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EC number: 400-910-1 | CAS number: 119822-74-1
- 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:
- 2.35 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
- Modified dose descriptor starting point:
- other: NOEC
- Value:
- 176.3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Inhalation is an unlikely but possible route for exposure to the substance in regular use. According to ECHA guidance document the oral NOEL (50 mg/kg bw/d) is converted to an inhalatory NOEC Worker as follows: 50 mg/kg bw /d / 0.38 m3/kg/d * 6.7 m3/10m3 * 100/50 = 176.3 mg/m3, whereas the first factor accounts for different respiratory volume from rats to humans, the second factor considers light weight activity respiratory volume increase by workers and the third factor takes account of an anticipated lower absorption via inhalative route compared to oral route (i.e. 100% for oral absorption, and 50% for inhalation).
- AF for dose response relationship:
- 1
- Justification:
- NOEC is used as the starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- based on the subacute study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- allometric scaling is not applied for the derivation of inhalation DNEL.
- AF for other interspecies differences:
- 2.5
- Justification:
- no other substance-specific data are available.
- AF for intraspecies differences:
- 5
- Justification:
- default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Available data from substance fulfilling scientific principle is used .
- AF for remaining uncertainties:
- 1
- Justification:
- no other uncertainties needed to be considered.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.35 mg/m³
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:
- 3.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- other: NOEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- The NOEL from a subacute dermal toxicity study with rats (1000 mg/kg bw) forms the basis for the derivation of the DNEL systemic for dermal exposure and thus no route-to-route extrapolation is required.
- AF for dose response relationship:
- 1
- Justification:
- NOEL is used as the starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- based on the subacute study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats are used
- AF for other interspecies differences:
- 2.5
- Justification:
- no other substance-specific effects are available
- AF for intraspecies differences:
- 5
- Justification:
- default factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- Available data fulfill the scientific requirements
- AF for remaining uncertainties:
- 1
- Justification:
- no other uncertainties need to be considered.
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
In the available sub-acute toxicity study, FAT 20'306 was administered daily by gavage to SPF-bred Wistar rats of both sexes at dose levels of 0, 50, 200 and 1000 mg/kg body weight/day for a period of 28 days. Based upon the results obtained in this study, the "no-observed-effect level" of FAT 20'306 was considered to be 50 mg/kg body weight for male and female rats when administered orally by gavage under the conditions described in this study.
FAT 20306 is expected to be absorbed in human via different routes - oral, dermal and inhalation route due to the physico-chemical properties (i.e., relatively high molecular weight, high water solubility, particle size: 22.9 μm (50%), low Log Pow). A worst case scenario is assumed in which the absorption rate from dermal route is considered to be 50%, for oral route 100% and for inhalative route 50%. Therefore, NOELcorr for the dermal route is 100 mg/kg bw/day.
According to ECHA guidance document the oral NOEL is converted to an inhalatory NOECWorker of 176.3 mg/m3.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.58 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
- Modified dose descriptor starting point:
- other: NOEC
- Value:
- 87 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Inhalation is an unlikely but possible route for exposure to the substance in regular use. According to ECHA guidance document the oral NOEL (50 mg/kg bw/d) is converted to an inhalatory NOEC Worker as follows: 50 mg/kg bw /d / 1.15 m3/kg/d * 100/50 = 87.0 mg/m3, whereas the first factor accounts for different respiratory volume from rats to humans and the second factor considers an anticipated higher absorption via inhalative route compared to oral route (i.e. 100% for oral absorption, and 50% for inhalation).
- AF for dose response relationship:
- 1
- Justification:
- NOEC is used as the starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- based on the sub-acute study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- allometric scaling is not applied for derivation of inhalation DNEL
- AF for other interspecies differences:
- 2.5
- Justification:
- no other substance-specific effects are available
- AF for intraspecies differences:
- 10
- Justification:
- default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- available data fulfill the scientific requirments
- AF for remaining uncertainties:
- 1
- Justification:
- no other uncertainties needed to be considered.
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.58 mg/m³
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:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Modified dose descriptor starting point:
- other: NOEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- The NOEL from a subacute dermal toxicity study with rats (1000 mg/kg bw forms the basis for the derivation of the DNEL systemic for dermal exposure and thus no route-to-route extrapolation is required.
- AF for dose response relationship:
- 1
- Justification:
- NOEL is used as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- based on the subacute study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats are used
- AF for other interspecies differences:
- 2.5
- Justification:
- no other substance-specific data are available
- AF for intraspecies differences:
- 10
- Justification:
- default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- available data fulfill the scientific requirements
- AF for remaining uncertainties:
- 1
- Justification:
- no other uncertainties need to be considered
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:
- 83.3 µg/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
- Modified dose descriptor starting point:
- other: NOEL
- Value:
- 50 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no route to route extrapolation
- AF for dose response relationship:
- 1
- Justification:
- NOEL is used as the starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- based on the subacute study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats are used
- AF for other interspecies differences:
- 2.5
- Justification:
- no other substance-specific data are availalbe
- AF for intraspecies differences:
- 10
- Justification:
- default factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- available data fulfill the scientific principles
- AF for remaining uncertainties:
- 1
- Justification:
- no other uncertainties need to be considered
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 83.3 µg/kg bw/day
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
In an available sub-acute toxicity study, FAT 20306 was administered daily by gavage to SPF-bred Wistar rats of both sexes at dose levels of 0, 50, 200 and 1000 mg/kg body weight/day for a period of 28 days. Based upon the results obtained in this study, the "no-observed-effect level" of FAT 20306 was considered to be 50 mg/kg body weight for male and female rats when administered orally by gavage under the conditions described in this study. This study forms the basis for derivation of inhalation and oral DNELs.
Additionally, a subacute study by dermal application to rats is available with doses applied of 0, 40, 200, and 1000 mg/kg bw. No significant effects were observed in this study and thus the NOEL was set to 1000 mg/kg bw/d. This NOEL is used for derivation of dermal DNELs accordingly.
FAT 20306 is expected to be absorbed in human via different routes - oral, dermal and inhalation route due to the physico-chemical properties (i.e., relatively high molecular weight, high water solubility, particle size: 22.9 μm (50%), low Log Pow).
A worst case scenario is assumed in which the absorption rate from dermal route is considered to be 50%, for oral route 100% and for inhalative route 50%. Therefore, NOELcorr for the inhalation route is 100 mg/kg bw/day, based on the NOEL resulting from the subacute oral study and the corresponding NOEC is 176.3 for workers accordingly.
According to ECHA guidance document the oral NOEL is converted to an inhalatory NOECConsumer of 87.0 mg/m3.
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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