(2S)-5-amino-2-[(aminoacetyl)amino]-5-oxopentanoic acid

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:

2009-09-15 to 2009-09-17

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)

Version / remarks:

13 April, 2004

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

31 May, 2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

- Concentrations: control, 6.25, 12.5, 25, 50 and 100 mg a.i./L (after 0 and 24 h first exposure interval and after 0 and 24 h second exposure interval)

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A stock solution with a concentration of 1 g a.i./L was prepared. The required amount of test material was added to the test medium and stirred for 15 minutes. The test concentrations were prepared separately by dilution of the stock solution.
- Eluate: no
- Differential loading: no
- Controls: yes, test medium control

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Age at study initiation (mean and range, SD): < 24 h
- Source: bred at testing facility, originally obtained from "Landesumweltamt (NRW)", Düsseldorf, Germany
- Feeding during test : no
- Method of breeding: Bred in M4 medium at 20 ± 2 °C and a photoperiod of 16:8 h day/night.
- Type and amount of food: algae cultures (Desmodesmus subspicatus)

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test temperature:

20.4 - 21.3 °C

pH:

7.71 - 8.51

Dissolved oxygen:

4.6 - 5.8 mg/L

Nominal and measured concentrations:

Nominal test substance concentrations. 6.25, 12.5, 25, 50 and 100 mg a.i./L
Recovery rate: 93% and 97% of nominal test concentration

Details on test conditions:

TEST SYSTEM
- Test vessel: 50 mL glass beakers
- Fill volume: 30 mL
- Aeration: no
- Renewal rate of test solution: after 24 hours
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 5
- No. of vessels per control (replicates): 5

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: M4 medium
- Culture medium different from test medium: same as test

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16:8 h day-night cycle
- Light intensity: 700 ± 50 Lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable):
- Mobility after 24 and 48 hours

RANGE-FINDING STUDY
A range-finding study was performed but the results were not presented in detail.

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Basis for effect:

mobility

Details on results:

- Immobilisation of control: no

Results with reference substance (positive control):

- Results with reference substance valid? Yes (conducted 2009-08-05 to 2009-08-06)
- Relevant effect levels: EC50 (24 h): 0.99 mg/L

Reported statistics and error estimates:

No statistical evaluation was necessary because no effects on daphnia were observed.

Validity criteria fulfilled:

yes

Conclusions:

The results of this study show that the test substance Glycyl-L-glutamine monohydrate induced no immobilisation to the exposed Daphnia within 48 hours. The EC50 value after 2 days of exposure was >100 mg a.i./L and the NOEC was ≥ 100 mg a.i./L, respectively. As analytical determination showed no relevant loss of test substance during the first and the second exposure interval EC values were based on nominal concentration.

Description of key information

EC50 (48 h) >100 mg/L (nominal, OECD 202)

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Dose descriptor:

EC50

Effect concentration:

> 100 mg/L

Additional information

The acute toxicity of the substance to aquatic invertebrates was investigated in a semi-static test set up according to OECD 202 (GLP). Daphnia magna were expsoed for 48 hours to nominal test concentrations of 6.25, 12.5, 25, 50 and 100 mg a.i./L including a control. The test solutions were renewed daily. An analytical dose verfication of freshly prepared and aged medium was performed (HPLC/UV) and the determined recovery rate ranged from 93% - 97% of nominal. During the 48 hour exposure period no immobilisation of Daphnids was observed and therefore an EC50 (48 h) >100 mg/L was determined.