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Diss Factsheets
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EC number: 203-401-0 | CAS number: 106-47-8
- 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:
- genetic toxicity in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study Report from 1986/1987, but main requirements of the test guideline are fulfilled.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1987
- Reference Type:
- review article or handbook
- Title:
- p-Chloranilin, BUA-Stoffbericht 151
- Author:
- BUA
- Year:
- 1 995
- Bibliographic source:
- Beratergremium für umweltrelevante Altstoffe (BUA) der Gesellschaft Deutscher Chemiker, 1995
Materials and methods
- Principles of method if other than guideline:
- Micronucleus test
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-chloroaniline
- EC Number:
- 203-401-0
- EC Name:
- 4-chloroaniline
- Cas Number:
- 106-47-8
- Molecular formula:
- C6H6ClN
- IUPAC Name:
- 4-chloroaniline
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: CFLP
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Softwood sawdust bedding material, 24 hour cycle of 12 hours light/12 hours dark; room temperature 21 +/- 2 °C, tap water and Heygate´s rat and mouse diet 41B.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: suspended in 0.25% Gum Tragacanth
- Duration of treatment / exposure:
- 24, 48, and 72 hours
- Frequency of treatment:
- single exposure
Doses / concentrations
- Remarks:
- Doses / Concentrations:
180 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Doses / concentrations: 40 mg/kg bw
Examinations
- Tissues and cell types examined:
- Femur bone marrow
Results and discussion
Test resultsopen allclose all
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Sex:
- female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Mean Frequency of micronucleus formation % |
||||||||||
Treatment 24 hours | 48 hours | 72 hours | ||||||||
M | F | Total | M | F | Total | M | F | Total | ||
Negative control | 0.29 | 0.20 | 0.24 | 0.14 | 0.08 | 0.11 | 0.27 | 0.00 | 0.14 | |
Positive control | 0.91 | 1.06 | 0.99 | |||||||
180 mg/kg 4 -chloraniline |
0.40 | 0.18 | 0.29 | 0.29 | 0.18 | 0.23 | 0.23 | 0.06 | 0.15 |
p-chloroaniline is negative in the micronucleus test in the mouse at the maximum tolerated oral dose (180 mg/kg body weight). There was one female outlier after 48 hours, therefore that dose group was repeated and revealed a negative response. Overall there was a slight decrease of the mean ratio PCE/NCE not enough to show a toxic effect on erythropoiesis, but indicating that the bone marrow was reached by the test substance.
- The dose was selected based on a range-finding study using 4, 20, 100 and 500 mg/kg (3 male and 3 female mice/group). All the females and one male dosed with 500 mg/kg died, but non dosed with 100 mg/kg. A LD50 of 225 mg/kg bw was derived from these data, with a maximum tolerated dose of 180 mg/kg,
The positive control group showed the expected positive response.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
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