Tetrasodium N,N-bis(carboxylatomethyl)-L-glutamate

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:

6-8 December, 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The test was performed according to standard guidelines under GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

amd EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

not specified

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tetrasodium N,N-bis(carboxylatomethyl)-L-glutamate

EC Number:

257-573-7

EC Name:

Tetrasodium N,N-bis(carboxylatomethyl)-L-glutamate

Cas Number:

51981-21-6

Molecular formula:

C9H9NO8Na4

IUPAC Name:

tetrasodium 2-[bis(carboxylatomethyl)amino]pentanedioate

Details on test material:

- Name of test material (as cited in study report): GBS-5
- Physical state: white powder
- Composition of test material, percentage of components:
- Substance (incl impurities) 95.26% w/w
- Water 4.74% w/w
- Lot/batch No.: GLS 30P (see CoA in the report attached)
- Stability under test conditions: No information
- Storage condition of test material: room temperature over silica gel

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Control and 100 mg/L
- Sampling method: The control replicates were pooled and 100 mg/L R1 and R2 were pooled and R3 and R4. Samples were taken at 0 and 48 hours.
- Sample storage conditions before analysis: No information

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 200 mg of test material was dispersed in reconstituted water and the volume was adjusted to 2 L to give a 100 mg/L test concentration.

RPEPARATION FO RECONSTITUTED WATER
Stock solutions: 11.76 g/L CaCl2*2H2O, 4.93 g/L MgSO4*7H2O, 2.59 g/L NaHCO3, 0.23 g/L KCl
25 mL of each stock solution was added to deionised water and filled up to 1 L.
pH was adjusted to 7.8 and aerated until the dissolved oxygen concentration was approximately air-saturated.
The theoretical hardness was 270 mg/L CaCO3.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Source: Laboratory culture originating from a strain supplied by the Institut National de Recherche Chimique Appliquee, France
- Age at study initiation: < 24 hours
- Method of breeding: At 21 ºC in polypropylene vessels containing 2 L of reconstituted water. Cultures were fed daily with a suspension of mixed algae (mainly chlorella sp.).
- Feeding during test: No

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

theoretical hardness of the reconstituted water is 270 mg/L CaCO3.

Test temperature:

21.0 ºC

pH:

7.7 - 8.3

Dissolved oxygen:

8.0 - 8.4 mg O2/L

Nominal and measured concentrations:

Nominal: 0 and 100 mg/L
Measured:
Samples Nominal concentration (mg/L) Concentration measured (mg/L)
0 h Control < LOD
100 R1 & R2 86.6
100 R3 & R4 87.5
48 h Control < LOD
100 R1 & R2 97.2
100 R3 & R4 97.6

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): open / closed
- Material, size, headspace, fill volume:
- Aeration:
- Type of flow-through (e.g. peristaltic or proportional diluter):
- Renewal rate of test solution (frequency/flow rate):
- No. of organisms per vessel:
- No. of vessels per concentration (replicates):
- No. of vessels per control (replicates):
- No. of vessels per vehicle control (replicates):
- Biomass loading rate:


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water:
- Total organic carbon:
- Particulate matter:
- Metals:
- Pesticides:
- Chlorine:
- Alkalinity:
- Ca/mg ratio:
- Conductivity:
- Culture medium different from test medium:
- Intervals of water quality measurement:


OTHER TEST CONDITIONS
- Adjustment of pH:
- Photoperiod:
- Light intensity:


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :


TEST CONCENTRATIONS
- Spacing factor for test concentrations:
- Justification for using less concentrations than requested by guideline:
- Range finding study
- Test concentrations:
- Results used to determine the conditions for the definitive study:

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 95.26 mg/L

Nominal / measured:

nominal

Conc. based on:

act. ingr.

Remarks:

4.74% water

Basis for effect:

mobility

Details on results:

- Behavioural abnormalities: No abnormalities were observed during the test.

Reported statistics and error estimates:

No statistics were performed because no immobility was observed during the test.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Remarks:

No immobile organisms in the control; dissolved oxygen concentration was above 3 mg/L.

Conclusions:

The test material is not toxic to aquatic invertebrates.

Executive summary:

TEST MATERIAL: GBS-5
TEST SPECIES : Daphnia magna Straus tested in the 1st instar.
TEST TYPE: Acute toxicity. 48h EC50 (immoilisation).
TEST CONDITIONS: Static test conditions according to OECD Guideline No. 202, referenced as Method C.2 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).

The following results are based on nominal test substance concentrations

EC50 -24h > 100 mg/L
EC50 -48h > 100 mg/L
“No Observed Effect Concentration” (NOEC) at 24 h 100 mg/L
“No Observed Effect Concentration” (NOEC) at 48 h 100 mg/L
It was considered unnecessary and unrealistic to test at concentrations in excess of 100 mg/L.