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EC number: 412-540-8 | CAS number: 22471-55-2 ET 344 SP
- 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:
- 0.71 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 52.9 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification of the dose descriptors is necessary, because the routes of exposure are different between animals (oral) and humans (inhalation). For this purpose the default respiratory volume for the rat corresponding to the daily duration of human exposure is considered in the first step, followed by a correction for the difference between respiratory rates of workers under standard conditions and under light activity in the second step, followed by a correction for the difference in oral absorption in the rat and inhalation absorption in humans.
In accordance with ECHA Guidance Chapter R.8: Characterisation of dose [concentration]-response for human health, Example B.3, the following equation is used for workers to convert the oral NOAEL rat (15 mg/kg bw/day - the lowest NOAEL value, obtained in the 28 day study as a worst case) into the inhalatory NOAEC rat:
NAECcorr_inh = oral NOAEL x (1/sRVrat) x (ABSoral-rat/ABSinhalation-human) x (sRVhuman/wRV)
Where:
ABS: Absorption;
sRVrat: standard Respiratory Volume (rat) = 0.38 m3/kg bw/day (8 hours);
sRVhuman: standard Respiratory Volume (human) = 6.7 m3
wRV: worker Respiratory Volume = 10 m3
Therefore NAECcorr_inh = 15 x (1/0.38) x (ABSoral-rat/ABSinhalation-human) x (6.7/10)
Oral absorption in rats/humans is assumed to be 100% and inhalation absorption in rats/humans is assumed to be 100% (see IUCLID Chapter 7.1, Toxicokinetics), however, in compliance with ECHA guidance, for the purposes of extrapolation from the oral to the inhalation route, it is assumed that oral absorption in rats is 100% and inhalation absorption in humans is 50% as a worst case.
NAECcorr_inh = 15 x (1/0.38) x (100/50) x (6.7/10) = 52.9 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default factor when a NOAEL value is available, in accordance with REACH Guidance R.8
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- Justification:
- No allometric scaling required for inhalation route.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers, in accordance with REACH Guidance R.8
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor for good quality database (Klimisch 1 study), in accordance with REACH Guidance R.8
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor, in accordance with REACH Guidance R.8
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
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.125 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 37.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In accordance with ECHA Guidance Chapter R.8: Characterisation of dose [concentration]-response for human health, Example B.5, the following equation is used to convert the oral NOAEL rat (15 mg/kg bw/day - the lowest NOAEL value, obtained in the 28 day study as a worst case) into the dermal NOAEL rat:
corrected dermal NOAEL = oral NOAEL x ABSoral-rat/ABSdermal-human
Where:
ABS: Absorption
The oral absorption in rats is assumed to be 100% and the dermal absorption in humans is assumed to be 40% - see IUCLID Chapter 7.1, Toxicokinetics.
Therefore, the corrected dermal NOAEL = 15 x 100/40 = 37.5 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default factor when a NOAEL value is available, in accordance with REACH Guidance R.8
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor (rat to human), in accordance with REACH Guidance R.8
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers, in accordance with REACH Guidance R.8
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor for good quality database (Klimisch 1 study), in accordance with REACH Guidance R.8
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor, in accordance with REACH Guidance R.8
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The lowest NOAEL for this substance was obtained in the 28 day oral repeated dose toxicity study (15 mg/kg bw/day); as a worst case, this NOAEL was selected as the starting point for deriving the long-term systemic inhalation DNEL and the long-term systemic dermal DNEL. Acute systemic dermal/inhalation DNELs and local inhalation DNELs were not derived because the substance is not classified for acute dermal or inhalation toxicity and it is considered that derivation from long term systemic effects provides a suitable margin for safety of use.
The substance is classified as a Skin Irritant Category 2, however, no dose response data are available therefore a qualitative risk assessment has been conducted for local dermal effects.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.17 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 26.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Modification of the dose descriptors is necessary, because the routes of exposure are different between animals (oral) and humans (inhalation). For this purpose the default respiratory volume for the rat corresponding to the daily duration of human exposure is considered in the first step, followed by a correction for the difference in oral absorption in the rat and inhalation absorption in humans.
