2-(m-benzoylphenyl)propionitrile

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:

Experimental starting: 16 March, 2009 - experimental completion: 19 March, 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study according to international guideline

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-(m-benzoylphenyl)propionitrile

EC Number:

255-982-5

EC Name:

2-(m-benzoylphenyl)propionitrile

Cas Number:

42872-30-0

Molecular formula:

C16H13NO

IUPAC Name:

2-(3-benzoylphenyl)propanenitrile

Details on test material:

TEST ITEM: Ketoprofen I BPPN
Batch Number: F-CHN-080080-01
Chemical name: 2-(3-Benzoylphenyl)propionitrile
Content: 98.94%
Appearance: Off white powder
Expiry date: 2009-08-12
Recommended storage: Refrigerator, protected from moisture and light
Storage at test facility: 6 ± 2 °C, protected from moisture and light
Retention of test item: At least 1 g has been retained.

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

- Concentrations: dilution levels 1:1 to 1:8 were diluted with mobile phase
- Sampling method: According to ICH Harmonised Tripartite Guideline (1996) and SANCO 3029/99 rev.4 (2000).
- Sample storage conditions before analysis: All samples were stored at 6 ± 2 °C until start of analysis if necessary.
- Evaluation: Quantification of the active ingredient was calculated by peak area based on the external standard.

Test solutions

Details on test solutions:

Stock solution: The stock solution (100 mg/L test item was weighed out) was prepared with dilution water one day prior to application.
Test dilutions of the saturated solution: 1:1 -1:2- 1:4-1:8-1:16 (factor 2) (Equivalent to geometric mean measured test item concentrations: 1.49- 2.90- 6.01 - 12.2- 24.7 mg/L).

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Daphnia magna
- Strain: STRAUS (Clone 5)
- Source: lnstitut für Wasser-, Boden- und Lufthygiene (WaBolu)
- Age at study initiation: 2 to 24 h old daphnids were used for the definitive study. They were obtained by removing the mother animals twice within 22 h.
- Feeding during test: The daphnids were not fed during the study.
- Food type: a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata,Desmodesmus subspicatus and Chlorella vulgaris, with an algae cell density of> 10^6 cells/ml.

ACCLIMATION
- Acclimation period: at least 2 h in dilution water
- Acclimation conditions: Diffuse light, illumination strength max. 20 µE.m-2 . s-1, photoperiod: 16/8h ligh/dark cycle
- Type and amount of food: a mix of unicellular green algae, e.g. Pseudokirchneriella subcapitata,Desmodesmus subspicatus and Chlorella vulgaris, with an algae cell density of> 10^6 cells/ml.
- Feeding frequency: At least 5 times per week ad libitum

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Hardness:

Total hardness: 271 mg CaCO3/L

Test temperature:

18 - 22 °C, ± 1 °C constant

pH:

At test start: From 7.69 to 7.72

Dissolved oxygen:

At test start (0h, new media)
From 6.67 to 8.21 mg/l
Control: 8.32 mg/l

Salinity:

Conductivity: 656 µS/cm

Nominal and measured concentrations:

Geometric Mean Measured Concentration [mg/L]: 1.49, 2.90, 6.01, 12.2, 24.7 mg/l

Details on test conditions:

TEST SYSTEM
- Test vessel: Glass beakers (4 cm ID x 7 cm H), 50 ml capacity
- Fill volume: 20 mL
- No. of organisms per vessel: 20 animals, divided into 4 parallel samples, each with 5 animals per dilution level and control

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: According to Directive 92/69/EEC Method C.2, Annex 1
- Culture medium: Elendt M4, according to ELENDT (1990), modified to a total hardness of 160 to 180 mg CaC03/L.

OTHER TEST CONDITIONS
- Photoperiod: 16h illumination
- Light intensity: illumination strength max. 20 µE.m-2.S-1 .

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2

Reference substance (positive control):

yes

Remarks:

Potassium dichromate

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

24 h

Dose descriptor:

EC10

Effect conc.:

5.38 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 2

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

6.28 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 6.13 - 6.43

Effect concentrations 3

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

4.17 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 2.90 - 6.01

Effect concentrations 4

Duration:

24 h

Dose descriptor:

EC100

Effect conc.:

12.2 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 5

Duration:

48 h

Dose descriptor:

EC100

Effect conc.:

6.01 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 6

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

2.9 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Effect concentrations 7

Duration:

48 h

Dose descriptor:

LOEC

Effect conc.:

6.01 mg/L

Nominal / measured:

meas. (geom. mean)

Conc. based on:

test mat.

Basis for effect:

mobility

Results with reference substance (positive control):

EC50= 1.95 mg/L (Cl 1.80- 2.12 mg/L). The EC50-value of the reference item potassium dichromate after 24 h is within the prescribed concentration range of 1.0 - 2.5 mg/L of quality criteria according to AQS P 9/2 (05/1996) for daphnids clone 5 cultured in Elendt M4 medium. The EC50-value of the reference item is also within the recommended range of 0.6 - 2.1 mg/L according to OECD-Guideline 202.

Any other information on results incl. tables

No data

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

In this study Ketoprofen / BPPN was found to be toxic to Daphnia magna after 48 h at concentrations of 6.01 mg/l (LOEC48 h) and higher.
The EC50 (48 h) was determined to be 4.17 mg/l. The NOEC after 48 hours was 2.90 mg/l.
All effect values are given based on the geometric mean measured concentrations of the test item Ketoprofen / BPPN.