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Diss Factsheets
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EC number: 939-071-6 | 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:
- 1.05 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 26.17 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Long term inhalation studies are not available. The long term systemic DNEL for the inhalation route has been derived from the oral repeated dose toxicity study. For derivation of the dose descriptor starting point a factor of 2 has been included for route-to-route extrapolation from oral to inhalative.
- AF for dose response relationship:
- 1
- Justification:
- default - ECHA REACH Guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- default - ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default corrections for respiratory rate and respiratory volume have been included in route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default - ECHA REACH Guidance
- AF for intraspecies differences:
- 5
- Justification:
- default - ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- The available studies were conducted according to modern regulatory standards and were adequately reported. On this basis the quality of the database is not considered to contribute to uncertainty and it is therefore not necessary to apply an additional factor.
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
General considerations
Short-term data
No data on acute toxicity are available for the oral, inhalation and dermal route due to the corrosive nature of the substance.
Long-term data
Data relevant for long-term toxicity are available from an oral sub-chronic toxicity study, subacute toxicity study and a developmental toxicity study, all conducted in rats.
Selection of the relevant dose descriptors:
NOAEL = 30 mg/kg bw/day; 90 d Repeated Dose Toxicity Study, rat, oral (gavage)
NOEL = 50 mg/kg bw/d (systemic effects); 28 d Repeated Dose Toxicity Study, rat, oral (gavage)
NOAEL(embryotoxicity) = 100 mg/kg bw/d, NOEL(maternal toxicity)= 30 mg/kg bw/d; Prenatal Developmental Toxicity Test, rat, oral (gavage)
Hazard for the eyes
The substance is classified as corrosive.
Dermal DNELs have not been derived. Due to the severity of the local effects (skin corrosion and sensitisation) maximum PPE will have to be used. In case dermal exposure occurs, immediate washing is recommended. Thus, systemic exposure is unlikely. As none of the exposure software models takes that into consideration, and thereby overestimating exposure, a qualitative assessment is carried out. According to the Guidance on information requirements and chemical safety assessment, Part E: Risk Characterisation, the substance is of high hazard.
Modification of the relevant dose descriptors to the correct starting point:
Oral absorption
No data exist on differences in bioavailability following oral or dermal exposure between experimental animals and humans, and a similar bioavailability is assumed by default.
Oral to inhalation
For inhalation exposure as a worst case assumption a 100% absorption is assumed in absence of any experimental data (Guidance on Information Requirements and Chemical Safety Assessment, R8).
Extrapolation oral to inhalation: AF 2
DNELs derived from oral repeated dose toxicity NOAEL (90-d study, rat, OECD Guideline 408)
Worker-DNEL long-term for inhalation route (systemic): 1.05 mg/m³
Start value: 30 mg/kg bw/d
Route of original study: oral
Dose descriptor starting point after route-to-route extrapolation: 26.17 mg/m³
For workers the corrected inhalation NOEC is calculated according to the following equation:
corrected inhalation NOAEC = oral NOAEL x 1/sRVrat x ABSoral-rat/ ABSinh-human x sRVhuman/ wRV
= 30 x 1/0.384 x 50/100 x 6.7/10
The corrected inhalation NOAECworker (8h) is therefore:
= 26.17 mg/m³ (8h-TWA)
Overall AF: 1*2.5*5*2*1*1*1 = 25
This DNEL does not address the potential for local irritation. The risk characterization will consider whether specific risk management measures are necessary to protect against local effects.
DNELs derived from oral prenatal developmental toxicity NOAEL (rat, OECD Guideline 414)
No time extrapolation is required for this type of study, since the susceptible window is fully covered.
Worker-DNEL long-term for inhalation route (systemic): 6.98 mg/m³
Start value: 100 mg/kg bw/d
Route of original study: oral
Dose descriptor starting point after route-to-route extrapolation: 87.24 mg/m³
For workers the corrected inhalation NOEC is calculated according to the following equation:
corrected inhalation NOAEC = oral NOAEL x 1/sRVrat x ABSoral-rat/ ABSinh-human x sRVhuman/ wRV
= 100 x 1/0.384 x 50/100 x 6.7/10
The corrected inhalation NOAECworker (8h) is therefore:
= 87.24 mg/m³ (8h-TWA)
Overall AF: 1*2.5*5*1*1*1*1 = 12.5
This DNEL does not address the potential for local irritation. The risk characterization will consider whether specific risk management measures are necessary to protect against local effects.
The DNELs for developmental toxicity were higher than those for repeated dose toxicity. Thus, the repeated dose toxicity-DNELs are also protective for development.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.26 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
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 13.02 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Long term inhalation studies are not available. The long term systemic DNEL for the inhalation route has been derived from the oral repeated dose toxicity study. For derivation of the dose descriptor starting point a factor of 2 has been included for route-to-route extrapolation from oral to inhalative.
