N-[[-2[[[(4-Aminoiminomethyl)phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-beta-alaninethylester p-toluolsulfonat

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

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2005

Report date:

2005

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

[amino({4-[({5-[(3-ethoxy-3-oxopropyl)(pyridin-2-yl)carbamoyl]-1-methyl-1H-1,3-benzodiazol-2-yl}methyl)amino]phenyl})methylidene]azanium 4-methylbenzene-1-sulfonate

EC Number:

927-186-4

Cas Number:

872728-85-3

Molecular formula:

C27 H29 N7 O3 x C7 H8 O3 S

IUPAC Name:

[amino({4-[({5-[(3-ethoxy-3-oxopropyl)(pyridin-2-yl)carbamoyl]-1-methyl-1H-1,3-benzodiazol-2-yl}methyl)amino]phenyl})methylidene]azanium 4-methylbenzene-1-sulfonate

Test organisms

Test organisms (species):

Daphnia magna

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

NOEC

Effect conc.:

0.46 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

0.46 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 3

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

62 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 4

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

8.8 mg/L

Nominal / measured:

not specified

Conc. based on:

test mat.

Basis for effect:

mobility

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Five valid experiments were performed. In the first four experiments each, a EC50i-value could not derived fram the data, since the observed
immobility did not cover the respective effect range. As validity of the experiments was given, this was considered to be due to the test item
properties and the flat concentration-effect relationship observed for the test item. In the last experiment, the concentration range was expanded
and a clear concentrationeffect relationship could be observed. The evaluation of EC50i and NOEC was made using the data obtained in the last
experiment (main study). In addition, the EC50i value was determined based on the data obtained in all five valid experiments together.
The two 48h-EC50i-values showed to be comparable. The last experiment (main study) was performed using 10 concentrations ranging
fram 100 to 0.1 mg/L. In each treatment, twenty daphnia were exposed to the test item for 48 hours in a static test system. After 24 and 48 hours,
the immobilized daphnia were counted.
Seven treatments showed immobility between 0 and 100 %. These were used for the determination of the results.
The following results could be determined for the test item BIBR 1048 Amidin TS RS1 (species: Daphnia magna) based on the observations made
in the last experiment.
24h NOEC = 0.46 mg/L
24h EC50j = 62 mg/L
48h NOEC = 0.46 mg/L
48h EC50j = 8.8 mg/L