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

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

4 June - 8 June 2007

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 guidelines, see below).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

not specified

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 850.1075 (Freshwater and Saltwater Fish Acute Toxicity Test)

Deviations:

not specified

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
- Physical state: Solid
- Analytical purity: 99.7%
- Purity test date: 20 March 2007
- Lot/batch No.: 80A
- Expiration date of the lot/batch: 08 March 2008
- Stability under test conditions: yes
- Storage condition of test material: At room temperature, dark and dry

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

samples were taken at the start and the end of the test

Test solutions

Vehicle:

yes

Details on test solutions:

A test solution of the test substance in water was prepared at c = 100 mg/L (nominal).

Test organisms

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout
- Source: Piscicultura Farm, Hungary
- Age at study initiation (mean and range, SD): Juveniles
- Length at study initiation (length definition, mean, range and SD): 4.6 - 6.5 cm
- Weight at study initiation (mean and range, SD): 2.17 - 2.19 g

ACCLIMATION
- Acclimation period: 12 days
-- Type and amount of food: commercial fish diet
- Health during acclimation (any mortality observed): none observed

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

none

Test conditions

Hardness:

168.5 mg/L

Test temperature:

13.9°C - 14.3 °C

pH:

8.4

Dissolved oxygen:

90 - 93%

Salinity:

not stated

Nominal and measured concentrations:

nominal: 100 mng/L
measured: (start of the test) 106 mg/L; (end of the test) 103 mg/L

Details on test conditions:

Fish were placed in 25L glass aquaria with 20L test solution.
The maximum biomass loading per aquarium was 0.767 g/L.

Reference substance (positive control):

not required

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Effect concentrations 2

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Effect concentrations 3

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Effect concentrations 4

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Any other information on results incl. tables

Sublethal observations / clinical signs:

No mortality or any symptoms of intoxication occured in any of the fish.

The method chosen was valid because none of the control fish died and the oxygen saturation was > 60%.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

In this test, the 96h toxicity of BIBR 277 Nitril to Rainbow trout was observed.
The following paramters were determined: 96h LC0 > 100 mg/L; 96h LC100 > 100 mg/L; 96h NOEC = 100 mg/L and 96h LOEC > 100mg/L.