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EC number: 701-426-6 | 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:
- 7.7 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC guidance (ECETOC, Technical Report No. 110, 2010)
- Overall assessment factor (AF):
- 6
- Dose descriptor starting point:
- NOAEL
- Value:
- 37.5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 46.3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The substance fulfils the REACH Annex VII to Annex X information requirements in accordance with ECHA guidance R7.5-7.7 (2016) for assessing long-term systemic toxicity. Since no repeated dose inhalation study is available, route-to-route extrapolation from the oral exposure route is performed. The starting point is the NOAEL from the 90-day gavage study in rats; 37.5 mg/kg bw/day.
This oral rat NOAEL is converted to an inhalation NOAEC for rats by using a default respiratory volume for the rat corresponding to 8 hours (0.38 m3/kg bw/day). A factor for route-to-route extrapolation is included based on the default absorption values (R.7.12. June 2017). The resulting rat inhalation NOAEC is converted into inhalation worker NOAEC by correction for respiratory rate based on activity (6.7 m³ for normal light activity versus 10 m³ for worker activity) and by correction for 5 day exposure (7 days exposure per week in the study versus 5 days per week for workers): 37.5 * (1/0.38) * (50/100) * (6.7/10) * (7/5) = 46.3 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, no assessment factor for dose response relationship is necessary since an appropriate NOAEL, derived from a study which is of good quality and without uncertainties, is available.
- AF for differences in duration of exposure:
- 2
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, a default assessment factor of 2 is recommended for extrapolation from sub-chronic to chronic exposure.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, no assessment factor for allometric scaling needs to be applied in case of oral to inhalation route-to-route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, the application of allometric scaling is recommended for the interspecies extrapolation from animals to humans of systemic effects, with no need for a factor for any residual interspecies variability after scaling.
- AF for intraspecies differences:
- 3
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, a default assessment factor of 3 is recommended for the worker population.
- AF for the quality of the whole database:
- 1
- Justification:
- A sub-chronic study is available, that is a Klimisch 1 study (OECD Guideline and compliant to GLP). Therefore, the quality of the whole database is good and no assessment factor for this aspect is necessary.
- AF for remaining uncertainties:
- 1
- Justification:
- There were no remaining uncertainties and therefore no assessment factor for this aspect is necessary.
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:
- 2.2 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC guidance (ECETOC, Technical Report No. 110, 2010)
- Overall assessment factor (AF):
- 24
- Dose descriptor starting point:
- NOAEL
- Value:
- 37.5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 52.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The substance fulfils the REACH Annex VII to Annex X information requirements in accordance with ECHA guidance R7.5-7.7 (2016) for assessing long-term systemic toxicity. Since no repeated dose inhalation study is available, route-to-route extrapolation from the oral exposure route is performed. The starting point is the NOAEL from the 90-day gavage study in rats; 37.5 mg/kg bw/day.
No data for oral and dermal absorption is available, the default absorption factors are for both routes 50%, hence no factor for route-to-route extrapolation is included (R.7.12. June 2017). The resulting rat dermal NOAEL is corrected for 5-day exposure (7 days exposure per week in the study versus 5 days per week for workers): 37.5 * (7/5) = 52.5 mg kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, no assessment factor for dose response relationship is necessary since an appropriate NOAEL, derived from a study which is of good quality and without uncertainties, is available.
- AF for differences in duration of exposure:
- 2
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, a default assessment factor of 2 is recommended for extrapolation from sub-chronic to chronic exposure.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, the default assessment factor for allometric scaling from rat to human is 4.
- AF for other interspecies differences:
- 1
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, the application of allometric scaling is recommended for the interspecies extrapolation from animals to humans of systemic effects, with no need for a factor for any residual interspecies variability after scaling.
- AF for intraspecies differences:
- 3
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, a default assessment factor of 3 is recommended for the worker population.
- AF for the quality of the whole database:
- 1
- Justification:
- A sub-chronic study is available, that is a Klimisch 1 study (OECD Guideline and compliant to GLP). Therefore, the quality of the whole database is good and no assessment factor for this aspect is necessary.
- AF for remaining uncertainties:
- 1
- Justification:
- There were no remaining uncertainties and therefore no assessment factor for this aspect is necessary..
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low 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:
- 1.6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC guidance (ECETOC, Technical Report No. 110, 2010)
- Overall assessment factor (AF):
- 10
- Dose descriptor starting point:
- NOAEL
- Value:
- 37.5 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 16.3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The substance fulfils the REACH Annex VII to Annex X information requirements in accordance with ECHA guidance R7.5-7.7 (2016) for assessing long-term systemic toxicity. Since no repeated dose inhalation study is available, route-to-route extrapolation from the oral exposure route is performed. The starting point is the NOAEL from the 90-day gavage study in rats; 37.5 mg/kg bw/day.
