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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:
19 February 2017 - 22 March 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Version / remarks:
The study plan states that the density of the test item is 0.965 g/cm3, however, this value
should be 0.967 g/cm3.
Deviations:
yes
Remarks:
This deviation was considered to have not affected the integrity or validity of the study.
Qualifier:
according to
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Version / remarks:
The study plan states that the density of the test item is 0.965 g/cm3, however, this value
should be 0.967 g/cm3.
Deviations:
yes
Remarks:
This deviation was considered to have not affected the integrity or validity of the study.
GLP compliance:
yes (incl. certificate)
Specific details on test material used for the study:
Physical state/Appearance: Pale Yellow Liquid
Batch: L003
Purity: 95.5% by weight
Solubility: Insoluble in water; soluble in acetone, ethanol and
tetrahydrofuran
Density: 0.967 g/cm3
Expiry Date: 11 January 2018
Storage Conditions: Room temperature in the dark
Analytical monitoring:
yes
Details on sampling:
The test samples were thawed with the aid of a water bath. The test sample was quantitatively transferred to 500 mL volumetric, test medium and acetonitrile added, and then made to volume with propan-2-ol.
Vehicle:
no
Details on test solutions:
Due to the poorly water soluble nature of the test item, for the purposes of testing, the test media was prepared as a saturated solution based on the results of a preliminary media preparation trial conducted during a previous study.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: rainbow trout
- Length at study initiation (length definition, mean, range and SD): 5.5 cm (sd = 0.26)
- Weight at study initiation (mean and range, SD): 1.2 g (sd = 0.22)

ACCLIMATION
- Acclimation period: 7 days
- Food type: trout pellets
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
140 mg/L as CaCO3
Test temperature:
14 ºC - 16 °C
pH:
7.9 - 8.2
Dissolved oxygen:
9.1 - 11.3 mg O2/L
Nominal and measured concentrations:
Nominal concentration: 100% v/v saturated solution
Details on test conditions:
TEST SYSTEM
- Test vessel: 25-30 liter glass exposure vessels
- Aeration: aerated via narrow bore glass tubes

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 1.0, 10 and 100% v/v saturated solution
- Results used to determine the conditions for the definitive study: to confirm that at the highest attainable test concentration, no mortalities or sub-lethal effects of exposure were observed.
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 other: % v/v Saturated Solution
Nominal / measured:
nominal
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mortality
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 other: % v/v Saturated Solution
Nominal / measured:
nominal
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mortality
Details on results:
There were no sub-lethal effects of exposure observed in 7 fish exposed to a test concentration of 100% v/v saturated solution for a period of 96 hours.
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 100% v/v saturated solution. The No Observed Effect Concentration was
100% v/v saturated solution.
This study showed that there were no toxic effects at saturation.

Description of key information

Acute Toxicity to Fish:

LC50 : >100 % v/v Saturated Solution

No Observed Effect Concentration (NOEC): 100% v/v saturated solution.

Key value for chemical safety assessment

LC50 for freshwater fish:
100

Additional information