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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 vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- 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 acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicology and carcinogenesis studies of p-chloroaniline hydrochloride (CAS no. 20265-96-7) in F344/N rats and B6C3F1 mice (gavage studies)
- Author:
- NTP
- Year:
- 1 989
- Bibliographic source:
- U.S. department of health and human services Public Health Service National Institutes of HealthNational toxicology program Technical Report Series No. 351
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Only Salmonella strains tested. No E.coli strain or TA 102
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-chloroanilinium chloride
- EC Number:
- 243-656-5
- EC Name:
- 4-chloroanilinium chloride
- Cas Number:
- 20265-96-7
- IUPAC Name:
- 4-chloroanilinium chloride
- Reference substance name:
- p-chloroaniline hydrochloride
- IUPAC Name:
- p-chloroaniline hydrochloride
- Details on test material:
- - Name of test material (as cited in study report): p-chloroniline hydrochloride
- Analytical purity: >99%
Constituent 1
Constituent 2
Method
- Target gene:
- his+
Species / strain
- Species / strain / cell type:
- other: TA 97, TA 98, TA 100, TA 1535, and/or TA 1537
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague Dawley rat or Syrian hamster liver)
- Test concentrations with justification for top dose:
- SRI international: 0, 33, 100, 333, 1000, 1666 µg/plate;
Microbiological Associates: 0, 33, 100, 333, 1000, 1500, 2000 µg/plate;
Case Western Reserve University: 0, 10, 33, 100, 333, 1000, 3333 µg/plate
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene was used on all strains (+S9). 4-nitro-o-phenylenediamine was used with TA98, sodium-azide was used with TA100 and TA1535, and 9-aminoacridine was used with TA97 and TA1537 (-S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: Each test consisted of triplicate plates of concurrent positive and negative controls and of at least five doses of the study chemical.
DETERMINATION OF CYTOTOXICITY
- Method: no data - Evaluation criteria:
- Positive response was defined as a reproducible, dose-related increase in histidine-independent (revertant) colonies in any one strain/activation combination. An equivocal response was defined as an increase in revertants which was not dose related, not reproducible, or of insufficient magnitude to support a determination of mutagenicity. A response was considered negative when no increase in revertant colonies was observed after chemical treatment.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- other: TA97, TA98, TA100, TA1535, and/or TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- Study performed at Case Western Reserve University
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- other: TA 97, TA100, TA 1535, or TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- TA 97 at high dosis (-S9). Study performed at SRI International.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- other: T98
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Remarks:
- Study performed at SRI international
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- Study performed at SRI international
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- other: TA97, TA98, TA100, TA1535, and/or TA1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Remarks:
- Study performed at Microbiological Associates
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- Weakly positive with + S9 hamster at 5% and 30%; positive + S9 hamster at 10%; positive with +S9 rat between 5-30%. Study performed at Microbiological Associates
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- +S9 (hamster) at 30%
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- other: TA97, TA98, TA100, TA1535, and/or TA1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Remarks:
- Study performed at Microbiological Associates
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive with metabolic activation strain TA98 with rat or Syrian hamster S9 (2 laboratories), strain TA100 (1 laboratory) with hamster S9 only. - Executive summary:
NTP (1989)
p-Chloroaniline has been tested for mutagenicity with a method similar to OECD guideline 471 with restrictions (Only Salmonella strains tested. No E.coli strain or TA 102) in three different laboratories.
Mutagenic activity for p-chloroaniline was observed by two laboratories in strain TA98 in the presence of Aroclor 1254-induced male Sprague Dawley rat or Syrian hamster S9, and one laboratory noted an increase in revertant colonies in strain TA100 in the presence of hamster S9 only.
No mutagenic activity was reported in strains TA97, TA1535, or TA1537.
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