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EC number: 206-885-1 | CAS number: 393-36-2
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 4-bromo-α,α,α-trifluoro-m-toluidine
- EC Number:
- 206-885-1
- EC Name:
- 4-bromo-α,α,α-trifluoro-m-toluidine
- Cas Number:
- 393-36-2
- Molecular formula:
- C7H5BrF3N
- IUPAC Name:
- 4-bromo-α,α,α-trifluoro-m-toluidine
- Test material form:
- solid: crystalline
Constituent 1
- Specific details on test material used for the study:
- Manufacturer: Fuxin Jintelai FluorineBatch No.: 0026DB4 (D150701CC14001)Physical state: solid, crystalline substanceStorage: in a cool, dry
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Species and strain: Crl:(WI)Br ratsSource: TOXI COOP ZRT. Budapest, HungaryHygienic level during the study: good conventionalNumber of animals: 3 animals/groupSex: Female, nulliparous and non pregnant animalsAge of animals: Young adult rat, 8 weeks old in first, second, third and fourth stepBody weight range at starting (first step): 152 - 156 gBody weight range at starting (second step): 157 - 164 gBody weight range at starting (third step): 160 - 164 gBody weight range at starting (fourth step): 170 - 174 gAcclimatization time: 5 days in first step, 6 days in second step, 7 days in third step and 8 days in fourth stepAnimal health: Only healthy animals were used for the study. Health status was certified by the study director.Housing: Group caging (3 animals/cage)Light: Artificial light, from 6 a.m. to 6 p.m.Temperature: 22 ± 3 °CRelative humidity: 30 - 70 %Ventilation: 10-15 air exchanges/hour by central air-condition system.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Helianthi annui oleum raffinatum
- Details on oral exposure:
- A single oral administration - followed by a fourteen-day observation period - was performed by gavage. The day before treatment the animals were fasted. The food but not water was withheld overnight. Animals were weighed before the application and the food was given back 3 hours after the treatment.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3 animals/group
- Control animals:
- no
- Details on study design:
- Starting dose was selected on the basis of the available information about the test item.The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. Since all female animals died the test was continued at 300 mg/kg bw dose level on further three female rats. Two animals were sacrificed as moribund in the second step at 300 mg/kg bw dose level, the test was continued at 50 mg/kg bw dose level on further three female rats. There was no death in third step, so three further female rats were treated with the same (50 mg/kg bw) dose. No animal died in the fourth step, too, so the test was finished, the stopping criteria of Annex 2d of OECD Guideline No. 423. (presented in Appendix VII) was met.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 50 - <= 300 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Three animals died in group 1 treated with 2000 mg/kg bw dose of the test item and two out of three animals were sacrificed as moribund in group 2 treated with 300 mg/kg bw dose of the test item. No death occurred after the single 50 mg/kg bw oral dose of the test item.
- Clinical signs:
- The observed clinical signs were related to the effect of the test item.There was no any effects related to the test item in body weight and body weight gain in the survived animal of group 2 (300 mg/kg bw) and in the animals of group 3 and 4 (50 mg/kg bw) during the study.Autopsy revealed treatment related pathological change as piloerection in group 2 treated with 300 mg/kg bw dose.
- Body weight:
- The body weight and body weight gain data of group 1 (2000 mg/kg bw) could not be evaluated, because of mortalities. In group 2 (300 mg/kg bw) the body weight of the survivor animal corresponded to its species and age throughout the study.In group 3 and 4 (50 mg/kg bw) the mean body weight of the animals corresponded to their species and age throughout the study.
- Gross pathology:
- All rats treated with 2000 mg/kg bw dose (group 1) of the test item spontaneously died during the study. An internal necropsy finding as autolysis was observed in these animals. It is normal physiological process after death.Two rats treated with 300 mg/kg bw dose (group 2) of the test item were sacrificed as moribund. External finding as piloerection and internal necropsy finding as pale kidneys was observed in these animals. External alterations could be related to the test item toxic effect. Pale kidneys could not be related to the test item toxic effect, but was regarded an individual variation. Most likely the observation is a congenital anomaly.The third animal of this dose group survived until the scheduled necropsy on Day 15. No pathological changes were found related to the effect of the test item in this animal.All animals treated with 50 mg/kg bw dose survived until the scheduled necropsy on Day 15. Slight hydrometra was observed in one animal of group 3 and moderate hydrometra was recorded in other animal of group 4. The hydrometra is physiological finding and connected to the cycle of the animal. No pathological changes were found related to the effect of the test item during the macroscopic examination of these animals.
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- The test item 4-BROMO-3-(TRIFLUOROMETHYL)ANILINE (CAS 393-36-2) was ranked into classes of Globally Harmonized Classification System (GHS) Category 3.
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