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Diss Factsheets
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EC number: 235-741-0 | CAS number: 12645-31-7
- 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:
- 36.73 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC Technical Report No. 110 "Guidance on Assessment Factors to Derive a DNEL"
- Overall assessment factor (AF):
- 6
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 220.39 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No inhalation study was available, therefore standard route to route extrapolation was conducted in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R8.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic (ECHA approach)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required: allometric scaling was taken into account during route-to-route extrapolation
- AF for other interspecies differences:
- 1
- Justification:
- Allometry is generally accepted in the scientific community when the parent chemical or a stable metabolite is the toxic entity that is metabolically detoxified and when renal excretion is the predominant route of elimination (ECETOC Technical Report No. 110)
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC Technical Report 110
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium 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:
- 10.42 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC Technical Report No. 110 "Guidance on Assessment Factors to Derive a DNEL"
- Overall assessment factor (AF):
- 24
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No dermal study is available therefore standard route to route extrapolation was conducted in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R8, assuming 100 % dermal absorption.
- AF for dose response relationship:
- 1
- Justification:
- Default (ECHA)
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic (ECHA approach)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (ECHA)
- AF for other interspecies differences:
- 1
- Justification:
- Allometry is generally accepted in the scientific community when the parent chemical or a stable metabolite is the toxic entity that is metabolically detoxified and when renal excretion is the predominant route of elimination (ECETOC Technical Report No. 110)
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC Technical Report 110
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
The substance is classified for human health as corrosive to the skin (and assumed corrosive to the eye).
The hazard statement H314: Causes severe skin burns and eye damage, is applicable.
An in-vivo skin irritation/corrosion study showed the substance to be corrosive.
Short-term systemic effects
DNELs for short-term systemic effects were not derived as acute toxicity testing was not conducted by either dermal or inhalation routes due to the corrosivity of the substance. Therefore, no adequate data is available for deriving DNELs for short-term systemic effects. It is considered that dermal effects will be characterised by local tissue damage rather than by systemic effects due to uptake via the skin and inhalation is not considered to be a significant route of exposure.
If the substance is used in concentrations below the limit for corrosivity, operational conditions and risk management measures prescribed for long-term effects will resolve any risk due to short-term exposure.
Short-term local effects
A DNEL for short-term local dermal effects was not derived as the skin irritation/corrosion study, which showed corrosion, does not give suitable dose-response information required to derive a DNEL. For corrosive substances, appropriate PPE should be used by all workers. As a result, direct dermal contact occurs only infrequently/accidentally.
A DNEL for short-term local inhalation systemic effects was not derived as no acute toxicity testing has been conducted via the inhalation route. The substance has a vapour pressure of 0.085 Pa at 25°C and is not considered to be volatile. Inhalation is not considered to be a significant route of exposure if used in a well ventilated area.
If the substance is used in concentrations below the limit for corrosivity, operational conditions and risk management measures prescribed for long-term effects will resolve any risk due to short-term exposure.
Long-term system effects
A DNEL was derived for long-term inhalation and dermal systemic effects by route-to-route extrapolation from an oral NOAEL (see justification).
Inhalation DNEL long-term systemic
The corrected dose descriptor of 220.39 mg/m3 for inhalation was calculated in accordance with the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8. The conversion of an oral rat NOAEL into a corrected inhalatory NOAEC (for workers 8h exposure) was performed using the following equation:
Corrected inhalatory N(L)OAEC = oral N(L)OAEL x (1 / sRVrat) x (ABSoral-rat / ABSinh-human) x (sRVhuman / wRV)
Where:
ABS: Absorption
sRV: standard Respiratory Volume
wRV: worker Respiratory Volume (light activity)
Variables were based on worst case assumptions for absorption (i.e. the absorption percentage for the oral route is half that for the inhalation route). The inclusion of this factor means that 50% absorption was assumed for oral absorption and 100% absorption assumed for inhalation. This leads to the most conservative corrected dose descriptor.
Default parameters for rats and human (for 8 hour exposure) were used for the modification of starting point under the allometric scaling principle.
