Registration Dossier
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EC number: 204-409-7 | CAS number: 120-57-0
- 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:
- 17.6 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 441 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- For potential inhalation exposure, route-to-route extrapolation from the oral NOAEL value was considered appropriate. Regarding absorption, the available toxicokinetic data suggest rapid and nearly complete absorption by the oral route. Specifically, nearly 90% of an oral dose is excreted in the urine of mice within 12 hours of administration, and 92.6% of an oral dose is excreted in the urine of rats within 24 hours of administration. Since a maximal absorption already occurred by oral route, no additional factor was introduced for inhalation. To convert the oral NOAEL into inhalatory NOAEC, the following usual equation was applied: worker corrected inhalation NOAEC = oral NOAEL * (1/0.38 m3/kg/day)*0.67. Thus, the corrected dose descriptor for inhalation is: 250*(1/0.38)*0.67 = 441 mg/m3 for workers.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL determined in study
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on subacte study, but data available from other repeated dose toxicity study (up to 2-years) indicated that increasing the exposure duration does not increase the incidence of severity of adverse effects. For the purpose of conservatism, an AF of 2 was kept since all parameters were not evaluated in available repeated dose toxicity studies.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Table R.8-4 ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- Table R.8-6 ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- Table R.8-6 ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- studies available for all key systemic endpoints
- AF for remaining uncertainties:
- 1
- Justification:
- studies available for all key systemic endpoints
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:
- 2.5 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- For potential dermal exposure, route-to-route extrapolation from the oral NOAEL value was considered appropriate. Since a maximal absorption already occurred by oral route, no additional factor was introduced.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL determined in study
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on subacte study, but data available from other repeated dose toxicity study (up to 2-years) indicated that increasing the exposure duration does not increase the incidence of severity of adverse effects. For the purpose of conservatism, an AF of 2 was kept since all parameters were not evaluated in available repeated dose toxicity studies.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Table R.8-4 ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- Table R.8-6 ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- Table R.8-6 ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- studies available for all key systemic endpoints
- AF for remaining uncertainties:
- 1
- Justification:
- studies available for all key systemic endpoints
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)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.3 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NOAEL
- Value:
- 217 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- For potential inhalation exposure, route-to-route extrapolation from the oral NOAEL value was considered appropriate. Regarding absorption, the available toxicokinetic data suggest rapid and nearly complete absorption by the oral route. Specifically, nearly 90% of an oral dose is excreted in the urine of mice within 12 hours of administration, and 92.6% of an oral dose is excreted in the urine of rats within 24 hours of administration. Since a maximal absorption already occurred by oral route, no additional factor was introduced for inhalation. To convert the oral NOAEL into inhalatory NOAEC, the following usual equation was applied: general population corrected inhalation NOAEC = oral NOAEL * (1/1.15 m3/kg/day). Thus, the corrected dose descriptor for inhalation is: 250*(1/1.15) = 217 mg/m3 for general population.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL determined in study
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on subacte study, but data available from other repeated dose toxicity study (up to 2-years) indicated that increasing the exposure duration does not increase the incidence of severity of adverse effects. For the purpose of conservatism, an AF of 2 was kept since all parameters were not evaluated in available repeated dose toxicity studies.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Table R.8-4 ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- Table R.8-6 ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- Table R.8-6 ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- studies available for all key systemic endpoints
- AF for remaining uncertainties:
- 1
- Justification:
- studies available for all key systemic endpoints
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:
- 1.25 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- For potential dermal exposure, route-to-route extrapolation from the oral NOAEL value was considered appropriate. Since a maximal absorption already occurred by oral route, no additional factor was introduced.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL determined in study
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on subacte study, but data available from other repeated dose toxicity study (up to 2-years) indicated that increasing the exposure duration does not increase the incidence of severity of adverse effects. For the purpose of conservatism, an AF of 2 was kept since all parameters were not evaluated in available repeated dose toxicity studies.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Table R.8-4 ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- Table R.8-6 ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- Table R.8-6 ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- studies available for all key systemic endpoints
- AF for remaining uncertainties:
- 1
- Justification:
- studies available for all key systemic endpoints
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)
- Most sensitive endpoint:
- sensitisation (skin)
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:
- 1.25 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Not applicable
- AF for dose response relationship:
- 1
- Justification:
- NOAEL determined in study
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on subacte study, but data available from other repeated dose toxicity study (up to 2-years) indicated that increasing the exposure duration does not increase the incidence of severity of adverse effects. For the purpose of conservatism, an AF of 2 was kept since all parameters were not evaluated in available repeated dose toxicity studies.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Table R.8-4 ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- Table R.8-6 ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- Table R.8-6 ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- studies available for all key systemic endpoints
- AF for remaining uncertainties:
- 1
- Justification:
- studies available for all key systemic endpoints
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
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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