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EC number: 938-654-2 | 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:
- 0.26 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:
- NOAEC
- Value:
- 19.39 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- oral to inhalation (no direct data for inhalation route is available)
- AF for dose response relationship:
- 1
- Justification:
- NOAEC is used as a starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- based on a 28-day study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- allometric scaling is not applied for the derivation of inhalation DNEL.
- AF for other interspecies differences:
- 2.5
- Justification:
- no other substance-specific data are available.
- AF for intraspecies differences:
- 5
- Justification:
- default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Available data from substance fulfilling scientific principle is used.
- AF for remaining uncertainties:
- 1
- Justification:
- no other uncertainties needed to be considered.
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- 0.37 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:
- NOAEL
- Value:
- 110 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- oral to dermal (no direct data for dermal route is available); for adjustment of the NOAEL 100% oral absorption and 10% dermal absorption was assumed
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as the starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- based on the 28-day toxicity study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats are used in the animal test
- AF for other interspecies differences:
- 2.5
- Justification:
- no other substance-specific data are available
- AF for intraspecies differences:
- 5
- Justification:
- default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Available data from substance fulfilling scientific principle is used .
- AF for remaining uncertainties:
- 1
- Justification:
- No further uncertainties to be taken into account
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Considering very low vapor pressure (4.8E-3 Pa at 20 °C) and low water solubility (125 µg/ml), the inhalation route is not considered further as exposure scenarios for the test article do not indicate inhalative exposure to be the likely route of exposure to workers in regular process. Therefore, a worst case scenario is assumed in which the inhalation absorption is considered to be the same as that of the oral absorption.
Since the water solubility is far below 1 mg/L (125 µg/ml) and the log POW values is outside the range [-1, 4], dermal uptake is likely to be low. There is no quantitative data available for dermal adsorption of test material, thus, a default value of dermal absorption rate is proposed to be 10%. (i.e. the absorption rate from dermal is assumed to be one-tenth that of oral route).
NOAEL of 11 mg/kg/day resulted from the available sub-acute oral study is selected as the basis of DNEL calculation in light of the whole toxicity database. NOAELcorr for the dermal route is 110 mg/kg.bw/day. According to ECHA guidance document the oral NOAEL is converted to an inhalative NOAECworker resulting in a NOAEC of 19.39 mg/m3 (NOAELoral / 0.38 m3/kg × 6.7 m3 (8h)/10 m3 (8h)).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.064 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
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 9.57 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- oral to inhalation (no direct data for inhalation route is available)
- AF for dose response relationship:
- 1
- Justification:
- NOAEC is used as the starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- based on the subacute study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- allometric scaling is not applied for the derivation of inhalation DNEL.
- AF for other interspecies differences:
- 2.5
- Justification:
- no other substance-specific data are available.
- AF for intraspecies differences:
- 10
- Justification:
- default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Available data from substance fulfilling scientific principle is used .
- AF for remaining uncertainties:
- 1
- Justification:
- Available data from substance fulfilling scientific principle is used .
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- 0.18 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 110 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- oral to dermal(no direct data for dermal route is available)
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as the starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- based on the sub-acute toxicity
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats are used in the animal test
- AF for other interspecies differences:
- 2.5
- Justification:
- no other substance-specific data are available
- AF for intraspecies differences:
- 10
- Justification:
- default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Available data from substance fulfilling scientific principle is used .
- AF for remaining uncertainties:
- 1
- Justification:
- No further uncertainties to be taken into account
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- 0.018 mg/kg bw/day
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 11 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no route to route extrapolation
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as the starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- based on the sub-acute toxicity
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats are used in the animal tests
- AF for other interspecies differences:
- 2.5
- Justification:
- no other substance-specific data are available
- AF for intraspecies differences:
- 10
- Justification:
- default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Available data from substance fulfilling scientific principle is used.
- AF for remaining uncertainties:
- 1
- Justification:
- No further uncertainties to be taken into account
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
Although the general population is not exposed to the test article as a chemical substance and consequently inhalative exposure to the substance is unlikely (vapor pressure: 4.8E-3 Pa at 20 °C), a DNEL has been derived. A worst case scenario is assumed in which the inhalation absorption is considered to be the same as that of the oral absorption.
Since the water solubility is far below 1 mg/L (125 µg/ml), log P values is outside the range [-1, 4], dermal uptake is likely to be low and there is no quantitative data available for dermal adsorption of test material, thus, a default value of dermal absorption rate is proposed to be 10%. (i.e. the absorption rate from dermal is assumed to be one-tenth that of oral route.)
According to ECHA guidance, it is usually assumed that a default assessment factor of 10 is sufficient to protect the larger part of the population, including e.g. children and the elderly.
In this case, NOAEL of 11 mg/kg/day resulted from the available sub-acute oral study is selected as the basis of DNEL calculation in light of the whole toxicity database. NOAELcorr for the dermal route is 110 mg/kg bw/day. According to ECHA guidance document the oral NOAEL is converted to an inhalative NOAECgeneral population by dividing through 1.15 m3/kg resulting in a NOAEC of 9.57 mg/m3.
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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