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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 226-901-0 | CAS number: 5538-94-3
- 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:
- 18.79 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance and ECETOC (2010)
- Overall assessment factor (AF):
- 3
- Dose descriptor starting point:
- NOAEL
- Value:
- 32 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 56.39 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEL is taken from a combined chronic/carcinogenicity feeding study in rats, resulting in a NOAEL of 32 mg/kg bw/day. The recommended factor of 2 when doing route to route extrapolation for oral to inhalation exposure, recognizing higher absorption via the lungs has not been applied here. Due to low vapour pressure, exposure is only possible as aerosol (use is without fine spraying, only larger droplets). Droplets will deposit mainly on upper airways, and will be subsequently swallowed following mucociliary transportation to pharynx. This results to no principal difference in absorption compared oral route.
Inhalatory N(L)OAEC = oral N(L)OAEL*(1/0.38 m3/kg bw/d)*0.67
= 32 * 2.63 * 0.67
= 56.39 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- As the dose descriptor is the NOAEL, the default assessment factor is 1.
- AF for differences in duration of exposure:
- 1
- Justification:
- To account for using PoD taken from a chronic study to calculate a chronic DNEL.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is usually not applied in the derivation of the inhalation DNEL.
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC reported in 2010 after an extensive review that there is no justification for the suggested additional factor of 2.5 for this, therefore a factor of 1 would also be acceptable. In addition, as effects are local and related to the route of exposure, the already applied allometric scaling already represents a worst case.
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC reported in 2010 after an extensive scientific review that the appropriate factor for intraspecies differences for workers is 3 and not 5. As the effects for which the risk assessment is made is based on a local response following a specific mechanism for irritation/corrosion with inherently relative low variation between individuals no additional factor is needed to accommodate for possible high uncertainty between individuals on the basis of possible specific sensitivities.
- AF for the quality of the whole database:
- 1
- Justification:
- The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties identified therefore not applicable.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 18.79 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance and ECETOC (2010)
- Overall assessment factor (AF):
- 3
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.67 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance and ECETOC (2010)
- Overall assessment factor (AF):
- 12
- Dose descriptor starting point:
- NOAEL
- Value:
- 32 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 32 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL is taken from a combined chronic/carcinogenicity feeding study in rats, resulting in a NOAEL of 32 mg/kg bw/day.
Dermal N(L)OAEL=oral (N(L)OAEL*( ABSoral/ABSdermal)
= 32 x (1/1)
= 32 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- As the dose descriptor is the NOAEL, the default assessment factor is 1.
- AF for differences in duration of exposure:
- 1
- Justification:
- To account for using PoD taken from a chronic study to calculate a chronic DNEL.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling to account for differences in allometry in using the rat as a test model.
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC reported in 2010 after an extensive review that there is no justification for the suggested additional factor of 2.5 for this, therefore a factor of 1 would also be acceptable. In addition, as effects are local and related to the route of exposure, the already applied allometric scaling already represents a worst case.
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC reported in 2010 after an extensive scientific review that the appropriate fact for intraspecies differences for workers is 3 and not 5. As the effects for which the risk assessment is made is based on a local response following a specific mechanism for irritation/corrosion with inherently relative low variation between individuals no additional factor is needed to accommodate for possible high uncertainty between individuals on the basis of possible specific sensitivities
- AF for the quality of the whole database:
- 1
- Justification:
- The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties identified therefore not applicable.
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- medium 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:
- 7.36 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance and ECETOC (2010)
- Overall assessment factor (AF):
- 5
- Dose descriptor starting point:
- NOAEL
- Value:
- 32 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 36.82 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEL is taken from a combined chronic/carcinogenicity feeding study in rats, resulting in a NOAEL of 32 mg/kg bw/day. The recommended factor of 2 when doing route to route extrapolation for oral to inhalation exposure, recognizing higher absorption via the lungs has not been applied here. Due to low vapour pressure, exposure is only possible as aerosol (use is without fine spraying, only larger droplets). Droplets will deposit mainly on upper airways, and will be subsequently swallowed following mucociliary transportation to pharynx. This results to no principal difference in absorption compared oral route.
