[No public or meaningful name is available]

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:

July 2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

1999

Deviations:

yes

Remarks:

no test item analysis possible

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Version / remarks:

Dec. 1992

Deviations:

yes

Remarks:

no test item analysis possible

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Sampling and analysis

Analytical monitoring:

no

Details on sampling:

Due to the insolubility of the test item no concentration-control analysis could have been carried out. Therefore, no information on stability and recovery of the test itemunder test conditions were given.

Test solutions

Vehicle:

yes

Remarks:

dilution water

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method:
An appropriate amount of test item was crushed with a mortar. The solution (100 mg/L test item was weighed out) was prepared with dilution water one day prior to application. the stock solution was shaken with 20 rpm for 24 h and membrane filtered with 0.45 µm.

Dilution water: according to EC 92/69 L383A C.2. Annex

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Strain/clone: STRAUS
- Justification for species other than prescribed by test guideline: n.a.
- Source:
a. Origin: Institut für Wasser-, Boden- und Lufthygiene
b. Breeder: Dr. Noack-Laboratorium, Sarstedt, Germany
- Age of test organisms: 2-24 h
- Feeding during test: none
during culture:
- Food type: mix of Desmodesmus subspicatus and Chlorella vulgaris
- Amount: lgae densitiy of > 10(exp6) cells/mL
- Frequency: at least 5x weekly, ad libitum

ACCLIMATION
- Acclimation period: ca. 2 h in dilution water
- Type and amount of food: none
- Feeding frequency: n.a.
- Health during acclimation (any mortality observed): no

Study design

Test type:

static

Water media type:

other: dilution water according to EC 92/69 L383A C.2. Annex

Limit test:

yes

Total exposure duration:

48 h

Post exposure observation period:

none

Test conditions

Hardness:

CaCO3: 268 mg/mL

Test temperature:

19 +/- 1°C

pH:

Test item:
- study beginning: 7.99
- study end: 7.6

Control:
- study beginning: 7.89
- study end: 7.72

Dissolved oxygen:

Test item:
- study beginning: 9.14 mg/L
- study end: 8.73 mg/L

Control:
- study beginning: 8.84 mg/mL
- study end: 8.2 mg/mL

Salinity:

according to EC 92/69 L383A C.2. Annex

Conductivity:

676 µS/cm

Nominal and measured concentrations:

saturated solution as limit concentration
Saturation concentration: The maximum dissolved concentration of the test item that can be achieved under the test conditions in the test medium acc. to OECD

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers (5 cm diameter x 8 cm height), 50 mL volume
- Fill volume: 20 mL
- Aeration: none
- Type of flow-through (e.g. peristaltic or proportional diluter): n.a.
- 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): 2


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to EC 92/69 L383A C.2. Annex
- Total organic carbon: 268 mg CaCO3/mL
- Conductivity: 676 µS/cm
- Culture medium different from test medium: Elendt M4 modified to a total hardness of 160 to 180 mg/ CaCO3/L
- Intervals of water quality measurement: at the study start and after 48 h

OTHER TEST CONDITIONS
- Adjustment of pH: none
- Photoperiod: 15/8 h light/dark cycle
- Light intensity: diffuse light, illumination range max. 20 µmol x m(-2) x s(-1)

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) :

VEHICLE CONTROL PERFORMED: yes

RANGE-FINDING STUDY
- Test concentrations: 1:1, 1:10 and 1:100 dilution of the saturated solution
- Results used to determine the conditions for the definitive study: yes

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: saturated solution/saturation concentration; the maximum dissolved concentration of the test item that can be achieved under the test conditions in the test medium according to OECD. 100 mg/L weighed out for preapration of the saturation concentration

Effect concentrations 2

Key result

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: saturated solution/saturation concentration; the maximum dissolved concentration of the test item that can be achieved under the test conditions in the test medium according to OECD. 100 mg/L weighed out for preapration of the saturation concentration

Effect concentrations 3

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: saturated solution/saturation concentration; the maximum dissolved concentration of the test item that can be achieved under the test conditions in the test medium according to OECD. 100 mg/L weighed out for preapration of the saturation concentration

Effect concentrations 4

Duration:

24 h

Dose descriptor:

EC0

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: saturated solution/saturation concentration; the maximum dissolved concentration of the test item that can be achieved under the test conditions in the test medium according to OECD. 100 mg/L weighed out for preapration of the saturation concentration

Effect concentrations 5

Key result

Duration:

24 h

Dose descriptor:

EC10

Effect conc.:

0.58 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 6

Key result

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

1.49 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 7

Key result

Duration:

24 h

Dose descriptor:

EC100

Effect conc.:

5.8 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mobility

Any other information on results incl. tables

There is no biologically significant effect neither in the tested saturation concentration nor in the control group.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

At the saturation concentration of the test substance (i.e. the maximum dissolved concentration of the test item that can be achieved under the test consitions in the test medium according to OECD guideline) no biologically significant effect was determined.

Executive summary:

In the acute immobilisation test with Daphnia magna (STRAUS) the effcet of the saturated solution (i.e. the maximum dissolved concentration of the test item that can be achieved under the test consitions in the test medium according to OECD guideline) as limit concentration of the test item was determined accodring to OECD guideline 202. The test item was clearly dissolved in the saturation concentration. 100 mg/L were weighed out for the preaparation of the saturation concentration. The study was conducted under static conditions over a duration of 48 h. 20 test organisms were exposed to the saturation concentration and control. The limit concentration was not analytically verified, due to the insolubility of the test item. Effect values are given based on the nominal concentration. A reference test is carried out once per month with potassium dichromate to determine the reference toxicity. The EC50 -value of the reference item at 1.49 mg/L after 24 h was within the prescribed concentration range of 1.0 to 2.5 mg/L according to AQS, DIN Guideline 38412 L 30. Water quality parameters of pH-value and dissolved oxygen concentration measured at 0 and 48 h were determined to be within acceptable limits.

The validity criteria of the test guideline were fulfilled.