Reaction mass of (2S)-2-[(4R)-2-oxo-4-propylpyrrolidin-1-yl]butanamide and (2S)-2-[(4S)-2-oxo-4-propylpyrrolidin-1-yl]butanamide

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:

9 - 27 October 2006

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)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0 and 100 mg/l
- Sampling method: water samples were taken from the control and each replicate test vessel at 0 (fresh media), 24 and 96 hours (old media) for analysis.
- Sample storage conditions before analysis: Duplicate samples and samples at 24 (fresh media), 48 and 72 hours (fresh and old media) were taken and stored at -20°C for further analysis if necessary.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
The test material was dissolved directly in dechlorinated tap water.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: Rainbow trout
- Source: Brow Well Fisheries Ltd., Hebden, Yorkshire, UK
- Age at study initiation (mean and range, SD): not indicated
- Length at study initiation (length definition, mean, range and SD): 4.3 cm (sd =0.4 cm)
- Weight at study initiation (mean and range, SD): 0.98 g (sd = 0.26g)
- Feeding during test: no food during exposure

ACCLIMATION
- Acclimation period: 12 days
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: commercial trout pellets
- Feeding frequency: discontinued ca. 24 hours before the start of the definitive test
- Health during acclimation (any mortality observed): no mortality

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

140 mg/l as CaCO3

Test temperature:

13.5-14.7°C

pH:

7.6-8.2

Dissolved oxygen:

8.6-10.1 mg O2/l

Nominal and measured concentrations:

Nominal concentration: 100 mg/l
Measured concentrations: 98.7-101 mg/l

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type: closed
- Material, size, headspace, fill volume: glass, 20 litre
- Aeration: yes, via narrow bore glass tubes
- Renewal rate of test solution (frequency/flow rate): daily total renewal
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.34 g bw/l

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: laboratory tap water was dechlorinated by passage through an activated carbon filter and partly softened.
- Total organic carbon: 1.6 mg/l
- Particulate matter: <0.1 NTU
- Metals: below prescribed concentration
- Pesticides: 0.028 µg/l
- Chlorine: 0.2-0.3 mg/l
- Alkalinity:
- Ca/mg ratio:
- Conductivity: 410 µS/cm
- Culture medium different from test medium: no
- Intervals of water quality measurement: 8-180 times per year, depending on quality parameter

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 hours light, 8 hours dark
- Light intensity: not indicated

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality

- Range finding study
- Test concentrations: 100 mg/l, a single test concentration was used as results from the range-finding tests for daphnia and algae indicated that toxicity was not expected at this concentration.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

No mortality and no sub-lethal effects were observed.

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of the test substance to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated in a study performed according to OECD/EC guidelines and GLP principles. The 96-h LC50 was found to exceed 100 mg/L (measured concentration 98.7-101 mg/l) and the No Observed Effect Concentration was considered to be 100 mg/L.

Description of key information

The acute toxicity of the test substance to the freshwater fish rainbow trout (Oncorhynchus mykiss) has been investigated in a study performed according to OECD/EC guidelines and GLP principles. The 96-h LC50 was found to exceed 100 mg/L (measured concentration 98.7-101 mg/l) and the No Observed Effect Concentration was considered to be 100 mg/L.