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EC number: 203-581-0 | CAS number: 108-42-9
- 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
Endpoint summary
Administrative data
Description of key information
A valid oral toxicity guideline study is available. From a secondary source data from an acute inhalation toxicity study is on hand.
Acute dermal LD50 values were determined in a valid dermal toxicity study.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline stdy
- Qualifier:
- according to guideline
- Guideline:
- other: 84/449/EWG
- Principles of method if other than guideline:
- Five male and 5 female Wistar rats received per gavage 100, 250, 312, 400, 500 or 1000 mg m-chloroaniline/kg bw. Animals were observed for mortality, clinical signs and body weight gain during a post-observation period of 14 days. A pathological examination was performed on all animals which died during the observation period or were sacrificed at the end of the study period.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Doses:
- 100, 250, 312, 400, 500 or 1000 mg/kg bw
- No. of animals per sex per dose:
- 5 male and 5 female animals/dose
- Control animals:
- no
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 353 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 400 mg/kg bw
- Based on:
- test mat.
- Executive summary:
Five male and 5 female Wistar rats received per gavage 100, 250, 312, 400, 500 or 1000 mg m-chloroaniline/kg bw. Animals were observed for mortality, clinical signs and body weight gain during a post-observation period of 14 days. A pathological examination was performed on all animals which died during the observation period or were sacrificed at the end of the study period.
The LD50 was approx. 353 mg/kg bw for female and 400 mg/kg bw for male rats.
Reference
At a dose of 100 mg/kg bw a bad general condition, ruffle fur, discharge of the nose, sedation, bloody shout and salivation was observed. Beginning with 250 mg/kg bw most of the animals revealed cyanosis and some animals showed gasping. At a dose of 1000 mg/kg bw 2 females had a lateral position 2 hours after application of the test substance and one female showed convulsions.
Pathological signs of the deceased animals at doses of 400 to 1000 mg/kg bw were changes of the gastrointestinal tract, brownish discoloured and edematuos lungs and at 500 mg/kg bw black discoulered livers. All animals sacrificed at the end of the study revealed no pathological signs.
The LD50 for male rats was ca. 400 mg/kg bw and the approximative LD50 for females was 353 mg/kg bw.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 353 mg/kg bw
- Quality of whole database:
- The materials/methods and results are described in detail und are sufficient for evaluation.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: secondary literature
- Principles of method if other than guideline:
- Determination of LC50 in mice after inhalation
- GLP compliance:
- no
- Test type:
- other: no data
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- inhalation
- Type of inhalation exposure:
- not specified
- Vehicle:
- not specified
- Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 4 h
- Concentrations:
- no data
- No. of animals per sex per dose:
- no data
- Control animals:
- not specified
- Sex:
- not specified
- Dose descriptor:
- LC50
- Effect level:
- 550 mg/m³ air
- Based on:
- not specified
- Exp. duration:
- 4 h
- Executive summary:
The inhalation LC50(mouse) of m-chloroaniline is 550 mg/m³
Reference
no data
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 550 mg/m³ air
- Quality of whole database:
- secondary source (an inhalation study is not required because a reliable oral and dermal study is available)
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 000 mg/kg bw
- Quality of whole database:
- The materials/methods and results are described in detail und are sufficient for evaluation.
Additional information
Five male and 5 female Wistar rats received per gavage 100, 250, 312, 400, 500 or 1000 mg m-chloroaniline/kg bw. Animals were observed for mortality, clinical signs and body weight gain during a post-observation period of 14 days. A pathological examination was performed on all animals which died during the observation period or were sacrificed at the end of the study period.
At a dose of 100 mg/kg bw a bad general condition, ruffle fur, discharge of the nose, sedation, bloody shout and salivation was observed. Beginning with 250 mg/kg bw most of the animals revealed cyanosis and some animals showed gasping. At a dose of 1000 mg/kg bw 2 females had a lateral position 2 hours after application of the test substance and one female showed convulsions.
Pathological signs of the deceased animals at doses of 400 to 1000 mg/kg bw were changes of the gastrointestinal tract, brownish discoloured and edematuos lungs and at 500 mg/kg bw black discoulered livers. All animals sacrificed at the end of the study revealed no pathological signs.
The LD50 was approx. 353 mg/kg bw for female and 400 mg/kg bw for male rats.
A weight of evidence with 3 inhalation studies was conducted and the lowest LC50 is taken for risk assessment.
The LC50 was determined to be 550 mg/m³.
Five male and 5 female Wistar rats were occlusively applied 1000 or 2000 mg m-chloroaniline/kg bw. The test substance was applied on gauze covering about 10% of the body surface and caped with aluminium foil. After 24 hours the test substance was remouved with lukewarm water. The animals were observed for mortality, clinical signs and body weight gain during a post-observation period of 14 days. A pathological examination was performed on all animals which died during the observation period or were sacrificed at the end of the study period.
Signs of intoxicition at a dose of 2000 mg/kg bw were cyanosis and sedation on male and female rats. A single female rats showed at a dose of 1000 mg/kg bw cyanosis, gaunt flanks and a bad general condition. All other animals revealed no symptoms at a dose of 1000 mg/kg bw.
The LD50 is > 1000 and < 2000 mg/kg bw for female rats and ca. 2000 mg/kg bw for male rats.
Justification for selection of acute toxicity – oral endpoint
The most reliable study was used as key study and for classification.
Justification for selection of acute toxicity – inhalation endpoint
A weight of evidence with 3 studies was conducted and the lowest LC50 is taken for risk assessment
Justification for selection of acute toxicity – dermal endpoint
The most reliable study was used as key study and for classification.
Justification for classification or non-classification
LD50(oral) = 353 mg/kg bw
LC50(inhalation) = 550 mg/m³
LD50(dermal) > 1000 mg/kg bw
The primary toxic effect of m-chloroaniline is methemoglobin formation.
Therefore the classifcation based on the key values for chemicals safety assessment is one level stronger compared with the classification according to Directive 67/548 (EEC) and Regulation (EC) 1272/2008.
A classification as R25, R23 and R24 (GHS: Acute Tox 3;H301, Acute Tox. 2; H330 and Acute Tox.3; H311) is justified.
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