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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with restrictions (Method shortly described. Analytical purity, housing and feeding conditions were not reported. Only 4 vehicle control used)
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- The local lymph node assay: results of a final inter-laboratory validation under field conditions
- Author:
- Scholes EW, Basketter DA, Sarll AE, Kimber I, Evans CD, Miller K, Robbins MC, Harrison PTC, Waite SJ
- Year:
- 1 992
- Bibliographic source:
- Journal of Applied Toxicology, 12(3):217-222.
- Reference Type:
- review article or handbook
- Title:
- 4-CHLOROANILINE
- Author:
- IPCS-INCHEM
- Year:
- 2 003
- Bibliographic source:
- in: Concise International Chemical Assessment Document 48
- Reference Type:
- secondary source
- Title:
- Chlortoluidine
- Author:
- BUA
- Year:
- 1 990
- Bibliographic source:
- BUA-Report, VCH Weinheim, 1990
- Reference Type:
- review article or handbook
- Title:
- p-Chloranilin, BUA-Stoffbericht 153
- Author:
- BUA
- Year:
- 1 995
- Bibliographic source:
- Beratergremium für umweltrelevante Altstoffe (BUA) der Gesellschaft Deutscher Chemiker, S Hirzel Vorlag, Stuttgart
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Method shortly described. Analytical purity, housing and feeding conditions were not reported. Only 4 vehicle control used.
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
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
- Details on test material:
- - Name of test material (as cited in study report): 4-Chloroaniline
- Analytical purity: no data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Porcellus, Heathfield, Sussex, UK
- Weight at study initiation: 300-350 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- no data
- Concentration / amount:
- Intradermal induction concentration : 0.3%
Topical induction concentration: 10%
Challenge concentration: 2.5%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- no data
- Concentration / amount:
- Intradermal induction concentration : 0.3%
Topical induction concentration: 10%
Challenge concentration: 2.5%
- No. of animals per dose:
- 10 treated animals and 4 controls
- Details on study design:
- p-Chloroaniline was evaluated by Laboratory A using a GPMT based on that described by Magnusson and Kligman. Preliminary skin irritation studies were conducted to determine suitable concentrations of test chemical for induction and elicitation of sensitization. Test guinea pigs (n=10) were sensitized by a series of intradermal injections of a slightly irritant concentration of the test chemical in combination with Freund´s complete adjuvant (FCA) in the shoulder region. Six to eight days a mildly irritant concentration of test chemical was applied over the injection site using a 48 h occluded patch. Control guinea pigs (n=4) were treated similarly, but with vehicle alone. After 12-14 days all animals were challenged with the maximum non-irritant concentration of the test chemical on one clipped andrazoredflank using a 24-h occluded patch. The potential of a test chemical to cause skin sensitization was determined by visual assessment oferythema at the challenge sites, 24 and 48 hours after removal of challenge patches. The sensitization potential was expressed as the percentage of test guinea pigs exhibiting a reaction significantly greater than in control guinea pigs.
- Challenge controls:
- No data
- Positive control substance(s):
- not specified
Results and discussion
- Positive control results:
- no data
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- other: visual assessment of erythema at the challenge sites, 24 and 48 hours after removal of challenge patches
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other: visual assessment of erythema at the challenge sites, 24 and 48 hours after removal of challenge patches. . Hours after challenge: 72.0. Group: test group. Dose level: 2.5%. No with. + reactions: 6.0. Total no. in groups: 10.0.
- Reading:
- other: visual assessment of erythema at the challenge sites, 24 and 48 hours after removal of challenge patches
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 4
- Remarks on result:
- other: Reading: other: visual assessment of erythema at the challenge sites, 24 and 48 hours after removal of challenge patches. . Hours after challenge: 72.0. Group: negative control. Dose level: 2.5%. No with. + reactions: 0.0. Total no. in groups: 4.0.
Any other information on results incl. tables
In the GMPT, 4-Chloroaniline did not elicited positive reactions in the control guinea pigs. 4-Chloroaniline was classified as a moderate sensitizer in GPMT.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information
- Executive summary:
Scholes (1992):
In guinea-pigs, the sensitizing potential of 4-chloroaniline in the guinea-pig maximization test according to Magnusson & Kligman (1969) [similar to OECD guideline 406 with deviations (Method shortly described. Analytical purity, housing and feeding conditions were not reported. Only 4 vehicle controls have been used).
In the GMPT, 4-Chloroaniline did not elicited positive reactions in the control guinea pigs, but induced sensitization in 60 % of the treated animals. Therefore 4-Chloroaniline was classified as a moderate sensitizer in GPMT.
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