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EC number: 202-805-4 | CAS number: 99-97-8
- 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
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- 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
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- Nanomaterial pour density
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- 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
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- Repeated dose toxicity
- Genetic toxicity
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- Specific investigations
- Exposure related observations in humans
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- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
The substance N,N-dimethyl-p-toluidine is toxic via oral. inhalation and dermal route
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:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- The objectives are to evaluate rates and routes of excretion, tissue distribution, and metabolism of [14C]DMPT.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Species:
- mouse
- Strain:
- not specified
- Sex:
- not specified
- Route of administration:
- oral: gavage
- Vehicle:
- other: Alkamules
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2.5, 25, or 250 mg/kg
- Amount of vehicle (if gavage): in 10% aqueous Alkamuls
- Justification for choice of vehicle: no data
- Lot/batch no. (if required): no data
- Purity: no data - Doses:
- 2.5, 25, or 250 mg/kg
- No. of animals per sex per dose:
- Groups of three or four male mice
- Control animals:
- not specified
- Details on study design:
- Mice received oral doses of [14C]DMPT, then were housed individually in metabolism cages; urine, feces, volatile organics (VOCs), and CO2 were collected for up to 72 h.
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- 250 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Death of one mouse at ~24 h, the remaining mice were euthanized. Mice excreted little urine and feces during the study
- Clinical signs:
- decreased activity and labored breathing was observed at 250 mg DMPT/kg 6 h after dosing
- Other findings:
- This result indicated near complete absorption and excretion of the high dose over the extended holding period. N,N-Dimethyl-p-toluidine derived radioactivity was excreted at similar rates over time in the 2.5 and 25 mg/kg male mouse dosing groups. Disposition data are not reported here for mice receiving 250 mg/kg by gavage due to acute toxicity, including mortality in the group
- Interpretation of results:
- Toxicity Category III
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The Acute oral LD50 value of N,N-dimethyl-p-toluidine in mice was observed at dose concentration on 250 mg/kg. These results suggest that the N,N-dimethyl-p-toluidine is toxic to mouse via oral route of exposure and falls under acute oral category 3.
- Executive summary:
The objectives are to evaluate rates and routes of excretion, tissue distribution, and metabolism of [14C]DMPT. Mice received oral doses of [14C]DMPT, then were housed individually in metabolism cages; urine, feces, volatile organics (VOCs), and CO2 were collected for up to 72 h. At sacrifice the tissue distribution of carbon-14 was determined. Death of one mouse at ~24 h, the remaining mice were euthanized. Mice excreted little urine and feces during the study. decreased activity and labored breathing was observed at 250 mg DMPT/kg 6 h after dosing. This appears to be the case in mice since the 250 mg/kg oral dose, which is close to the IP LD50 in this species, was acutely toxic. Hence LD50 was considered to be 250 mg/kg.
These results suggest that the N,N-dimethyl-p-toluidine is toxic to mouse via oral route of exposureand falls under acute oral category 3.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 250 mg/kg bw
- Quality of whole database:
- K2 level data from publication
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Data is from RTECS
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- not specified
- Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 4 h
- Concentrations:
- 0.3, 0.99, 1.73, or 5.27mg/l.
