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Diss Factsheets
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EC number: 246-910-3 | CAS number: 25376-45-8
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- 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: Comparable to guideline study with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- environmental conditions were not reported and observation period was only 7 days.
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 2-methyl-m-phenylenediamine
- EC Number:
- 212-513-9
- EC Name:
- 2-methyl-m-phenylenediamine
- Cas Number:
- 823-40-5
- Molecular formula:
- C7H10N2
- IUPAC Name:
- 2-methylbenzene-1,3-diamine
- 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:
- 4-methyl-3-phenylenediamine
- IUPAC Name:
- 4-methyl-3-phenylenediamine
- Details on test material:
- - Name of test material (as cited in study report): TDA 8020
no other data
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: data not available
- Age at study initiation: data not available
- Weight at study initiation: 160-180 g
- Fasting period before study: data not available
- Housing: data not available
- Diet : ad libitum
- Water : ad libitum
- Acclimation period: data not available
ENVIRONMENTAL CONDITIONS
- Temperature (°C): data not available
- Humidity (%): data not available
- Air changes (per hr): data not available
- Photoperiod (hrs dark / hrs light): data not available
IN-LIFE DATES: data not available
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- arachis oil
- Details on dermal exposure:
- TEST SITE
- Area of exposure: data not available
- % coverage: data not available
- Type of wrap if used: data not available
REMOVAL OF TEST SUBSTANCE
No
TEST MATERIAL
- For solids, paste formed: yes
VEHICLE
data not available - Duration of exposure:
- 24 hours
- Doses:
- 50, 100, 250, 500, 750 and 1000 mg/kg
- No. of animals per sex per dose:
- 5 to 10 females per dose
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 7 days
- Frequency of observations and weighing: data not available
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs - Statistics:
- LD50 was calculated accordint to Litchfield and Wilcoxon method.
Results and discussion
- Preliminary study:
- No preliminary study.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 463 mg/kg bw
- 95% CL:
- 326 - 658
- Mortality:
- Mortality was observed at 250 mg/kg bw (2/10), 500 mg/kg bw (5/10), 750 mg/kg bw (8/10) and 1000 mg/kg bw (5/5) (see Table 1).
- Clinical signs:
- other: Clinical signs observed included bad general appearance, disturbance of respiration and convulsions starting at about 1 hour after application and lasting till the end of the study at day 7. At higher doses, paralysis of hind legs and cyanosis were observ
- Gross pathology:
- At higher doses blue-black discolouration of skin and subdermis, sub-serous and petechial haemorrhages in stomach, ulcera in the gastro-intestinal tract, discoloured kidneys, changes in the liver and enlarged adrenals were detected at necropsy.
- Other findings:
- No
Any other information on results incl. tables
Table 1: Number of females dead and with evident toxicity and time range within which mortality occured
Dose (mg/kg bw) | Mortality (# dead/ total) | Time range of deaths (days) | Number with evident toxicity (#/ total) |
50 | 0/5 | - | 0/5 |
100 | 0/5 | - | 5/5 |
250 | 2/10 | 4 -6 | 10/10 |
500 | 5/10 | 2 -6 | 10/10 |
750 | 8/10 | 2 -3 | 10/10 |
1000 | 5/5 | 2 -3 | 5/5 |
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this test, TDA 80/20 is considered as harmful according to EU criteria and is classified in category 3 according to EU-GHS.
- Executive summary:
In an acute dermal LD50 study (Bayer unpublished report, 1974), five or ten Wistar female rat were exposed to TDA 80/20 moistened with arachis oil at the dose levels of 50, 100, 250, 500, 750 and 1000 mg/kg bw. The animals were then observed for 7 days. Mortality was observed at 250 mg/kg bw (2/10), 500 mg/kg bw (5/10), 750 mg/kg bw (8/10) and 1000 mg/kg bw (5/5). Clinical signs observed included bad general appearance, disturbance of respiration and convulsions starting at about 1 hour after application and lasting till the end of the study at day 7. At higher doses, paralysis of hind legs and cyanosis were observed. The animals dosed at 50 mg/kg did not demonstrate any macroscopically visible changes at necropsy. At higher doses blue-black discolouration of skin and subdermis, sub-serous and petechial haemorrhages in stomach, ulcera in the gastro-intestinal tract, discoloured kidneys, changes in the liver and enlarged adrenals were detected at necropsy. Under the conditions of this test, TDA 80/20 is considered as harmful according to EU criteria and is classified in category 3 according to EU-GHS.
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