Inhalatory N(L)OAEC = oral N(L)OAEL*(1/1.15 m3/kg bw/d)
= 32 * 0.869
= 36.82 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- As the dose descriptor is the NOAEL, the default assessment factor is 1.
- AF for differences in duration of exposure:
- 1
- Justification:
- To account for using PoD taken from a chronic study to calculate a chronic DNEL.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is usually not applied in the derivation of the inhalation DNEL.
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC reported in 2010 after an extensive review that there is no justification for the suggested additional factor of 2.5 for this, therefore a factor of 1 would also be acceptable. In addition, as effects are local and related to the route of exposure, the already applied allometric scaling already represents a worst case.
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC reported in 2010 after an extensive scientific review that the appropriate factor for intraspecies differences for workers is 5 and not 10. As the effects for which the risk assessment is made is based on a local response following a specific mechanism for irritation/corrosion with inherently relative low variation between individuals no additional factor is needed to accommodate for possible high uncertainty between individuals on the basis of possible specific sensitivities.
- AF for the quality of the whole database:
- 1
- Justification:
- The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties identified therefore not applicable.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.36 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance and ECETOC (2010)
- Overall assessment factor (AF):
- 5
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.6 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance and ECETOC (2010)
- Overall assessment factor (AF):
- 20
- Dose descriptor starting point:
- NOAEL
- Value:
- 32 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 32 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL is taken from a combined chronic/carcinogenicity feeding study in rats, resulting in a NOAEL of 32 mg/kg bw/day.
Dermal N(L)OAEL=oral (N(L)OAEL*( ABSoral/ABSdermal)
= 32 * (1/1)
= 32 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- As the dose descriptor is the NOAEL, the default assessment factor is 1.
- AF for differences in duration of exposure:
- 1
- Justification:
- To account for using PoD taken from a chronic study to calculate a chronic DNEL.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling to account for differences in allometry in using the rat as a test model.
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC reported in 2010 after an extensive review that there is no justification for the suggested additional factor of 2.5 for this, therefore a factor of 1 would also be acceptable. In addition, as effects are local and related to the route of exposure, the already applied allometric scaling already represents a worst case.
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC reported in 2010 after an extensive scientific review that the appropriate factor for intraspecies differences for workers is 5 and not 10. As the effects for which the risk assessment is made is based on a local response following a specific mechanism for irritation/corrosion with inherently relative low variation between individuals no additional factor is needed to accommodate for possible high uncertainty between individuals on the basis of possible specific sensitivities.
- AF for the quality of the whole database:
- 1
- Justification:
- The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties identified therefore not applicable.
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- 1.6 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance and ECETOC (2010)
- Overall assessment factor (AF):
- 20
- Dose descriptor starting point:
- NOAEL
- Value:
- 32 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- As the dose descriptor is the NOAEL, the default assessment factor is 1.
- AF for differences in duration of exposure:
- 1
- Justification:
- To account for using PoD taken from a chronic study to calculate a chronic DNEL.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling to account for differences in allometry in using the rat as a test model.
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC reported in 2010 after an extensive review that there is no justification for the suggested additional factor of 2.5 for this, therefore a factor of 1 would also be acceptable. In addition, as effects are local and related to the route of exposure, the already applied allometric scaling already represents a worst case.
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC reported in 2010 after an extensive scientific review that the appropriate factor for intraspecies differences for workers is 5 and not 10. As the effects for which the risk assessment is made is based on a local response following a specific mechanism for irritation/corrosion with inherently relative low variation between individuals no additional factor is needed to accommodate for possible high uncertainty between individuals on the basis of possible specific sensitivities.
- AF for the quality of the whole database:
- 1
- Justification:
- The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties identified therefore not applicable.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.6 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECHA REACH guidance and ECETOC (2010)
- Overall assessment factor (AF):
- 20
- DNEL extrapolated from long term DNEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium 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.
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.