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EC number: 202-453-1 | CAS number: 95-80-7
- 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
- Study period:
- data not available
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The method is similar to accepted test guidelines. The purity of the substance is unknown. Compliance with GLP was not mentioned.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 4-methyl-m-phenylenediamine
- EC Number:
- 202-453-1
- EC Name:
- 4-methyl-m-phenylenediamine
- Cas Number:
- 95-80-7
- Molecular formula:
- C7H10N2
- IUPAC Name:
- 4-methylbenzene-1,3-diamine
- Reference substance name:
- 1,3-diamino-4-methylbenzene
- IUPAC Name:
- 1,3-diamino-4-methylbenzene
- Details on test material:
- - Name of test material (as cited in study report): pure m-Toluylendiamin (= tolamin-2,4)
no other data
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Stamm Wistar TNO W 74, Züchter: Winkelmann, Borchen
- Age at study initiation: 14 weeks
- Weight at study initiation: 155 g
- Fasting period before study: data not available
- Housing: 5 animals per cage
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: data not available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5
- Humidity (%): 60 +/- 5
- Air changes (per hr): data not available
- Photoperiod : 12 hrs dark / 12 hrs light
IN-LIFE DATES: data not available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: lutrol
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: data not available
- Amount of vehicle (if gavage): data not available
- Justification for choice of vehicle: data not available
- Lot/batch no. (if required): data not available
- Purity: data not available
MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg
- Doses:
- 500, 100, 70, 50 and 10 mg/kg
- No. of animals per sex per dose:
- 10 females per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: two-fold per day (one-fold per Week-end)
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- no data
Results and discussion
- Preliminary study:
- No preliminary study was performed.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 73 mg/kg bw
- 95% CL:
- 60 - 90
- Mortality:
- Mortality was observed at 50 mg/kg (1/10), 70 mg/kg (5/10), 100 mg/kg (8/10) and 500 mg/kg (10/10)
- Clinical signs:
- other: Bad general appearance, sedation and loss of body weight.
- Gross pathology:
- At necropsy, no macroscopically visible changes were detected.
- Other findings:
- no data
Any other information on results incl. tables
Table 1: Number of animals dead and day or time range within mortality occured
Dose (mg/kg bw) |
Mortality (# dead/total) | Day or time range of deaths (days) | ||
female | ||||
500 | 10/10 | (1 -2) | ||
100 | 8/10 | (3 -10) | ||
70 | 5/10 | (1 -4) | ||
50 | 1/10 | (3) | ||
10 | 0/10 | - |
Applicant's summary and conclusion
- Interpretation of results:
- toxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is considered as toxic according to EU criteria and is classified in Category 3 according to the EU-GHS
- Executive summary:
In an acute oral toxicity study (Bayer 1981, unpublished report), groups of 14 weeks old wistar female rats (10 females per group) were given a single oral dose of pure 2,4 -toluylene diamine in lustrol at doses of 500, 100, 70, 50 and 10 mg/kg bw and observed for 14 days. A dose of 10 mg/kg did not cause mortalities or clinical signs in this test. 1/10 female rats died after application of 50 mg/kg at day 3; 5/10 died after application of 70 mg/kg within 4 days; 8/10 did after 100 mg/kg and 10/10 after application of 500 mg/kg. Clinical signs observed included bad general appearance, diuresis and loss of body weight. At necropsy, no macroscopically visible changes were detected. In this test similar to current OECD guidelines, an oral LD50 value of 73 mg/kg bw was determined for female rats. Therefore, 2,4 -toluylene diamine is considered as toxic according to EU criteria and is classified in Category 3 according to the EU-GHS.
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