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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
not specified
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
not specified
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

Constituent 1
Chemical structure
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 concentrationsopen allclose all
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
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.