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EC number: 808-257-8 | CAS number: 749927-69-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 2 021
- Report date:
- 2021
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
- Version / remarks:
- April 2004
- Deviations:
- no
- 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
- 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
Constituent 1
- 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.
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