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EC number: 207-317-5 | CAS number: 461-82-5
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- August 1984 to February 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- 4-(trifluoromethoxy)aniline
- EC Number:
- 207-317-5
- EC Name:
- 4-(trifluoromethoxy)aniline
- Cas Number:
- 461-82-5
- Molecular formula:
- C7H6F3NO
- IUPAC Name:
- 4-(trifluoromethoxy)aniline
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other:
- Remarks:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 26-38 g
- Assigned to test groups randomly: yes
- Fasting period before study: no
- Housing: Housed 3-5 mice per cage by sex and test group in Makrolon cages type I or Type II
- Diet: Altromin 1324 (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water ad libitum
- Acclimation period: minimum of one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 24-26
- Humidity (%): 72-85
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours electric lighting
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: peanut oil
- Amount of vehicle (if gavage or dermal): 5 mL/kg bw - Details on exposure:
- the test item was dissolved in peanut oil and given orally by gavage; no further details are available
- Duration of treatment / exposure:
- not applicable since single oral application by gavage
- Frequency of treatment:
- single exposure
- Post exposure period:
- 24, 48, and 72 hours post exposure
Doses / concentrations
- Dose / conc.:
- 66 mg/kg bw/day
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Endoxan dissolved in demineralized water
- Justification for choice of positive control(s): known as mutagen and cytostatic
- Route of administration: orally
- Doses / concentrations: 29 mg/kg bw or equivalent to 20 mg/kg bw in relation to the active ingredient cyclophosphamide
Examinations
- Tissues and cell types examined:
- Femoral marrow smears were prepared according to the method of Schmid (1975) and polychromatic erythrocytes (PCE's) were examined for micronuclei.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Doses were based on a pilot study, in which groups of 5 animals were orally administered 0.05 mL/kg, 0.075 mL/kg and 0.1 mL/kg test substance. Doses of 0.05 mL/kg were tolerated with cyanosis and somnolence, while 2/5 animals died after being administered 0.075 mL/kg. Three out of 5 animals administered 0.1 mL/kg died.
TREATMENT AND SAMPLING TIMES Animals were administered the test material once. At times of 24, 48, and 72 hours after administration, the animals were sacrificed by decapitation and the femoral marrow smears were prepared. Smears from the negative and positive controls were produced only after 24 hours.
METHOD OF ANALYSIS: A minimum of 1000 PCE's were examined microscopically for each animal per sample time. The PCE/normochromatic erythrocyte (NCE) ratio for approximately 1000 total cells was calculated and recorded. The number of micronucleated PCE/1000 NCE was recorded. - Evaluation criteria:
- A test result is considered to be negative if no statistically significant or dose related increases are apparent between the vehicle control and groups of treated animals.
- Statistics:
- The highest values in the treated animals and positive controls were statistically evaluated with Wilcoxon's non-parametric rank sum test.
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- cyanosis lasting up to 6 hours
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In a study conducted in a similar manner to OECD 474, there were no indications of a clastogenic effect after mice were treated with 0.05 mL/kg bw of 4-trifluoromethoxyaniline, corresponding to a dose level of 66 mg/kg bw (conversion based on density 1.32 g/mm3).
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