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Registration Dossier
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EC number: 214-881-6 | CAS number: 1205-17-0
- 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:
- 1.2 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:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 88.16 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEL(oral) converted to NOAEC(inhal)
= 100 mg/kg/day x 1/0.38 (sRV rat) × 50% / 100% (oral abs. rat / inhal abs. human) × 6.7 / 10 (resting/work human respiratory rate)
= 88.16 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from subacute study to chronic exposure value in line with Table R.8-5 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Interspecies differences addressed in calculation of dose descriptor starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Sufficient data for tonnage.
- 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:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- 0.17 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
It is assumed that absorption via the tested route (oral) is greater that of the route of interest (dermal). i.e. oral absorption is 100% and dermal absorption is 50%. This gives a modified dose descriptor starting point of 100 mg/kg/day x 50% / 100% = 50 mg/kg/day
- AF for dose response relationship:
- 1
- Justification:
- Clear NOELs derived. No uncertainty about dose response
- AF for differences in duration of exposure:
- 6
- Justification:
- Sub-acute to chronic default factor.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human default factor.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers.
- AF for the quality of the whole database:
- 1
- Justification:
- Sufficient data for tonnage.
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 0.01 mg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 375
- Dose descriptor:
- other: EC3
- Value:
- 4.1 mg/m³
- AF for dose response relationship:
- 3
- Justification:
- Default factor for correction of EC3 to EC1.
- AF for differences in duration of exposure:
- 10
- Justification:
- LLNA to chronic exposure.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required for local effects.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining interspecies differences.
- AF for intraspecies differences:
- 5
- Justification:
- Default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Sufficient data for tonnage.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
The substance is not acutely toxic via the oral or dermal routes, with LD50 values greater than 3000 mg/kg bw and 2000 mg/kg bw, respectively. There were no effects in the GLP compliant OECD 422 study (klimisch 1) that would indicate there was a potential for adverse local effects. In addition, the substance is not irritating to skin or eyes. On this basis no acute DNELs were considered necessary either for systemic or local effects. However, the substance is a skin sensitiser. Therefore, a dermal, long term, local effects DNEL has been set. Risk Management Measures to prevent exceedance of the long term dermal DNEL are considered to protect against acute exposure with respect to skin sensitisation potential.
Based on a complete set of in vitro genotoxicity studies, it is concluded that the substance has no genotoxic properties.
In a fully GLP compliant OECD 422 study (Klimisch 1), the overall NOAEL for the study was 100 mg/kg/day based on involution of the acinus in the mammary glands (inguinal region) in the female 300 mg/kg/day dose group and a high value in albumin in the male 300 mg/kg/day dose group. This study was used for setting long-term systemic DNELs.
For the purposes of human risk assessment there is sufficient information to consider that the substance would be fully absorbed (100%) by the oral route, and metabolised and excreted. Human dermal absorption is assumed at 50% and inhalation absorption is assumed to be complete.
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
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 43.48 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NOAEL(oral) converted to NOAEC(inhal)
= 100 mg/kg/day x 1/1.15 (sRV rat)×50% / 100% (oral abs. rat / inhal abs. human)
= 43.48 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from subacute study to chronic exposure value in line with Table R.8-5 of Chapter R.8 of Guidance on information requirements and chemical
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Interspecies differences addressed in calculation of dose descriptor starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Sufficient data for tonnage.
- 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:
- 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:
- 0.083 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:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
It is assumed that absorption via the tested route (oral) is greater that of the route of interest (dermal). i.e. oral absorption is 100% and dermal absorption is 50%. This gives a modified dose descriptor starting point of 100 mg/kg/day x50% / 100% = 50 mg/kg/day
- AF for dose response relationship:
- 1
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from subacute study to chronic exposure value in line with Table R.8-5 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default for allometric scaling between rat and man
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Sufficient data for tonnage.
- 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:
- DNEL (Derived No Effect Level)
- Value:
- 0.005 mg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 750
- Dose descriptor:
- other: EC50
- Value:
- 4.1 mg/m³
- AF for dose response relationship:
- 3
- Justification:
- Default factor for correction of EC3 to EC1.
- AF for differences in duration of exposure:
- 10
- Justification:
- LLNA to chronic exposure.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required for local effects.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default factor for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- Sufficient data for tonnage.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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
- Dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification
- AF for dose response relationship:
- 1
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for differences in duration of exposure:
- 6
- Justification:
- Extrapolation from subacute study to chronic exposure value in line with Table R.8-5 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default factor for extrapolating from rat to man
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining interspecies differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default value in line with Section R.8.4.3.1 of Chapter R.8 of Guidance on information requirements and chemical safety assessment
- AF for the quality of the whole database:
- 1
- Justification:
- Sufficient data for tonnage.
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties.
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 substance is not acutely toxic via the oral or dermal routes, with LD50 values greater than 3000 mg/kg bw and 2000 mg/kg bw, respectively. There were no effects in the GLP compliant OECD 422 study (klimisch 1) that would indicate there was a potential for adverse local effects. In addition, the substance is not irritating to skin or eyes. On this basis no acute DNELs were considered necessary either for systemic or local effects. However, the substance is a skin sensitiser. Therefore, a dermal, long term, local effects DNEL has been set. Risk Management Measures to prevent exceedance of the long term dermal DNEL are considered to protect against acute exposure with respect to skin sensitisation potential.
Based on a complete set of in vitro genotoxicity studies, it is concluded that the substance has no genotoxic properties.
In a fully GLP compliant OECD 422 study (Klimisch 1), the overall NOAEL for the study was 100 mg/kg/day based on involution of the acinus in the mammary glands (inguinal region) in the female 300 mg/kg/day dose group and a high value in albumin in the male 300 mg/kg/day dose group. This study was used for setting long-term systemic DNELs.
For the purposes of human risk assessment there is sufficient information to consider that the substance would be fully absorbed (100%) by the oral route, and metabolised and excreted. Human dermal absorption is assumed at 50% and inhalation absorption is assumed to be complete.
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.
