecotoxicological information

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:
Nov 08, 2018 - Jan 16, 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
yes
Details on sampling:
The samples were taken from the biological phase of the study. Collecting, storage and handing over of the samples were the Study Director’s responsibility. The information concerning the samples was provided by the Study Director.
At least duplicate samples from the freshly prepared test media of all test concentrations and the control were taken at the start of the test and at each test medium renewal.
For the determination of the stability of the test item under the test conditions and the maintenance of the test item concentrations during the test period, respectively, at least duplicate samples were taken from all aged test media of all treatment groups at each test medium renewal and at the end of the test.
All samples were taken from the approximate centre of the aquaria.
The samples were diluted by a factor of two with acetonitrile.
Additional samples of the control and of the dilution solvent were taken at each sampling without any sample treatment.
Vehicle:
no
Details on test solutions:
Reconstituted Water
(ISO Medium):
In deionised water (conductivity <= 10 µScm-1) analytical grade salts were added to following nominal concentrations:
CaCl2 x 2H2O : 2.0 mmol/L (= 294.0 mg/L)
MgSO4 x 7H2O: 0.5 mmol/L (= 123.0 mg/L)
NaHCO3 : 0.75 mmol/L (= 65.0 mg/L)
KCl : 0.075 mmol/L (= 5.8 mg/L)

Water Hardness : 2.5 mmol/L (= 250.0 mg/L) as CaCO3
Alkalinity : 0.8 mmol/L
Ratio of Ca : Mg = 4 : 1 (based on molarity)
Na : K = 10 : 1 (based on molarity)
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Strain: Oncorhynchus mykiss
- Source: Forellenzuchtbetrieb Störk, 88348 Bad Saulgau, Germany
- Age at study initiation (mean and range, SD): juvenile
- Length at study initiation (length definition, mean, range and SD): 4.75 +/- 0.48 cm
- Weight at study initiation (mean and range, SD): 1.20 +/- 0.36 g
- Method of breeding: laboratory standard
- Maintenance of the brood fish: 12 days under test conditions

ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions (same as test or not): same
- Type and amount of food during acclimation: ca. 2% of body weight - Inicio Plus G 0.6 mm
- Feeding frequency during acclimation: three times per week or daily until 24 hours before the test was started
- Health during acclimation (any mortality observed): no


FEEDING DURING TEST
- Food type: --
- Amount: --
- Frequency: --
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
250 mg/L
Test temperature:
14 - 15 °C
pH:
7.4 - 7.9
Dissolved oxygen:
87 to 101 %
Nominal and measured concentrations:
Due to the low limit of water solubility of the test item, a filtrate of nominal 100 mg/L and dilutions of 1:2, 1:4, 1:8 and 1:16 of this filtrate resulting in nominal concentrations of 50.0, 25.0, 12.5 and 6.25 mg test item/L were tested. Additionally, a control was tested in parallel. In this study, nominal concentrations are equivalent to nominal loading rates. Thus, in the following, test item concentrations will be reported as nominal loading rates.
The quantification of the test item in the test samples was performed using liquid chromatography with fluorescence detection.
The analytical results showed about 126 µg test item/L in the freshly prepared test samples of day 3, the last test medium renewal. The results of the other freshly prepared samples of the test showed less to no test item.
Further the results show that the test item concentration decreased during the 24 hours in each renewal period.
Reference substance (positive control):
not required
Key result
Duration:
96 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: filtrate of nominal loading rate
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: filtrate of nominal loading rate
Details on results:
- Behavioural abnormalities: no
- Observations on body length and weight:no
- Other biological observations: no
- Mortality of control: no
- Other adverse effects control: no
- Abnormal responses: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no
- Effect concentrations exceeding solubility of substance in test medium: no

Observed Mortality of unfed Rainbow Trout (Oncorhynchus mykiss) exposed to the test item filtrate for 96 hours

Nominal Loading Rate / [mg/L]
Mortality
0 h
2 h
24 h
48 h
72 h
96 h






Control
0
0
0
0
0
0
6.25
0
0
0
0
0
0
12.5
0
0
0
0
0
0
25
0
0
0
0
0
0
50
0
0
0
0
0
0
100
0
0
0
0
0
0







LC50 / [mg/L]
> 100
> 100
> 100
> 100
> 100
> 100
95 % Cl
n.d. n.d. n.d. n.d. n.d. n.d.




Validity criteria fulfilled:
yes
Conclusions:
The toxic effect of the test item to Rainbow Trout (Oncorhynchus mykiss) was assessed in a semi-static concentration-response test. Based on the test results the 96-hour LC50 was determined to be >100 mg test item/L based on nominal loading rates. The NOEC was determined to be ≥ 100 mg/L mg test item/L also based on nominal loading rates.

Description of key information

GLP compliant OECD 203 Study: EC50 > 100 mg/L (nominal loading rate)

Key value for chemical safety assessment

Additional information