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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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Diss Factsheets
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EC number: 221-220-5 | CAS number: 3033-62-3
- 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:
- 0.16 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):
- 25
- Dose descriptor starting point:
- NOAEC
- Value:
- 8.2 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- default assessment factor
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on 14 week inhalation study - sub-chronic to chronic AF of 2 is applied
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- No data are available on any remaining interspecies uncertainties; therefore, the default factor of 2.5 was applied.
- AF for intraspecies differences:
- 5
- Justification:
- Standard default for workers
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 0.08 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 15
- Dose descriptor:
- LOAEC
- Value:
- 1.51 mg/m³
- AF for dose response relationship:
- 3
- Justification:
- LOAEC
- AF for differences in duration of exposure:
- 1
- Justification:
- Increasing the duration does not increase the severity as is the case for certain local effects in the respiratory tract. This is relevant when there is no substantial difference in the N(L)OAECs following acute and subacute exposure by inhalation. The effects can thus be considered concentration rather than dose-dependent (ECHA R8, pg 29).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for local effects
- AF for other interspecies differences:
- 1
- Justification:
- Since local effects are independent of the basal metabolic rate, allometric scaling should not be applied (allometric scaling factor of 1). For the remaining uncertainties in kinetic (at a smaller extent) and in dynamic (at a larger extent) interspecies differences, consideration of the mechanism of toxicity is crucial, e.g. if the effect is a simple destruction of membranes due to the physicochemical properties (e.g. pH) of the chemical concerned as opposed to a mechanism involving local metabolism (see pg 26 of R8). The mechanism of action for the test substance is corrosion which is a simple destruction of membranes.
- AF for intraspecies differences:
- 5
- Justification:
- Standard default for workers
- AF for the quality of the whole database:
- 1
- Justification:
- N/A
- AF for remaining uncertainties:
- 1
- Justification:
- N/A
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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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
Long term exposure inhalation DNELs for systemic effects have been calculated for workers as 0.16 mg/m3. A long term inhalation DNEL for local effects was calculated as 0.08 mg/m3.
A DNEL could not be derived for dermal local effects as all doses tested produced local corrosivity effects. No systemic effects were observed at any of the doses tested. Therefore, in accordance with ECHA guidance, a qualitative assessment will be performed for long-term dermal effects.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.041 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):
- 50
- Dose descriptor starting point:
- NOAEC
- Value:
- 8.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No route to route extrapolation used
- AF for dose response relationship:
- 1
- Justification:
- N/A
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on 14 week inhalation study - sub-chronic to chronic AF of 2 is applied
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF for inhalation not used
- AF for other interspecies differences:
- 2.5
- Justification:
- No data are available on any remaining interspecies uncertainties; therefore, the default factor of 2.5 was applied.
- AF for intraspecies differences:
- 10
- Justification:
- Standard default for general population
- AF for the quality of the whole database:
- 1
- Justification:
- N/A
- AF for remaining uncertainties:
- 1
- Justification:
- N/A
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.013 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Dose descriptor:
- LOAEC
- Value:
- 1.51 mg/m³
- AF for dose response relationship:
- 3
- Justification:
- LOAEC used
- AF for differences in duration of exposure:
- 1
- Justification:
- Increasing the duration does not increase the severity as is the case for certain local effects in the respiratory tract. This is relevant when there is no substantial difference in the N(L)OAECs following acute and subacute exposure by inhalation. The effects can thus be considered concentration rather than dose-dependent (ECHA R8, pg 29).
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF for inhalation exposure not used
- AF for other interspecies differences:
- 1
- Justification:
- Since local effects are independent of the basal metabolic rate, allometric scaling should not be applied (allometric scaling factor of 1). For the remaining uncertainties in kinetic (at a smaller extent) and in dynamic (at a larger extent) interspecies differences, consideration of the mechanism of toxicity is crucial, e.g. if the effect is a simple destruction of membranes due to the physicochemical properties (e.g. pH) of the chemical concerned as opposed to a mechanism involving local metabolism (see pg 26 of R8). The mechanism of action for the test substance is corrosion which is a simple destruction of membranes.
- AF for intraspecies differences:
- 10
- Justification:
- Standard default for general population
- AF for the quality of the whole database:
- 1
- Justification:
- N/A
- AF for remaining uncertainties:
- 1
- Justification:
- N/A
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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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:
- 0.047 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):
- 50
- Dose descriptor starting point:
- NOAEC
- Value:
- 8.2 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2.36 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- A systemic inhalation NOAEC of 8.2 mg/m3 was obtained in a 14-wk repeated dose study on rats. 100% absorption for the oral and the inhalative route for animals and humans is assumed. A conversion factor from 6 hours of exposure in the study to 24 hours for the general population (4) is applied. An inhalation to oral conversion factor of of 1.15 m3/kg bw is applied following REACH R.8 Example 8.1 to obtain a corrected NOAEL for the general population of: 8.2 mg/m3 *1.15 m3/kg bw / 4 = 2.36 mg/kg bw /d.
- AF for dose response relationship:
- 1
- Justification:
- N/A
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on 14 week inhalation study - sub-chronic to chronic AF of 2 is applied
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- N/A
- AF for other interspecies differences:
- 2.5
- Justification:
- No data are available on any remaining interspecies uncertainties; therefore, the default factor of 2.5 was applied.
- AF for intraspecies differences:
- 10
- Justification:
- Standard default for general population
- AF for the quality of the whole database:
- 1
- Justification:
- N/A
- AF for remaining uncertainties:
- 1
- Justification:
- N/A
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
Long term exposure inhalation DNELs for systemic effects have been calculated for the general population as 0.041 mg/m3. A long term inhalation DNEL for local effects was calculated as 0.013 mg/m3.
A long term oral DNEL of 0.047 mg/kg bw/day was determined. A systemic long term dermal DNEL could not be derived as all doses tested produced local corrosivity effects. Therefore, in accordance with ECHA guidance, a qualitative assessment will be performed for dermal exposure.
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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