Dimethyl 2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]terephthalate

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:

From 11 FEB 2004 to 13 FEB 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study compliant to GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

Testguideline 202 Daphnia sp., 14-day Reproduction Test (including an Acute Immobilisation Test) Adopted April 4, 1984

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Deviations:

no

GLP compliance:

yes

Remarks:

According to German Chemical Law (ChemG), Annex 1, in the version of May 8, 2001 and 1999/11/EU of March 8, 1999

Analytical monitoring:

no

Details on sampling:

Analytical monitoring of the concentration of the test substance in the test water was not conducted since no relevant results could be expected. The solubility limit of the test substance in water is below 1 mg/L. The concentration data given in the present report are therefore based on nominal concentrations.

Vehicle:

no

Details on test solutions:

The test substance was weighed into a beaker, mixed with water for dilution and homogenized
with the Ultra-Turrax. The mixtures were then stirred for approximately 48
hours with a magnetic stirrer to ensure that the solubility limit of the test substance in
the test water was reached. To remove fine undissolved particles the test batches
were filtered through a cellulose filter, which was saturated with the test substance
prior to use.

Test organisms (species):

Daphnia magna

Details on test organisms:

Species Daphnia magna - Clone 5 (IRChA, France)
Origin Stock culture of Aventis Pharma Deutschland GmbH, ProTox
Breeding conditions 100 mL beakers (height 90 mm, diameter 50 mm), filled with 70 mL test water (according to Elendt, M4) served as culture vessels. One daphnid was used per culture vessel. The animals were used for breeding up to an age of 42 days. The reproduction rate and the state of health of the animals were monitored daily apart from weekends. From these cultures daphnids with an age of < 24 h are taken as test animals.
The animals were fed three times a week with monocellular green algae (Desmodesmus subspicatus). The supplied diet was based on the amount of organic carbon (C). The ration level is 0.2 mg carbon / day / animal.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

The total hardness of the dilution water was at 2.1 mmol Ca(2+) + Mg(2+) / L during the study.

Test temperature:

Control: 20.8 - 21.1 deg C
Treatment: 21.0 - 21.1 deg C

pH:

Control: 7.7 - 8.0
Treatment: 7.8 - 8.0

Dissolved oxygen:

[mg/L]
Control: 8.4 - 8.6
Treatment: 8.3 - 8.5

Nominal and measured concentrations:

100 mg/L nominal concentration
Control: 0 mg/L

Details on test conditions:

Reconstituted fresh water was used for breeding and dilution. Demineralized water with a conductance of < 1µS / cm was used for preparing the
artificial fresh water (according to Elendt, M4). The test water was allowed to stand for at least a further 24 hours in order to stabilize and was aerated until saturation. The pH-value, oxygen content, conductivity and total hardness were measured and recorded once a week.
The study was conducted in a static system. As test chambers 250 mL beakers were used (height 110 mm, diameter 70 mm, water level about 75 mm), each filled with 200 mL test water. The room temperature was about 21 deg C. The room was illuminated by fluorescent tubes for 16 hours each day.
20 daphnids, divided into two parallel groups of 10 animals, were used for each concentration. The test concentrations, which were selected on the basis of range finding tests, were as follows:
0 mg/L (control)
100 mg/L nominal limit concentration (treatment)

Reference substance (positive control):

no

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: Due to the poor solubility of the test item, a saturated soution had been prepared at the nominal concentration and used after filtration

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: Due to the poor solubility of the test item, a saturated soution had been prepared at the nominal concentration and used after filtration

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: Due to the poor solubility of the test item, a saturated soution had been prepared at the nominal concentration and used after filtration

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: Due to the poor solubility of the test item, a saturated soution had been prepared at the nominal concentration and used after filtration

Details on results:

Neither in the treatment replicates nor in the control any immobilized daphnids could be detected.

Validity criteria fulfilled:

yes

Conclusions:

In the acute immobilization test on Daphnia magna with the submission substance neither in the treatment nor in the control groups any immobilized daphnids could be observed:
EC0 (24 and 48 h) = 100 mg/L
EC50 (24 and 48 h) > 100 mg/L

Executive summary:

The submission substance was tested in Daphnia magna (water flea) for 48 hours in a static system. The concentrations tested were 100 mg/L and 0 mg/L (control). Before insertion of the test organisms the chamber contents were stirred for approximately 48 hours with a magnetic stirrer to ensure that the solubility limit of the test substance in the test water was reached. To remove fine undissolved particles the test batches were filtered through a cellulose filter, which was saturated with the test substance prior to use. Analytical monitoring of the concentration of the test substance in the test water was not conducted since no relevant results could be expected. The solubility limit of the test substance in water is below 1 mg/L. The concentration data given in the present report are therefore based on nominal concentrations. In this 48-hour acute toxicity study of the submission substance the following immobility values were determined:

	after 24 hours	after 48 hours
ECo(mg/L)	100	100
EC50(mg/L)	> 100	> 100
EC100(mg/L)	not determined	not determined

In the control group no immobility was observed. The 100 mg/L group showed no effect in comparison to the control.

Description of key information

In the acute immobilization test on Daphnia magna with the submission substance neither in the treatment nor in the control groups any immobilized daphnids could be observed:

EC0 (24 and 48 h) = 100 mg/L

EC50 (24 and 48 h) > 100 mg/L