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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.164 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Dose descriptor starting point:
- LOAEL
- Value:
- 30 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 12.34 mg/m³
- Explanation for the modification of the dose descriptor starting point:
A long term study (>12 months) which can be used for assessment and derivation of a respective DNEL is not available. Furthermore, there are no quantitative data on inhalation absorption of m-toluidine. Therefore, the available OECD TG 422 study can be taken using oral application (MHLW 1995). The LOAEL for repeat dose toxicity was 30 mg/kg bw/day (UNEP 2003).
According to the ECHA guidance document R8 (Characterisation of dose [concentration]-response for human health) a factor 3 (When the starting point for the DNEL calculation is a LOAEL, it is suggested to use an assessment factor 3 (as minimum/majority of cases)) is used. Therfore the corrected human NOAEL/LOAEL = 1/3.
Bioavailability: animal experiment (oral) = 50% (default)
Bioavailability human route = 100% (default inhalation)
For the expose in animal study/exposure in humans a correction factor of 7/5 is used.
Corrected human LOAEC = 37 mg/m³ (30 x 1/0,38 x7/5 x50/100 x 6.7/10)
Corrected human NOAEC = 12.34 mg/m³
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- Sub-acute exposure to chronic exposure (defalut value ECHA)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Rat versus human According to Table R8-4 in chapter R8 of EChA Guidance Document (Version 2.1, November 2012) the AF of 4 is already included in the route to route extrapolation (defalut value ECHA)
- AF for other interspecies differences:
- 2.5
- Justification:
- (defalut value ECHA)
- AF for intraspecies differences:
- 5
- Justification:
- Sub-acute exposure to chronic exposure (defalut value ECHA)
- AF for the quality of the whole database:
- 1
- Justification:
- There are valid studies available for all required toxicological endpoints for that tonnage band
- AF for remaining uncertainties:
- 1
- Justification:
- As the increased susceptibility of humans to methemoglobinemia is already considered by using factors for intraspecies and interspecies differences the remaining differences between worker and rats might be low and a factor of 1 justified.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.82 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.046 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- LOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 14 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In a study according to OECD TG 422 and GLP conditions male and female SD (Crj:CD) rats received 0, 30, 100, or 300 mg/kg bw/day m-toluidine by gavage (MHLW 1995). Hematological and biochemical analysis was conducted only for males. Compound related clinical signs were low locomotor activity and pale skin at 300 mg/kg bw. At the lowest dose of 30 mg/kg bw marginal deposit pigmentation and extramedullary hematopoiesis in the spleen were observed suggesting that a slight hemolysis occurred. Therefore, the dose of 30 mg/kg bw/day should be considered to be adverse effect level because of suggestive evidence of hemolytic anemia. LOAEL for repeat dose toxicity was 30 mg/kg bw/day (UNEP 2003).
According to the ECHA gueidance document R8 (Characterisation of dose [concentration]-response for human health) a factor 3 (When the starting point for the DNEL calculation is a LOAEL, it is suggested to use an assessment factor 3 (as minimum/majority of cases)) is used. Therfore the corrected human NOAEL/LOAEL = 1/3.
Bioavailability: animal experiment (oral) = 50% (default)
Bioavailability human route = 50% (default inhalation)
For the expose in animal study/exposure in humans a correction factor of 7/5 is used.
DNEL (systemic long term) = 0.046 mg/kg ( (14 / 300)
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chronic exposure (defalut value ECHA)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat versus human (defalut value ECHA)
- AF for other interspecies differences:
- 2.5
- Justification:
- defalut value ECHA
- AF for intraspecies differences:
- 5
- Justification:
- defalut value ECHA
- AF for the quality of the whole database:
- 1
- Justification:
- There are valid studies available for all required toxicological endpoints for that tonnage band.
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.23 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.029 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- LOAEC
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 4.34 mg/m³
- Explanation for the modification of the dose descriptor starting point:
A long term study (>12 months) which can be used for assessment and derivation of a respective DNEL is not available. Furthermore, there are no quantitative data on inhalation absorption of m-toluidine. Therefore, the available OECD TG 422 study can be taken using oral application (MHLW 1995). The LOAEL for repeat dose toxicity was 30 mg/kg bw/day (UNEP 2003).
