Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 263-094-4 | CAS number: 61789-87-5
- 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:
- 11.75 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 881.58 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Justification for NOAEC ( mg/m3) calculation attached to technical dossier
- AF for dose response relationship:
- 1
- Justification:
- Table R8-6
- AF for differences in duration of exposure:
- 6
- Justification:
- Table R8-6
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is accounted for in NOAEL extrapolation.
- AF for intraspecies differences:
- 5
- Justification:
- intraspecies – workers Table R8-6
- AF for the quality of the whole database:
- 1
- Justification:
- Table R8-6
- AF for remaining uncertainties:
- 2.5
- Justification:
- Table R8-6
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:
- 3.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Table R8-6
- AF for differences in duration of exposure:
- 6
- Justification:
- Table R8-6
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Table R8-3
- AF for intraspecies differences:
- 5
- Justification:
- Table R8-6
- AF for the quality of the whole database:
- 1
- Justification:
- Table R8-6
- AF for remaining uncertainties:
- 2.5
- Justification:
- Table R8-6
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The long term exposure DNELs have all be derived based upon the NOAEL(C) values observed from repeated dose exposure with Assessment Factor based adjustment to make the DNELs appropriate to workers, based on Table R. 8 -6. The dermal DNEL is estimated directly from the available 28 -day repeated dose dermal toxicity data. As the inhlataion data are considered unsafe, however, due to a high proportion of mineral oil mist in the exposure concentration the NOAEL(C) is calculated from the 28 -day repeated dose oral toxicity data.
Based on formulae in R. 8-3, as a worst case it is assumed 100% adsorption orally to rats and by inhalation to human. Due to the presence of mineral oil changing the physical state of the substance, granulometry data are not available and deposition in the lungs cannot be determined. Target endpoints are also assumed to be equivalent.
For workers (8h exposure/d)
NOAEC (inhal) = 500 * 1/0.38 m3/kg/d * 100/100 * 6.7m3/10m3
NOAEC (inhal) = 881.58 mg/m3
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.9 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 434.78 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Justification for NOAEC (434.78 mg/m3) calculation attached to technical dossier.
- AF for dose response relationship:
- 1
- Justification:
- Table R8-6
- AF for differences in duration of exposure:
- 6
- Justification:
- Table R8-6 subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is accounted for in NOAEL extrapolation
- AF for intraspecies differences:
- 10
- Justification:
- Table R8-6 general population
- AF for the quality of the whole database:
- 1
- Justification:
- Table R8-6
- AF for remaining uncertainties:
- 2.5
- Justification:
- Table R8-6
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:
- 1.667 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Table R8-6
- AF for differences in duration of exposure:
- 6
- Justification:
- Table R8-6
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Table R8-3
- AF for intraspecies differences:
- 10
- Justification:
- Table R8-6 general population
- AF for the quality of the whole database:
- 1
- Justification:
- Table R8-6
- AF for remaining uncertainties:
- 2.5
- Justification:
- Table R8-6
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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.833 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Table R8-6
- AF for differences in duration of exposure:
- 6
- Justification:
- Table R8-6
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Table R8-3
- AF for intraspecies differences:
- 10
- Justification:
- Table R8-6 general population
- AF for the quality of the whole database:
- 1
- Justification:
- Table R8-6
- AF for remaining uncertainties:
- 2.5
- Justification:
- Table R8-6
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
The long term exposure DNELs have all be derived based upon the NOAEL(C) values observed from repeated dose exposure with Assessment Factor based adjustment to make the DNELs appropriate to workers, based on Table R. 8 -6. The dermal DNEL is estimated directly from the available 28 -day repeated dose dermal toxicity data. As the inhlataion data are considered unsafe, however, due to a high proportion of mineral oil mist in the exposure concentration the NOAEL(C) is calculated from the 28 -day repeated dose oral toxicity data.
Based on formulae in R. 8-3, as a worst case it is assumed 100% adsorption orally to rats and by inhalation to human. Due to the presence of mineral oil changing the physical state of the substance, granulometry data are not available and deposition in the lungs cannot be determined. Target endpoints are also assumed to be equivalent.
For general population (24h exposure/d)
NOAEC (inhal) = 500 * 1/1.15 m3/kg/d * 100/100
NOAEC (inhal) = 434.78 mg/m3Information 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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