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Diss Factsheets
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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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Justification for type of information:
- As m-toluidine hydrochloride dissociates into m-toluidine and hydrochloride the studies concerning the ecotoxicology of m-toludine are considered relevant for the registration according to REACH.
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:
- Cultured Chinese hamster lung (CHL/IU) cells were exposed to m-toluidine up to 1.1 mg/mL with and without metabolic activation. The positive controls gave expected re-sponses.
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- m-toluidine
- EC Number:
- 203-583-1
- EC Name:
- m-toluidine
- Cas Number:
- 108-44-1
- Molecular formula:
- C7H9N
- IUPAC Name:
- m-toluidine
- Test material form:
- not specified
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- Chinese hamster lung (CHL/IU)
- Test concentrations with justification for top dose:
- Highest concentration: 1.1 mg/mL
- Details on test system and experimental conditions:
- Cultured Chinese hamster lung (CHL/IU) cells were exposed to m-toluidine up to 1.1 mg/mL with and without metabolic activation. The positive controls gave expected re-sponses. Structural chromosomal aberrations were not induced up to the highest con-centrations tested. Polyploidy was significantly increased (p < 0.05), but remained within historical controls and was not considered positive.
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster lung (CHL/IU)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Cultured Chinese hamster lung (CHL/IU) cells were exposed to m-toluidine up to 1.1 mg/mL with and without metabolic activation. The positive controls gave expected re-sponses. Structural chromosomal aberrations were not induced up to the highest con-centrations tested. Polyploidy was significantly increased (p < 0.05), but remained within historical controls and was not considered positive. m-Toluidine did not induce chromo-somal aberrations in this assay.
- Executive summary:
As m-toluidine HCl dissociates into m-toluidine and hydrochloride the study is considered relevant for the registration according to REACH.
Cultured Chinese hamster lung (CHL/IU) cells were exposed to m-toluidine up to 1.1 mg/mL with and without metabolic activation. The positive controls gave expected re-sponses. Structural chromosomal aberrations were not induced up to the highest con-centrations tested. Polyploidy was significantly increased (p < 0.05), but remained within historical controls and was not considered positive. m-Toluidine did not induce chromo-somal aberrations in this assay.
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 deemed genotoxic.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.