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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
- 5.88 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):
- 37.5
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 220 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Transformation from oral to inhalation & Comp. for Route & Comp. for increased respiratory rate for workers
- AF for dose response relationship:
- 3
- Justification:
- Started from LOAEL (factor 3 is considered acceptable as there is also a NOAEL of 250 mg/kg in dogs)
- AF for differences in duration of exposure:
- 1
- Justification:
- ECHA default (based on chronic studies)
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- ECHA default. For more information check ECHA R8.1 2012 pg 23 and following.
- AF for other interspecies differences:
- 1
- Justification:
- No indication that a factor is needed
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- No indication that a factor for quality is needed
- AF for remaining uncertainties:
- 1
- Justification:
- No indication that a factor for quality is needed
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 15.2 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):
- 150
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 2 273 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Compensation for route-to-route extrapolation: 90% oral absorption versus 10% dermal absorption are estimated.
- AF for dose response relationship:
- 3
- Justification:
- Started from LOAEL (factor 3 is considered acceptable as there is also a NOAEL of 250 mg/kg in dogs)
- AF for differences in duration of exposure:
- 1
- Justification:
- ECHA default (based on chronic studies)
- AF for interspecies differences (allometric scaling):
- 10
- Justification:
- ECHA default. For more information check ECHA R8.1 2012 pg 23 and following.
- AF for other interspecies differences:
- 1
- Justification:
- No indication that a factor is needed
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- No indication that a factor for quality is needed
- AF for remaining uncertainties:
- 1
- Justification:
- No indication that a factor is needed
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
Weight-of-Evidence for repeated dose oral toxicity was obtained from subacute and chronic toxicity studies with read-across substances Epoxidized tall-oil 2 -EH (ETP: subacute oral combined repeated dose toxicity and reproductive screening study in rats) and Epoxidized soybean oil (ESBO: chronic oral toxicity in rats and dogs). Read-across data from ESBO indicate that increased liver and kidney effects in rats (1 and 5% in the diet) and fatty infiltration in the liver of dogs (5% in the diet at 12 months) were identified after 12 and 24 months, respectively. A LOAEL of 250 mg/kg/d was identified in rats after 24 months dosing, whereas in dogs a NOAEL of 250 mg/kg/d was identified after 12 months dosing. For ETP, subacute dosing in rats did not result in any parental or reproductive changes up to 1000 mg/kg/d, therefore this dose was considered as subacute NOAEL. For PSLG-5, a chronic LOAEL of 250 mg/kg/d in rats was retained as most relevant descriptor.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.45 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:
- LOAEC
- Value:
- 109 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Correction: 250 / (1,150 * 2) = 108,696 mg/kg bw (Transformation from oral to inhalation & Comp. for Route)
- AF for dose response relationship:
- 3
- Justification:
- Started from LOAEL (factor 3 is considered acceptable as there is also a NOAEL of 250 mg/kg in dogs)
- AF for differences in duration of exposure:
- 1
- Justification:
- ECHA default (based on chronic studies)
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- ECHA default. For more information check ECHA R8.1 2012 pg 23 and following.
- AF for other interspecies differences:
- 1
- Justification:
- No indication that a factor is needed
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- No indication that a factor for quality is needed
- AF for remaining uncertainties:
- 1
- Justification:
- No indication that a factor is needed
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.58 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:
- LOAEL
- Value:
- 2 273 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Compensation for route-to-route extrapolation: 90% oral absorption versus 10% dermal absorption are estimated.
- AF for dose response relationship:
- 3
- Justification:
- Started from LOAEL (factor 3 is considered acceptable as there is also a NOAEL of 250 mg/kg in dogs)
- AF for differences in duration of exposure:
- 1
- Justification:
- ECHA default (based on chronic studies)
- AF for interspecies differences (allometric scaling):
- 10
- Justification:
- ECHA default. For more information check ECHA R8.1 2012 pg 23 and following.
- AF for other interspecies differences:
- 1
- Justification:
- No indication that a factor is needed
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- No indication that a factor for quality is needed
- AF for remaining uncertainties:
- 1
- Justification:
- No indication that a factor is needed
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:
- 0.83 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:
- LOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Correction: 250 / (1) = 250 mg/kg bw (No comp. for route)
- AF for dose response relationship:
- 3
- Justification:
- Started from LOAEL (factor 3 is considered acceptable as there is also a NOAEL of 250 mg/kg in dogs)
- AF for differences in duration of exposure:
- 1
- Justification:
- EECHA default (based on chronic studies)
- AF for interspecies differences (allometric scaling):
- 10
- Justification:
- ECHA default. For more information check ECHA R8.1 2012 pg 23 and following.
- AF for other interspecies differences:
- 1
- Justification:
- No indication that a factor is needed
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- No indication that a factor for quality is needed
- AF for remaining uncertainties:
- 1
- Justification:
- No indication that a factor is needed
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
Weight-of-Evidence for repeated dose oral toxicity was obtained from subacute and chronic toxicity studies with read-across substances Epoxidized tall-oil 2 -EH (ETP: subacute oral combined repeated dose toxicity and reproductive screening study in rats) and Epoxidized soybean oil (ESBO: chronic oral toxicity in rats and dogs). Read-across data from ESBO indicate that increased liver and kidney effects in rats (1 and 5% in the diet) and fatty infiltration in the liver of dogs (5% in the diet at 12 months) were identified after 12 and 24 months, respectively. A LOAEL of 250 mg/kg/d was identified in rats after 24 months dosing, whereas in dogs a NOAEL of 250 mg/kg/d was identified after 12 months dosing. For ETP, subacute dosing in rats did not result in any parental or reproductive changes up to 1000 mg/kg/d, therefore this dose was considered as subacute NOAEL. For PSLG-5, a chronic LOAEL of 250 mg/kg/d in rats was retained as most relevant descriptor.
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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