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EC number: 203-583-1 | CAS number: 108-44-1
- 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
Oral application of 1350 -700 mg/kg bw m-toluidine dissolved in corn oil, resulted in a LD50 value of 922 mg/kg bw (DuPont De Nemours 1980).
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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: only males and only 3 doses used instead of 5 as required.
- Principles of method if other than guideline:
- Method: other:
3 doses tested, 10 male animals/dose, single dose by gavage, observation period up to 14 d.
A range finding study was conducted to determine the initial dose. - GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- young adult males, no further data
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- single oral application by gavage
- Doses:
- 700, 1000, 1350 mg/kg bw diluted in corn oil
- 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 analylysis
- 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: 1350 mg/kg bw: lacrimation, chromodacryorrhea, cyanosis, moribundity and weight loss 1000 mg/kg bw lacrimation, chromodacryorrhea, cyanosis, labored breathing, diarrhea, stained and wet perineal area, stained face, weakness, moribunditss, and moderate
- Gross pathology:
- no data
- Other findings:
- no data
- Interpretation of results:
- Category 4 based on GHS criteria
- Executive summary:
Oral application of 1350 -700 mg/kg bw m-toluidine diluted in corn oil to male rats resulted in a LD50 value of 922 mg/kg bw (DuPont De Nemours 1980). Clinical signs observed at most dose levels included lacrimation, stained face, chromodacryorrhea, stained and wet perineal areas, cyanosis, morbundity and moderate weight loss. All deaths occurred within 3 days after dosing.
Reference
No further data.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 922 mg/kg bw
- Quality of whole database:
- This is the only available study which is equal to the respective guideline and is there fore be evaluated with Klimisch score: 2.
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given (comparable to standards)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- not applicable
- GLP compliance:
- yes
- Species:
- rat
- Sex:
- male/female
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 030 mg/kg bw
- Remarks on result:
- other: rat
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 000 mg/kg bw
- Remarks on result:
- other: rat
- Interpretation of results:
- Category 3 based on GHS criteria
- Conclusions:
- Mean value LD50 = 1015 mg/kg bw (used for classification)
Risk of cutaneous absorption. Risk of methaemoglobin formation even after skin contact (leads to increased classification).
Symptoms may be delayed. - Executive summary:
As mention in chapter toxicikinetics read across to p-isopropyl aniline is appropriate and justified by ECB 2000 (peer reviewed data collection). p-Isopropyl aniline was applied to the skin of male and female rats as described by OECD TG 402 under GLP conditions to determine acute dermal toxicity.
The LD50 for males is 1000 mg/kg bw and for females 1030 mg/kg bw (Hoechst AG 1988)
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 1 015 mg/kg bw
- Quality of whole database:
- The available study is performed according to OECD testguideline and therefore evaluated with Klimisch Score 2
Additional information
Acute Oral Toxixity
Groups of 10 male rats received single oral application of 1350 -700 mg/kg bw m-toluidine dissolved in corn oil, resulting in a LD50 value of 922 mg/kg bw (DuPont De Nemours 1980). Clinical signs included lacrimation, stained face, chromodacryorrhea, stained and wet perineal area, cyanosis, moribundity and moderate weight loss.
Acute Dermal Toxicity
As mentioned in toxicokinetics read across to p-isopropyl aniline and justified by ECB 2000 (peer reviewed data collection) the surrogate moleule p-isopropyl aniline was applied to the skin of male and female rats as described by OECD TG 402 under GLP conditions to determine acute dermal toxicity.
The LD50 for males is 1000 mg/kg bw and for females 1030 mg/kg bw (Hoechst AG 1988)
Justification for selection of acute toxicity – oral endpoint
This is the only available study which is equal to the respective
guideline and is there fore be evaluated with Klimisch score: 2
Justification for selection of acute toxicity – dermal endpoint
the available study is performed according to OECD testguideline and
therefore evaluated with Klimisch Score 2
Justification for classification or non-classification
Based on the available data and taking into account that m-toluidine (3 -Methyl-aniline) is known to be a methemoglobine forming molecule m-toluidine is classified according to Regulation (EC) 1972/2008 (GHS) as Category 3 for acute toxicity (H301, H311, H331).
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