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Diss Factsheets
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EC number: 203-571-6 | CAS number: 108-31-6
- 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:
- 0.19 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.95 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.32 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- sensitisation (respiratory tract)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.2 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.2 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Additional information - workers
The inhalation DNEL for acute toxicity is derived based on the long-term inhalation DNEL (modified by multiplying with a factor of 5, considering the potency and the dose-response curve of the substance) because acute toxicity hazard (leading to C&L) has been identified and there is a potential for high peak exposures. For the dermal and oral exposure routes, ‘short-term’ exposures will be assessed using the long-term DNELs.
In relation to repeated dose toxicity (assuming the same bioavailability for experimental animals and humans), a NOAEL of 10 mg/kg bw/day was derived from a chronic oral study. NOAECs of 3.3 and 9.8 mg/m3for local and systemic effects respectively were derived from a subchronic inhalation study.
In line with Guidance on Information Requirements and Chemical Safety Assessment (2008), the overall AF for oral and dermal repeated dose toxicity is 50. This is established by taking into account an interspecies factor of 10 (4 for metabolic rate differences×2.5 for remaining differences) and an intraspecies factor of 5. The overall AFs for inhalation repeated dose toxicity which should be applied to the corrected NOAECs (3.3 mg/m3×6 h/d /8 h/d×6.7 m3/10 m3& 9.8 mg/m3×6 h/d /8 h/d×6.7 m3/10 m3) are 5 and 25. These are established by taking into account an interspecies factor of 2.5 (only for remaining differences of systemic effects), an intraspecies factor of 5, and a further factor of 2 to allow for subchronic to chronic extrapolation (only for exposure duration differences of systemic effects). A factor of 2.5 which would be normally used to take into account the remaining differences for local effects is not considered necessary here, as the adverse local effects in the repeated dose toxicity study (mainly eye/nasal irritation) are considered as effects via simple destruction of membranes. In addition, a factor to allow for subchronic to chronic extrapolation (usually a factor of 2) was not used for local effects here. It is not considered necessary, as relatively similar effects on the eye and nose, at doses of a comparable order of magnitude were observed in the 28-day study and so it is felt that exposure duration is not significant.
In relation to reproductive toxicity (assuming the same bioavailability for experimental animals and humans), a LOAEL of 20 mg/kg bw/day for effects on fertility and a NOAEL of 140 mg/kg bw/day for developmental toxicity were derived from a 2-generation study and a prenatal developmental toxicity study respectively.
In line with Guidance on Information Requirements and Chemical Safety Assessment (2008), the overall AFs for effects on fertility and developmental toxicity are 150 and 50. These are established by taking into account an interspecies factor of 10 (4 for metabolic rate differences×2.5 for remaining differences) and an intraspecies factor of 5, and a further factor of 3 to take into account the use of a LOAEL rather than a NOAEL.General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.05 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.25
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.08 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 10
- Dose descriptor:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- sensitisation (respiratory tract)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- Overall assessment factor (AF):
- 10
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.06 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
DNEL related information
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- LOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.1 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
General Population - Hazard for the eyes
Additional information - General Population
The inhalation DNEL for acute toxicity is derived based on the long-term inhalation DNEL (modified by multiplying with a factor of 5, considering the potency and the dose-response curve of the substance) because acute toxicity hazard (leading to C&L) has been identified and there is a potential for high peak exposures. For the dermal and oral exposure routes, ‘short-term’ exposures will be assessed using the long-term DNELs.
In relation to repeated dose toxicity (assuming the same bioavailability for experimental animals and humans), a NOAEL of 10 mg/kg bw/day was derived from a chronic oral study. NOAECs of 3.3 and 9.8 mg/m3for local and systemic effects respectively were derived from a subchronic inhalation study.
In line with Guidance on Information Requirements and Chemical Safety Assessment (2008), the overall AF for oral and dermal repeated dose toxicity is 100. This is established by taking into account an interspecies factor of 10 (4 for metabolic rate differences×2.5 for remaining differences) and an intraspecies factor of 10. The overall AFs for inhalation repeated dose toxicity which should be applied to the corrected NOAECs (3.3 mg/m3×6 h/d /24 h/d& 9.8 mg/m3×6 h/d /24 h/d) are 10 and 50. These are established by taking into account an interspecies factor of 2.5 (only for remaining differences of systemic effects), an intraspecies factor of 10, and a further factor of 2 to allow for subchronic to chronic extrapolation (only for exposure duration differences of systemic effects). A factor of 2.5 which would be normally used to take into account the remaining differences for local effects is not considered necessary here, as the adverse local effects in the repeated dose toxicity study (mainly eye/nasal irritation) are considered as effects via simple destruction of membranes. In addition, a factor to allow for subchronic to chronic extrapolation (usually a factor of 2) was not used for local effects here. It is not considered necessary, as relatively similar effects on the eye and nose, at doses of a comparable order of magnitude were observed in the 28-day study and so it is felt that exposure duration is not significant.
In relation to reproductive toxicity (assuming the same bioavailability for experimental animals and humans), a LOAEL of 20 mg/kg bw/day for effects on fertility and a NOAEL of 140 mg/kg bw/day for developmental toxicity were derived from a 2-generation study and a prenatal developmental toxicity study respectively.
In line with Guidance on Information Requirements and Chemical Safety Assessment (2008), the overall AFs for effects on fertility and developmental toxicity are 300 and 100. These are established by taking into account an interspecies factor of 10 (4 for metabolic rate differences×2.5 for remaining differences) and an intraspecies factor of 10, and a further factor of 3 to take into account the use of a LOAEL rather than a NOAEL.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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