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Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 264-761-2 | CAS number: 64265-45-8
- 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:
- 16.4 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:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 230 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL generation plugin)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL generation plugin)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL generation plugin)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL generation plugin)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL generation plugin)
- 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
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.67 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:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL generation plugin)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL generation plugin)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL generation plugin)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL generation plugin)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL generation plugin)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
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 is not established because no acute toxicity hazard (leading to classification and labelling) has been identified in the available acute dermal toxicity study.
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 153 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- other: generally accepted sensitisation assessment factors
- Overall assessment factor (AF):
- 50
- Dose descriptor:
- other: NESIL [µg/cm²] =7650
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
- Most sensitive endpoint:
- sensitisation (skin)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
Local DNEL
Based on the No Expected Sensitization Induction Level (NESIL) of 7650 µg/cm² obtained from the LLNA, a local DNEL of 153 µg/cm² has been derived for workers.
Type of assessment factor |
Explanation |
SAF for worker |
Inter-individual variability |
The uncertainty factor (SAF: sensitisation assessment factor) for inter-individual variability allows for possible variations in the sensitivity of individuals within the human population. Default AF for workers (ECHA) |
5 |
Inter-species variability |
Inter-species variability is not taken into account in this approach for quantitative risk assessment of contact allergens when extrapolating from the experimental situation to the real life exposure scenarios. This is on the basis that the LLNA data have been correlated with the human data, which is typically not the case in general systemic toxicology. |
1 |
Matrix Effects |
Differences between the matrix used under experimental conditions and real life Exposure, especially the possible presence of irritating substances and penetration enhancers. The substance itself is not irritating to skin, but might be used in formulations, where irritants are present, which could increase dermal penetration. DMF, which is a penetration enhancer, was used as vehicle. |
3.16 (=sqrt(10))
|
Use considerations |
Site of contact (regional differences in absorption) Barrier integrity (e.g. dermatitis) Occlusion (increased dermal penetration) |
3.16 (=sqrt(10))
|
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.47 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:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 370 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL generation plugin)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL generation plugin)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL generation plugin)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL generation plugin)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL generation plugin)
- 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:
- 1.67 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:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL generation plugin)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL generation plugin)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL generation plugin)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL generation plugin)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL generation plugin)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL generation plugin)
- 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:
- 76.5 µg/cm²
- Most sensitive endpoint:
- sensitisation (skin)
DNEL related information
- DNEL derivation method:
- other: generally accepted sensitisation assessment factors
- Overall assessment factor (AF):
- 100
- Dose descriptor:
- other: NESIL [µg/cm²] =7650
Acute/short term exposure
- Hazard assessment conclusion:
- medium 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:
- 1.67 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:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL generation plugin)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL generation plugin)
- AF for differences in duration of exposure:
- 6
- Justification:
- Default (DNEL generation plugin)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL generation plugin)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL generation plugin)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL generation plugin)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL generation plugin)
- 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:
- low hazard (no threshold derived)
Additional information - General Population
Local DNEL
Based on the No Expected Sensitization Induction Level (NESIL) of 7650 µg/cm² obtained from the LLNA, a local DNEL of 76.5 µg/cm² has been derived for the general population.
Type of assessment factor |
Explanation |
SAF for general population |
Inter-individual variability |
The uncertainty factor (SAF: sensitisation assessment factor) for inter-individual variability allows for possible variations in the sensitivity of individuals within the human population. Default AF for general population (ECHA) |
10 |
Inter-species variability |
Inter-species variability is not taken into account in this approach for quantitative risk assessment of contact allergens when extrapolating from the experimental situation to the real life exposure scenarios. This is on the basis that the LLNA data have been correlated with the human data, which is typically not the case in general systemic toxicology. |
1 |
Matrix Effects |
Differences between the matrix used under experimental conditions and real life Exposure, especially the possible presence of irritating substances and penetration enhancers. The substance itself is not irritating to skin, but might be used in formulations, where irritants are present, which could increase dermal penetration. DMF, which is a penetration enhancer, was used as vehicle. |
3.16 (=sqrt(10))
|
Use considerations |
Site of contact (regional differences in absorption) Barrier integrity (e.g. dermatitis) Occlusion (increased dermal penetration) |
3.16 (=sqrt(10))
|
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.