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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 218-345-2 | CAS number: 2128-93-0
- 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:
- 2.35 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 37.5
- Dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 88.105 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEL is taken from a 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test according to OECD TG 422
in rats. It is assumed that oral absorption of the substance is half that of inhalation absorption.
Inhalatory N(L)OAEC = oral N(L)OAEL*(1/0.38 m3/kg/d)*0.67*(ABSoral/ABSinh.)
= 100 * 2.63 * 0.67 * 0.5
= 88.105 mg/m3
- AF for dose response relationship:
- 3
- Justification:
- As the dose descriptor is the LOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- To account for using PoD taken from a developmental study to calculate a chronic DNEL. Timescales are not applicable since developmental toxicity does not get worse with longer exposure but is relevant to a critical time window and the experimental exposure adequately covers the pregnancy of the species under investigation.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is usually not applied in the derivation of the inhalation DNEL.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor.
- AF for intraspecies differences:
- 5
- Justification:
- To account for intraspecies differences in an occupational setting.
- AF for the quality of the whole database:
- 1
- Justification:
- The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties identified therefore not applicable.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.35 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 37.5
- DNEL extrapolated from long term DNEL
- Explanation for the modification of the dose descriptor starting point:
As an acute toxicity hazard leading to classification and labelling of the substance has not been identified, the long-term DNEL is considered sufficient to ensure that effects from acute exposure to the substance do not occur.
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.67 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The LOAEL is taken from a 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test according to OECD TG 422 in rats, resulting in a LOAEL of 100 mg/kg bw/day.
Dermal N(L)OAEL=oral (N(L)OAEL*( ABSoral/ABSdermal)
= 100 x (1/1)
- AF for dose response relationship:
- 3
- Justification:
- As the dose descriptor is the LOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- To account for using PoD taken from a developmental study to calculate a chronic DNEL. Timescales are not applicable since developmental toxicity does not get worse with longer exposure but is relevant to a critical time window and the experimental exposure adequately covers the pregnancy of the species under investigation.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling to account for differences in allometry in using the rat as a test model.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor.
- AF for intraspecies differences:
- 5
- Justification:
- To account for intraspecies differences in an occupational setting.
- AF for the quality of the whole database:
- 1
- Justification:
- The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties identified therefore not applicable.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.67 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- DNEL extrapolated from long term DNEL
- Explanation for the modification of the dose descriptor starting point:
As an acute toxicity hazard leading to classification and labelling of the substance has been identified, the long-term DNEL is considered sufficient to ensure that effects from acute exposure to the substance do not occur.
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.183 mg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 262.5
- Dose descriptor:
- LOAEC
- Value:
- 480 000 mg/m³
- AF for dose response relationship:
- 3
- Justification:
- As the dose descriptor is the LOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- To account for specific exposure condition considerations - this concerns situations when the experimental set up (animal or human) differs from actual human exposure conditions, by e.g. different parts of the body being exposed, differences in skin integrity caused by specific human activities, occlusion of the exposed skin and differences in exposure frequency between the animal/human study and actual human exposure situation.
- AF for interspecies differences (allometric scaling):
- 7
- Justification:
- Allometric scaling to account for differences in allometry in using the mouse as a test model.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor.
- AF for intraspecies differences:
- 5
- Justification:
- To account for intraspecies differences.
- AF for the quality of the whole database:
- 1
- Justification:
- The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties identified therefore not applicable.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.183 mg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 262.5
- Dose descriptor starting point:
- LOAEC
- Value:
- 480 000 mg/m³
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.58 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 43.45 mg/m³
- Explanation for the modification of the dose descriptor starting point:
In the absence of a repeated dose toxicity study conducted via the inhalation route of exposure the use of a PoD using the oral route of exposure has been employed.
The NOAEL is taken from a 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test according to OECD TG 422 in rats. It is assumed that oral absorption of the substance is half that of inhalation absorption.
Inhalatory N(L)OAEC = oral N(L)OAEL*(1/1.15 m3/kg bw/d)*(ABSoral/ABSinh.)
= 100 * 0.869 * 0.5
= 43.45 mg/m3
- AF for dose response relationship:
- 3
- Justification:
- As the dose descriptor is the LOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- To account for using PoD taken from a developmental study to calculate a chronic DNEL. Timescales are not applicable since developmental toxicity does not get worse with longer exposure but is relevant to a critical time window and the experimental exposure adequately covers the pregnancy of the species under investigation.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is usually not applied in the derivation of the inhalation DNEL.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor.
- AF for intraspecies differences:
- 10
- Justification:
- To account for intraspecies differences.
- AF for the quality of the whole database:
- 1
- Justification:
- The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties identified therefore not applicable.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.58 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.33 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NOAEL is taken from a repeat dose toxicity study via the oral route of exposure.
Dermal N(L)OAEL=oral (N(L)OAEL*( ABSoral/ABSdermal)
= 100 * (1/1)
= 100 mg/kg bw/day
- AF for dose response relationship:
- 3
- Justification:
- As the dose descriptor is the LOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- To account for using PoD taken from a developmental study to calculate a chronic DNEL. Timescales are not applicable since developmental toxicity does not get worse with longer exposure but is relevant to a critical time window and the experimental exposure adequately covers the pregnancy of the species under investigation.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling to account for differences in allometry in using the rat as a test model.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor.
- AF for intraspecies differences:
- 10
- Justification:
- To account for intraspecies differences.
- AF for the quality of the whole database:
- 1
- Justification:
- The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties identified therefore not applicable.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.33 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- DNEL extrapolated from long term DNEL
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.14 mg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 525
- Dose descriptor:
- LOAEC
- Value:
- 4 800 µg/m³
- AF for dose response relationship:
- 3
- Justification:
- As the dose descriptor is the LOAEL, the assessment factor is 3.
- AF for differences in duration of exposure:
- 1
- Justification:
- To account for specific exposure condition considerations - this concerns situations when the experimental set up (animal or human) differs from actual human exposure conditions, by e.g. different parts of the body being exposed, differences in skin integrity caused by specific human activities, occlusion of the exposed skin and differences in exposure frequency between the animal/human study and actual human exposure situation.
- AF for interspecies differences (allometric scaling):
- 7
- Justification:
- Allometric scaling to account for differences in allometry in using the mouse as a test model.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor.
- AF for intraspecies differences:
- 10
- Justification:
- To account for intraspecies differences in an occupational setting.
- AF for the quality of the whole database:
- 1
- Justification:
- The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
- AF for remaining uncertainties:
- 1
- Justification:
- The matrix is very similar to the matrix used to determine the EC3 and is not expected to increase the potential for induction of sensitisation.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.14 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 525
- Dose descriptor starting point:
- LOAEC
- Value:
- 4 800 µg/m³
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.33 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- LOAEL
- Value:
- 100 mg/kg bw/day
- AF for dose response relationship:
- 3
- Justification:
- As the dose descriptor is the LOAEL.
- AF for differences in duration of exposure:
- 1
- Justification:
- To account for using PoD taken from a developmental study to calculate a chronic DNEL. Timescales are not applicable since developmental toxicity does not get worse with longer exposure but is relevant to a critical time window and the experimental exposure adequately covers the pregnancy of the species under investigation.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling to account for differences in allometry in using the rat as a test model.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor.
- AF for intraspecies differences:
- 10
- Justification:
- To account for intraspecies differences.
- AF for the quality of the whole database:
- 1
- Justification:
- The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
- AF for remaining uncertainties:
- 1
- Justification:
- There are no remaining uncertainties identified therefore not applicable.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.33 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- DNEL extrapolated from long term DNEL
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - 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.
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.