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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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given (comparable to guidelines)
Data source
Reference
- Reference Type:
- publication
- Title:
- Tissue distribution, subcellular localization and covalent binding of 2-chloroaniline and 4-chloroaniline in Fischer 344 rats
- Author:
- Dial, LD et al.
- Year:
- 1 998
- Bibliographic source:
- Toxicology, 131: 109-119
Materials and methods
- Objective of study:
- distribution
- excretion
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.36 (Toxicokinetics)
- Deviations:
- yes
- Remarks:
- purity not reported, no metabolites identified, limited investigation of absorption
- Principles of method if other than guideline:
- Radiolabeled 4-chloroaniline hydrochloride (0.5 or 1 mmol/ kg bw) was injected i.p in male Fisher 344 rats tissue distribution and faecal and urinary radioactivity output were determinded 3 h post-dose. An additional third group received 1 mmol/ kg bw and tissue distribution as well as radioactivity output were determined after 24 h.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- 2-chloroaniline
- EC Number:
- 202-426-4
- EC Name:
- 2-chloroaniline
- Cas Number:
- 95-51-2
- Molecular formula:
- C6H6ClN
- IUPAC Name:
- 1-amino-2-chlorobenzene
- Details on test material:
- - Name of test material (as cited in study report): 4-chloroaniline hydrochloride
- Analytical purity: test substance was converted to the resepective hydrochloride and purified
- Radiochemical purity (if radiolabelling): not reported
- Specific activity (if radiolabelling): 8.9 mCi/mmol
- Locations of the label (if radiolabelling): U
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- [14C]-4-chloroaniline
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hilltop Lab Animals (Scottdale, PA)
- Weight at study initiation: 200-260 g
- Fasting period before study: no
- Housing: in standard plastic cages prior to experiment
- Individual metabolism cages: yes, one day prior and then throughout the study
- Diet: prior to experiment ad libitum, fasted during experiment
- Water: ad libitum
- Acclimation period: 1 week acclimation to animal fascility and one day to the metabolism cages
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 40-55
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- water
- Duration and frequency of treatment / exposure:
- single
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0.5 mmol/ kg/ bw, 1 mmol/kg bw
- No. of animals per sex per dose / concentration:
- 4 male rats per dose
- Control animals:
- no
- Positive control reference chemical:
- no
- Details on study design:
- no data
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled (delete / add / specify): urine, faeces, erythrocytes, plasma, kidney (cortex, medulla), liver, spleen
- Time and frequency of sampling: after 3 h and 24 h
METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled: urine and faeces
- Time and frequency of sampling: 3h and 24 h
- From how many animals: 4, pooled
- Method type(s) for identification: Liquid scintillation counting, NMR
- Other: only detection and quantification no identification of metabolites - Statistics:
- values were expressed as means +- standard error.
Annova followed by Dunnett's or Newman-Keuls analysis
p<0.05
Results and discussion
- Preliminary studies:
- no data
Toxicokinetic / pharmacokinetic studies
- Details on distribution in tissues:
- Target organs
In the 0.5 mmol/kg 4-chloroaniline treatment group, liver and kidney medulla had the highest tissue concentrations of radioactivity at 3 hours, while the liver had the highest percentage of injected dose in total tissue (whole organ or kidney section). Plasma radioactivity derived from 4-chloroaniline than in erythrocytes.
Increasing the 4-chloroaniline dose to 1 mmol/kg had little effect on increasing tissue concentrations of 4-chloroaniline-derived radioactivity except in liver.
In blood, erythrocyte concentrations were unchanged (µmol/mL) or decreased (percentage of injected dose/mL), while plasma radioactivity tended to increase, but the increase was not significant.
24 hour post-treatment with 4-chloroaniline 1.0 mmol/kg , kidney, liver, plasma and erythrocyte values of 4-chloroaniline-derived radioactivity were not altered from 3 h values, but splenic concentrations were increased.
Subcellular distribution and covalent binding
In kidney, 4-chloroaniline was located first in cytosolic compartment at 3h post-treatment, regarless of the dose administered. At 24 h post-treatment 4-chloroaniline treatment group only the cytosolic compartment had decreased radioactivity to the corresponding h values. Covalent binding of metabolites were present in liver and kidney
- Details on excretion:
- 30% of the administered radioactivity was excreted in the corresponding 4-chloroaniline group. Fecal excretion accounted for less than 1% of adminisstered radioactivity in both groups at all time points.
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- no qualitative determination of metabolites
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.
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