Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 940-822-5 | 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 1.92 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 218 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 192.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Oral to inhalation extrapolation taking into account a standard assessment factor of 2 for differences in absorption.
- AF for dose response relationship:
- 1
- Justification:
- According to guideline
- AF for differences in duration of exposure:
- 4
- Justification:
- Standard assessment factor intrapolated to reflect a study duration of 42 days.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Included in route-to-route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- According to guideline
- AF for intraspecies differences:
- 5
- Justification:
- According to guideline
- AF for the quality of the whole database:
- 2
- Justification:
- DNEL derived based on read-across data
- AF for remaining uncertainties:
- 1
- Justification:
- According to guideline
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:
- 0.545 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):
- 400
- Dose descriptor starting point:
- NOAEL
- Value:
- 218 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 218 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Oral-to-dermal extrapolation taking into account a standard assessment factor of 1 for differences in absorption.
- AF for dose response relationship:
- 1
- Justification:
- According to REACH guideline
- AF for differences in duration of exposure:
- 4
- Justification:
- Standard assessment factor intrapolated to reflect a study duration of 42 days.
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- Justification:
- According to REACH guideline
- AF for remaining uncertainties:
- 2
- Justification:
- DNEL derived based on read-across data
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:
- no hazard identified
Additional information - workers
WORKERS
Long-term systemic effects via inhalation route
Starting point: NOAEL = 218 mg/kg bw/d.
This NOAEL is determined based on a NOAEL obtained in a 42d study available on a read-across substance. As FAV-ES is a UVCB substance it has a broad molecular weight distribution (300-1294 g/mol). The calculated NOAEL for FAV-ES takes into account the lower limit of this range, i.e. 300 g/mol, in order to come to a conservative NOAEL for FAV-ES.
Correction of the starting point:
NOAEC = 218 mg/kg bw/d * (1/0.38 m3/kg bw) * (6.7 m3/10 m3) = 384 mg/m3
Assessment factor for oral-to-inhalation extrapolation: 2
NOAEC = 384 mg/m3* (1/2) = 192 mg/m3
Long-term systemic effects via dermal route
Starting point: NOAEL = 218 mg/kg bw/d.
This NOAEL is determined based on a NOAEL obtained in a 42d study available on a read-across substance. As FAV-ES is a UVCB substance it has a broad molecular weight distribution (300-1294 g/mol). The calculated NOAEL for FAV-ES takes into account the lower limit of this range, i.e. 300 g/mol, in order to come to a conservative NOAEL for FAV-ES.
Correction of the starting point not required.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.474 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):
- 200
- Dose descriptor starting point:
- NOAEL
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 94.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Oral to inhalation extrapolation taking into account a standard assessment factor of 2 for differences in absorption.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 4
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Included in route-to-route extrapolation.
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 2
- Justification:
- DNEL derived based on read-across data
- AF for remaining uncertainties:
- 1
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:
- 0.273 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):
- 800
- Dose descriptor starting point:
- NOAEL
- Value:
- 218 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 218 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Oral-to-dermal extrapolation taking into account a standard assessment factor of 1 for differences in absorption.
- AF for dose response relationship:
- 1
- Justification:
- According to REACH guideline
- AF for differences in duration of exposure:
- 4
- Justification:
- Standard assessment factor intrapolated to reflect a study duration of 42 days.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- According to REACH guideline
- AF for other interspecies differences:
- 2.5
- Justification:
- According to REACH guideline
- AF for intraspecies differences:
- 10
- Justification:
- According to REACH guideline
- AF for the quality of the whole database:
- 1
- Justification:
- According to REACH guideline
- AF for remaining uncertainties:
- 2
- Justification:
- DNEL derived based on read-across data
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
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.273 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):
- 800
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 218 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 4
- Justification:
- Standard assessment factor intrapolated to reflect a study duration of 42 days.
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 2
- Justification:
- DNEL derived based on read-across data
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
GENERAL POPULATION
Long-term systemic effects via inhalation route
Starting point: NOAEL = 218 mg/kg bw/d.
This NOAEL is determined based on a NOAEL obtained in a 42d study available on a read-across substance. As FAV-ES is a UVCB substance it has a broad molecular weight distribution (300-1294 g/mol). The calculated NOAEL for FAV-ES takes into account the lower limit of this range, i.e. 300 g/mol, in order to come to a conservative NOAEL for FAV-ES.
Correction of the starting point:
NOAEC = 218 mg/kg bw/d * (1/1.15 m3/kg bw) = 189.6 mg/m3
Assessment factor for oral-to-inhalation extrapolation: 2
NOAEC = 190 mg/m3* (1/2) = 94.8 mg/m3
Long-term systemic effects via dermal route
Starting point: NOAEL = 218 mg/kg bw/d.
This NOAEL is determined based on a NOAEL obtained in a 42d study available on a read-across substance. As FAV-ES is a UVCB substance it has a broad molecular weight distribution (300-1294 g/mol). The calculated NOAEL for FAV-ES takes into account the lower limit of this range, i.e. 300 g/mol, in order to come to a conservative NOAEL for FAV-ES.
Correction of the starting point not required.
Long-term systemic effects via oral route
Starting point: NOAEL = 218 mg/kg bw/d.
This NOAEL is determined based on a NOAEL obtained in a 42d study available on a read-across substance. As FAV-ES is a UVCB substance it has a broad molecular weight distribution (300-1294 g/mol). The calculated NOAEL for FAV-ES takes into account the lower limit of this range, i.e. 300 g/mol, in order to come to a conservative NOAEL for FAV-ES.
Correction of the starting point not required.
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.
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