Corrected inhalatory N(L)OAEC= 250mg/kg bw/day x (1 / 0.38 m3/kg/d) x (1 / 2) x (6.7 m3(8h) / 10 m3(8h)) = 220.39 mg/m3
Default parametrs:
sRVrat (8 h) : 0.38m3/kg bw
sRVhuman (8 h) : 6.7 m3/ person
wRV (8 h): 10 m3/ person
Conversion of corrected inhalatory NOAEC into a long-term DNEL (inhalation) of workers:
DNEL (inhalation)= Inhalatory NOAEC / Overall assessment factor = 220.26 mg/m3/ 6 = 36.73 mg/m3
Dermal DNELlong-term Systemic
The dose descriptor for dermal exposure was not modified from the oral NOAEL, in the absence of dermal absorption data it is assumed that the dermal NOAEL is equivalent to the oral NOAEL, i.e. 250 mg/kg bw/day.
Conversion of corrected dermal NOAEL into a dermal DNEL long-term for workers:
Dermal DNEL = Dermal NOAEL / Overall assessment factor = 250 mg/kg bw/day / 24 =10.42 mg/kg bw/day
Long-term local effects
No DNEL can be derived for long-term dermal local effects as no long-term dermal study has been conducted as the substance is corrosive. It is considered that dermal effects will be characterised by local tissue damage. For corrosive substances, appropriate PPE should be used by all workers. Therefore, repeated substantial daily dermal exposure is unlikely.
A DNEL for long-term local inhalation effects was not derived as no acute toxicity testing has been conducted via the inhalation route. The substance has a vapour pressure of 0.085 Pa at 25°C and is not considered to be volatile. Inhalation is not considered to be a significant route of exposure if used in a well ventilated area.
If the substance is used in concentrations below the limit for corrosivity, operational conditions and risk management measures prescribed for long-term effects will resolve any risk due to short-term exposure.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10.87 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC Technical Report No. 110 "Guidance on Assessment Factors to Derive a DNEL"
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 108.7 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No inhalation study was available, therefore standard route to route extrapolation was conducted in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R8.
- AF for dose response relationship:
- 1
- Justification:
- Default
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic (ECHA approach)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required: allometric scaling was taken into account during route-to-route extrapolation
- AF for other interspecies differences:
- 1
- Justification:
- Allometry is generally accepted in the scientific community when the parent chemical or a stable metabolite is the toxic entity that is metabolically detoxified and when renal excretion is the predominant route of elimination (ECETOC Technical Report No. 110)
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC Technical Report No. 110
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC Technical Report No. 110 "Guidance on Assessment Factors to Derive a DNEL"
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No dermal study is available therefore standard route to route extrapolation was conducted in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R8, assuming 100 % dermal absorption.
- AF for dose response relationship:
- 1
- Justification:
- Default (ECHA)
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic (ECHA approach)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (ECHA)
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC - Allometry is generally accepted in the scientific community when the parent chemical or a stable metabolite is the toxic entity that is metabolically detoxified and when renal excretion is the predominant route of elimination.
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC Technical Report No. 110
- AF for the quality of the whole database:
- 1
- Justification:
- Default (ECHA)
- AF for remaining uncertainties:
- 1
- Justification:
- Not applicable.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- 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:
- 6.25 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC Technical Report No. 110 "Guidance on Assessment Factors to Derive a DNEL"
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 250 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default (ECHA)
- AF for differences in duration of exposure:
- 2
- Justification:
- Subchronic to chronic (ECHA approach)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (ECHA)
- AF for other interspecies differences:
- 1
- Justification:
- ECETOC - Allometry is generally accepted in the scientific community when the parent chemical or a stable metabolite is the toxic entity that is metabolically detoxified and when renal excretion is the predominant route of elimination.
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC Technical Report No. 110
- AF for the quality of the whole database:
- 1
- Justification:
- Default
- AF for remaining uncertainties:
- 1
- Justification:
- Default
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
The substance is classified for human health as corrosive to the skin (and assumed corrosive to the eye).
The hazard statement H314: Causes severe skin burns and eye damage, is applicable.
An in-vivo skin irritation/corrosion study showed the substance to be corrosive.
