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Registration Dossier
Diss Factsheets
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EC number: 204-809-1 | CAS number: 126-86-3
- 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:
- 1.76 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 132 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- long term 28 day repeated dose toxicity is chosen
- AF for dose response relationship:
- 1
- Justification:
- not a LOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- 28 day subacute study to chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- there is no need for the species-specific allometric scaling factor for inhalation exposures (ECHA, 2010, table R.8-4)
- AF for other interspecies differences:
- 2.5
- Justification:
- remainder
- AF for intraspecies differences:
- 5
- Justification:
- individual variability
- AF for the quality of the whole database:
- 1
- Justification:
- full data set
- AF for remaining uncertainties:
- 1
- Justification:
- no others
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.28 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):
- 0.33
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 132 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- One simple and well-established method used to estimate an acute threshold limit value (TLV) is multiplication of the long-term DNEL by a factor of 3 (Guidance R.8, Appendix R.8.8, 2010)
- AF for dose response relationship:
- 1
- Justification:
- not a LOAEL
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- there is no need for the species-specific allometric scaling factor for inhalation exposure
- AF for other interspecies differences:
- 2.5
- Justification:
- remainder
- AF for intraspecies differences:
- 5
- Justification:
- individual variability
- AF for the quality of the whole database:
- 1
- Justification:
- full data set
- AF for remaining uncertainties:
- 1
- Justification:
- no others
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 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):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- long term 28 day repeated dose toxicity is chosen
- AF for dose response relationship:
- 1
- Justification:
- not a LOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- 28 day subchronic study to chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remainder
- AF for intraspecies differences:
- 5
- Justification:
- individual variability in response
- AF for the quality of the whole database:
- 1
- Justification:
- full data set
- AF for remaining uncertainties:
- 1
- Justification:
- no other
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.5 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):
- 0.33
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- long term 28 day repeated dose toxicity is chosen
- AF for dose response relationship:
- 1
- Justification:
- not a LOAEL
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remainder
- AF for intraspecies differences:
- 5
- Justification:
- individual variability in response
- AF for the quality of the whole database:
- 1
- Justification:
- full data set
- AF for remaining uncertainties:
- 1
- Justification:
- no other
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
The overall assessment factor for chronic oral/dermal exposure for workers is 300, which is divided into the NOAEL of 150 mg/kg bw/day, for a final value of 0.5 mg/kg bw/day. The overall workers assessment factors is comprised of 4 independent AFs: - allometric scaling scaling factor of 4, - remainder factor of 2.5, - intraspecies factor of 5, - study duration factor of 6. It is dived into the NOEL of 150 mg/kg Bw/day from the following study: Envirogem AD01, H-104, in a 28-day gavage study in Hsd:WISnrats, at dose concentrations of 0, 15, 150, and 1000 mg/kg bw/d. The NOAEL in this study was 150 mg/kg bw/day.
For the longterm inhalation DNEL route-to-route extrapolation is used.
