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Diss Factsheets
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EC number: 939-498-8 | 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:
- 146 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: according to ECETOC 2003
- Overall assessment factor (AF):
- 6
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 875 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- no inhalation toxicity study available, worst case assumption based on oral results
- AF for dose response relationship:
- 1
- Justification:
- according to ECETOC
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- already in starting point correction
- AF for other interspecies differences:
- 3
- Justification:
- worker
- AF for intraspecies differences:
- 1
- Justification:
- according to ECETOC
- AF for the quality of the whole database:
- 1
- Justification:
- according to ECETOC
- AF for remaining uncertainties:
- 1
- Justification:
- according to ECETOC
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- 208.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: according to ECETOC 2003
- Overall assessment factor (AF):
- 24
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 5 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no dermal toxicity study available, assumption based on oral results and literature
- AF for dose response relationship:
- 1
- Justification:
- according to ECETOC
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat -> human
- AF for other interspecies differences:
- 3
- Justification:
- worker
- AF for intraspecies differences:
- 1
- Justification:
- according to ECETOC
- AF for the quality of the whole database:
- 1
- Justification:
- according to ECETOC
- AF for remaining uncertainties:
- 1
- Justification:
- according to ECETOC
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
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Based on a comparison of the different available studies the most reliable and relevant NOEAL for the derivations of a DNEL can be obtained from the following studies:
Most sensitive record for systemic effects is:
Subchronic study, rats, 90 days, OECD 408: NOAEL (f/m, systemic, rat) = 500 mg/kg bw/day (A.I., highest tested dosage) (HENKEL/COGNIS.R9400320, 1995)
Most sensitive record for local effects:
Only very less skin effects (HENKEL/COGNIS. R9700923)
Severe eye effects observed, mild to strong signs at 50%, no reversible till 21d (HENKEL/COGNIS.TDB900762)
No sensitisation (HENKEL/COGNIS.R9701260)
All DNEL were derived using, if necessary, route-to-route extrapolation as there is no adequate subacute/subchronic studies for dermal or inhalation available.
The information available points to a moderate to severe eye effect. One of the available studies (which is therefore assumed as key study) shows irreversible effects on the iris. This severity could be not confirmed in another study. But nevertheless as both tests were not conducted with 100% As the registrant believes in a worst case approach that severe and maybe irreversible effects are possible also more likely for 100% AS. Therefore the substance should be regarded as severely irritating to eye GHS cat. 1.
Qualitative CSA:
The available data for eye irritation do not provide quantitative dose-response information; thus, no short-term local DNELs have been derived for dermal exposure and no quantitative risk assessment was performed. Exposure assessment and risk characterization are performed on a qualitative basis.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 43.8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: according to ECETOC 2003
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 437.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- no inhalation toxicity study available, worst case assumption based on oral results
- AF for dose response relationship:
- 1
- Justification:
- according to ECETOC
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- already in starting point correction
- AF for other interspecies differences:
- 5
- Justification:
- general pop.
- AF for intraspecies differences:
- 1
- Justification:
- according to ECETOC
- AF for the quality of the whole database:
- 1
- Justification:
- according to ECETOC
- AF for remaining uncertainties:
- 1
- Justification:
- according to ECETOC
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- 125 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: according to ECETOC 2003
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 5 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no dermal toxicity study available, assumption based on oral results and literature
- AF for dose response relationship:
- 1
- Justification:
- according to ECETOC
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat -> human
- AF for other interspecies differences:
- 5
- Justification:
- general pop.
- AF for intraspecies differences:
- 1
- Justification:
- according to ECETOC
- AF for the quality of the whole database:
- 1
- Justification:
- according to ECETOC
- AF for remaining uncertainties:
- 1
- Justification:
- according to ECETOC
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: according to ECETOC 2003
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no extrapolation
- AF for dose response relationship:
- 1
- Justification:
- according to ECETOC
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat -> human
- AF for other interspecies differences:
- 5
- Justification:
- general pop.
- AF for intraspecies differences:
- 1
- Justification:
- according to ECETOC
- AF for the quality of the whole database:
- 1
- Justification:
- according to ECETOC
- AF for remaining uncertainties:
- 1
- Justification:
- according to ECETOC
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
Based on a comparison of the different available studies the most reliable and relevant NOEAL for the derivations of a DNEL can be obtained from the following studies:
Most sensitive record for systemic effects is:
Subchronic study, rats, 90 days, OECD 408: NOAEL (f/m, systemic, rat) = 500 mg/kg bw/day (A.I., highest tested dosage) (HENKEL/COGNIS.R9400320, 1995)
Most sensitive record for local effects:
Only very less skin effects (HENKEL/COGNIS. R9700923)
Severe eye effects observed, mild to strong signs at 50%, no reversible till 21d (HENKEL/COGNIS.TDB900762)
No sensitisation (HENKEL/COGNIS.R9701260)
All DNEL were derived using, if necessary, route-to-route extrapolation as there is no adequate subacute/subchronic studies for dermal or inhalation available.
The information available points to a moderate to severe eye effect. One of the available studies (which is therefore assumed as key study) shows irreversible effects on the iris. This severity could be not confirmed in another study. But nevertheless as both tests were not conducted with 100% As the registrant believes in a worst case approach that severe and maybe irreversible effects are possible also more likely for 100% AS. Therefore the substance should be regarded as severely irritating to eye GHS cat. 1.
Qualitative CSA:
The available data for eye irritation do not provide quantitative dose-response information; thus, no short-term local DNELs have been derived for dermal exposure and no quantitative risk assessment was performed. Exposure assessment and risk characterization are performed on a qualitative basis.
But nevertheless as there are no consumer uses, therefore no qualitative risk assessment for consumer concerning eye irriation is performed.
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.