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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 237-898-0 | CAS number: 14059-33-7
- 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:
- no hazard identified
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:
- 0.02 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 2.5
- Dose descriptor:
- NOAEC
- AF for differences in duration of exposure:
- 1
- Justification:
- a factor of 1 is used because the local effect on the lung seems to be concentration rather than time dependent if the clearance mechanism of the lung is not impaired. This appears to be true for the effects caused by the pigment.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- the NOAEC is based on a local effect, therefore, the allometric scaling factor is set to 1, corrected NOAEC of 0.075 mg/m3 was multiplied by 6.7 m3/10 m3 to account for differences in the respiratory rate of humans at rest and workers (light activity) (POD = 0.075 mg/m3 x 0.67 = 0.050 mg/m3)
- AF for other interspecies differences:
- 2.5
- Justification:
- a factor of 2.5 is used for remaining uncertainties (such as differences in lung clearance between rats and humans)
- AF for intraspecies differences:
- 1
- Justification:
- a factor of 1 is used for the worker because healthy individuals are not expected to differ significantly in their susceptibility to local irritants/cytotoxicants
- AF for the quality of the whole database:
- 1
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:
- 0.67 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- worker
- AF for the quality of the whole database:
- 1
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 DNEL for long-term inhalation exposure - local effects was derived from the NOAEC of the 90 day repeated dose study (inhalation) where the substance caused cytotoxicity and respiratory tract irritation at concentrations of 0.1 mg/m3. The effect is thought to be due to particles that may accumulate at certain concentrations if the capacity of the clearance by aveolar macrophages is exceeded.
Point of Departure (POD)
a. exposure pattern: the 90 day NOAEC was modified to account for the difference in inhalation pattern between rats (6 h) and humans (8 h for the worker). 0.1 mg/m3 (NOAEC) x 6 h / 8 h = 0.075 mg/m3
b. correction for respiratory rate: the corrected NOAEC of 0.075 mg/m3 was multiplied by 6.7 m3/10 m3 to account for differences in the respiratory rate of humans at rest and workers (light activity) (POD = 0.075 mg/m3 x 0.67 = 0.050 mg/m3).
POD = 0.050 mg/m3
Assessment Factors
a. interspecies: the NOAEC is based on a local effect, therefore, the allometric scaling factor is set to 1, a factor of 2.5 is used for remaining uncertainties (such as differences in lung clearance between rats and humans).
b. intraspecies: a factor of 1 is used for the worker because healthy individuals are not expected to differ significantly in their susceptibility to local irritants/cytotoxicants.
c. subchronic to chronic extrapolation: a factor of 1 is used because the local effect on the lung seems to be concentration rather than time dependent if the clearance mechanism of the lung is not impaired. This appears to be true for the effects caused by the pigment.
Overall assessment factor is 1 x 2.5 x 1 x 1 = 2.5; the DNEL is 0.050 mg/m3 / 2.5 = 0.02 mg/m3.
General Population - Hazard via inhalation 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:
- DNEL (Derived No Effect Level)
- Value:
- 0.005 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
- AF for differences in duration of exposure:
- 1
- Justification:
- a factor of 1 is used because the local effect on the lung seems to be concentration rather than time dependent if the clearance mechanism of the lung is not impaired. This appears to be true for the effects caused by the pigment
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- the NOAEC is based on a local effect, therefore, the allometric scaling factor is set to 1
- AF for other interspecies differences:
- 2.5
- Justification:
- the NOAEC is based on a local effect, therefore, the allometric scaling factor is set to 1
- AF for intraspecies differences:
- 2
- Justification:
- a factor of 2 is used to account for differences in susceptibility to local irritants/cytotoxicants
- AF for the quality of the whole database:
- 1
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:
- 0.33 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:
- 200 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
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:
- 0.33 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:
- 200 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
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 DNEL for long-term inhalation exposure - local effects was derived from the NOAEC of the 90 day repeated dose study (inhalation) where the substance caused cytotoxicity and respiratory tract irritation at concentrations of 0.1 mg/m3. The effect is thought to be due to particles that may accumulate at certain concentrations if the capacity of the clearance by aveolar macrophages is exceeded.
Point of Departure (POD)
exposure pattern: the 90 day NOAEC was modified to account for the difference in inhalation pattern between rats (6 h) and humans (24 h for the general population). 0.1 mg/m3 (NOAEC) x 6 h / 24 h = 0.025 mg/m3
POD = 0.025 mg/m3
Assessment Factors
a. interspecies: the NOAEC is based on a local effect, therefore, the allometric scaling factor is set to 1, a factor of 2.5 is used for remaining uncertainties (such as differences in lung clearance between rats and humans).
b. intraspecies: a factor of 2 is used to account for differences in susceptibility to local irritants/cytotoxicants.
c. subchronic to chronic extrapolation: a factor of 1 is used because the local effect on the lung seems to be concentration rather than time dependent if the clearance mechanism of the lung is not impaired. This appears to be true for the effects caused by the pigment.
Overall assessment factor is 1 x 2.5 x 2 x 1 = 5; the DNEL is 0.025 mg/m3 / 5 = 0.005 mg/m3.
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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