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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-585-2 | CAS number: 108-46-3
- 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:
- 5.6 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 80 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 140 mg/m³
- Explanation for the modification of the dose descriptor starting point:
A 14 -day range finding study (Industrial Health Foundation Inc., 1977) is the only available inhalation study. This study is considered inadequate for assessing endpoints such as histopathological examination. Therefore, the NOAEL from the key oral study (CIT, 2004) was used for DNEL derivation, with route-to-route extrapolation based on default values from the ECHA guidance, and assuming 8 hour/day worker exposure.
- AF for dose response relationship:
- 1
- Justification:
- Best professional judgment and ECHA default for NOAEL-based DNEL calculation. Presumes minimal or no uncertainty in the oral NOAEL. Criteria met in regards to dose spacing, shape and slope of dose-response curve, extent/severity of effect at LOAEL, quality of study (=1, valid without restriction).
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA default for subchronic to chronic extrapolation.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA default. Allometrric scaling is not required when using the oral NOAEL to estimate an inhalation DNEL.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default.
- AF for the quality of the whole database:
- 1
- Justification:
- Best professional judgement. Although the inhalation data base is limited to a single 14-day range finding study with one test concentration in rats, the oral database is of good/standard quality.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 132.8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- NOAEC
- Value:
- 664 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- The DNEL derivation is based on a NOAEC.
- AF for differences in duration of exposure:
- 1
- Justification:
- ECHA default
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA default
- AF for other interspecies differences:
- 1
- Justification:
- ECHA default
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 40 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:
- NOAEL
- Value:
- 80 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No dermal repeat-dose study available. Therefore, the NOAEL from the key oral study (CIT, 2004) was used for DNEL derivation, with route-to-route extrapolation based on default values from the ECHA guidance, and assuming 8 hour/day worker exposure.
- AF for dose response relationship:
- 1
- Justification:
- Best professional judgment and ECHA default for NOAEL-based DNEL calculation. Presumes minimal or no uncertainty in the oral NOAEL. Criteria met in regards to dose spacing, shape and slope of dose-response curve, extent/severity of effect at LOAEL, quality of study (=1, valid without restriction).
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA default for subchronic to chronic extrapolation.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default.
- AF for the quality of the whole database:
- 1
- Justification:
- Best professional judgment. Although no repeated dose dermal studies were identified, the oral data base is of a good/standard quality.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- repeated dose toxicity
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
Based on available data, the most relevant reproducible effect, body weight changes, was identified as the basis for establishing the DNEL. This value is more conservative than those identified in association with local and/or acute effects. As such, and in accordance with ECHA Guidance Document R.8, Characterization of Dose[Concentration]-Response for Human Health dated May 2008, DNELs for several of the above identified population groups and effects were not performed.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.39 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:
- 80 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 69 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Only one inhalation study available. In this study, only one concentration was used, with a small number of animals and no histopathological examination. The 90-day inhalation study is considered invalid as it does not meet the requirements of current guidelines. Therefore, the NOAEL from the key oral study (CIT, 2004) was used for DNEL derivation, with route-to-route extrapolation based on default values from the ECHA guidance, and assuming 24 hour/day exposure.
- AF for dose response relationship:
- 1
- Justification:
- Best professional judgment and ECHA default for NOAEL-based DNEL calculation. Presumes minimal or no uncertainty in the oral NOAEL. Criteria met in regards to dose spacing, shape and slope of dose-response curve, extent/severity of effect at LOAEL, quality of study (=1, valid without restriction).
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA default for subchronic to chronic extrapolation.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA default. Allometrric scaling is not required when using the oral NOAEL to estimate an inhalation DNEL.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default.
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default.
- AF for the quality of the whole database:
- 1
- Justification:
- Best professional judgement. Although the inhalation data base is limited to a single 14-day range finding study with one test concentration in rats, the oral database is of good/standard quality.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 33 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor:
- NOAEC
- Value:
- 330 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- The DNEL derivation is based on a NOAEC.
- AF for differences in duration of exposure:
- 1
- Justification:
- ECHA default
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA default
- AF for other interspecies differences:
- 1
- Justification:
- ECHA default
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20 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:
- 80 mg/m³
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No dermal repeat-dose study available. Therefore, the NOAEL from the key oral study (CIT, 2004) was used for DNEL derivation, with route-to-route extrapolation based on default values from the ECHA guidance, and assuming 24 hour/day exposure.
- AF for dose response relationship:
- 1
- Justification:
- Best professional judgment and ECHA default for NOAEL-based DNEL calculation. Presumes minimal or no uncertainty in the oral NOAEL. Criteria met in regards to dose spacing, shape and slope of dose-response curve, extent/severity of effect at LOAEL, quality of study (=1, valid without restriction).
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA default for subchronic to chronic extrapolation.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default.
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default.
- AF for the quality of the whole database:
- 1
- Justification:
- Best professional judgment. Although no repeated dose dermal studies were identified, the oral data base is of a good/standard quality.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- repeated dose toxicity
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.4 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:
- 80 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 80 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Best professional judgment and ECHA default for NOAEL‐based DNEL calculation. Presumes minimal or no uncertainty in the oral NOAEL. Criteria met in regards to dose spacing, shape and slope of dose‐response curve, extent/severity of effect at LOAEL, quality of study (=1, valid without restriction).
- AF for differences in duration of exposure:
- 2
- Justification:
- ECHA default for subchronic to chronic extrapolation.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA default.
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA default.
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default.
- AF for the quality of the whole database:
- 1
- Justification:
- Best professional judgment and ECHA default. Presumes a good/standard quality oral data base.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - General Population
Based on available data, the most relevant reproducible effect, body weight changes, was identified as the basis for establishing the DNEL. This value is more conservative than those identified in association with local and/or acute effects. As such, and in accordance with ECHA Guidance Document R.8, Characterization of Dose[Concentration]-Response for Human Health dated May 2008, DNELs for several of the above identified population groups and effects were not performed.
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.