Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Currently viewing:

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
migrated information: read-across based on grouping of substances (category approach)
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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guidelineopen allclose all
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

Test material

Constituent 1
Reference substance name:
Dimethyl 2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]terephthalate
EC Number:
252-650-1
EC Name:
Dimethyl 2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]terephthalate
Cas Number:
35636-63-6
IUPAC Name:
dimethyl 2-({2-oxo-1-[(2-oxo-2,3-dihydro-1H-benzimidazol-5-yl)carbamoyl]propyl}diazenyl)terephthalate

Sampling and analysis

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.

Test solutions

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

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.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
48 h

Test conditions

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

Results and discussion

Effect concentrationsopen allclose all
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
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
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.

Applicant's summary and conclusion

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.