This oral rat NOAEL is converted to an inhalation NOAEC for rats by using a default respiratory volume for the rat corresponding to 24 hours (1.15 m3/kg bw/day). A factor for route-to-route extrapolation is included based on the default absorption values (R.7.12. June 2017): 37.5 * (1/1.15) * (50/100) = 16.3 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, no assessment factor for dose response relationship is necessary since an appropriate NOAEL, derived from a study which is of good quality and without uncertainties, is available.
- AF for differences in duration of exposure:
- 2
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, a default assessment factor of 2 is recommended for extrapolation from sub-chronic to chronic exposure.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, no assessment factor for allometric scaling needs to be applied in case of oral to inhalation route-to-route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, the application of allometric scaling is recommended for the interspecies extrapolation from animals to humans of systemic effects, with no need for a factor for any residual interspecies variability after scaling.
- AF for intraspecies differences:
- 5
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, a default assessment factor of 5 is recommended for the general population.
- AF for the quality of the whole database:
- 1
- Justification:
- A sub-chronic study is available, that is a Klimisch 1 study (OECD Guideline and compliant to GLP). Therefore, the quality of the whole database is good and no assessment factor for this aspect is necessary.
- AF for remaining uncertainties:
- 1
- Justification:
- There were no remaining uncertainties and therefore no assessment factor for this aspect is necessary.
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:
- 0.9 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC guidance (ECETOC, Technical Report No. 110, 2010)
- Overall assessment factor (AF):
- 40
- Dose descriptor starting point:
- NOAEL
- Value:
- 37.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The substance fulfils the REACH Annex VII to Annex X information requirements in accordance with ECHA guidance R7.5-7.7 (2016) for assessing long-term systemic toxicity. Since no repeated dose inhalation study is available, route-to-route extrapolation from the oral exposure route is performed. The starting point is the NOAEL from the 90-day gavage study in rats; 37.5 mg/kg bw/day.
No data for oral and dermal absorption is available, the default absorption factors are for both routes 50%, hence no factor for route-to-route extrapolation is included (R.7.12. June 2017).
- AF for dose response relationship:
- 1
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, no assessment factor for dose response relationship is necessary since an appropriate NOAEL, derived from a study which is of good quality and without uncertainties, is available.
- AF for differences in duration of exposure:
- 2
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, a default assessment factor of 2 is recommended for extrapolation from sub-chronic to chronic exposure.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, the default assessment factor for allometric scaling from rat to human is 4.
- AF for other interspecies differences:
- 1
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, the application of allometric scaling is recommended for the interspecies extrapolation from animals to humans of systemic effects, with no need for a factor for any residual interspecies variability after scaling.
- AF for intraspecies differences:
- 5
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, a default assessment factor of 5 is recommended for the worker population.
- AF for the quality of the whole database:
- 1
- Justification:
- A sub-chronic study is available, that is a Klimisch 1 study (OECD Guideline and compliant to GLP). Therefore, the quality of the whole database is good and no assessment factor for this aspect is necessary.
- AF for remaining uncertainties:
- 1
- Justification:
- There were no remaining uncertainties and therefore no assessment factor for this aspect is necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.9 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC guidance (ECETOC, Technical Report No. 110, 2010)
- Overall assessment factor (AF):
- 40
- Dose descriptor starting point:
- NOAEL
- Value:
- 37.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The substance fulfils the REACH Annex VII to Annex X information requirements in accordance with ECHA guidance R7.5-7.7 (2016) for assessing long-term systemic toxicity. Since no repeated dose inhalation study is available, route-to-route extrapolation from the oral exposure route is performed. The starting point is the NOAEL from the 90-day gavage study in rats; 37.5 mg/kg bw/day.
- AF for dose response relationship:
- 1
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, no assessment factor for dose response relationship is necessary since an appropriate NOAEL, derived from a study which is of good quality and without uncertainties, is available.
- AF for differences in duration of exposure:
- 2
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, a default assessment factor of 2 is recommended for extrapolation from sub-chronic to chronic exposure.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, the default assessment factor for allometric scaling from rat to human is 4.
- AF for other interspecies differences:
- 1
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, the application of allometric scaling is recommended for the interspecies extrapolation from animals to humans of systemic effects, with no need for a factor for any residual interspecies variability after scaling.
- AF for intraspecies differences:
- 5
- Justification:
- In accordance with ECETOC guidance on derivation of assessment factors for human health risk assessment – No. 110, a default assessment factor of 3 is recommended for the worker population.
- AF for the quality of the whole database:
- 1
- Justification:
- A sub-chronic study is available, that is a Klimisch 1 study (OECD Guideline and compliant to GLP). Therefore, the quality of the whole database is good and no assessment factor for this aspect is necessary.
- AF for remaining uncertainties:
- 1
- Justification:
- There were no remaining uncertainties and therefore no assessment factor for this aspect is necessary.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
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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