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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
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
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:
The range-finding test: nominal test concentrations of 1.0, 10 and 100% v/v saturated solution
The definitive test: 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
- Type (delete if not applicable): closed
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 7
- No. of vessels per control (replicates): 7

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 (fish)
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 (fish)
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 (96 hours):

LC50 : >100 % v/v Saturated Solution

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

Key value for chemical safety assessment

Additional information

A determination of the acute toxicity to freshwater fish rainbow trout (Oncorhynchus mykiss) of DAILUBE IS-30 was conducted (Envigo Research Limited, 2017, Study GX63MM). The study was performed in accordance with EC method C.1 and OECD test guideline 203, and in compliance with GLP.

Preliminary solubility work conducted indicated that it was not possible to obtain a testable solution of the test item using traditional methods of preparation. Group of 7 rainbow trout were exposed to 100% v/v saturated solution of DAILUBE IS-30 for 96 hours.

This study showed that there were no toxic effects and there were no sub-lethal effects of exposure observed in 7 fish exposed to a test concentration of 100% v/v saturated solution.

It was concluded that the 96-Hour LC50 in Rainbow trout was of greater than 100% v/v saturated solution. The No Observed Effect Concentration was concluded to 100% v/v saturated solution.