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Registration Dossier
Diss Factsheets
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EC number: 947-663-0 | CAS number: -
- 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:
- 7.01 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:
- NOAEL
- Value:
- 298 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 525.4 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Using bioavailability of 100% for the oral and 100% for the inhalation route and assuming that rat oral and inhalation absorptions are equal to human oral and inhalation absorption, a NOAEC corr of 298 mg/kg/day / 0.38 m³/kg * 6.7/10 * 100/100 = 525.4 mg/m³ is used.
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL/NOAEC
- AF for differences in duration of exposure:
- 6
- Justification:
- due to subacute study data used
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required due to route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- for worker, a default AF of 5 is to be used
- AF for the quality of the whole database:
- 1
- Justification:
- not required, as supporting studies for the oral NOAEL are available
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.9 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:
- 298 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 980 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Using bioavailability of 100% for the oral and 10% for the dermal route and assuming that rat oral and dermal absorptions are equal to human oral and dermal absorption, thus the corrected dermal NOAEL is 298 * 100/10 = 2980 mg/kg/day based on the oral NOAEL of 298 mg/kg bw/d derived from a subacute study.
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- due to subacute study data used
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling factor rat-human
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- for worker, a default AF of 5 is to be used
- AF for the quality of the whole database:
- 1
- Justification:
- not required, as supporting studies for the oral NOAEL are available
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
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:
- 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:
- 1.73 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:
- NOAEL
- Value:
- 298 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 259.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Using bioavailability of 100% for the oral and 100% for the inhalation route and assuming that rat oral and inhalation absorptions are equal to human oral and inhalation absorption, a NOAEC corr of 298 mg/kg/day / 1.15 m³/kg * 100/100 = 259.1 mg/m³ is used.
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL/NOAEC
- AF for differences in duration of exposure:
- 6
- Justification:
- due to subacute study data used
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required due to route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- for consumer, a default AF of 10 is to be used
- AF for the quality of the whole database:
- 1
- Justification:
- not required, as supporting studies for the oral NOAEL are available
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
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:
- 4.97 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:
- 298 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 980 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Using bioavailability of 100% for the oral and 10% for the dermal route and assuming that rat oral and dermal absorptions are equal to human oral and dermal absorption, thus the corrected dermal NOAEL is 298 * 100/10 = 2980 mg/kg/day based on the oral NOAEL of 298 mg/kg bw/d derived from a subacute study.
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- due to subacute study data used
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling factor rat-human
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- for consumer, a default AF of 10 is to be used
- AF for the quality of the whole database:
- 1
- Justification:
- not required, as supporting studies for the oral NOAEL are available
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
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:
- 0.5 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 298 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 298 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No route-to-route extrapolation is required.
- AF for dose response relationship:
- 1
- Justification:
- not required, starting point is NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- due to subacute study data used
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling factor rat-human
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- for consumer, a default AF of 10 is to be used
- AF for the quality of the whole database:
- 1
- Justification:
- not required, as supporting studies for the oral NOAEL are available
- AF for remaining uncertainties:
- 1
- Justification:
- not required
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
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