Short-term systemic effects
DNELs for short-term systemic effects were not derived as acute toxicity testing was not conducted by either dermal or inhalation routes due to the corrosivity of the substance. Therefore, no adequate data is available for deriving DNELs for short-term systemic effects. It is considered that dermal effects will be characterised by local tissue damage rather than by systemic effects due to uptake via the skin and inhalation is not considered to be a significant route of exposure.
If the substance is used in concentrations below the limit for corrosivity, operational conditions and risk management measures prescribed for long-term effects will resolve any risk due to short-term exposure.
Short-term local effects
A DNEL for short-term local dermal effects was not derived as the skin irritation/corrosion study, which showed corrosion, does not give suitable dose-response information required to derive a DNEL. For corrosive substances, appropriate risk management measures are applied for consumer products.
A DNEL for short-term local inhalation systemic effects was not derived as no acute toxicity testing has been conducted via the inhalation route. The substance has a vapour pressure of 0.085 Pa at 25°C and is not considered to be volatile. Inhalation is not considered to be a significant route of exposure if used in a well ventilated area.
If the substance is used in concentrations below the limit for corrosivity, operational conditions and risk management measures prescribed for long-term effects will resolve any risk due to short-term exposure.
Long-term systemic effects
A DNEL has been derived for long-term inhalation and dermal systemic effects by route-to-route extrapolation from an oral NOAEL (see justification).
Inhalation DNEL long-term systemic
The corrected dose descriptor of 108.70 mg/m3for inhalation was calculated in accordance with the ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8. The conversion of an oral rat NOAEL into a corrected inhalatory NOAEC (for consumer 24h exposure) was performed using the following equation:
Corrected inhalatory N(L)OAEC = oral N(L)OAEL x (1 / sRVrat) x (ABSoral-rat / ABSinh-rat) x (ABSinh-rat / ABSinh-human)
Where:
ABS: Absorption
sRV: standard Respiratory Volume
Variables were based on worst case assumptions for absorption (i.e. the absorption percentage for the oral route is half that for the inhalation route). The inclusion of this factor means that 50% absorption was assumed for oral absorption and 100% absorption assumed for inhalation. This leads to the most conservative corrected dose descriptor.
Default parameters for rats and human (for 24 hour exposure) were used for the modification of starting point under the allometric scaling principle.
Corrected inhalatory N(L)OAEC= 250mg/kg bw/day x (1 / 1.15 m3/kg/d) x (1 / 2) x (1 / 1)=108.7mg/m3
Default parametrs:
sRVrat (24 h) : 1.15m3/kg bw
Conversion of corrected inhalatory NOAEC into a long-term DNEL (inhalation) for the general population:
DNEL (inhalation)= Inhalatory NOAEC / Overall assessment factor = 108.70 mg/m3/ 10 =10.87 mg/m3
Dermal DNEL ling-term Systemic
The dose descriptor for dermal exposure was not modified from the oral NOAEL, in the absence of dermal absorption data it is assumed that the dermal NOAEL is equivalent to the oral NOAEL, i.e. 250 mg/kg bw/day.
Conversion of corrected dermal NOAEL into a dermal DNEL long-term for workers:
Dermal DNEL = Dermal NOAEL / Overall assessment factor = 250 mg/kg bw/day / 40 = 6.25 mg/kg bw/day
Oral DNEL long-term Systemic
A DNEL was derived for systemic effects via the oral route based on the NOAEL from the subacute oral toxicity study.
Conversion of oral NOAEL into a long-term DNEL (oral) for the general population:
Oral DNEL= oral NOAEL / Overall assessment factor = 250 mg/kg bw/d / 40 = 6.25 mg/kg bw/d
Long-term local effects
No DNEL can be derived for long-term dermal local effects as no long-term dermal study has been conducted as the substance is corrosive. It is considered that dermal effects will be characterised by local tissue damage. For corrosive substances, appropriate risk management measures are applied to consumer products.
A DNEL for long-term local inhalation effects was not derived as no acute toxicity testing has been conducted via the inhalation route. The substance has a vapour pressure of 0.085 Pa at 25°C and is not considered to be volatile. Inhalation is not considered to be a significant route of exposure if used in a well ventilated area.
If the substance is used in concentrations below the limit for corrosivity, operational conditions and risk management measures prescribed for long-term effects will resolve any risk due to short-term exposure.
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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