4-Bromo-2-fluoro-N-methylbenzamide

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:

11 Sep 2020 to 24 Sep 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Version / remarks:

April 2004

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Guidance Document on Aqueous-phase Aquatic Toxicity Testing of Difficult Test Chemicals, OECD series on testing and assessment number 23 (2nd edition)

Version / remarks:

February 2019

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-Bromo-2-fluoro-N-methylbenzamide

EC Number:

808-257-8

Cas Number:

749927-69-3

Molecular formula:

C8H7BrFNO

IUPAC Name:

4-Bromo-2-fluoro-N-methylbenzamide

Test material form:

solid: particulate/powder

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- lot/batch number of test material: FFP-106-200011
- Expiry date: 17 March 2021 (retest date)
- Physical Description: Almost white powder
- Purity: 99.0%
- Purity correction factor: not required
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature
- Stability under test conditions: not indicated
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium: not indicated

Sampling and analysis

Analytical monitoring:

yes

Details on sampling:

Sampling method: Samples for possible analysis were taken from all test concentrations and the control at t=0 and t=48h. 1.5 mL of volume was taken from the approximate centre of the test vessels. Samples were stored in a freezer (≤-15°C) until analysis at the analytical laboratory of the Test Facility. At the end of the exposure period, the replicates were pooled at each concentration before sampling.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Preparation of test solutions started with the highest concentration of 100 mg/L applying a fifteen-minute period of ultrasonic waves followed by a one-hour period of magnetic stirring to accelerate dissolution of the test item in test medium. Lower test concentrations were prepared by subsequent dilutions of the highest concentration in test medium.
- Evidence of undissolved material (e.g. precipitate, surface film, etc.): All test solutions were clear and colorless at the end of the preparation procedure.

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water-flea
- Straus, 1820
- Source: in-house laboratory culture with a known history
- Age at study initiation (mean and range, SD): < 24 h (from parental daphnids of more than 2 weeks old, maximum age 4 weeks)
- Method of breeding: 250 newborn daphnids (i.e. less than 3 days old) are placed into 5 liters of medium in an all-glass culture vessel. Medium is M7. After 7 days of cultivation half of the medium is renewed twice a week.
- Feeding during cultivation: fresh water algae, daily
- Feeding during test: no
ACCLIMATION
- Acclimation period: not relevant

Study design

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Test conditions

Hardness:

The hardness of test medium expressed as CaCO3: 180 mg/L

Test temperature:

19-20 °C

pH:

At t=0h: 7.5
At t=48h: 7.9 - 8.0

Dissolved oxygen:

At t-0h: 8.5 - 8.9
At t-48h: 9.0 - 9.1

Salinity:

Not relevant

Nominal and measured concentrations:

nominal: 0.10, 1.0, 10 and 100 mg/L

Samples taken from the highest test concentration and the control were analysed. The measured concentration at the start of the test was 98 mg/L. The concentration remained stable during the 48-hour exposure period, i.e. was at 95% relative to the initial concentration at the end of the test. No test item was detected in the control sample. Based on these results, effect parameters were expressed as analytically confirmed nominal concentrations

Details on test conditions:

TEST SYSTEM
- Test vessel: beaker
- Material, size, headspace, fill volume: 60mL, glass beaker filled with 50 mL
- Aeration: not during the test
- no feeding
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4 for the highest concentration, 2 for the intermediate concentrations
- No. of vessels per control (replicates): 4
- Test medium: adjusted ISO medium
OTHER TEST CONDITIONS
- Photoperiod: 16h light daily
EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Immobility was defined as those organisms which are not able to swim within 15 seconds after gentle agitation of the test container and was monitored after 24 and 48 hours of continuous treatment with the test substance.
TEST CONCENTRATIONS
- setup: combined range finder/limit test

Reference substance (positive control):

yes

Remarks:

potassium dichromate

Results and discussion

Effect concentrations

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Details on results:

- Immobility of control: none
- Other adverse effects control: no
- Abnormal responses: none
- EC50 (24) > 100 mg/L

Results with reference substance (positive control):

- Results with reference substance valid? yes
- The batch of Daphnia magna tested, showed expected sensitivity to Potassium dichromate based on the range specified in ISO International Standard 6341, October 2012. The raw data from this study are kept in the Charles River Den Bosch archives. The test described above was performed non-GLP.

Reported statistics and error estimates:

No EC50 could be calculated because the test item proved to be non-toxic (EC50 > maximum soluble concentration tested).

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Toxicity of T003669 towards Daphnia magna was tested during exposure of 48 hours according to OECD 202 guideline. In conclusion, the 48h-EC50 for Daphnia magna exposed to JNJ-61789975-AAA (T003669) was beyond the range of concentrations tested, i.e. exceeded an analytically confirmed nominal concentration of 100 mg/L.