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 aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 September 2006 - 5 October 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

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 (replicates R1 – R4 pooled) and the 100 mg/l test group (replicates R1 – R2 and R3 – R4 pooled) at 0 and 48 hours for quantitative analysis.
- Sample storage conditions before analysis: Duplicate samples were taken and stored at approximately -20°C for further analysis if necessary.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
The test material was dissolved directly in reconstituted water.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Source: in-house laboratory culture
- Age at study initiation (mean and range, SD): <24 hours old
- Method of breeding: Culture conditions ensured that reproduction was by parthenogenesis.
- Feeding during test: no food during exposure

ACCLIMATION
- Acclimation period: not indicated
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: suspension of algae (Chlorella sp.)
- Feeding frequency: daily
- Health during acclimation (any mortality observed): The diet and diluent water are considered not to contain any contaminant that would affect the integrity or outcome of the study.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

250 mg/L as CaCO3

Test temperature:

19.3 - 20.1°C

pH:

7.7 - 7.8

Dissolved oxygen:

8.8 - 8.9 mg O2/L

Nominal and measured concentrations:

Range-finding test: nominal 0.010, 0.10, 1.0, 10 and 100 mg/L (no measurements)
Main test: nominal 100 mg/l and measured: 99 mg/L (at 0 hours) and 113-116 mg/L (at 48 hours)

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type: closed
- Material, size, headspace, fill volume: glass, 250 ml
- Aeration: no
- Renewal rate of test solution (frequency/flow rate): no renewal
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- Biomass loading rate: not indicated

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Reconstituted water prepared by adding 25 ml of each of solutions a-d to each litre (final volume) of deionised water. Solutions: a) 11.76 g/L CaCl2.2H20; b) 4.93 g/L MgSO4.7H2O; c) 2.59 g/L NaHCO3; d) 0.23 g/L KCl
- Conductivity: <5 µS/cm
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH: if necessary with NaOH or HCl to 7.8 +/- 0.2
- Photoperiod: 16 hours light, 8 hours dark

EFFECT PARAMETERS MEASURED: An estimate of the EC50 values was given by inspection of the immobilisation data.

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 0.010, 0.10, 1.0, 10 and 100 mg/L.
- Results used to determine the conditions for the definitive study: No significant immobilisation was observed at the test concentrations of 0.010, 0.10, 1.0, 10 and 100 mg/L.

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

meas. (TWA)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

There was no immobilisation in 20 daphnids exposed to a test concentration of 100 mg/l for a period of 48 hours.
The test preparations were observed to be clear, colourless solutions throughout the duration of the test.
Analysis of the test preparations at 0 and 48 hours showed measured test concentrations to range from 99% to 116% of nominal and so it was considered justifiable to estimate the EC50 values in terms of the nominal test concentrations only.

Results with reference substance (positive control):

- Results with reference substance valid? Yes
- EC50: 48h EC50 = 0.60 mg/L (95% CI = 0.53-0.68 mg/L)
- Other: 48h NOEC = 0.32 mg/L

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of the test material to the freshwater invertebrate Daphnia magna has been investigated according to OECD/EC guidelines and GLP principes. The 48-Hour EC50 was found to exceed 100 mg/L (measured concentration, TWA), the No Observed Effect Concentration was 100 mg/L.

Description of key information

There was no immobilisation in 20 daphnids exposed to a test concentration of 100 mg/l for a period of 48 hours.

The test preparations were observed to be clear, colourless solutions throughout the duration of the test.

Analysis of the test preparations at 0 and 48 hours showed measured test concentrations to range from 99% to 116% of nominal and so it was considered justifiable to estimate the EC50 values in terms of the nominal test concentrations only.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

100 mg/L