Registration Dossier
Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 203-957-4 | CAS number: 112-31-2
- 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:
- 24.86 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 409.7 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 242.8 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for differences in duration of exposure:
- 2
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 5
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 2
- Justification:
- Read-across
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 49.71 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 409.7 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 242.76 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 5
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 2
- Justification:
- Read-Across
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 62.14 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 20
- Dose descriptor:
- NOAEC
- Value:
- 1 242.76 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for differences in duration of exposure:
- 2
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 1
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 5
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 2
- Justification:
- Read-across
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 124.28 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor starting point:
- NOAEC
- Value:
- 1 242.76 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 1
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 5
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 2
- Justification:
- Read-across
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.05 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 409.7 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 409.7 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for differences in duration of exposure:
- 2
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 5
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 2
- Justification:
- Read-across
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14.1 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 409.76 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 409.7 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 5
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 2
- Justification:
- Read-across
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 17.62 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 80
- Dose descriptor:
- NOAEC
- Value:
- 1 242.76 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for differences in duration of exposure:
- 2
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 1
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 5
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 2
- Justification:
- Read-across
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 35.24 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Dose descriptor starting point:
- NOAEC
- Value:
- 1 242.76 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 1
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 5
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 2
- Justification:
- Read-across
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Worker-Inhalation-Long-term-Systemic
NOEC calculated as described in guidance R.8 example B.3 assuming 50% and 100% absorption via oral and inhalatory routes respectively. The above factors were used to calculate a DNEL of 24.9 mg/m3
Worker-Inhalation-Acute-Systemic
The material is not classified for acute systemic effects, therefore derivation of acute DNEL is not required. Long term DNELs are considered sufficient to ensure acute effects do not occur.
Worker-Inhalation-Long-term-Local
No DNEL has been derived for long-term inhalation local effects as no long-term inhalation study has been conducted. In case significant repeated exposure via the inhalation route did occur, it is anticipated that local effects would be more prominent then any possible systemic effects based on the irritant properties of the substance, i. e. irritation of the respiratory tract would be a likely local effect.
Worker-Inhalation-Acute-Local
No short term inhalatory study is available hence no DNEL has been derived. The substance is classified as a skin irritant (Category 2) based on the results of an in-vivo skin irritation study, which showed effects for erythema and edema. An acute dermal toxicity study also showed evidence of dermal irritation. However, the skin irritation study does not provide suitable dose-response information to derive a DNEL for local effects (study only exposed animals to undiluted, neat test substance). Dermal effects will be characterised by local tissue damage and irritation. In case significant exposure via the inhalation route did occur, it is anticipated that local effects would be more prominent then any possible systemic effects based on the irritant properties of the substance, i. e. irritation of the respiratory tract would be a likely local effect.
Worker-Dermal-Long-term-Systemic
NOEC calculated as described in guidance R.8 example B.5 assuming 50% and 50% absorption via oral and dermal routes respectively. The above factors were used to calculate a DNEL of 7.0 mg/m3
Worker-Dermal-Long-term-Systemic
The material is not classified for acute systemic effects, therefore derivation of acute DNEL is not required. Long term DNELs are considered sufficient to ensure acute effects do not occur.
Worker-Dermal-Acute-Systemic
The test material was found to be non-sensitising in a Human Repeat Insult Patch Test (HRIPT), with this data in mind, no long term local effects are expected. The substance is a skin irritant therefore effects following repeated dermal exposure will be characterised by local irritant effects that are related to duration, quantity and concentration of the substance.
Worker-Dermal-Long-term-Local
The substance is classified as a skin irritant (Category 2) based on the results of an in-vivo skin irritation study, which showed effects for erythema and edema. An acute dermal toxicity study also showed evidence of dermal irritation. However, the skin irritation study does not provide suitable dose-response information to derive a DNEL for local effects (study only exposed animals to undiluted, neat test substance). Dermal effects will be characterised by local tissue damage and irritation.
Worker-Dermal-Acute-Local
NOEC calculated as described in guidance R.8 example B.3 assuming 50% and 100% absorption via oral and inhalatory routes respectively. The above factors were used to calculate a DNEL of 6.1 mg/m3The material is not classified for acute systemic effects, therefore derivation of acute DNEL is not required. Long term DNELs are considered sufficient to ensure acute effects do not occur.
