1-butylpyrrolidin-2-one

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2014-01-14 to 2014-01-22

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP Guideline Study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material: Not applicable

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Water samples were taken from the control and the 100 mg/L test vessel at 0 and 72 hours (fresh media) and at 24 and 96 hours (old media) for quantitative analysis.
- Sampling method: The samples were stored frozen prior to analysis.
- Sample storage conditions before analysis:

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
A nominal amount of test item (2000 mg) was dissolved in 500 mL of test water to give the 4000 mg/L stock solution. The entire volume of the 4000 mg/L stock solution was then added to a final volume of 20 liters of test water to give the 100 mg/L test concentration.
The stock solution was inverted several times and the prepared concentration was stirred using 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 and 72 hours (fresh media) and at 24 and 96 hours.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Oncorhynchus mykiss
- Strain: Not reported
- Source: Brow Well Fisheries Limited, Hebden, near Skipton, Yorkshire, UK
- Age at study initiation (mean and range, SD): juvenile

- Feeding during test
- Food type: No feeding during test

ACCLIMATION
- Acclimation period: Fish were acclimatized to test conditions from 02 January 2014 to 14 January 2014.
- Acclimation conditions (same as test or not): Fish were maintained in a glass fiber tank with a "single pass" water renewal system.
- Type and amount of food: The stock fish were fed commercial trout pellets which was discontinued approximately 24 hours prior to the start of the definitive test.
- Health during acclimation (any mortality observed): There was 1 mortality in the 7 days prior to the start of the test

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

None

Hardness:

During the test it was found that the dechlorinated tap water source being used during the definitive test was below (i.e. 104 mg/L as CaCO3) the expected level of water hardness stated in the study plan (approximately 140 mg/L as CaCO3). Whilst this was a deviation to the study plan this was considered not to impact the test as no toxic effects were observed.

Test temperature:

Temperature was maintained at 14 °C throughout the test.

pH:

There were no treatment related differences for pH.

Dissolved oxygen:

There were no treatment related differences for oxygen concentration.

Salinity:

Not reported

Nominal and measured concentrations:

Water samples were taken from the control and the 100 mg/L test vessel at 0 and 72 hours (fresh media) and at 24 and 96 hours (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.

Details on test conditions:

TEST SYSTEM
- Test vessel: In the definitive test 20 liter glass exposure vessels were used for the test concentration
- Type (delete if not applicable): open
- Aeration: The test vessels were aerated via narrow bore glass tubes.
- Renewal rate of test solution (frequency/flow rate): Daily renewal (semi-static test)
- No. of organisms per vessel: Seven fish per vessel
- Biomass loading rate: loading rate of 0.39 g body weight/liter (static volume).

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory tap water was dechlorinated by passage through an activated carbon filter (Purite Series 500) and partly softened (Elga Nimbus 1248D Duplex Water Softener).
- Culture medium different from test medium: The test water used for the definitive test was the same as that used to maintain the stock fish.
- Intervals of water quality measurement: the test. The measurements at 0 hours, and after each test media renewal at 24, 48 and 72 hours, represent those of the freshly prepared test preparations while the measurements taken prior to each test media renewal, and on termination of the test after 96 hours, represent those of the used or 24-Hour old test preparations. The pH and dissolved oxygen concentration were measured using a Hach HQ30d Flexi handheld meter whilst the temperature was measured using a Hanna Instruments HI 93510 digital thermometer.

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: The lighting cycle was controlled to give a 16 hours light and 8 hours darkness cycle with 20 minute dawn and dusk transition periods.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Any mortalities and sub-lethal effects of exposure were recorded at 3, 6, 24, 48, 72 and 96 hours after the start of exposure. The criteria of death were taken to be the absence of both respiratory movement and response to physical stimulation.

TEST CONCENTRATIONS
- Test concentrations: 100 mg/L only

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mortality (fish)

Remarks on result:

other: There were no mortalities in 7 fish exposed to a test concentration of 100 mg/L for a period of 96 hours.

Details on results:

There were no sub-lethal effects of exposure observed in the test.
- Behavioural abnormalities: No
- Observations on body length and weight: Fish had a mean standard length of 4.4 cm (sd = 0.3) and a mean weight of 1.12 g (sd = 0.23) at the end of the definitive test.
- 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

Results with reference substance (positive control):

No positive control investigated.

Reported statistics and error estimates:

An estimate of the LC50 values was given by inspection of the mortality data.

Sublethal observations / clinical signs:

Analysis of the 100 mg/L test preparation at 0 and 72 hours (fresh media) and at 24 and 96 hours (old media) showed measured test concentrations to range from 88% to 95% of nominal and so the results are based on nominal test concentrations only.

Validity criteria fulfilled:

yes

Conclusions:

No mortality was observed during test duration of 96 h. Hence NOEL amounts to 100 mg/L, LC50 > 100 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. Seven fish were exposed to an aqueous solution of the test item, at a single concentration level of 100 mg/L for a period of 96 hours at a temperature of 14 °C under semi-static test conditions.

Analysis of the 100 mg/L test preparation at 0 and 72 hours (fresh media) and at 24 and 96 hours (old media) showed measured test concentrations to range from 88% to 95% of nominal and so the results are based on nominal test concentrations only. There were no mortalities in 7 fish exposed to a test concentration of 100 mg/L for a period of 96 hours. The results of the definitive test showed the highest test concentration resulting in 0% mortality to be 100 mg/L (LC50 > 100 mg/L).

The No Observed Effect Concentration (NOEC) was 100 mg/L;

Description of key information

A study was performed to assess the acute toxicity of the test item to Rainbow trout (Oncorhynchus mykiss), following OECD Guideline No 203 (1992), and EU Method C.1 of Commission Regulation (EC) No. 440/2008. Seven fish were exposed to an aqueous solution of the test item, at a single concentration level of 100 mg/L for a period of 96 hours at a temperature of 14 °C under semi-static test conditions.

Analysis of the 100 mg/L test preparation at 0 and 72 hours (fresh media) and at 24 and 96 hours (old media) showed measured test concentrations to range from 88 % to 95 % of nominal and so the results are based on nominal test concentrations only. There were no mortalities in 7 fish exposed to a test concentration of 100 mg/L for a period of 96 hours. The results of the definitive test showed the highest test concentration resulting in 0 % mortality to be 100 mg/L (LC50 > 100 mg/L).

The No Observed Effect Concentration (NOEC) was 100 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L