Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 3 (not reliable)
- 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 followed
- Principles of method if other than guideline:
- A range finding study was conducted to determine the initial dose.
3 doses tested, 10 male animals/dose, single dose by gavage, observation period up to 14 d. - GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
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
- Specific details on test material used for the study:
- test material was in liquid form
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- 10 young adult males per dose
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Single oral applicable via gavage
- Doses:
- Diluted by corn oil:
700 mg/kg bw, 1000 mg/kg bw, 1350 mg/kg bw - No. of animals per sex per dose:
- 10
- Control animals:
- not specified
- Details on study design:
- The range-finding study was run with 1 rat per dose for levels of 100-3500 mg/kg bw and produced death at 1500 mg/kg bw and above.
Main study:
Single oral application by gavage to 10 male rats and observation for 14 days. The surviving rats were weighed and observed during a 14-day recovery period and then sacrificed. The LD50 value was calculated from the mortality data using probit analysis of DJ Finney, 1971, Cambridge University Press. - Statistics:
- probit analysis
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 922 mg/kg bw
- 95% CL:
- >= 792 - <= 1 054
- Remarks on result:
- other: clinical signs included lacrimation, stained face, chromodacryorrhea, stained and wet perineal area, cyanosis, moribundity and moderate weight loss
- Mortality:
- 1350 mg/kg bw: 10/10 all deaths occurred wintin 2 days after dosing
1000 mg/kg bw: 6/10 all deaths occurred within 3 days after dosing
700 mg/kg bw: 1/10 death occurred 2 days after dosing - Clinical signs:
- other: clinical signs included lacrimation, stained face, chromodacryorrhea, stained and wet perineal area, cyanosis, moribundity and moderate weight loss
- Other findings:
- not applicable
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- 10 male young adult rats were given one dose of m-touidine diluted in corn oil at concentrations of 700 mg/kg bw, 1000 mg/kg bw and 1350 mg/kg bw resulting in an LD50 of 922 mg/kg bw. All deaths occurred within 3 days after dosing.
Clinical signs included lacrimation, stained face, chromodacryorrhea, stained and wet perineal area, cyanosis, moribundity and moderate weight loss. - Executive summary:
As m-toluidine HCl dissociates in solution into m-toluidine and hydrochloride the study was considered relevant for the registration according to REACH.
In 1980 DuPont conducted an acute toxicity study via gavage at 3 doses (700 mg/kg bw, 1,000 mg/kg bw and 1,350 mg/kg bw) and 10 young adult male rats per dose. An LD50 at 922 mg/kg bw had been assessed.
The experimental study was not conducted according to an OECD test guideline and is not publicly available, thus the study has been rated as Klimisch 3 (not reliable).
As the study has to been rated as Klimisch 3, the study cannot be used for the classification for m-toluidine HCl.
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.