Worker-Hazard for eyes
Classified as eye irritant (Category 2)
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 6.13 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 409.7 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 612.91 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for differences in duration of exposure:
- 2
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 2
- Justification:
- Read-across
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.26 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 409.7 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 612.91 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 2
- Justification:
- Read-across
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 15.32 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 40
- Dose descriptor:
- NOAEC
- Value:
- 612.91 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for differences in duration of exposure:
- 2
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 1
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 2
- Justification:
- Read-across
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 30.65 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 20
- Dose descriptor starting point:
- NOAEC
- Value:
- 612.91 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 1
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 2
- Justification:
- Read-across
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.52 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):
- 400
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 409.7 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 409.7 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for differences in duration of exposure:
- 2
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 2
- Justification:
- Read-across
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.05 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 409.7 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 2
- Justification:
- Read-across
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.81 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 160
- Dose descriptor:
- NOAEC
- Value:
- 612.91 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for differences in duration of exposure:
- 2
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 1
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 2
- Justification:
- Read-across
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 17.62 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 80
- Dose descriptor starting point:
- NOAEC
- Value:
- 612.91 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 1
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 2
- Justification:
- Read-across
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.52 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):
- 400
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 409.7 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for differences in duration of exposure:
- 2
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 2
- Justification:
- Read-across
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7.05 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 409.7 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default ECHA assessment
- AF for other interspecies differences:
- 2.5
- Justification:
- Default ECHA assessment
- AF for intraspecies differences:
- 10
- Justification:
- Default ECHA assessment
- AF for the quality of the whole database:
- 2
- Justification:
- Read-across
- AF for remaining uncertainties:
- 1
- Justification:
- Default ECHA assessment
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
General population-Inhalation-Long-term-Systemic
NOEC calculated as described in guidance R.8 example B.3 assuming 50% and 100% absorption via oral and inhalatory routes respectively. The above factors were used to calculate a DNEL of 6.1 mg/m3
General population-Inhalation-Acute-Systemic
The material is not classified for acute systemic effects, therefore derivation of acute DNEL is not required. Long term DNELs are considered sufficient to ensure acute effects do not occur.
General population-Inhalation-Long-term-Local
No DNEL has been derived for long-term inhalation local effects as no long-term inhalation study has been conducted. In case significant repeated exposure via the inhalation route did occur, it is anticipated that local effects would be more prominent then any possible systemic effects based on the irritant properties of the substance, i. e. irritation of the respiratory tract would be a likely local effect.
General population-Inhalation-Acute-Local
No short term inhalatory study is available hence no DNEL has been derived. The substance is classified as a skin irritant (Category 2) based on the results of an in-vivo skin irritation study, which showed effects for erythema and edema. An acute dermal toxicity study also showed evidence of dermal irritation. However, the skin irritation study does not provide suitable dose-response information to derive a DNEL for local effects (study only exposed animals to undiluted, neat test substance). Dermal effects will be characterised by local tissue damage and irritation. In case significant exposure via the inhalation route did occur, it is anticipated that local effects would be more prominent then any possible systemic effects based on the irritant properties of the substance, i. e. irritation of the respiratory tract would be a likely local effect.
General population-Dermal-Long-term-Systemic
NOEC calculated as described in guidance R.8 example B.5 assuming 50% and 50% absorption via oral and dermal routes respectively. The above factors were used to calculate a DNEL of 3.5 mg/m3
General population-Dermal-Long-term-Systemic
The material is not classified for acute systemic effects, therefore derivation of acute DNEL is not required. Long term DNELs are considered sufficient to ensure acute effects do not occur.
General population-Dermal-Acute-Systemic
The test material was found to be non-sensitising in a Human Repeat Insult Patch Test (HRIPT), with this data in mind, no long term local effects are expected. The substance is a skin irritant therefore effects following repeated dermal exposure will be characterised by local irritant effects that are related to duration, quantity and concentration of the substance.
General population-Dermal-Long-term-Local
The substance is classified as a skin irritant (Category 2) based on the results of an in-vivo skin irritation study, which showed effects for erythema and edema. An acute dermal toxicity study also showed evidence of dermal irritation. However, the skin irritation study does not provide suitable dose-response information to derive a DNEL for local effects (study only exposed animals to undiluted, neat test substance). Dermal effects will be characterised by local tissue damage and irritation.
General population-Dermal-Acute-Local
NOEC calculated as described in guidance R.8 example B.3 assuming 50% and 100% absorption via oral and inhalatory routes respectively. The above factors were used to calculate a DNEL of 6.1 mg/m3The material is not classified for acute systemic effects, therefore derivation of acute DNEL is not required. Long term DNELs are considered sufficient to ensure acute effects do not occur.
General population-Oral-Long-term-Systemic
NOEL provided by 90d read across study. The above factors were used to calculate a DNEL of 3.5 mg/m3
General population-Oral-Acute-Systemic
The material is not classified for acute systemic effects, therefore derivation of acute DNEL is not required. Long term DNELs are considered sufficient to ensure acute effects do not occur.
General population-Hazard for eyes
Classified as eye irritant (Category 2)
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