The NOAEL from the H-104 28 day repeated dose toxicity study in rats is chosen (150 mg/kg bw/d). The NOAEL is multiplied by an absorption factor of 0.5 (gastric absorption from the oral route is half that of inhalation exposure, as per an ECHA default value), and a modifier (0.75) to convert from a 6 h/day exposure to the 8 h/day exposure of a worker’s shift. This is also multiplied by another modifier (0.67) to reflect an increased respiratory volume (10.0 m3) during light exertion of a worker compared to the resting level typical of animal exposure (6.7 m3). This results in the dose descriptor being reduced to to 132.26 mg/ m3. There is no need for the species-specific allometric scaling factor for inhalation exposures (ECHA, 2010, Table R.8-4). The overall AF is 75, divided into the modified dose descriptor, resulting in a DNEL of 1.76 mg/ m3.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.43 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 150 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- long term 28 day repeated dose toxicity is chosen
- AF for dose response relationship:
- 1
- Justification:
- not a LOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- 28 day subacute study to chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remainder
- AF for intraspecies differences:
- 10
- Justification:
- individual varability in response
- AF for the quality of the whole database:
- 1
- Justification:
- full data set
- AF for remaining uncertainties:
- 1
- Justification:
- no other
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.29 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):
- 0.33
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 150 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- existing long term test on rats (oral)
- AF for dose response relationship:
- 1
- Justification:
- not a LOAEL
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remainder
- AF for intraspecies differences:
- 10
- Justification:
- individual varability in response
- AF for the quality of the whole database:
- 1
- Justification:
- full data set
- AF for remaining uncertainties:
- 1
- Justification:
- no other
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- long term 28 day repeated dose toxicity is chosen
- AF for dose response relationship:
- 1
- Justification:
- not a LOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- 28 day subacute study to chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remainder
- AF for intraspecies differences:
- 10
- Justification:
- individual varability in response
- AF for the quality of the whole database:
- 1
- Justification:
- full data set
- AF for remaining uncertainties:
- 1
- Justification:
- no other
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.75 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):
- 0.33
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- long term 28 day repeated dose toxicity is chosen
- AF for dose response relationship:
- 1
- Justification:
- not a LOAEL
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remainder
- AF for intraspecies differences:
- 10
- Justification:
- individaual varability in response
- AF for the quality of the whole database:
- 1
- Justification:
- full data set
- AF for remaining uncertainties:
- 1
- Justification:
- no other
Local effects
Long term exposure
- Hazard assessment conclusion:
- DMEL (Derived Minimum Effect Level)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Explanation for the modification of the dose descriptor starting point:
- long term 28 day repeated dose toxicity is chosen
- AF for dose response relationship:
- 1
- Justification:
- not a LOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- 28 day subacute study to chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remainder
- AF for intraspecies differences:
- 10
- Justification:
- individual variability in response
- AF for the quality of the whole database:
- 1
- Justification:
- full data set
- AF for remaining uncertainties:
- 1
- Justification:
- no other
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.75 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):
- 0.33
- DNEL extrapolated from long term DNEL
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- long term 28 day repeated dose toxicity is chosen
- AF for dose response relationship:
- 1
- Justification:
- not a LOAEL
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- remainder
- AF for intraspecies differences:
- 10
- Justification:
- individual variability in response
- AF for the quality of the whole database:
- 1
- Justification:
- full data set
- AF for remaining uncertainties:
- 1
- Justification:
- no other
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
The overall assessment factor for chronic oral/dermal exposure for the population is 600, which is divided into the NOAEL of 150 mg/kg bw/day, for a final value of 0.25 mg/kg bw/day. The overall population assessment factor is comprised of 4 independent AFs: - allometric scaling scaling factor of 4, - remainder factor of 2.5, - intraspecies factor of 10, - study duration factor of 6. It is dived into the NOEL of 150 mg/kg Bw/day from the following study: Envirogem AD01, H-104, in a 28-day gavage study in Hsd:WISnrats, at dose concentrations of 0, 15, 150, and 1000 mg/kg bw/d. The NOAEL in this study was 150 mg/kg bw/day.
For the longterm inhalation DNEL route-to-route extrapolation is used. The NOAEL from the H-104 28 day repeated dose toxicity study in rats is chosen (150 mg/kg bw/d). The NOAEL is multiplied by an absorption factor of 0.5 (gastric absorption from the oral route is half that of inhalation exposure, as per an ECHA default value), and a modifier (0.87) to convert from a 6 h/day exposure to the 24 h/day exposure for the population. The final dosedescriptor is 64.22 mg/m³. Three AFs are applied: remainder 2.5, intraspecies 10, duration 6. There is no need for the species-specific allometric scaling factor. The overall AF is 150, divided into the modified dose descriptor, resulting in a DNEL of 0.43 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.
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.

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