- No. of animals per sex per dose:
- 5/sex/group
- Control animals:
- not specified
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- 1.4 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Clinical signs:
- other: Clinical signs of toxicity included hypoactivity,a comatose/prostrate condition,dyspnea, rapid respiration, salivation, eye and nasal discharge and red material around nose
- Body weight:
- Exposure did not affect body weight gain
- Gross pathology:
- Mottled lungs, Red ovaries and gas filled gastrointestinal organs were seen at 1.73 and 5.27 mg/l
- Interpretation of results:
- Toxicity Category II
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Acute Inhalation toxicity (LC50) value of N,N-dimethyl-p-toluidine was examined in rats on the basis of motality effect at a dose concentration of 1.4 mg/l after 4 hrs of exposure. From this value it is concluded that the substance N,N-dimethyl-p-toluidine is toxic to rat by inhalation route in category 2
- Executive summary:
N, N Dimethyl-p toluidene was aerosolized and administered for 4 hrs by wholebody inhalation exposure to Sparague-dawley derived rats (5/sex/group) at concentration of 0.3, 0.99, 1.73, OR 5.27 mg/l. Exposure did not affect body weight gain.Clinical signs of toxicity included hypoactivity,a, a comatose/prostrate condition, dyspnea, rapid respiration, salivation, eye and nasal discharge and red material around nose.Mottled lungs, Red ovaries and gas filled gastrointestinal organs were seen at 1.73 and 5.27 mg/l. Hence LC50 was considered to be 1.4 mg/l air
From this value it is concluded that the substance N,N-dimethyl-p-toluidine is toxic to rat by inhalation route in category 2
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 1.4
- Quality of whole database:
- K4 level data from publication
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Principles of method if other than guideline:
- Data is from Study report
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Type of coverage:
- not specified
- Vehicle:
- other: neat
- No. of animals per sex per dose:
- 10
- Control animals:
- not specified
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Details of toxic effects not reported other than lethal dose value
- Mortality:
- 50 percent kill
- Interpretation of results:
- Toxicity Category IV
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Acute dermal toxicity (LD50) value of N.N-dimethyl-p-toluidine in rabbit was found to be >2000 mg/kg . From this value it is concluded that N.N-dimethyl-p-toluidine is not toxic to rabbit by dermal route
- Executive summary:
Dermal toxicity (LD50) of N,N-dimethyl-p-toluidine was examined in rabbit at dose concentration of >2000 mg/kg of skin exposure. Details of toxic effects not reported other than lethal dose value. These results suggest that the N,N-dimethyl-p-toluidine is non toxic to rabbit via dermal contact. However, since this substance has a harmonized classification of exhibiting Acute Toxicity Category 3 via the dermal route; for the purpose of the chemical safety assessment the harmonized classification shall be adhered to.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- K4 level data from study report
Additional information
Acute toxicity Oral:
Based on studies of target substance CAS NO 99-97-8 reviewed for acute oral toxicity from reliable sources having Klimisch rating 2 and 4 considering the weight of evidence approach.
The summary of the results are presented below
Sr. No | End point | Value | Species | Remark |
1 | LD50 | 250 mg/kgbw | mouse | Data from publication for target chemical |
2 | LD50 | 1300 mg/kg(male) 1950 mg/kg(female) 1650 mg/kg(male/female) | Rat | Data from study report for target chemical |
3 | LD50 | 139 mg/kgbw | Mouse | Data from publication for target chemical |
4 | LD50 | 980 mg/kgbw | Rat | Data from publication for target chemical |
Based on above table, endpoint value was found to vary between 139 mg/kg bw to 1950 mg/kg bw based on these values it can be concluded that the substance N,N-dimethyl-p-toluidine exhibits acute toxicity by the oral route in category 3. However, since this substance has a harmonized classification of exhibiting Acute Toxicity Category 3 via the oral route; for the purpose of the chemical safety assessment the harmonized classification shall be adhered to.
Acute toxicity Inhalation:
Based on studies of target substance CAS NO 99-97-8 and read across reviewed for acute Inhalation toxicity from reliable sources having Klimisch rating 4 considering weight of evidence approach
The summary of the results are presented below
Sr. No | End point | Value | Species | Remark |
1 | LC50 | 1.4 mg/l | Rat | Data from study report for target chemical |
2 | TCLo | 800 mg/m3 | mouse | Data from publication for target chemical |
3 | LC50 | 1.92 mg/l | Rat | Data from study report for CAS no 91-66-7 |
4 | LC50 | 1.9 mg/lair 4.3 mg/l air | Rat | Data from study report for CAS no 91-66-7 |
Based on the values summarized in above table, it was found that the endpoint values vary between 1.4 mg/L to 4.3 mg/l. and theTCLo value was found to be 800 mg/m3. From this value it can be concluded thatN,N-dimethyl-p-toluidine exhibits acute toxicity by the inhalation route Acute Toxicity Category 2. However, since this substance has a harmonized classification of exhibiting Acute Toxicity Category 3 via the oral route; for the purpose of the chemical safety assessment the harmonized classification shall be adhered to.
