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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 940-308-0 | 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:
- 0.78 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):
- 112.5
- Dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 88 mg/m³
- Explanation for the modification of the dose descriptor starting point:
LOAEL (oral) = 100 mg/kg/day has been considered conservative enough to cover also the reproductive (fertility and developmental) end-point; as NOAEL for reproduction was estimated at 300 mg/kg/day.
In the study, considered for this evaluation (OECD 422 combined study), some effects were seen at 100 mg/kg/day only for general toxicity, while reproductive effects were seen well above this level (3 fold); the NOAEL for effects on reproduction was set at 300 mg/kg/day.
No information on bioavailability to oral administration of the substance to animals and humans are available; therefore it is assumed that the same bioavailability occurs in the two species (1 is applied).
The substance is adsorbed after oral administration leading to some effects at higher dosage. Nevertheless the rate of this absorption is not known. For a conservative evaluation, a limited absorption is assumed to occur during oral administration (starting route). Therefore a default ABS factor of 2 is included in the calculation of the corrected NOAEC inhalation.
- AF for dose response relationship:
- 3
- Justification:
- When the starting point for the DNEL calculation is a LOAEL, it is suggested to use an assessment factor between 3 to obtain the most suitable and realistic NAEL(No Adverse Effect Level).
This assessment factor should take into account the dose spacing, the shape and the slope of the dose response curve, the extent and severity of the effects seen at the LOAEL.
In the study considered for this evaluation (OECD 422 combined study), some effects were seen at 100 mg/kg/day only for general toxicity, while reproductive effects were seen well above this level (3 fold); the NOAEL for effects on reproduction was set at 300 mg/kg/day.
Regarding the dose response relationship, all effects seen at 100 mg/kg/day (LOAEL) are less important in severity (overall “minimal” and not all treatment related effects seen at the higher doses (MD and HD) are present at the Low Dose).
The Low Dose (LD) = 100 mg/kg/day was spaced three fold from the Median Dose (MD) = 300 mg/kg/day; this means that the slope of the dose response curve is well pronounced.
An assessment factor equal to 3 has been considered. - AF for differences in duration of exposure:
- 3
- Justification:
- The value selected is referred to the OECD 422 combined study, which can be considered as sub-acute study in terms of treatment period. A higher factor is not deemed necessary as no indication of increase of severe toxicity is available.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is not appropriate for inhalation route; this is already implicitly done in the calculation of corrected inhalatory NOAEC
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor for other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- This standard value is considered sufficient to cover the worker sub-population as it is not composed by very young, very old or very ill persons.
- AF for the quality of the whole database:
- 1
- Justification:
- The testing programme was considered good in relation to the registration level, reliability of data is very good (GLP and quality certification of the testing laboratories). All studies and data/results were consistent for hazard assessment and classification/labelling purposes.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.22 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):
- 450
- Dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
LOAEL (oral) = 100 mg/kg/day has been considered conservative enough to cover also the reproductive (fertility and developmental) end-point; as NOAEL for reproduction was estimated at 300 mg/kg/day.
In the study, considered for this evaluation (OECD 422 combined study), some effects were seen at 100 mg/kg/day only for general toxicity, while reproductive effects were seen well above this level (3 fold); the NOAEL for effects on reproduction was set at 300 mg/kg/day.
No information on bioavailability to oral administration of the substance to animals and humans are available; therefore it is assumed that the same bioavailability occurs in the two species (1 is applied).
No default absorption value is applied when extrapolating oral to dermal route as, in general, dermal absorption is not higher than the oral one.
- AF for dose response relationship:
- 3
- Justification:
- When the starting point for the DNEL calculation is a LOAEL, it is suggested to use an assessment factor between 3 to obtain the most suitable and realistic NAEL(No Adverse Effect Level).
This assessment factor should take into account the dose spacing, the shape and the slope of the dose response curve, the extent and severity of the effects seen at the LOAEL.
In the study considered for this evaluation (OECD 422 combined study), some effects were seen at 100 mg/kg/day only for general toxicity, while reproductive effects were seen well above this level (3 fold); the NOAEL for effects on reproduction was set at 300 mg/kg/day.
Regarding the dose response relationship, all effects seen at 100 mg/kg/day (LOAEL) are less important in severity (overall “minimal” and not all treatment related effects seen at the higher doses (MD and HD) are present at the Low Dose).
The Low Dose (LD) = 100 mg/kg/day was spaced three fold from the Median Dose (MD) = 300 mg/kg/day; this means that the slope of the dose response curve is well pronounced.
An assessment factor equal to 3 has been considered. - AF for differences in duration of exposure:
- 3
- Justification:
- The value selected is referred to the OECD 422 combined study, which can be considered as sub-acute study in terms of treatment period. A higher factor is not deemed necessary as no indication of increase of severe toxicity is available.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling factor for rats as compared to humans.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor for other interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- This standard value is considered sufficient to cover the worker sub-population as it is not composed by very young, very old or very ill persons.
- AF for the quality of the whole database:
- 1
- Justification:
- The testing programme was considered good in relation to the registration level, reliability of data is very good (GLP and quality certification of the testing laboratories). All studies and data/results were consistent for hazard assessment and classification/labelling purposes.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
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:
- 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
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:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
The substance is intended only to industrial use. No general population exposure is foreseen (see CSR Section 9).
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:
- 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 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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