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EC number: 211-314-4 | CAS number: 638-03-9
- 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
Carcinogenicity
Administrative data
- Endpoint:
- carcinogenicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- publication
- Title:
- Screening-level hazard characterization: Monocyclic aromatic amines category
- Author:
- U.S. Environmental Protection Agency
- Year:
- 2 009
- Bibliographic source:
- U.S. Environmental Protection Agency, September 2009, pp1-32
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- 25 SD rats (sex unspecified) were administerd with 8,000 ppm and 16,000 ppm (400 mg/kg bw and 800 mg/kg bw, respectively) m-toluidine HCl for 13 weeks; then with 4,000 ppm and 8,000 ppm (200 mg/kg bw and 400 mg/kg bw, respectivly) for 65 weeks.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- m-toluidinium chloride
- EC Number:
- 211-314-4
- EC Name:
- m-toluidinium chloride
- Cas Number:
- 638-03-9
- Molecular formula:
- C7H9N.ClH
- IUPAC Name:
- 3-methylanilinium chloride
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- 25 SD rats per dose
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 13 weeks with 400 mg/kg bw and 800 mg/kg bw;
65 weeks with 200 mg/kg bw and 400 mg/kg bw - Frequency of treatment:
- once daily
- No. of animals per sex per dose:
- 25 animals, sex unspecified
- Control animals:
- not specified
- Details on study design:
- 25 Sprague-Dawley rats per dose group (sex unspecified) were administered m-toluidine HCl in the diet at 8,000 and 16,000 ppm (400 and 800 mg/kg bw/d) for 13 weeks, then 4000 and 8,000 ppm (200 and 400 mg/kg bw/d) for 65 weeks. A greater than 10% reduction in body weight gain and death was observed at 400 and 800 mg/kg bw/d following 13 weeks, therefore the dosages were reduced to 200 and 400 mg/kg bw/d for the remaining 65 weeks.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- A greater than 10% reduction in body weight gain and death was observed at 400 and 800 mg/kg bw/d following 13 weeks, therefore the dosages were reduced to 200 and 400 mg/kg bw/d for the remaining 65 weeks.
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- A greater than 10% reduction in body weight gain and death was observed at 400 and 800 mg/kg bw/d following 13 weeks, therefore the dosages were reduced to 200 and 400 mg/kg bw/d for the remaining 65 weeks.
- Food consumption and compound intake (if feeding study):
- not specified
- Relevance of carcinogenic effects / potential:
- After reduction of dosage, no increase in tumours was observed. There was no evidence of carcinogenicity in this assay.
Effect levels
- Key result
- Dose descriptor:
- dose level: mg/kg bw
- Effect level:
- >= 200 - <= 400 mg/kg diet
- Based on:
- not specified
- Sex:
- not specified
- Basis for effect level:
- other: no tumour development was observed
- Remarks on result:
- other: Effect typs: carcinogenicity
Applicant's summary and conclusion
- Conclusions:
- In a chronic toxicity study, 25 Sprague-Dawley rats per dose group (sex unspecified) were administered m-toluidine HCl in the diet at 8,000 and 16,000 ppm (400 and 800 mg/kg bw/d) for 13 weeks, then 4000 and 8,000 ppm (200 and 400 mg/kg bw/d) for 65 weeks. A greater than 10% reduction in body weight gain and death was observed at 400 and 800 mg/kg bw/d following 13 weeks, therefore the dosages were reduced to 200 and 400 mg/kg bw/d for the remaining 65 weeks. No increase in tumours was observed. There was no evidence of carcinogenicity in this assay.
- Executive summary:
In a chronic toxicity study, 25 Sprague-Dawley rats per dose group (sex unspecified) were administered m-toluidine HCl in the diet at 8,000 and 16,000 ppm (400 and 800 mg/kg bw/d) for 13 weeks, then 4000 and 8,000 ppm (200 and 400 mg/kg bw/d) for 65 weeks. A greater than 10% reduction in body weight gain and death was observed at 400 and 800 mg/kg bw/d following 13 weeks, therefore the dosages were reduced to 200 and 400 mg/kg bw/d for the remaining 65 weeks. No increase in tumours was observed. No other details were provided. There was no evidence of carcinogenicity in this assay.
No information on the TG is given. As the information has been published by the EPA and is publicly available, the study has been rated as Klimisch 2.
m-toluidine HCl is not classified as carcinogetic.
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