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Diss Factsheets
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EC number: 206-735-5 | CAS number: 371-40-4
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Peer reviewed publication.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 984
Materials and methods
- Objective of study:
- metabolism
Test guideline
- Qualifier:
- no guideline available
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 4-fluoroaniline
- EC Number:
- 206-735-5
- EC Name:
- 4-fluoroaniline
- Cas Number:
- 371-40-4
- Molecular formula:
- C6H6FN
- IUPAC Name:
- 4-fluoroaniline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Sittingbourne Research Centre, Shell Research Limited
- Weight at study initiation: 220-267 g (test for methaemoglobin content), 216-309 g (test for isolation and identification of the metabolites), 218- 281 g (test for metabolite excretion)
- Fasting period before study: Overnight and the following morning
- Housing: Glass metabolism cages
- Individual metabolism cages: No, two per cage
- Diet: free access to food 1 h after dosing
- Water: ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS
Test substance: Prepared no more than 24 h before administration
VEHICLE
- Amount of vehicle: Dose in 2 mL per kg of corn oil
Doses / concentrations
- Remarks:
- Doses / Concentrations:
14, 28, 56, 112 mg/kg bw (0.13, 0.25, 0.5, 1 mmol/kg)
- No. of animals per sex per dose / concentration:
- 4
- Control animals:
- yes, concurrent vehicle
- Positive control reference chemical:
- 4-Chloroaniline (1 mmol/kg)
- Details on study design:
- Two different approaches were investigated: Analysis of urinary metabolites and determination of methaemoglobin content in blood.
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: Blood
- Time and frequency of sampling: 1 h before, and at 1, 2, 4, 6, 8 and 24 h after dosing
- Limit detection of exposure: 5 mg/kg bw, when methaemoglobinaemia is greatest
METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled: Urine
- Time and frequency of sampling: 0 to 24 h
- From how many animals: 10
- Method type for identification NMR
- Limits of detection: The limit of detection of the analytical method was of the order of 0.1 µg/mL expressed as parent fluoroanilie.
Results and discussion
Main ADME results
- Type:
- metabolism
- Results:
- Identified metabolite: ortho-sulphate of 2 amino-5-fluorophenol
Toxicokinetic / pharmacokinetic studies
- Details on excretion:
- The excretion of urinary conjugated aminophenols in the male rat after oral administration is rapid.
Only very low concentrations of these urinary metabolites were detected on the second day after dosing.
Metabolite characterisation studies
- Metabolites identified:
- yes
- Details on metabolites:
- At all doses the maximum methaemoglobinaemia occurs rapidly, within 1 or 2 h, indicating that both absorption and metabolism to the oxidised derivatives (Kiese and Uehleke 1961; Kampffmeyer and Kiese 1964) is rapid.
The test substance is a potent inducers of methaemoglobinaemia in the rat.
The amount of methaemoglobin induced is proportional to the dose administered and varies rapidly with the time since dosing.
39% of the test substance dose is metabolised by rats to the corresponding o-sulphate of 2 amino-5-fluorophenol, which is excreted in the urine.
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.