In accordance with ECHA Guidance Chapter R.8: Characterisation of dose [concentration]-response for human health, Figure R. 8-3, the following equation is used for the general population to convert the oral NOAEL rat (15 mg/kg bw/day - the lowest NOAEL value, obtained in the 28 day study as a worst case) into the inhalatory NOAEC rat:
NAECcorr_inh = oral NOAEL x (1/sRVrat) x (ABSoral-rat/ABSinhalation-human)
Where:
ABS: Absorption;
sRVrat: standard Respiratory Volume (rat) = 1.15 m3/kg bw/day (24 hours)
Therefore NAECcorr_inh = 15 x (1/1.15) x (ABSoral-rat/ABSinhalation-human)
Oral absorption in rats/humans is assumed to be 100% and inhalation absorption in rats/humans is assumed to be 100% (see IUCLID Chapter 7.1, Toxicokinetics), however, in compliance with ECHA guidance, for the purposes of extrapolation from the oral to the inhalation route, it is assumed that oral absorption in rats is 100% and inhalation absorption in humans is 50% as a worst case.
NAECcorr_inh = 15 x (1/1.15) x (100/50) = 26.1 mg/m3.
- AF for dose response relationship:
- 1
- Justification:
- Default factor when a NOAEL value is available, in accordance with REACH Guidance R.8
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- Justification:
- No allometric scaling required for inhalation route.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population, in accordance with REACH Guidance R.8
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor for good quality database (Klimisch 1 study), in accordance with REACH Guidance R.8
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor, in accordance with REACH Guidance R.8
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
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.062 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 37.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In accordance with ECHA Guidance Chapter R.8: Characterisation of dose [concentration]-response for human health, Example B.5, the following equation is used to convert the oral NOAEL rat (15 mg/kg bw/day - the lowest NOAEL value, obtained in the 28 day study as a worst case) into the dermal NOAEL rat:
corrected dermal NOAEL = oral NOAEL x ABSoral-rat/ABSdermal-human
Where:
ABS: Absorption
The oral absorption in rats is assumed to be 100% and the dermal absorption in humans is assumed to be 40% - see IUCLID Chapter 7.1, Toxicokinetics.
Therefore, the corrected dermal NOAEL = 15 x 100/40 = 37.5 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default factor, when a NOAEL is available, in accordance with REACH Guidance R.8
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor (rat to human), in accordance with REACH Guidance R.8
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population, in accordance with REACH Guidance R.8
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor for good quality database (Klimisch 1 study), in accordance with REACH Guidance R.8
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor, in accordance with REACH Guidance R.8
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.03 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
- Dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 15 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Assuming that oral absorption in rats is 100% and that oral absorption in humans is 100% as a worst case (see IUCLID Chapter 7.1 Toxicokinetics), modification of the dose descriptor starting point is not required.
- AF for dose response relationship:
- 1
- Justification:
- Default factor, when NOAEL is available, in accordance with REACH Guidance R.8
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor (rat to human), in accordance with REACH Guidance R.8
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor, in accordance with REACH Guidance R.8
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for general population, in accordance with REACH Guidance R.8
- AF for the quality of the whole database:
- 1
- Justification:
- Default factor for good quality database (Klimisch 1 study), in accordance with REACH Guidance R.8
- AF for remaining uncertainties:
- 1
- Justification:
- Default factor, in accordance with REACH Guidance R.8
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
The lowest NOAEL for this substance was obtained in the 28 day oral repeated dose toxicity study (15 mg/kg bw/day); as a worst case, this NOAEL was selected as the starting point for deriving the long-term systemic oral DNEL, the long-term systemic inhalation DNEL and the long-term systemic dermal DNEL. Acute systemic dermal/inhalation/oral DNELs and local inhalation DNELs were not derived because the substance is not classified for acute oral, dermal or inhalation toxicity and it is considered that derivation from long term systemic effects provides a suitable margin for safety of use.
The substance is classified as a Skin Irritant Category 2, however, no dose response data are available therefore a qualitative risk assessment has been conducted for local dermal effects.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.