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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 213-635-5 | CAS number: 996-35-0
- 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:
- 3.6 mg/m³
DNEL related information
- DNEL derivation method:
- other: German MAK commission (2002)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.2 mg/m³
DNEL related information
- DNEL derivation method:
- other: German MAK commission (2002)
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.6 mg/m³
DNEL related information
- DNEL derivation method:
- other: German MAK commission (2002)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.2 mg/m³
DNEL related information
- DNEL extrapolated from long term DNEL
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.22 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):
- 100
- Dose descriptor starting point:
- NOAEC
- Value:
- 318 mg/m³
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 922.2 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
DNEL derivation is based on a 90-day toxicity study by inhalation administration to rats (Beede, 2021). The starting dose for DNEL calculation is a NOAEC of 318 mg/m3 (106 ppm). Considering a ventilation rate of 0.29 m3/kg for a 6-hour exposure and a default inhalation absorption of 100%, the corresponding internal NOAEL is 92.22 mg/kg bw/d. DMEA is expected to be poorly absorbed by the skin (10% of the dose), therefore the dermal NAEL derived for workers is 922.2 mg/kg bw/d. The dermal DNEL for systemic effect is derived from this value applying the safety factors of 2,5x4 for interspcies and 5 for intraspecies and 2 for exposure duration which lead to a value of 9,22 mg/kg/day.
- AF for dose response relationship:
- 1
- Justification:
- Not needed
- AF for differences in duration of exposure:
- 2
- Justification:
- Default AF
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- Default AF
- AF for other interspecies differences:
- 4
- Justification:
- Default AF
- AF for intraspecies differences:
- 5
- Justification:
- Default AF
- AF for the quality of the whole database:
- 1
- Justification:
- Not needed
- AF for remaining uncertainties:
- 1
- Justification:
- Not needed
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high 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:
- 0.32 mg/m³
DNEL related information
- DNEL derivation method:
- other: Derivation from MAK value
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.32 mg/m³
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- high 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:
- 3.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEC
- Value:
- 318 mg/m³
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 658 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The starting dose for DNEL calculation is a NOAEC of 318 mg/m3 (106 ppm) from the 90 days inhalation study performed with the analogue DMEA. Considering a ventilation rate of 0.29 m3/kg for a 6-hour exposure of rats and a default inhalation absorption of 100%, the corresponding internal NOAEL is 92.22 mg/kg bw/d. DMEA is expected to be poorly absorbed by the skin (10% of the dose), therefore the dermal NAEL derived for general populations after adjustment for exposure duration (7 days/week) is 658 mg/kg bw/d. The safety factor applied to this value are (10 for interspecies differences, 10 for interspecies differences and 2 for exposure duration), the resulted DNEL is 3,3 mg/kg/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- AF for interspecies differences (allometric scaling):
- 2.5
- AF for other interspecies differences:
- 4
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high 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:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Dose descriptor starting point:
- NOAEC
- Value:
- 318 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 65.8 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Not needed
- AF for differences in duration of exposure:
- 2
- Justification:
- Default AF
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF
- AF for intraspecies differences:
- 10
- Justification:
- Default AF
- AF for the quality of the whole database:
- 1
- Justification:
- Not needed
- AF for remaining uncertainties:
- 1
- Justification:
- Not needed
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high 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.
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