[1,1'-Biphenyl]-2-carbonitrile, 4'-[(1,4'-dimethyl-2'-propyl[2,6'-bi-1H-benzimidazol]-1'-yl)methyl]-

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:

20 February - 23 February 2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted in GLP compliance and in accordance with several internationally established guidelines (OECD, EEC, EPA, see below).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1010 (Aquatic Invertebrate Acute Toxicity Test, Freshwater Daphnids)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

480-420-2

EC Name:

-

Cas Number:

144702-27-2

Molecular formula:

C33 H29 N5

IUPAC Name:

4'-{[4-methyl-6-(1-methyl-1H-1,3-benzodiazol-2-yl)-2-propyl-1H-1,3-benzodiazol-1-yl]methyl}-[1,1'-biphenyl]-2-carbonitrile

Test material form:

other: solid

Details on test material:

- Name of test material (as cited in study report): BIBR 277 Nitril
- Molecular formula (if other than submission substance): C33H29N5
- Molecular weight (if other than submission substance): 495.6 g/mol
- Substance type:
- Physical state:
- Analytical purity: 99.7 %
- Impurities (identity and concentrations): not indicated
- Purity test date: 17 October 2005
- Lot/batch No.: T02/03
- Expiration date of the lot/batch: April 2006
- Stability under test conditions:
- Storage condition of test material: At room temperature, dark and dry

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
Stock suspension: 50 mg test item was diluted in 500 ml Elendt M4 media. The test medium was prepared just before introduction of test Daphnia (=start of the test). At this concentration the test item formed a stable dispersion (suspension) in the medium used. The test suspensions were prepared without using organic solvent substance.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: daphnia Magna (Straus)
-sex: female
- Source:National Institute of Public Health, Hungary
- Age at study initiation (mean and range, SD): more than 6 and less 24 hours old
- Method of breeding: The daphnia were bred in the laboratories of LAB International Hungary under similar temperature and light conditions as in the test, and in reconstitute water of a similar quality regarding to pH, compoments of the main ions and the total hardness of the test water used in the test


ACCLIMATION
- Acclimation period: more than 6 hours under test conditions
- Acclimation conditions (same as test or not): yes, same
- Type and amount of food: none

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

Water hardness was reported as 163.2 mg/L CaCO3

Test temperature:

18-22 °C with a maximum deviation of +/- 1 °C

pH:

7.4 - 7.5

Dissolved oxygen:

The dissolved oxygen concentration in the test media was always >60% of the air saturation value at the temperature used

Salinity:

Not applicable

Nominal and measured concentrations:

nominal concentration: 100 mg/l
measured concentrations (mg/L): 102, 104, 105

Details on test conditions:

TEST SYSTEM
The Test vessels were glass beakers of 40 ml test medium. Each concentration had 4 replicate vessels and each vessel contain 5 test organisms. The age of the test organisms were < 24 hours and they were not fed during the test. Vessels were kept at 19.4 to 20.0°C .

The dilution water was synthetic freshwater with a hardness of 163.2 mg/L CaCO3.

Reference substance (positive control):

yes

Remarks:

(potassium dichromate)

Results and discussion

Effect concentrations

Duration:

48 h

Dose descriptor:

EC0

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Basis for effect:

mobility

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

A 48-hour EC0 value of > 100 mg/L have been determined for the effects of the test substance on mobility of Daphnia magna.