Acute Toxicity Dermal:
Based on studies of target substance CAS NO 99-97-8 and read across reviewed for acute dermal toxicity from reliable sources having Klimisch rating 4 considering weight of evidence approach
The summary of the results are presented below
Sr. No | End point | Value | Species | Remark |
1 | LD50 | >2000 mg/kg bw | Rabbit | Data from study report of target chemical |
2 | LD50 | <935 mg/kg bw | Rabbit | Data from study report for CAS no 91-66-7 |
Based on the values summarized in above table, it was found that the endpoint values was found to be in the range of <935 mg/kg bw to >2000 mg/kg bw. From this value it can be concluded that N,N-dimethyl-p-toluidine exhibits acute toxicity by the dermal route in category 4. Since this substance has a harmonized classification of exhibiting Acute Toxicity Category 3 via the dermal route; for the purpose of the chemical safety assessment the harmonized classification shall be adhered to.
Justification for selection of acute toxicity – oral endpoint
The objectives are to evaluate rates and routes of excretion, tissue distribution, and metabolism of [14C]DMPT. Mice received oral doses of [14C]DMPT, then were housed individually in metabolism cages; urine, feces, volatile organics (VOCs), and CO2 were collected for up to 72 h. At sacrifice the tissue distribution of carbon-14 was determined. Death of one mouse at ~24 h, the remaining mice were euthanized. Mice excreted little urine and feces during the study. decreased activity and labored breathing was observed at 250 mg DMPT/kg 6 h after dosing. This appears to be the case in mice since the 250 mg/kg oral dose, which is close to the IP LD50 in this species, was acutely toxic. Hence LD50 was considered to be 250 mg/kg.
These results suggest that the N,N-dimethyl-p-toluidine is toxic to mouse via oral route of exposureand falls under acute oral category 3.
Justification for selection of acute toxicity – inhalation endpoint
N, N Dimethyl-p toluidene was aerosolized and administered for 4 hrs by wholebody inhalation exposure to Sparague-dawley derived rats (5/sex/group) at concentration of 0.3, 0.99, 1.73, OR 5.27 mg/l. Exposure did not affect body weight gain.Clinical signs of toxicity included hypoactivity,a, a comatose/prostrate condition, dyspnea, rapid respiration, salivation, eye and nasal discharge and red material around nose.Mottled lungs, Red ovaries and gas filled gastrointestinal organs were seen at 1.73 and 5.27 mg/l. Hence LC50 was considered to be 1.4 mg/l air
From this value it is concluded that the substance N,N-dimethyl-p-toluidine is toxic to rat by inhalation route in category 2
Justification for selection of acute toxicity – dermal endpoint
Dermal toxicity (LD50) of N,N-dimethyl-p-toluidine was examined in rabbit at dose concentration of >2000 mg/kg of skin exposure. Details of toxic effects not reported other than lethal dose value. These results suggest that the N,N-dimethyl-p-toluidine is non toxic to rabbit via dermal contact. However, since this substance has a harmonized classification of exhibiting Acute Toxicity Category 3 via the dermal route; for the purpose of the chemical safety assessment the harmonized classification shall be adhered to.
Justification for classification or non-classification
The substance N,N-dimethyl-p-toluidine is toxic via oral. inhalation and dermal route and hence classified as acute toxicity category 3( for Oral and dermal) and Acute toxicity category 2 (for Inhalation) as per CLP criteria
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