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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: 436-010-0 | CAS number: 422278-61-3 PRIMID V40-32
- 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:
- 4.7 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):
- 75
- Dose descriptor starting point:
- other: NOEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NOEL
- Value:
- 352.63 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Allometric scaling is applied as described in ECHA technical guidance the oral NOAEL in the rat mg/kg/day *1/0.38 * 6.7/10 = mg/m3 inhalation NOAEC for workers.
- AF for dose response relationship:
- 1
- Justification:
- The default assessment factor for NOEL is 1.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA guidance indicates a factor of 6 for extrapolation from subacute to chronic study.
- 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:
- 2.5
- Justification:
- No substance specific data is available.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA guidance indicates a default assessment factor of 5 for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- Available data from substance fulfilling scientific principle is used.
- AF for remaining uncertainties:
- 1
- Justification:
- No further uncertainties to be taken into account.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.7 mg/m³
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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
- Dose descriptor starting point:
- other: NOEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NOEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No default factor (i.e. factor 1) should be introduced when performing oral-to-dermal extrapolation.
- AF for dose response relationship:
- 1
- Justification:
- The default assessment factor for NOEL is 1.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA guidance indicates a factor of 6 for extrapolation from subacute to chronic study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for rat to human is 4.
- AF for other interspecies differences:
- 2.5
- Justification:
- No substance specific data is available.
- AF for intraspecies differences:
- 5
- Justification:
- ECHA guidance indicates a default assessment factor of 5 for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- Available data from substance fulfilling scientific principle is used.
- AF for remaining uncertainties:
- 1
- Justification:
- No further uncertainties to be taken into account.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.67 mg/kg bw/day
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
As basis for DNEL derivation the result from a 28-day oral toxicity study with rats was used, in which test item-related findings were generally restricted to salivation during daily observation and elevated liver weights and slight centrilobular hepatocellular hypertrophy after 4 weeks, in both sexes at the high dose level of 1000 mg/kg bw/day (no treatment related findings at 50 and 200 mg/kg bw/day). All these findings were reversible during the recovery period and histopathological findings in males and females treated with 1000 mg/kg/day, in the absence of commensurate changes in clinical biochemistry parameters, were considered to be metabolic adaptation. Therefore, 200 mg/kg bw/day was considered to be the NOEL and 1000 mg/kg bw/day was considered to be the NOAEL in this study. No factor was introduced in the route to route extrapolation based on toxicokinetic assessment of absorption. Allometric scaling is applied as described in ECHA technical guidance the oral NOEL in the rat mg/kg/day *1/0.38 * 6.7/10 = mg/m3 inhalation NOEC for workers. Based on toxicokinetic assessment, the absorption rate from dermal route is considered to be same as oral route. The NOELcorr for dermal therefore remains unchanged. The local effects are with low hazard (no threshold derived) due to the lack of significant response observed in available studies. The hazard for eyes are also considered to be low (no threshold derived) based on slightly effects observed in rabbit eye irritation study.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.16 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):
- 150
- Dose descriptor starting point:
- other: NOEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NOEL
- Value:
- 173.91 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Allometric scaling is applied as described in ECHA technical guidance the oral NOAEL in the rat mg/kg/day *1/1.15 = mg/m3 inhalation NOAEC for general population.
- AF for dose response relationship:
- 1
- Justification:
- The default assessment factor for NOEL is 1.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA guidance indicates a factor of 6 for extrapolation from subacute to chronic study.
- 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:
- 2.5
- Justification:
- No substance specific data is available.
- AF for intraspecies differences:
- 10
- Justification:
- ECHA guidance indicates a default assessment factor of 10 for general population.
- AF for the quality of the whole database:
- 1
- Justification:
- Available data from substance fulfilling scientific principle is used.
- AF for remaining uncertainties:
- 1
- Justification:
- No further uncertainties to be taken into account.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.16 mg/m³
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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
- Dose descriptor starting point:
- other: NOEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NOEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No default factor (i.e. factor 1) should be introduced when performing oral-to-dermal extrapolation.
- AF for dose response relationship:
- 1
- Justification:
- The default assessment factor for NOEL is 1.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA guidance indicates a factor of 6 for extrapolation from subacute to chronic study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for rat to human is 4.
- AF for other interspecies differences:
- 2.5
- Justification:
- No substance specific data is available.
- AF for intraspecies differences:
- 10
- Justification:
- ECHA guidance indicates a default assessment factor of 10 for general population.
- AF for the quality of the whole database:
- 1
- Justification:
- Available data from substance fulfilling scientific principle is used.
- AF for remaining uncertainties:
- 1
- Justification:
- No further uncertainties to be taken into account.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.33 mg/kg bw/day
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.33 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
- Dose descriptor starting point:
- other: NOEL
- Value:
- 200 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NOEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No route to route extrapolation is applied.
- AF for dose response relationship:
- 1
- Justification:
- The default assessment factor for NOEL is 1.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA guidance indicates a factor of 6 for extrapolation from subacute to chronic study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- The default allometric scaling factor for rat to human is 4.
- AF for other interspecies differences:
- 2.5
- Justification:
- No substance specific data is available.
- AF for intraspecies differences:
- 10
- Justification:
- ECHA guidance indicates a default assessment factor of 10 for general population.
- AF for the quality of the whole database:
- 1
- Justification:
- Available data from substance fulfilling scientific principle is used.
- AF for remaining uncertainties:
- 1
- Justification:
- No further uncertainties to be taken into account.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.33 mg/kg bw/day
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
As basis for DNEL derivation the result from a 28-day oral toxicity study with rats was used, in which test item-related findings were generally restricted to salivation during daily observation and elevated liver weights and slight centrilobular hepatocellular hypertrophy after 4 weeks, in both sexes at the high dose level of 1000 mg/kg bw/day (no treatment related findings at 50 and 200 mg/kg bw/day). All these findings were reversible during the recovery period and histopathological findings in males and females treated with 1000 mg/kg/day, in the absence of commensurate changes in clinical biochemistry parameters, were considered to be metabolic adaptation. Therefore, 200 mg/kg bw/day was considered to be the NOEL and 1000 mg/kg bw/day was considered to be the NOAEL in this study. No factor was introduced in the route to route extrapolation based on toxicokinetic assessment of absorption. Allometric scaling is applied as described in ECHA technical guidance the oral NOEL in the rat mg/kg/day *1/1.15 = mg/m3 inhalation NOEC for general population. Based on the toxicokinetic assessment, the absorption rate from dermal route is considered to be same as oral route. The NOELcorr for dermal therefore remains unchanged. The local effects are with low hazard (no threshold derived) due to the lack of significant response observed in available studies. The hazard for eyes are also considered to be low (no threshold derived) based on slightly effects observed in rabbit eye irritation study.
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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