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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: 406-690-3 | CAS number: 43136-14-7 MDI/ODA
- 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:
- 35.26 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The dose descriptor start point is modified from a NOAEL by oral administration in rats (mg/kg/day) to a No Observed Adverse Effect Concentration (NOAEC) in humans by inhalation exposure (mg/m3) before Adjustment Factors (AFs) can be applied to determine the DNEL. The conversion in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R8 is as follows (in case of Workers exposed 8 hours/day):
NOAEC = oral NOAEL x 1/sRVrat x ABSoral rat / ABSinh human x sRVhuman / wRV
Where: sRV = Standard respiratory volume (0.38 m3 rat and 6.7 m3 human)
ABS = Absorption
wRV = Worker respiratory volume (10 m3)
Therefore: NOAEC = 1000 x 1/0.38 x 1/1 x 6.7/10
NOAEC = 1763 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- NOAEL taken as PoD for modification
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic (OECD 422) to chronic duration
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required since modification of oral NOAEL to inhalation NOAEC in humans has been made
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for toxicokinetic and toxicodynamic differences
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Starting dose taken from a guideline, GLP study
- AF for remaining uncertainties:
- 2
- Justification:
- Assessment factor of 2 applied as data is read across from N,N''-(methylenedi-4,1-phenylene)bis[N'-octylurea] to 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 105.78 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
- Dose descriptor starting point:
- other: Systemic long term DNEL
- Value:
- 35.26 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The inhalation systemic acute DNEL has been taken from the systemic inhalation long term DNEL. In the absence of reliable experimental data an acute DNEL can by default be set at 1-5 times the long term DNEL. Although there is no acute inhalation data available, acute dermal and acute oral toxicity studies were conducted in rats, with LD50 values of >5000 mg/kg bodyweight and >2000 mg/kg bodyweight determined, respectively. Therefore, the extrapolation factor was set at 3.
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
- Justification:
- 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- other: No dose modification required
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL taken as Point of Departure
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic duration (OECD 421)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default assessment factor for rats to humans
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for toxicokinetic and toxicodynamic differences
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Starting dose taken from a guideline, GLP study
- AF for remaining uncertainties:
- 2
- Justification:
- Assessment factor of 2 applied as data is read across from N,N''-(methylenedi-4,1-phenylene)bis[N'-octylurea] to 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 25 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
- Dose descriptor starting point:
- other: Systemic long term DNEL
- Value:
- 5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The dermal systemic acute DNEL has been taken from the systemic dermal long term DNEL. An acute DNEL can by default be set at 1-5 times the long term DNEL. An acute dermal toxicity study was conducted with the test substance, with an LD50 value of >5000 mg/kg bodyweight. Additionally, a dermal toxicity study was conducted in rabbits with the test substamce, and no signs of erythema or oedema were observed in any animals. Therefore, it is considered appropriate to modify the systemic long-term DNEL of 5 mg/kg/day by a factor of 5.
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.7 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 869.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The dose descriptor start point is modified from a NOAEL by oral administration in rats (mg/kg/day) to a No Observed Adverse Effect Concentration (NOAEC) in humans by inhalation exposure (mg/m3) before Adjustment Factors (AFs) can be applied to determine the DNEL. The conversion in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R8 is as follows (in case of General Population exposed 24 hours/day):
NOAEC = oral NOAEL x 1/sRVrat x ABSoral rat / ABSinh human
Where: sRV = Standard respiratory volume (1.15 m3/kg/day)
ABS = Absorption
NOAEC = 1000 x 1/1.15 x 1/1
NOAEC = 869.6 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- NOAEL taken as Point of Departure
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic (OECD 421) to chronic duration
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required since modification of oral NOAEL to inhalation NOAEC in humans has been made
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for toxicokinetic and toxicodynamic differences
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Starting dose taken from a guideline, GLP study
- AF for remaining uncertainties:
- 2
- Justification:
- Assessment factor of 2 applied as data is read across from N,N''-(methylenedi-4,1-phenylene)bis[N'-octylurea] to 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 26.1 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
- Dose descriptor starting point:
- other: Systemic long-term DNEL
- Value:
- 8.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The inhalation systemic acute DNEL has been taken from the systemic inhalation long term DNEL. In the absence of reliable experimental data an acute DNEL can by default be set at 1-5 times the long term DNEL. Although there is no acute inhalation data available, acute dermal and acute oral toxicity studies were conducted in rats, with LD50 values of >5000 mg/kg bodyweight and >2000 mg/kg bodyweight determined, respectively. Therefore, the extrapolation factor was set at 3.
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 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):
- 400
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- other: No dose modification required
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL taken as Point of Departure
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic (OECD 421) to chronic duration
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default assessment factor for rats to humans
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for toxicokinetic and toxicodynamic differences
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Starting dose taken from a guideline, GLP study
- AF for remaining uncertainties:
- 2
- Justification:
- Assessment factor of 2 applied as data is read across from N,N''-(methylenedi-4,1-phenylene)bis[N'-octylurea] to 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.5 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
- Dose descriptor starting point:
- other: Systemic long-term DNEL
- Value:
- 2.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The dermal systemic acute DNEL has been taken from the systemic dermal long term DNEL. An acute DNEL can by default be set at 1-5 times the long term DNEL. An acute dermal toxicity study was conducted with the test substance, with an LD50 value of >5000 mg/kg bodyweight. Additionally, a dermal toxicity study was conducted in rabbits with the test substamce, and no signs of erythema or oedema were observed in any animals. Therefore, it is considered appropriate to modify the systemic long-term DNEL of 2.5 mg/kg/day by a factor of 5.
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 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):
- 400
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- other: No dose modification required
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- NOAEL taken as Point of Departure
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic (OECD 421) to chronic duration
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default assessment factor for rats to humans
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for toxicokinetic and toxicodynamic differences
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Starting dose taken from a guideline, GLP study
- AF for remaining uncertainties:
- 2
- Justification:
- Assessment factor of 2 applied as data is read across from N,N''-(methylenedi-4,1-phenylene)bis[N'-octylurea] to 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.5 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 2.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The oral systemic acute DNEL has been taken from the systemic oral long term DNEL. An acute DNEL can by default be set at 1-5 times the long term DNEL. An acute oral toxicity study was conducted in rats with the test substance, with an LD50 value of >2000 mg/kg bodyweight. Therefore, it is considered appropriate to modify the systemic long-term DNEL of 5 mg/kg/day by a factor of 5.
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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.