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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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: - | CAS number: -
- 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:
- 12.2 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: according to ECETOC guidance (Technical report no. 110, October 2010)
- Overall assessment factor (AF):
- 18
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 220 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- no evidence is available that route-to-route extrapolation is not possible
- AF for dose response relationship:
- 1
- Justification:
- reliable NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- assuming chronic exposure of worker
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- no correction for caloric demand applicable for inhalation
- AF for other interspecies differences:
- 1
- Justification:
- not relevant
- AF for intraspecies differences:
- 3
- Justification:
- differences in sensitivity among workers
- AF for the quality of the whole database:
- 1
- Justification:
- reliable studies available for each endpoint required
- AF for remaining uncertainties:
- 1
- Justification:
- not relevant
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 1.1 mg/kg bw/day
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 90
- Modified dose descriptor starting point:
- other: EC3
- Value:
- 96.7 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- not relevant
- AF for dose response relationship:
- 3
- Justification:
- from LOAEL to NAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- assuming chronic exposure of worker
- AF for interspecies differences (allometric scaling):
- 10
- Justification:
- rat to human, specific for skin sensitisation
- AF for other interspecies differences:
- 1
- Justification:
- not relevant
- AF for intraspecies differences:
- 3
- Justification:
- differences in sensitivity among workers
- AF for the quality of the whole database:
- 1
- Justification:
- reliable studies available for each endpoint required
- AF for remaining uncertainties:
- 1
- Justification:
- not relevant
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Dermal long term systemic:
The NOAEL of the reproduction/developmental screening study and the EC3 of the LLNA skin sensitsation study have both been used as starting point for derivation of the DNEL. The DNEL based on the EC3 appeared to be the worst case, and therefore is used in risk assessment.
Starting point: NOAEL of 250 mg/kg bw/day in a screening reproduction/developmental oral toxicity study in rats.
Correction dermal NOAEL: 250 x 50/10a= 1250 mg/kg bw/day
aoral/dermal absorption
Safety factors:
- Interspecies extrapolation: 4 (rat to human)
- Intraspecies extrapolation: 3
- Exposure duration: 6 (assuming chronic exposure of the worker)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 72
Based on the above, the long-term DNEL for systemic effects after dermal exposure of the worker is 17.4 mg/kg bw/day.
Second starting point: EC3=11.6% (is a LOAEL) in a skin sensitization study in mice.
See above, for specific derivation. Based on this, the long-term DNEL for systemic effects after dermal exposure of the worker is set at 1.1 mg/kg bw/day.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: according to ECETOC guidance (Technical report no. 110, October 2010)
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 109 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- no evidence is available that route-to-route extrapolation is not possible
- AF for dose response relationship:
- 1
- Justification:
- reliable NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- assuming chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- no correction for caloric demand for inhalation
- AF for other interspecies differences:
- 1
- Justification:
- not relevant
- AF for intraspecies differences:
- 5
- Justification:
- differences in sensitivity among general population
- AF for the quality of the whole database:
- 1
- Justification:
- reliable studies available for each endpoint required
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 0.64 mg/kg bw/day
- Most sensitive endpoint:
- sensitisation (skin)
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 96.7 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- not relevant
- AF for dose response relationship:
- 3
- Justification:
- from LOAEL to NAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- assuming chronic exposure
- AF for interspecies differences (allometric scaling):
- 10
- Justification:
- rat to human, specific for skin sensitsation
- AF for other interspecies differences:
- 1
- Justification:
- not relevant
- AF for intraspecies differences:
- 5
- Justification:
- differences in sensitivity among general population
- AF for the quality of the whole database:
- 1
- Justification:
- reliable studies available for each endpoint required
- AF for remaining uncertainties:
- 1
- Justification:
- not relevant
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.08 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: according to ECETOC guidance (Technical report no. 110, October 2010)
- Overall assessment factor (AF):
- 120
- 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:
- reliable NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- assuming chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 1
- Justification:
- not relevant
- AF for intraspecies differences:
- 5
- Justification:
- differences in sensitivity among general population
- AF for the quality of the whole database:
- 1
- Justification:
- reliable studies available for each endpoint required
- AF for remaining uncertainties:
- 1
- Justification:
- not relevant
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
Dermal long term systemic:
The NOAEL of the reproduction/developmental screening study and the EC3 of the LLNA skin sensitsation study have both been used as starting point for derivation of the DNEL. The DNEL based on the EC3 appeared to be the worst case, and therefore is used in risk assessment.
Starting point: NOAEL of 250 mg/kg bw/day in a screening reproduction/developmental oral toxicity study in rats.
Correction dermal NOAEL: 250 x 50/10a= 1250 mg/kg bw/day
aoral/dermal absorption
Safety factors:
- Interspecies extrapolation: 4 (rat to human)
- Intraspecies extrapolation: 5
- Exposure duration: 6 (assuming chronic exposure of the worker)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 120
Based on the above, the long-term DNEL for systemic effects after dermal exposure of the general population is 10.4 mg/kg bw/day.
Second starting point: EC3=11.6% (is a LOAEL) in a skin sensitization study in mice.
See above, for specific derivation. Based on this, the long-term DNEL for systemic effects after dermal exposure of the general population is set at 0.64 mg/kg bw/day.
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