- AF for dose response relationship:
- 1
- Justification:
- default - ECHA REACH Guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- default - ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default corrections for respiratory rate and respiratory volume have been included in route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- default - ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- default - ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- The available studies were conducted according to modern regulatory standards and were adequately reported. On this basis the quality of the database is not considered to contribute to uncertainty and it is therefore not necessary to apply an additional factor.
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
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:
- hazard unknown (no further information 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)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
- 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:
- 0.15 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 30 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- ECHA REACH Guidance
- AF for dose response relationship:
- 1
- Justification:
- default - ECHA REACH Guidance
- AF for differences in duration of exposure:
- 2
- Justification:
- default - ECHA REACH Guidance
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default - ECHA REACH Guidance
- AF for other interspecies differences:
- 2.5
- Justification:
- default - ECHA REACH Guidance
- AF for intraspecies differences:
- 10
- Justification:
- default - ECHA REACH Guidance
- AF for the quality of the whole database:
- 1
- Justification:
- The available studies were conducted according to modern regulatory standards and were adequately reported. On this basis the quality of the database is not considered to contribute to uncertainty and it is therefore not necessary to apply an additional factor.
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Additional information - General Population
DNELs for general population (for the oral and inhalation route) were only derived for assessment of risk related to exposure to man via the environment. No REACH-relevant consumer use has been identified.
General considerations
Short-term data
No data on acute toxicity are available for the oral, inhalation and dermal route due to the corrosive nature of the substance.
Long-term data
Data relevant for long-term toxicity are available from an oral sub-chronic toxicity study and a developmental toxicity study, both in rats.
Selection of the relevant dose descriptors:
NOAEL = 30 mg/kg bw/day; 90 d Repeated Dose Toxicity Study, rat, oral (gavage)
NOEL = 50 mg/kg bw/d (systemic effects); 28 d Repeated Dose Toxicity Study, rat, oral (gavage)
NOAEL(embryotoxicity) = 100 mg/kg bw/d, NOEL(maternal toxicity)= 30 mg/kg bw/d; Prenatal Developmental Toxicity Test, rat, oral (gavage)
Modification of the relevant dose descriptors to the correct starting point:
Oral absorption
No data exist on differences in bioavailability following oral or dermal exposure between experimental animals and humans, and a similar bioavailability is assumed by default.
Oral to inhalation
For inhalation exposure as a worst case assumption a 100% absorption is assumed in absence of any experimental data (Guidance on Information Requirements and Chemical Safety Assessment, R8).
Extrapolation oral to inhalation: AF 2
DNELs derived from oral repeated dose toxicity NOAEL (90-d study, rat, OECD Guideline 408)
General population-DNEL long-term for oral route (systemic): 0.15 mg/kg bw/d
Start value: 30 mg/kg bw/d
Route of original study: oral
Overall AF 4*2.5*10*2*1*1*1 = 200
General population -DNEL long-term for inhalation route (systemic): 0.26 mg/m³
Start value: 30 mg/kg bw/d
Route of original study: oral
Dose descriptor starting point after route-to-route extrapolation: 13.02 mg/m³
For general population the corrected inhalation NOEC is calculated according to the following equation:
corrected inhalation NOAEC = oral NOAEL x 1/sRVratx ABSoral-rat/ ABSinh-human
= 30 x 1/1.152 x 50/100
The corrected inhalation NOAECgeneral population (24 h) is therefore:
= 13.02 mg/m³ (24 h)
Overall AF: 1*2.5*10*2*1*1*1 = 50
DNELs derived from oral prenatal developmental toxicity NOAEL (rat, OECD Guideline 414)
No time extrapolation is required for this type of study, since the susceptible window is fully covered.
General population-DNEL long-term for oral route (systemic): 1 mg/kg bw/d
Start value: 100 mg/kg bw/d
Route of original study: oral
Overall AF 4*2.5*10*1*1*1*1 = 100
General population -DNEL long-term for inhalation route (systemic): 1.74 mg/m³
Start value: 100 mg/kg bw/d
Route of original study: oral
Dose descriptor starting point after route-to-route extrapolation: 43.4 mg/m³
For general population the corrected inhalation NOEC is calculated according to the following equation:
corrected inhalation NOAEC = oral NOAEL x 1/sRVrat x ABSoral-rat/ ABSinh-human
= 100 x 1/1.152 x 50/100
The corrected inhalation NOAECgeneral population (24 h) is therefore:
= 43.4 mg/m³ (24 h)
Overall AF: 1*2.5*10*1*1*1*1 = 25
The DNELs for developmental toxicity were higher than those for repeated dose toxicity. Thus, the repeated dose toxicity-DNELs are also protective for development.
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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