SUMILIZER GP

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:

25 - 28 Jun 2002

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

Test item dispersion was filtered through a membrane filter (0.45 µm) before testing.

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

Part I, 1984

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

1992

GLP compliance:

yes (incl. QA statement)

Remarks:

Swiss Federal Office of Public Health, Bern, Switzerland

Analytical monitoring:

yes

Details on sampling:

Additional flasks with adequate volumes of the freshly prepared test medium and the solvent control were incubated during the test period under the same conditions as in the actual test (but without daphnids). Sampling from the test beakers with daphnids was not possible because the test medium volumes (2 x 50 mL) were too small for the analytical requirements (1000 mL per sample).
- Concentrations: undiluted filtrate of the stock solution (only before test start), 0 (solvent control) and 10 mg/L
- Sampling method: Duplicate samples were taken before test start and after 48 hours
- Sample storage conditions before analysis: Samples were deep-frozen (at about -20 °C) immediately after sampling.

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: An undiluted filtrate of a supersaturated dispersion with the maximum concentration of dissolved test item was used. A stock solution was prepared at the start of the test by diluting 501 mg of the test item in 5 mL N,N-dimethylformamide (DMF) and ultrasonicating for 10 minutes. 450 µL were dosed into 4500 mL test water to obtain a loading rate of 10 mg/L. The dispersion was then stirred at room temperature over 96 hours. After stirring, the dispersion was filtered through a membrane filter (0.45 µm) just before test start.
- Controls: control: dilution water only, solvent control: dilution water and DMF
- Chemical name of vehicle: DMF
- Concentration of vehicle in test medium: stock solution: 100%, final test solutions: 100 µL/L, control: 0%, solvent control: 100 µL/L

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Strain/clone: defined from the supplier as clone 5
- Age at study initiation: 6-24 h (not first brood progeny)
- Source: originally supplied by the University of Sheffield, UK in 1992

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

250 mg/L as CaCO3

Test temperature:

20 °C

pH:

7.7 - 7.9

Dissolved oxygen:

8.0 - 8.8 mg/L

Nominal and measured concentrations:

Nominal concentration: 0 (control), 0 (solvent control) and 10 mg/L
Measured concentrations: < LOD (control), < LOD (solvent control) and 1.86 µg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 mL beakers
- Type: covered with glass plates
- Material, headspace, fill volume: glass, 50 mL, 50 mL
- Volume of solution: 50 mL
- Aeration: no
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): 2
- Biomass loading rate: < 1 daphnid/2 mL

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water, composition: CaCI2 x 2H2O (294 mg/L), MgSO4 x 7H2O (123 mg/L), NaHCO3 (65 mg/L), KCl (5.8 mg/L)
- Alkalinity: 0.8 mmol/L
- Ca/Mg ratio: 4:1 (based on molarity)
- Culture medium different from test medium: no
- Intervals of water quality measurement: dissolved oxygen, pH and temperature at 0 and 48 hours

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16/8 h light/dark with a 30-minute transition period
- Light intensity: 550 - 690 lux

EFFECT PARAMETERS MEASURED: immobility (after 24 and 48 h)

VEHICLE CONTROL PERFORMED: yes

Reference substance (positive control):

yes

Remarks:

Potassium dichromate is tested at least once a year.

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 10 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

No adverse effect up to its solubility limit in the test water

Basis for effect:

mobility

Remarks on result:

other: No adverse effect up to its solubility limit in the test water

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 1.9 µg/L

Nominal / measured:

meas. (arithm. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Mortality of control: 0%
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: no

Results with reference substance (positive control):

The latest result of the positive control test showed that the toxic performance was valid and within the historical range in the laboratory.

Table 1: Immobilization of daphnids

Nominal loading rate [mg/L]	Immobilization [%]
	24 hours		48 hours
	No	%	No	%
Control	0	0	0	0
Solvent control	0	0	0	0
10	0	0	0	0
2.0
4.0
8.0
16.0

Table 2: Measured test item concentrations

Nominal concentration of the test item [µg/L]	Sampling day / Age of sample (h)	Measured concentration   [µg/L]	% of nominal concentration	Average
Stock solution
100000	0 / 0	101879	102
Treatment samples
10	0 / 0	1.94	n.a.	1.86
	0 / 0	1.95	n.a.
	2 / 48	1.89	n.a.
	2 / 48	1.67	n.a.
Solvent control samples
0	0 / 0	n.d.	n.a.
	2 / 48	n.d.	n.a.
Spiked test water samples
4.92	0 h	3.91	79	3.93
	0 h	3.95	80

n.a. = not applicable

n.d. = no test item detected, respectively < LOD of 0.2 µg/L

Table 3: Validity criteria for OECD 202 (2004)

Criterion from the guideline	Outcome	Validity criterion fulfilled
In the control, including the control containing the solubilising agent, not more than 10% of the daphnids should have been immobilized.	0%	yes
The dissolved oxygen concentration at the end of the test should be ≥ 3 mg/L in control and test vessels.	8.0 - 8.8 mg/L	yes

Validity criteria fulfilled:

yes

Remarks:

For further, details, please refer to 'Any other information on results incl. tables'.

Description of key information

No adverse effect up to its solubility limit in the test water

EC50 (48h): > 10 mg/L (Daphnia magna, OECD202 part I, loading rate) [> 1.9 µg/L (meas. (arithm. mean))]

Additional information

The acute toxicity to Daphnia magna was assessed in a 48-hour static test according to OECD guideline 202, part I. An undiluted filtrate (0.45 µm filter pore size) of a supersaturated dispersion with the maximum concentration of dissolved test item was used as the only test concentration. The limit test was performed with the test item loading rate of 10 mg/L. Additionally, a control and a solvent control (100 µL/L N,N-dimethylformamide) were tested in parallel.

The analytically determined test item concentrations in the samples taken at start and test end were 1.9 and 1.8 µg/L, respectively. In the controls and at the loading rate of 10 mg/L (mean measured 1.9 µg/L) no immobilized test organisms were determined up to the solubility limits of the test item. The EC50 (48 h) was determined to be > 10 mg/L (loading rate) [> 1.9 µg/L (mean measured)].