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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 222-426-8 | CAS number: 3468-11-9
- 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:
- 0.3 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:
- 25 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 22.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Most sensitive endpoint: the NOAEL for a combined repeated dose oral toxicity study with the reproduction/developmental toxicity screening test was considered to be 25 mg/kg/day for males and females.
The NOAEL for repeated dose toxicity was considered to be 25 mg/kg/bw.
--> correct to worker, 8h inhalation:
NOAEC = 25 * (1/ 0.38) * (6.7 / 10) = 44.1 mg/m3
--> in the absence of information on gastro-intestinal absorption an assessment factor of 2, default value for oral-to-inhalation extrapolation has to be applied:
NOAEC = 44.1/ 2 = 22.1 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- No assessment factor required
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH standard AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not used for inhalation results
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA standard AF for "differences not related to calorimetric differences"
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH standard AF for intraspecies differences to workers (ECHA Guidance R8)
- AF for the quality of the whole database:
- 1
- Justification:
- No additional assessment factor required, sufficient data of good quality available
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.8 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):
- 12.5
- DNEL extrapolated from long term DNEL
- Dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 22.1 mg/m³
- Explanation for the modification of the dose descriptor starting point:
A DNEL for acute toxicity should be derived if an acute toxicity hazard (leading to C & L) has been identified and there is a potential for high peak exposures (ECHA R.8).
The median lethal dose of the test item after a single oral administration to female rats, observed
over a period of 14 days is a LD50 cut-off (rat) of 200 mg/kg bw and the test substance has an obligatory labelling requirement for toxicity and is classified into Category 3.
However the LD50 does not provide sufficient information on sub-lethal toxicity at lower doses. Therefore as a starting point the most sensitive endpoint, the NOAEL for a combined repeated dose oral toxicity study with the reproduction/developmental toxicity screening test with 25 mg/kg/day for males and females, was considered.
--> time scaling needed ?(correct to worker, 15 min inhalation)
NOAEC = 25 * (1/ 0.38) * (6.7 / 10) = 44.1 mg/m3
--> in the absence of information on gastro-intestinal absorption an assessment factor of 2, default value for oral-to-inhalation extrapolation has to be applied:
NOAEC = 44.1/ 2 = 22.1 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- No assessment factor required
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- No assessment factor required
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA standard AF for "differences not related to calorimetric differences"
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH standard AF for intraspecies differences to workers (ECHA Guidance R8)
- AF for the quality of the whole database:
- 1
- Justification:
- No additional assessment factor required, sufficient data of good quality available
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- 0.08 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:
- 25 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
25 mg/kg bw/d taken from the combined repeated oral dose toxicity study with the reproduction/
developmental toxicity screening in rats (oral administration).
Assuming 50% oral absorption according to R.7.12.2.4 (p. 179).
Assuming 50% dermal absorption.
- AF for dose response relationship:
- 1
- Justification:
- No assessment factor required.
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH standard AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH standard AF for rat to human extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH standard AF for "differences not related to calorimetric differences"
- AF for intraspecies differences:
- 5
- Justification:
- ECHA REACH standard AF for intraspecies differences to workers
- AF for the quality of the whole database:
- 1
- Justification:
- No issues with the quality of the data base
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties identified
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:
- 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 Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.07 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:
- 25 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 10.87 mg/m³
- Explanation for the modification of the dose descriptor starting point:
25 mg/kg bw/d taken from the combined repeated oral dose toxicity study with the reproduction/
developmental toxicity screening in rats (oral administration).
In the absence of information on oral absorption the assessment factor of 2, default value for oral-to inhalation
extrapolation is considered.
- AF for dose response relationship:
- 1
- Justification:
- No assessment factor required
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH standard AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not used for oral results
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH standard AF for "differences not related to calorimetric differences"
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH standard AF for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- no remaining uncertainties identified
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties identified
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:
- 0.042 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:
- 25 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
25 mg/kg bw/d taken from the combined repeated oral dose toxicity study with the reproduction/
developmental toxicity screening in rats (oral administration).
Assuming 50% oral absorption according to R.7.12.2.4 (p. 179).
Assuming 50% dermal absorption.
- AF for dose response relationship:
- 1
- Justification:
- No assessment factor required
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH standard AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH standard AF for rat to human extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH standard AF for "differences not related to calorimetric differences"
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH default AF for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- no issues with the quality of the database
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- Explanation for the modification of the dose descriptor starting point:
A DNEL for acute toxicity should be derived if an acute toxicity hazard (leading to C & L) has been identified and there is a potential for high peak exposures (ECHA R.8). However, the substance does not need to be classified.
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.042 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:
- 25 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification ot the dose descriptor required.
- AF for dose response relationship:
- 1
- Justification:
- No assessment factor required
- AF for differences in duration of exposure:
- 6
- Justification:
- ECHA REACH standard AF for sub-acute to chronic extrapolation
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- ECHA REACH standard AF for rat to human extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- ECHA REACH standard AF for "differences not related to calorimetric differences"
- AF for intraspecies differences:
- 10
- Justification:
- ECHA REACH default AF for the general population
- AF for the quality of the whole database:
- 1
- Justification:
- no issues with the quality of the database
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties identified
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
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.