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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 297-025-4 | CAS number: 93281-13-1
- 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:
- 5.76 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:
- 350 mg/kg bw/day
- Value:
- 432 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NAEC is the modified starting point; 350 mg/kg bw/day is the NOAEL for repeated dose toxicity; 0.38 m³/kg bw is the default respiratory volume for the rat corresponding to the daily duration of human exposure. 0.67 is correction for the difference between respiratory rates under standard conditions and under conditions of light activity, considering the inhalation volumes for workers in 8 hours under the respective conditions (6.7 m³ for base level, 10 m³ for light activity); 1.4 is correction for the differences between animal and workers exposure conditions (i.e. 7 days/5 days); 0.5 is correction for differences in bioavailability
- AF for dose response relationship:
- 1
- Justification:
- Default: data well supported
- AF for differences in duration of exposure:
- 6
- Justification:
- Default: subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default: scaling issues considered in modified starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- Default: remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default: worker population
- AF for the quality of the whole database:
- 1
- Justification:
- Default: good quality and reliability
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.63 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:
- 350 mg/kg bw/day
- Value:
- 490 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
NAEC is the modified starting point; 350 mg/kg bw is the NOAEL for repeated dose toxicity; 1.4 is correction for the differences between animal and workers exposure conditions (i.e. 7 days/5 days). Based on the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor for bioavailability should be introduced when performing oral-to-dermal extrapolation
- AF for dose response relationship:
- 1
- Justification:
- Default data well supported
- AF for differences in duration of exposure:
- 6
- Justification:
- Default subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric factor rat to man
- AF for other interspecies differences:
- 2.5
- Justification:
- Default remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- Default worker population
- AF for the quality of the whole database:
- 1
- Justification:
- Default good quality and reliability
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
The Derived No Effect Levels for both inhalation and dermal long-term exposure, systemic effects, are estimated on the basis of the No Observed Effect Level obtained in the subacute combined repeated with the reproduction/developmental toxicity screening test in Rats (Pasics Szakonyiné, 2018).
The NOAEL was established as equal/higher than 350 mg/kg body weight/day for systemic toxicity, as well as for reproductive and developmental toxicity.
The calculation of DNELs is based on the NOAEL identified, which should be corrected for the differences between effect assessment data and the real human exposure situation, taking into account variability and uncertainty within and between species. In order to correct the interspecies difference between rat and human the No Observed Adverse Effect Level has to be corrected, using the default values for DNEL calculation.
No DNEL is derived for inhalation acute exposure, systemic effects, based on the physical state of the substance, inhalation is not an appropriate route of exposure. In addition, no DNEL is derived is derived for both long-term/acute local effects because significant exposure is unlikely to occur due to RMM and OCs.
No DNEL is derived for dermal acute exposure, systemic effects, because no acute toxicity potential was observed up to 2000 mg/kg bw; details in the acute toxicity endpoint summary.
Since no substance-related local effects were observed, only the DNEL for long-term dermal systemic effects were derived.
Regarding the hazard for eyes, the substance can be considered as low hazardous, based on the indication given in the ECHA Guidance on Information Requirements and Chemical Safety Assessment, Part E: Risk Characterisation.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.02 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:
- 350 mg/kg bw/day
- Value:
- 152 mg/m³
- Explanation for the modification of the dose descriptor starting point:
NAEC m3/kg is the modified starting point; 350 mg/kg bw/day is the NOAEL for repeated dose toxicity; 1.15 m3/kg is correction for 24 hours exposure of general public; 0.5 is correction for differences in bioavailability
- AF for dose response relationship:
- 1
- Justification:
- Default data well supported
- AF for differences in duration of exposure:
- 6
- Justification:
- Default subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default scaling issues considered in modified starting point
- AF for other interspecies differences:
- 2.5
- Justification:
- Default remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default general population
- AF for the quality of the whole database:
- 1
- Justification:
- Default good quality and reliability
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
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:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.583 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:
- 350 mg/kg bw/day
- Value:
- 350 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Based on the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor for bioavailability should be introduced when performing oral-to-dermal extrapolation.
- AF for dose response relationship:
- 1
- Justification:
- Default data well supported
- AF for differences in duration of exposure:
- 6
- Justification:
- Default subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric factor rat to man
- AF for other interspecies differences:
- 2.5
- Justification:
- Default remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default general population
- AF for the quality of the whole database:
- 1
- Justification:
- Default good quality and reliability
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Dermal
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.583 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:
- 350 mg/kg bw/day
- Value:
- 350 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The modification of dose description is not necessary.
- AF for dose response relationship:
- 1
- Justification:
- Default data well supported
- AF for differences in duration of exposure:
- 6
- Justification:
- Default subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default allometric factor rat to man
- AF for other interspecies differences:
- 2.5
- Justification:
- Default remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- Default general population)
- AF for the quality of the whole database:
- 1
- Justification:
- Default good quality and reliability
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- Oral
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
The Derived No Effect Levels for inhalation, dermal and oral long-term exposure, systemic effects, are estimated on the basis of the No Observed Effect Level obtained in the subacute combined repeated with the reproduction/developmental toxicity screening test in Rats (Pasics Szakonyiné, 2018).
The NOAEL was established as equal/higher than 350 mg/kg body weight/day for systemic toxicity, as well as for reproductive and developmental toxicity.
The calculation of DNELs is based on the NOAEL identified, which should be corrected for the differences between effect assessment data and the real human exposure situation, taking into account variability and uncertainty within and between species. In order to correct the interspecies difference between rat and human the No Observed Adverse Effect Level has to be corrected, using the default values for DNEL calculation.
For general population, no DNEL is derived for inhalation acute exposure, systemic effects, as well as no DNEL is derived for long-term/acute local effects because, based on the physical state of the substance, inhalation is not an appropriate route of exposure.
No DNEL is derived for either oral or dermal acute exposure, systemic effects, because no acute toxicity potential was observed up to 2000 mg/kg bw of both oral/dermal exposure; details in the acute toxicity endpoint summary.
Since no substance-related local effects were observed, only the DNEL for dermal long-term systemic effects was derived.
Regarding the hazard for eyes, the substance can be considered as low hazardous, based on the indication given in the ECHA Guidance on Information Requirements and Chemical Safety Assessment, Part E: Risk Characterisation.
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.
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