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EC number: 837-106-9 | CAS number: 71472-57-6
- 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:
- 1.175 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:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 88.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The dose descriptor start point is modified from a NOAEL by oral administration in rats (mg/kg/day) to a No Observed Adverse Effect Concentration (NOAEC) in humans by inhalation exposure (mg/m3) before Adjustment Factors (AFs) can be applied to determine the DNEL. The conversion in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R8 is as follows (in case of Workers exposed 8 hours/day):
NOAEC = oral NOAEL x 1/sRVratx ABSoral rat/ABSinh humanx sRVhuman/wRV
Where: sRV = Standard Respiratory Volume (0.38 m3rat and 6.7 m3human)
ABS = Absorption
wRV = Worker Respiratory Volume (10 m3)NOAEC = 50 x 1/0.38 x 1/1 x 6.7/10 where worst-case absorption scenario is assumed
NOAEC = 88.1 mg/m3- AF for dose response relationship:
- 1
- Justification:
- NOAEL taken s PoD for modification
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to hronic duration
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required since modificatin of oral NOAEL to inhalation NOAEC has been made
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for toxicokinetic and toxicodynamic differences
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for Workers as does not include the very old, the young or very ill individuals
- AF for the quality of the whole database:
- 1
- Justification:
- Starting dose level taken from a GLP Guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- No other uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Value:
- 722 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
- Dose descriptor starting point:
- other: Systemic long term DNEL
- Value:
- 1.175 mg/m³
Local effects
Long term exposure
- Hazard assessment conclusion:
- insufficient hazard data available (further information necessary)
- Value:
- 722 mg/m³
- Most sensitive endpoint:
- acute toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Value:
- 722 mg/m³
- Most sensitive endpoint:
- acute toxicity
DNEL related information
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
- Dose descriptor starting point:
- LOAEL
- Value:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- other: The LOAEL from the repeat dose oral toxicity study was taken as a NOAEL by dermal application based on the absence of toxicity in a dermal acute toxicity study
- Value:
- 150 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No dermal hazard has been identified in an acute toxicity study in rats by the dermal route at the limit dose of 2000 mg/kg bw, and the substance has been classified as non-irritant and non-corrosive to the skin. There are no data available indicating any potential differences in absorption of the test substance between oral and dermal routes of exposure or between rats and humans. Consequently, selection of the acute NOAEL dose level of 2000 mg/kg bw was taken as indicative of lack of toxicological activity by this route and the high dose level in the repeat dose oral study, 150 mg/kg/day, was taken as the Point of Departure with no further modification other than the application of the AFs based upon the oral repeat dose LOAEL taken as a dermal NOAEL.
- AF for dose response relationship:
- 1
- Justification:
- A predicted NOAEL taken as the start point
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default conversion from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default to allow for possible differences in metabolic parameters
- AF for intraspecies differences:
- 5
- Justification:
- Default Worker AF which does not include the very old, very young or very ill.
- AF for the quality of the whole database:
- 1
- Justification:
- Both the acute toxicity study and the repeated dose toxicity study were GLP and/or Guideline studies
- AF for remaining uncertainties:
- 1
- Justification:
- There were no further uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Value:
- 2 000 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL extrapolated from long term DNEL
- Value:
- 0.5 mg/kg bw/day
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:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
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:
- 0.29 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Value:
- 43.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The dose descriptor start point is modified from a NOAEL by oral administration in rats (mg/kg/day) to a No Observed Adverse Effect Concentration (NOAEC) in humans by inhalation exposure (mg/m3) before Adjustment Factors (AFs) can be applied to determine the DNEL. The conversion in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment Chapter R8 is as follows (in case of the General Population exposed 24 hours/day):
NOAEC = oral NOAEL x 1/sRVratx ABSoral rat/ABSinh human
Where: sRV = Standard Respiratory Volume (1.15 m3/kg/day)
ABS = AbsorptionNOAEC = 50 x 1/1.15 x 1/1 where worst-case absorption scenario is assumed
NOAEC = 43.5 mg/m3- AF for dose response relationship:
- 1
- Justification:
- NOAEL taken as PoD for modification
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required since modification of oral NOAEL to inhalation NOAEC has been made
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for toxicokinetic and toxicodynamic differences
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for General Population
- AF for the quality of the whole database:
- 1
- Justification:
- Starting dose level taken from a GLP Guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- No further uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Value:
- 722 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- DNEL extrapolated from long term DNEL
- Dose descriptor starting point:
- other: Modification of systemic long term DNEL
- Value:
- 1.31 mg/m³
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
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
- Dose descriptor starting point:
- LOAEL
- Value:
- 150 mg/kg bw/day
- Modified dose descriptor starting point:
- other: The LOAEL from the repeat dose oral toxicity study was taken as a NOAEL by dermal application based on the absence of toxicity in a dermal acute toxicity study
- Value:
- 150 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No dermal hazard has been identified in an acute toxicity study in rats by the dermal route at the limit dose of 2000 mg/kg bw, and the substance has been classified as non-irritant and non-corrosive to the skin. There are no data available indicating any potential differences in absorption of the test substance between oral and dermal routes of exposure or between rats and humans. Consequently, selection of the acute NOAEL dose level of 2000 mg/kg bw was taken as indicative of lack of toxicological activity by this route and the high dose level in the repeat dose oral study, 150 mg/kg bw/day, was taken as the Point of Departure with no further modification other than the application of the AFs based upon the oral repeat dose LOAEL taken as a dermal NOAEL.
- AF for dose response relationship:
- 1
- Justification:
- A predicted NOAEL taken as the start point
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default conversion from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default to allow for possible differences in metabolic parameters
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for General Population
- AF for the quality of the whole database:
- 1
- Justification:
- Both the acute toxicity study and the repeated dose toxicity study were GLP and/or Guideline studies
- AF for remaining uncertainties:
- 1
- Justification:
- No other uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 83.3 µg/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:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Relevant dose descriptor is taken from a rat study by the same route of exposure and similar bioavailability is assumed by this route by rats and humans.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL taken as the start point
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default conversion from rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default to allow for possible differences in metabolic parameters
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for General Population
- AF for the quality of the whole database:
- 1
- Justification:
- Starting dose level taken from a GLP Guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- No other uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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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