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Diss Factsheets

Ecotoxicological information

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

Constituent 1
Chemical structure
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 concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
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.