According to the ECHA gueidance document R8 (Characterisation of dose [concentration]-response for human health) a factor 3 (When the starting point for the DNEL calculation is a LOAEL, it is suggested to use an assessment factor 3 (as minimum/majority of cases)) is used. Therfore the corrected human NOAEL/LOAEL = 1/3.
Bioavailability: animal experiment (oral) = 50% (default)
Bioavailability human route = 100% (default inhalation)
Corrected human LOAEC = 13.04 mg/m³ (30 x 1/1,15 x 50/100)
Corrected human NOAEC = 4.34 mg/m³
DNEL (systemic long term) = 0.029 mg/m³ (4.34 / 150)
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chronic exposure (defalut value ECHA)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Rat versus human: According to Table R8-4 in chapter R8 of EChA Guidance Document (Version 2.1, November 2012) the AF of 4 is already included in the route to route extrapolation (defalut value ECHA).
- AF for other interspecies differences:
- 2.5
- Justification:
- defalut value ECHA
- AF for intraspecies differences:
- 10
- Justification:
- defalut value ECHA
- AF for the quality of the whole database:
- 1
- Justification:
- There are valid studies available for all required toxicological endpoints for that tonnage band
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.145 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.016 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- LOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In a study according to OECD TG 422 and GLP conditions male and female SD (Crj:CD) rats received 0, 30, 100, or 300 mg/kg bw/day m-toluidine by gavage (MHLW 1995). Hematological and biochemical analysis was conducted only for males. Compound related clinical signs were low locomotor activity and pale skin at 300 mg/kg bw. At the lowest dose of 30 mg/kg bw marginal deposit pigmentation and extramedullary hematopoiesis in the spleen were observed suggesting that a slight hemolysis occurred. Therefore, the dose of 30 mg/kg bw/day should be considered to be adverse effect level because of suggestive evidence of hemolytic anemia. LOAEL for repeat dose toxicity was 30 mg/kg bw/day (UNEP 2003).
According to the ECHA gueidance document R8 (Characterisation of dose [concentration]-response for human health) a factor 3 (When the starting point for the DNEL calculation is a LOAEL, it is suggested to use an assessment factor 3 (as minimum/majority of cases)) is used. Therfore the corrected human NOAEL/LOAEL = 1/3.
Bioavailability: animal experiment (oral) = 50% (default)
Bioavailability human route = 50% (default inhalation)
DNEL (systemic long term) = 0.016 mg/kg (10 / 600)
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chronic exposure (defalut value ECHA)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- defalut value ECHA
- AF for other interspecies differences:
- 2.5
- Justification:
- defalut value ECHA
- AF for intraspecies differences:
- 10
- Justification:
- defalut value ECHA
- AF for the quality of the whole database:
- 1
- Justification:
- There are studies available for all required toxicological endpoints for that tonnage band
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.08 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.016 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- LOAEL
- Value:
- 30 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In a study according to OECD TG 422 and GLP conditions male and female SD (Crj:CD) rats received 0, 30, 100, or 300 mg/kg bw/day m-toluidine by gavage (MHLW 1995). Hematological and biochemical analysis was conducted only for males. Compound related clinical signs were low locomotor activity and pale skin at 300 mg/kg bw. At the lowest dose of 30 mg/kg bw marginal deposit pigmentation and extramedullary hematopoiesis in the spleen were observed suggesting that a slight hemolysis occurred. Therefore, the dose of 30 mg/kg bw/day should be considered to be adverse effect level because of suggestive evidence of hemolytic anemia. LOAEL for repeat dose toxicity was 30 mg/kg bw/day (UNEP 2003).
According to the ECHA guidance document R8 (Characterisation of dose [concentration]-response for human health) a factor 3 (When the starting point for the DNEL calculation is a LOAEL, it is suggested to use an assessment factor 3 (as minimum/majority of cases)) is used. Therfore the corrected human NOAEL/LOAEL = 1/3.
Bioavailability: animal experiment (oral) = 50% (default)
Bioavailability human route = 50% (default inhalation)
DNEL (systemic long term) = 0.016 mg/kg (10 / 600)
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chornic exposure (defalut value ECHA)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat versus human (defalut value ECHA)
- AF for other interspecies differences:
- 2.5
- Justification:
- defalut value ECHA
- AF for intraspecies differences:
- 10
- Justification:
- defalut value ECHA
- AF for the quality of the whole database:
- 1
- Justification:
- There are valid studies available for all required toxicological endpoints for that tonnage band.
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.08 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
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.