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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:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From February 23, 1996 to April 05, 1996
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Read across study
Remarks:
No analytical dose verification
Justification for type of information:
Refer to the section 13 for details on the read across justification.
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Analytical monitoring:
no
Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Solvent control: 100 µL/L Tetrahydrofuran
- Chemical name of vehicle (organic solvent): Tetrahydrofuran
- Concentration of vehicle in test medium (stock solution): 30 mg/mL
- Preparation of test solution: Test material (300 mg) was dissolved in 10 mL (final volume) of tetrahydrofuran to give the solvent stock solution from which an aliquot (2.0 mL) was dispersed in 20 L (final volume) of dechlorinated tap water to give the test concentration of 3.0 mg/L.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow trout
- Source: Donnington Fish Farm, Upper Swell, Gloucestershire, UK
- Age at study initiation (mean and range, SD): Juvenile
- Length at study initiation (length definition, mean, range and SD): 4.8 cm (SD = 0.2)
- Weight at study initiation (mean and range, SD): 1.56 g (SD = 0.15)
- Feeding during test: No


ACCLIMATION
- Acclimation period: 8 d
- Acclimation conditions (same as test or not): Maintained in a glass fiber tank with a single pass water renewal system
- Type and amount of food: Commercial trout pellets, discontinued 24 h prior to definitive study
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
100 mg/L as CaCO3
Test temperature:
14 ± 1 °C
pH:
7.4-7.9
Dissolved oxygen:
≥ 9.1 mg O2/L
Nominal and measured concentrations:
Nominal concentrations:
- Range finding study: 0.30 and 3.0 mg/L
- Definitive study: 3.0 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): Closed
- Material, size, headspace, fill volume: 20 L glass exposure vessel
- Aeration: Aerated via narrow bore glass tubes
- Renewal rate of test solution (frequency/flow rate): Daily
- No. of organisms per vessel: Three in range finding study, ten in definitive study
- No. of vessels per concentration (replicates): Two
- No. of vessels per vehicle control (replicates): Two
- Biomass loading rate: 0.78 g bw/L


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Dechlorinated tap water


OTHER TEST CONDITIONS
- Photoperiod: 16 h light and 8 h darkness


TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: 3 mg/L was reported to be highest attainable test concentration based on the solubility of the test material under the test conditions
- Range finding study
- Test concentrations: 0.30 and 3.0 mg/L
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: -
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
> 3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: -
Details on results:
- Behavioural abnormalities: No
- Mortality of 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

Table 1: Cumulative mortality data in the range-finding study

Nominal concentration (mg/L)

Cumulative Mortality (Initial Population: 3)

24 h

48 h

72 h

96 h

Control

0

0

0

0

Solvent Control

0

0

0

0

0.3

0

0

0

0

3

0

0

0

0

Table 2: Cumulative mortality data in the definitive study

Nominal concentration (mg/L)

Cumulative Mortality (Initial Population: 10)

% mortality

3 h

6 h

24 h

48 h

72 h

96 h

96 h

Control

0

0

0

0

0

0

0

Solvent control

0

0

0

0

0

0

0

3.0 R1

0

0

0

0

0

0

0

3.0 R2

0

0

0

0

0

0

0

* R1-R2 = Replicates 1 & 2

Validity criteria fulfilled:
yes
Conclusions:
Under the study conditions, the nominal 96 h LC50 and NOEC were determined to be greater than 3.0 mg/L.
Executive summary:

A study was conducted to determine the acute toxicity of the read across substance, amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl), to rainbow trout (Oncorhynchus mykiss) according to OECD Guideline 203, in compliance with GLP. Based on the results of a range-finding study, rainbow trout (n = 20) were exposed to the test substance (3 mg/L) for 96 h under static conditions. Mortality and adverse reactions were determined at 3, 6, 24, 48, 72 and 96 h post-exposure. No analytical dose verification was conducted. Under the study conditions, the nominal 96 h LC50 and NOEC were determined to be greater than 3.0 mg/L (Wetton, 1996).

Description of key information

Key value for chemical safety assessment

LC50 for freshwater fish:
3 mg/L

Additional information

A study was conducted to determine the acute toxicity of the read across substance, amides, C8-18 (even numbered) and C18-unsatd., N-(hydroxyethyl), to rainbow trout (Oncorhynchus mykiss) according to OECD Guideline 203, in compliance with GLP. Based on the results of a range-finding study, rainbow trout (n = 20) were exposed to the test substance (3 mg/L) for 96 h under static conditions. Mortality and adverse reactions were determined at 3, 6, 24, 48, 72 and 96 h post-exposure. No analytical dose verification was conducted. Under the study conditions, the nominal 96 h LC50 and NOEC were determined to be greater than 3.0 mg/L (Wetton, 1996).