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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
Groups of 10 male and 10 female F344/N rats and B6C3F1 mcie were administered 0, 10, 20, 40, 80, or 160 mg m-chloroaniline per kilogram body weight in dilute hydrochloric acid by gavage 5 days a week for 13 weeks. Animals were evaluated for hematology, clinical chemistry, histopathology, and reproductive system effects.
Groups of 16 mal Crl:CD rats were exposed head-only, 6 hrs/day, 5 days/week, for 2 weeks to either 6, 30 or 50 ppm( = ca. 31.8, 159 or 265 mg/m³) m-chloroaniline. A control group was simultaneously exposed to air only. Animals were evaluated for clinical and histopathological lesions following 10 exposures and after a 14-day recovery period.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic 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 study
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- Groups of 10 male and 10 female F344/N rats were administered 0, 10, 20, 40, 80, or 160 mg m-chloroaniline per kilogram body weight in dilute hydrochloric acid by gavage 5 days a week for 13 weeks. Animals were evaluated for hematology, clinical chemistry, histopathology, and reproductive system effects.
- GLP compliance:
- yes
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Route of administration:
- oral: gavage
- Vehicle:
- other: 1 M hydrochloric acid
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- 5 days a week for 13 weeks
- Remarks:
- Doses / Concentrations:
0, 10, 20, 40, 80, or 160 mg m-chloroaniline per kilogram body weight
Basis:
actual ingested - No. of animals per sex per dose:
- 10 male and 10 female rats/dose
- Control animals:
- yes, concurrent vehicle
- Dose descriptor:
- LOAEL
- Effect level:
- 10 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Hematotoxicity
- Critical effects observed:
- not specified
- Executive summary:
Groups of 10 male and 10 female F344/N rats were administered 0, 10, 20, 40, 80, or 160 mg m-chloroaniline per kilogram body weight in dilute hydrochloric acid by gavage 5 days a week for 13 weeks. Animals were evaluated for hematology, clinical chemistry, histopathology, and reproductive system effects.
The hematopoietic system was the target of m-chloroaniline in rats. One female rat in the 160 mg/kg m-chloroaniline group during week 12, possibly secondary to methemoglobinemia. The final mean body weights and weight gains of male rats in the highest dose group were significantly less than those of the respective controls. Clinical findings of toxicity included a transient bluish discoloration of the genital and footpad regions in rats administered m-chloroaniline; these effects occurred primarily in the 80 and 160 mg/kg groups. Methemoglobin concentrations were increased in dosed rats and resulted in a secondary anemia; the severity of the anemia increased with increasing dose. Microscopic lesions considered related to chemical administration in included hemosiderin pigmentation in the bone marrow, kidney, liver, and spleen; hematopoiesis in the liver and spleen; and erythroid cell hyperplasia in the bone marrow. These lesions reflected the response to hemolytic anemia and methemoglobinemia induced by chloroanilines.
The LOAEL is 10 mg/kg bw in this study.
Reference
The hematopoietic system was the target of m-chloroaniline in rats. One female rat in the 160 mg/kg m-chloroaniline group during week 12, possibly secondary to methemoglobinemia. The final mean body weights and weight gains of male rats in the highest dose group were significantly less than those of the respective controls. Clinical findings of toxicity included a transient bluish discoloration of the genital and footpad regions in rats administered m-chloroaniline; these effects occurred primarily in the 80 and 160 mg/kg groups. Methemoglobin concentrations were increased in dosed rats and resulted in a secondary anemia; the severity of the anemia increased with increasing dose. Microscopic lesions considered related to chemical administration in included hemosiderin pigmentation in the bone marrow, kidney, liver, and spleen; hematopoiesis in the liver and spleen; and erythroid cell hyperplasia in the bone marrow. These lesions reflected the response to hemolytic anemia and methemoglobinemia induced by chloroanilines.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEL
- 10 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Guideline study according OECD 408
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: secondary literature
- Principles of method if other than guideline:
- Groups of 16 mal Crl:CD rats were exposed head-only, 6 hrs/day, 5 days/week, for 2 weeks to either 6, 30 or 50 ppm( = ca. 31.8, 159 or 265 mg/m³) m-chloroaniline. A control group was simultaneously exposed to air only. Animals were evaluated for clinical and histopathological lesions following 10 exposures and after a 14-day recovery period.
