(2S)-[[(benzyloxy)carbonyl]amino](cyclohexyl)acetic acid

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006-11-10 to 2006-12-05

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study performed according to OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) and EU Method C.2 (Acute Toxicity for Daphnia) without deviations.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

Remarks:

The testing facility indicated that the protocol was followed without deviation.

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

Remarks:

The testing facility indicated that the protocol was followed without deviation.

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

Department of Health of the Government of the United Kingdom

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): VRT-126016
- Molecular formula (if other than submission substance): Not applicable
- Molecular weight (if other than submission substance): Not applicable
- Smiles notation (if other than submission substance): Not applicable
- InChl (if other than submission substance): Not applicable
- Structural formula attached as image file (if other than submission substance): Not applicable
- Substance type: No data
- Physical state: White to off-white powder
- Analytical purity: 99.8 area % by High Performance Liquid Chromatography (HPLC)
- Impurities: chloride: <0.1%
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: 2006-02-02
- Lot/batch No.: 25719
- Expiration date of the lot/batch: February 2008-02-01
- Stability under test conditions: No data
- Storage condition of test material: Room temperature
- Other: No data

Specific details on test material used for the study:

Details on properties of test surrogate or analogue material (migrated information):
Not applicable

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: All concentrations
- Sampling method: 4 samples of 10 mL were taken from the freshly prepared control and test media. After 48 h, the contents of the test vessels from each group were pooled, and further samples taken for analysis.
- Sample storage conditions before analysis: On each occasion, 2 samples from each set were stored frozen, for up to 7 days prior to analysis; the remaining samples were frozen in case further analysis was required.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: 100 mg of the test substance was dispersed in 1 L Elendt M4 medium in a volumetric flask, and used directly as the test medium.
- Eluate: Not applicable
- Differential loading: Not applicable
- Controls: Elendt M4 media
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): Not applicable
- Concentration of vehicle in test medium (stock solution and final test solution): Not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): No

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Strain: Straus
- Source: In-house culture, originally from the Institute National de Recherche Chimiqhue Applique, France
- Age at study initiation (mean and range, SD): <24 h
- Weight at study initiation (mean and range, SD): Not applicable
- Length at study initiation (length definition, mean, range and SD): Not applicable
- Valve height at study initiation, for shell deposition study (mean and range, SD): Not applicable
- Peripheral shell growth removed prior to test initiation: Not applicable
- Method of breeding: Parthanogenesis
- Feeding during test: Not fed during test
- Food type: Not apllicable
- Amount: Not applicable
- Frequency: Not applicable

ACCLIMATION
- Acclimation period: No
- Acclimation conditions (same as test or not): Not applicable
- Type and amount of food: Not applicable
- Feeding frequency: Not applicable
- Health during acclimation (any mortality observed): Not applicable

QUARANTINE (wild caught)
- Duration: Not applicable
- Health/mortality: Not applicable

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

none

Test conditions

Hardness:

244 mg/L

Test temperature:

19.8-20.7 deg C

pH:

7.42-7.77

Dissolved oxygen:

94-102 % air saturation value

Salinity:

Not applicable

Nominal and measured concentrations:

nominal- control and 100 mg/L
mean measured- control and 102 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): Closed-loosely covered
- Material, size, headspace, fill volume: Glass dishes, 100 mL fill volume
- Aeration: No
- Type of flow-through (e.g. peristaltic or proportional diluter): Not applicable
- Renewal rate of test solution (frequency/flow rate): None
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4
- No. of vessels per vehicle control (replicates): Not applicable
- Biomass loading rate: 20 mL media per organism


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Elendt M4 test media
- Total organic carbon: Not applicable
- Particulate matter: Not applicable
- Metals: Not applicable
- Pesticides: Not applicable
- Chlorine: Not applicable
- Alkalinity: 43 mg/L
- Ca/Mg ratio: Not applicable
- Conductivity: Not applicable
- Culture medium different from test medium: No
- Intervals of water quality measurement: Daily

OTHER TEST CONDITIONS
- Adjustment of pH: Yes
- Photoperiod: 16 h light 8 h dark
- Light intensity: No data

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): immobility, 24 and 48 h

TEST CONCENTRATIONS
- Spacing factor for test concentrations: Not applicable
- Justification for using less concentrations than requested by guideline: Not applicable
- Range finding study
- Test concentrations: 1, 10, and 100 mg/L
- Results used to determine the conditions for the definitive study: Yes

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 102 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

102 mg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: None
- Observations on body length and weight: Not applicable
- Other biological observations: No immobility was observed in the test group.
- Mortality of control: One control animal appeared to be immobile after 48 hours.
- Other adverse effects control: None
- Abnormal responses: None
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: None
- Effect concentrations exceeding solubility of substance in test medium: None

Results with reference substance (positive control):

Not applicable

Reported statistics and error estimates:

The NOEC was derived by direct inspection of the data, on the immobility of the animals.

Any other information on results incl. tables

Not applicable

Applicant's summary and conclusion

Conclusions:

The 48 h EC50 of the test substance to Daphnia magna was > 106 mg/L mean measured concentration, with a NOEC of 106 mg/L mean measured concentration.

Executive summary:

Not applicable