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EC number: 233-117-2 | CAS number: 10039-33-5
- 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:
- 8.58 µg/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:
- 0.525 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 0.643 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No long-term exposure data is available for the inhalation route therefore the NOAEL resulted from an animal study after an oral administration of the substance for 28 days to rats, is used. Route-to-route extrapolation is therefore needed from the oral to the inhalation route.
The NOAEL rat is converted to NOAEL human by dividing with the allometric scaling factor 4 for interspecies differences. By multiplying the NOAEL human with the default human body weight (70 kg) and dividing the default human breathing volume referring to workers (10 m3 in 8h and light activity), this dose is then translated into an air concentration.
NOAELoral= 0.3 mg/kg b.w corresponding to the Similar Substance 01 doses. Readjusting in Target substance doses: NOAELoral = 0.525 mg/kg b.w.
Standard human body weight = 70 kg
Default human breathing volume for workers in 8 hours = 10 m3
Due to the difference between human (workers) and experimental exposure conditions, a correction factor of 1.4 (7 d/w: 5 d/w) is applied. Furthermore, a correction factor of 0.5 is used due to differences in bioavailability considering 100 % oral absorption to 50 % inhalation absorption.
Therefore, NOAECinh= (0.525/4)*(70/10)*(1.4*0.5) = 0.643 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- The starting point for the DNEL derivation is a NOAEL; default factor AF=1 is used.
- AF for differences in duration of exposure:
- 6
- Justification:
- The duration of the animal study is 28 days. Extrapolation needed from subacute to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is already taken into consideration during the route-to-route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences).
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers is applied.
- AF for the quality of the whole database:
- 1
- Justification:
- Good/standard quality of database.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- 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:
- 0.087 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:
- NOAEL
- Value:
- 0.525 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 26.25 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No long-term exposure data is available for the dermal route therefore the NOAEL resulted from an animal study after the oral administration for 28 days to rats, is used.
The NOAELoral = 0.3 mg/kg bw/day corresponds to Similar Substance 01 doses. Readjusting in Target substance doses: NOAELoral= 0.525 mg/kg b.w.
Based on the physicochemical properties of the substance in comparison with the ones of the similar substance, dermal absorption is expected to be lower than the one of oral. In accordance with criteria in Chapter R.7c: Endpoint specific guidance (Guidance on information requirements and chemical safety assessment) a default value of 100 % skin absorption is generally used unless molecular mass is above 500 and log P is outside the range [-1, 4], in which case a value of 10 % skin absorption is chosen; the substance has a logPow of 13.15 and a molecular weight of 799.7. The substance is practically not soluble in water (insoluble material is considered in the guidance to have practically no absorption) so absorption would be considerably lower than 10 %. As an estimate, a value of 2 % is used for risk assessment purposes.
NOAELdermal = 0.525/0.02 = 26.25 mg/kg b.w.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used; default AF is 1.
- AF for differences in duration of exposure:
- 6
- Justification:
- Adjustment from sub-acute to chronic duration
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Extrapolation from rats to humans
- AF for other interspecies differences:
- 2.5
- Justification:
- No substance-specific data are available; the additional factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate - small part- and toxicodynamic differences - larger part).
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers is applied.
- AF for the quality of the whole database:
- 1
- Justification:
- Good/standard quality of database.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low 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:
- 0.001 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:
- 0.525 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 0.197 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No long-term exposure data is available for the inhalation route therefore the NOAEL resulted from an animal study after the oral administration for 28 days to rats, is used. Route-to-route extrapolation is therefore needed from the oral to the inhalation route.
The NOAEL rat is converted to NOAEL human by dividing with the allometric scaling factor 4 for interspecies differences. By multiplying the NOAEL human with the default human body weight (60 kg) and dividing the default human breathing volume referring to general population (20 m3in 24 hours and basal caloric demand this dose is then translated into an air concentration.
NOAELoral= 0.3 mg/kg b.w corresponding to the Similar Substance 01 doses. Readjsuting in Target substance doses: NOAELoral= 0.525 mg/kg b.w.
Standard human body weight = 60 kg
Default human breathing volume for general population for 24 hours = 20 m3
Furthermore, a correction factor of 0.5 is used due to differences in bioavailability considering 100 % oral absorption to 50 % inhalation absorption.
Therefore, NOAECinh= (0.525/4)* (60/20)* 0.5 = 0.197 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- The starting point for the DNEL derivation is a NOAEL; default factor AF=1 is used.
- AF for differences in duration of exposure:
- 6
- Justification:
- The duration of the animal study is 28 days. Extrapolation needed from subacute to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is already taken into consideration during the route-to-route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences).
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population is applied.
- AF for the quality of the whole database:
- 1
- Justification:
- Good/standard quality of database.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.044 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:
- NOAEL
- Value:
- 0.525 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 26.25 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No long-term exposure data is available for the dermal route therefore the NOAEL resulted from an animal study after the oral administration for 28 days to rats, is used.
The NOAELoral= 0.3 mg/kg bw/day corresponds to Similar Substance 01 doses. Readjusting in Target substance doses: NOAELoral= 0.525 mg/kg b.w
Based on the physicochemical properties of the substance in comparison with the ones of the similar substance, dermal absorption is expected to be lower than the one of oral.In accordance with criteria in Chapter R.7c: Endpoint specific guidance (Guidance on information requirements and chemical safety assessment)a default value of 100 % skin absorption is generally used unless molecular mass is above 500 and log P is outside the range [-1, 4], in which case a value of 10 % skin absorption is chosen; the substance has a logPow of 13.15 and a molecular weight of 799.7. The substance is practically not soluble in water (insoluble material is considered in the guidance to have practically no absorption) so absorption would be considerably lower than 10 %.As an estimate, a value of 2 % is used for risk assessment purposes.
NOAELdermal= 0.525/0.02 = 26.25 mg/kg b.w.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used; default AF is 1.
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation for subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- No adjustment for direct chemical reactivity with membrane
- AF for other interspecies differences:
- 2.5
- Justification:
- No adjustment for direct chemical reactivity with membrane
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Good/standard quality of database
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.001 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:
- NOAEL
- Value:
- 0.525 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The NOAEL resulted from an animal study where the substance was orally administered for 28 days to rats, is used. These NOAEL corresponds to Similar Substance 01 doses, therefore, readjusting to Target substance doses the NOAEL obtained is 0.525 mg/kg b.w.
- AF for dose response relationship:
- 1
- Justification:
- The starting point for the DNEL derivation is a NOAEL; default factor AF=1 is used.
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation for sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling from rat to humans
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor of 2.5 is applied for other interspecies differences (toxicokinetic differences not related to metabolic rate and toxicodynamic differences).
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population is applied.
- AF for the quality of the whole database:
- 1
- Justification:
- Good/standard quality of database.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low 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.
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