- GLP compliance:
- no
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male
- Route of administration:
- other: vapour/aerosol
- Type of inhalation exposure:
- head only
- Vehicle:
- air
- Remarks on MMAD:
- MMAD / GSD: no data
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 2 weeks
- Frequency of treatment:
- 6 hrs/day, 5 days/week, for 2 weeks
- Remarks:
- Doses / Concentrations:
6, 30 or 50 ppm( = ca. 31.8, 159 or 265 mg/m³) m-chloroaniline
Basis:
nominal conc. - No. of animals per sex per dose:
- 16 animals/dose
- Control animals:
- yes, concurrent vehicle
- Dose descriptor:
- LOAEC
- Effect level:
- 32 mg/L air (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: extramedullary hematopoesis, hemosiderin deposits in spleen, methemoglobinemia
- Critical effects observed:
- not specified
- Executive summary:
Groups of 16 mal Crl:CD rats were exposed head-only, 6 hrs/day, 5 days/week, for 2 weeks to either 6, 30 or 50 ppm( = ca. 31.8, 159 or 265 mg/m³) m-chloroaniline. A control group was simultaneously exposed to air only. animals were evaluated for clinical and histopathological lesions following 10 exposures and after a 14-day recovery period.
During and immediately following exposure, rats in the 30 and 50 ppm dose groups were slight to moderately cyanotic. Slight increase in body weights were observed in all test groups during exposure and recovery.
Clinical pathological examinations revealed a dose-dependent effect of m-chloroaniline on several hematologic parameters. Decrease in erythrocyte count, hemoglobin content, and hematocrit and increase in leucocytes, immature erythrocytes, mean cell volume and mean cell hemoglobin resulted from 10 exposures to all exposure levels.
Pathologic examinations revealed dose-dependent microscopic changes in hematopoetic tissues consistent with the development of hemolytic anemia and subsequent extramodullary hematopoesis.
Reference
During and immediately following exposure, rats in the 30 and 50 ppm dose groups were slight to moderately cyanotic. Slight increase in body weights were observed in all test groups during exposure and recovery.
Clinical pathological examinations revealed a dose-dependent effect of m-chloroaniline on several hematologic parameters. Decrease in erythrocyte count, hemoglobin content, and hematocrit and increase in leucocytes, immature erythrocytes, mean cell volume and mean cell hemoglobin resulted from 10 exposures to all exposure levels.
Pathologic examinations revealed dose-dependent microscopic changes in hematopoetic tissues consistent with the development of hemolytic anemia and subsequent extramodullary hematopoesis.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LOAEC
- 32 mg/m³
- Study duration:
- subacute
- Species:
- rat
- Quality of whole database:
- secondary literature - therefore reliability 4
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In the subchronic oral gavage study, the hematopoietic system was the target of m-chloroaniline in rats and mice. Methemoglobin concentrations were increased in dosed rats and mice studies and resulted in a secondary anemia; the severity of the anemia increased with increasing dose. Microscopic lesions considered related to chemical administration in rats and mice included hemosiderin pigmentation in the bone marrow, kidney, liver, and spleen; hematopoiesis in the liver and spleen; and erythroid cell hyperplasia in the bone marrow. These lesions reflected the response to hemolytic anemia and methemoglobinemia induced by the chloroanilines. In both studies the LOAEL is 10 mg/kg bw (lowest applied dose).
In the subacute inhalation study, during and immediately following exposure, rats in the 30 and 50 ppm dose groups were slight to moderately cyanotic. Clinical pathological examinations revealed a dose-dependent effect of m-chloroaniline on several hematologic parameters. Decrease in erythrocyte count, hemoglobin content, and hematocrit and increase in leucocytes, immature erythrocytes, mean cell volume and mean cell hemoglobin resulted from 10 exposures to all exposure levels. Pathologic examinations revealed dose-dependent microscopic changes in hematopoetic tissues consistent with the development of hemolytic anemia and subsequent extramodullary hematopoesis. The LOAEL was 32 mg/m³ (lowest applied dose).
Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
2 valid guideline studies on rats and mice conducted by the same test laboratory are available. m-chloroaniline has the same pattern of toxicity in rats and mice - but rats rats are more sensitive towards the test substance than mice.
Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:
only repeated dose results from a secondary soucre for inhalation is available
Repeated dose toxicity: via oral route - systemic effects (target organ) cardiovascular / hematological: other
Repeated dose toxicity: inhalation - systemic effects (target organ) cardiovascular / hematological: other
Justification for classification or non-classification
In the 90-day oral gavage studies in rats and mice, the hematopoietic system was the target of m-chloroaniline. Hematotoxicity occured at all doses (LOAEL = 10 mg/kg bw).
In the 14 day inhalation study in rats, clinical pathological examinations revealed a dose-dependent effect of m-chloroaniline on several hematologic parameters. Pathologic examinations revealed dose-dependent microscopic changes in hematopoetic tissues consistent with the development of hemolytic anemia and subsequent extramodullary hematopoesis. Hematotoxicity occured at all doses (LOAEL = 32 mg/m³).
Based on these results, a classification as R48/23 (GHS: STOT RE 1; H372) is justified.
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