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Diss Factsheets
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EC number: 203-640-0 | CAS number: 109-02-4
- 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:
- 3.24 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Dose descriptor starting point:
- NOAEC
- Value:
- 414 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 243 mg/m³
- Explanation for the modification of the dose descriptor starting point:
A NOAEC of 414 mg/m³ air was derived (NOAEC 100 ppm; Klimisch 2; key; equivalent to OECD 412; DiPasquale, 1979). DiPasquale (1979) investigated inhalation toxicity of the test substance after repeated whole body exposure for two weeks (1 or 7 hours per day, 5 days per week). Sprague Dawley male and female rats were exposed to 0 (control), 100 or 1000 ppm (eq. of 0, 414 or 4140 mg/m³; 15 males and 15 females/dose). The results of the current study suggest that gross signs of irritation, transient cloudiness of the eye, and possibly elevations in atypical lymphocyte differential counts were the only detectable manifestations of exposure of rats to the test substance vapors for five days per week for two weeks.
The dose descriptor starting point = 414 mg/m³ * (7h/d / 8h/d) * (6.7 m³ (8h) / 10 m³ (8h)) = 243 mg/m³ . For workers, the resulting air concentration needs to be corrected for the difference between basal caloric demand and caloric demand under light activity. This correction factor derives from the inhalative volumes in 8 hours under the respective conditions (6.7 m³ for base level, 10 m³ for light activity). A correction factor for duration of activity (or exposure) is added (factor 7/8).
- AF for dose response relationship:
- 1
- Justification:
- default assessment factor
- AF for differences in duration of exposure:
- 6
- Justification:
- difference in duration, subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- already included in route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- rat to human
- AF for intraspecies differences:
- 5
- Justification:
- worker population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
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:
- 0.67 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:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No reliable repeated dose toxicity study was available for the test substance via the dermal route of exposure. However, in a reliable oral repeated dose toxicity test of the read-across substance N-ethylmorpholine, a NOAEL of 200 mg/kg was determined. For the route-to-route extrapolation from oral to dermal, on the assumption that dermal absorption will not be higher than oral absorption, no default factor (i. e. factor 1) should be applied; bioavailability is assumed to be 50% after dermal and oral exposure. No additional factor is taken into account for the fact that the dose descriptor is taken from the read-across substance NEM. The available read-across data is sufficiently reliable and consistent.
- AF for dose response relationship:
- 1
- Justification:
- default assessment factor
- AF for differences in duration of exposure:
- 6
- Justification:
- difference in duration, subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- rat to human
- AF for intraspecies differences:
- 5
- Justification:
- worker population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium 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:
- 0.81 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- NOAEC
- Value:
- 414 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 121 mg/m³
- Explanation for the modification of the dose descriptor starting point:
DiPasquale (1979) investigated inhalation toxicity of the test substance after repeated whole body exposure for 10 days (1 or 7 hours per day, 5 days per week). Sprague Dawley male and female rats were exposed to 0 (control), 100 or 1000 ppm (eq. to 0, 414 and 4140 mg/m³; 15 males and 15 females/dose). The results of the current study suggest that gross signs of irritation, transient cloudiness of the eye, and possibly elevations in atypical lymphocyte differential counts were the only detectable manifestations of exposure of rats to the test substance vapors. A NOAEC of 100 ppm or 414 mg/m³ air was derived. The dose descriptor starting point = 414 mg/m³ * (7h/d / 24h/d) = 121 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- default assessment factor
- AF for differences in duration of exposure:
- 6
- Justification:
- difference in duration, subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- already included in route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- rat to human
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
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:
- 0.33 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:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In a reliable read-across information of N-ethylmorpholine repeated oral toxicity of the test substance was investigated in male/female Crj: CD(SD) IGS rats. A NOAEL of 200 mg/kg bw/d is proposed. No additional factor is taken into account for the fact that the dose descriptor is taken from the read-across substance NEM. The available read-across data is sufficiently reliable and consistent
For the route-to-route extrapolation from oral to dermal, on the assumption that dermal absorption will not be higher than oral absorption, no default factor (i. e. factor 1) should be applied as part of the overall assessment factor.
- AF for dose response relationship:
- 1
- Justification:
- default assessment factor
- AF for differences in duration of exposure:
- 6
- Justification:
- difference in duration; subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- rat to human
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.33 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:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In a reliable read-across information of N-ethylmorpholine repeated oral toxicity of the test substance was investigated in male/female Crj: CD(SD) IGS rats. A NOAEL of 200 mg/kg bw/d is proposed. No additional factor is taken into account for the fact that the dose descriptor is taken from the read-across substance NEM. The available read-across data is sufficiently reliable and consistent.
- AF for dose response relationship:
- 1
- Justification:
- default assessment factor
- AF for differences in duration of exposure:
- 6
- Justification:
- difference in duration, subacute to chronic
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- rat to human
- AF for other interspecies differences:
- 4
- Justification:
- rat to human
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium 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.