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EC number: 943-535-3 | 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:
- 1.64 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:
- 123.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Figure R.8-3 of ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (Version 2.1; November 2012)
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor applied because starting point for DNEL calculation is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is based on administration of test material to the rat for six weeks (subacute to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not required because differences in breathing between rat and human already accounted for during modification of starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- Default correction for other interspecies differences to allow for variation in toxicokinetics and toxicodynamics
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- The starting point NOAEL was obtained from a GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- No other assessment factor is considered necessary
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 23.3 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:
- 7 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Example B.5 of ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (Version 2.1; November 2012)
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor applied because starting point for DNEL calculation is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is based on administration of test material to the rat for six weeks (subacute to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling to correct for differences in metabolic rate (rat to human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default correction for other interspecies differences to allow for variation in toxicokinetics and toxicodynamics
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- The starting point NOAEL was obtained from a GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- No other assessment factor is considered necessary
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 301 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 15
- Dose descriptor:
- other: EC3 = 18.6 %
- AF for differences in duration of exposure:
- 1
- AF for intraspecies differences:
- 5
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Long term systemic DNELs are based on the NOAEL of 100 mg/kg bw/day reported following administration of test substance to the rat by gavage for six weeks during a combined repeat dose toxicity study with reproductive/developmental screening (OECD 422). However, exposure of test animals took place on 7 days per week whereas exposure duration is expected to be 5 days per week for human workers. The modified starting points were therefore corrected to give 88 mg/m3 * 7/5 = 123.2 mg/m3 (worker, systemic, inhalation) and 5000 mg/kg bw/day * 7/5 = 7000 mg/kg bw/day (worker, systemic, dermal).
The overall assessment factor applied to the modified starting points was the product of contributions covering dose response: 1; differences in exposure (subacute to chronic): 6; interspecies variation: 1 (inhalation) or 4 (dermal); other interspecies differences: 2.5; intraspecies differences: 5; quality of database: 1; remaining uncertainties: 1. The resulting long term systemic inhalation DNEL for workers is 1.64 mg/m3 and the long term systemic dermal DNEL for workers is 23.3 mg/kg bw/day.
Derivation of short term systemic DNELs for the inhalation and dermal routes is not considered to be necessary for workers. The test material has been determined to have a low vapour pressure (2.8 x 10E-02 Pa at 25 °C) and a high onset boiling point range (156 °C at 101 kPa). As a result, the potential for generation of inhalable forms of the substance is low. Furthermore, acute studies conducted via the oral and dermal routes reported no mortalities, signs of systemic toxicity or abnormalities at necropsy that would lead to classification. It can therefore be concluded that the substance causes no systemic effects under acute exposure conditions.
A long term DNEL for local effects via the dermal route in workers has been derived because the substance is classified as a skin sensitiser (1B) and effects may occur at the site of first contact irrespective of whether the substance is systemically available. The skin sensitisation hazard to the worker is identical in the short term. Physico-chemical properties of the substance (low vapour pressure and high onset boiling point range) mean that the potential for generating inhalable forms is low and the possibility of respiratory sensitisation following dermal exposure to vapours is considered to be covered in the long term and the short term by the local DNELs derived for the dermal route.
In accordance with banding defined in ECHA Guidance on information requirements and chemical safety assessment Part E: Risk Characterisation (Version 2.0; November 2012), the test item is considered to be a low hazard with respect to the eyes of workers.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.29 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:
- NOAEC
- Value:
- 43.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Figure R.8-3 of ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (Version 2.1; November 2012)
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor applied because starting point for DNEL calculation is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is based on administration of test material to the rat for six weeks (subacute to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling not required because differences in breathing between rat and human already accounted for during modification of starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- Default correction for other interspecies differences to allow for variation in toxicokinetics and toxicodynamics
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- The starting point NOAEL was obtained from a GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- No other assessment factor is considered necessary
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.3 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:
- 5 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Example B.5 of ECHA Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (Version 2.1; November 2012)
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor applied because starting point for DNEL calculation is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is based on administration of test material to the rat for six weeks (subacute to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling to correct for differences in metabolic rate (rat to human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default correction for other interspecies differences to allow for variation in toxicokinetics and toxicodynamics
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- The starting point NOAEL was obtained from a GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- No other assessment factor is considered necessary
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
- Value:
- 301 µg/cm²
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 15
- Dose descriptor starting point:
- other: EC3 = 18.6%
- AF for intraspecies differences:
- 5
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.17 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:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Route to route extrapolation not required
- AF for dose response relationship:
- 1
- Justification:
- Default assessment factor applied because starting point for DNEL calculation is a NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- DNEL is based on administration of test material to the rat for six weeks (subacute to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling to correct for differences in metabolic rate (rat to human)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default correction for other interspecies differences to allow for variation in toxicokinetics and toxicodynamics
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- The starting point NOAEL was obtained from a GLP guideline study
- AF for remaining uncertainties:
- 1
- Justification:
- No other assessment factor is considered necessary
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
Long term systemic DNELs are based on the NOAEL of 100 mg/kg bw/day reported following administration of test substance to the rat by gavage for six weeks during a combined repeat dose toxicity study with reproductive/developmental screening (OECD 422). The modified starting points were 43.5 mg/m3 (general population, systemic, inhalation) and 5000 mg/kg bw/day (general population, systemic, dermal). Route to route extrapolation was not required when considering oral intake of the test substance by rats and humans; the NOAEL of 100 mg/kg bw/day was therefore used as the starting point for DNEL calculation.
The overall assessment factor applied to the modified starting points was the product of contributions covering dose response: 1; differences in exposure (subacute to chronic): 6; interspecies variation: 1 (inhalation) or 4 (dermal or oral); other interspecies differences: 2.5; intraspecies differences: 10; quality of database: 1; remaining uncertainties: 1. The resulting long term systemic inhalation DNEL for the general population is 0.29 mg/m3, the long term systemic dermal DNEL for the general population is 8.3 mg/kg bw/day and the long term systemic oral DNEL for the general population is 0.17 mg/kg bw/day.
Derivation of short term systemic DNELs for the inhalation, dermal and oral routes is not considered to be necessary for the general population. The test material has been determined to have a low vapour pressure (2.8 x 10E-02 Pa at 25 °C) and a high onset boiling point range (156 °C at 101 kPa). As a result, the potential for generation of inhalable forms of the substance is low. Furthermore, acute studies conducted via the oral and dermal routes reported no mortalities, signs of systemic toxicity or abnormalities at necropsy that would lead to classification. It can therefore be concluded that the substance causes no systemic effects under acute exposure conditions.
A short term DNEL for local effects via the dermal route in consumers has been derived because the substance is classified as a skin sensitiser (1B) and effects may occur at the site of first contact irrespective of whether the substance is systemically available. The skin sensitisation hazard to the consumer is identical in the long term although prolonged contact with the substance is not intended or envisaged. Physico-chemical properties of the substance (low vapour pressure and high onset boiling point range) mean that the potential for generating inhalable forms is low and the possibility of respiratory sensitisation following dermal exposure to vapours is considered to be covered in the long term and the short term by the local DNELs derived for the dermal route.
In accordance with banding defined in ECHA Guidance on information requirements and chemical safety assessment Part E: Risk Characterisation (Version 2.0; November 2012), the test item is considered to be a low hazard to the eyes of the 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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