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

Toxicity to aquatic algae and cyanobacteria

Administrative data

Endpoint:

toxicity to aquatic algae and cyanobacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5 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 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 201 (Alga, Growth Inhibition Test)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.3 (Algal Inhibition test)

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:

Determination of the test item, concentrations of the test solution and control were determined at the start and the end of the experiment.

Test solutions

Vehicle:

yes

Details on test solutions:

The test solution was prepared freshly before the start of the experiment.
The test item was dissolved in algal mineral salts medium to give a nominal concentration of c = 100 mg test substance/L.

Test organisms

Test organisms (species):

Raphidocelis subcapitata (previous names: Pseudokirchneriella subcapitata, Selenastrum capricornutum)

Details on test organisms:

TEST ORGANISM
- Strain: Printz-Starr
- Source (laboratory, culture collection): Georg-August-Universität, Göttingen
- Age of inoculum (at test initiation): 4 days
- Method of cultivation: the pre-culture was prepared with algal growth medium and incubated under test conditions, while algae were still exponentially growing.

ACCLIMATION
- Acclimation period: 4 days
- Culturing media and conditions (same as test or not): same

Study design

Test type:

static

Water media type:

not specified

Limit test:

yes

Total exposure duration:

72 h

Post exposure observation period:

none

Test conditions

Test temperature:

23°C +/- 2°C

pH:

8.1 - 8.0

Nominal and measured concentrations:

nominal: 100 mg/L, measured: 112 mg/L (start of the test); 91 mg/L 8end of the test)

Details on test conditions:

TEST SYSTEM
- Test vessel: Erlenmeyer Flasks, 250mL volume with each 100mL test solution
- Initial cells density:
- No. of vessels per concentration (replicates): 3
- No. of vessels per vehicle control (replicates): 6

GROWTH MEDIUM
- Standard medium used: yes

Reference substance (positive control):

yes

Remarks:

Potassium Dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

72 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Effect concentrations 2

Duration:

72 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Effect concentrations 3

Duration:

72 h

Dose descriptor:

LOEC

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Any other information on results incl. tables

The test item had no significant inhibitory effects on algae growth.

No remarkable observations on the behaviour of the test items were made.

The growth rate in the control was high enough to pass the validity criteria of the test.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

BIBR 277 Nitril at a concentration of 100 mg/L had no significant inhibitory effects on algae growth. Determined paramters were: 72h NOEC = 100 mg/L; 72h LOEC > 100 mg/L and 72h EC50 > 100 mg/L.