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Diss Factsheets
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EC number: 435-190-8 | CAS number: 246871-16-9
- 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:
- 23.5 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:
- NOAEC
- Value:
- 1 763 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- oral to inhalation (no direct data for inhalation route is available)
- AF for dose response relationship:
- 1
- Justification:
- NOAEC is used as a starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- based on a 28-day 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:
- medium hazard (no threshold derived)
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:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- oral to dermal (no direct data for dermal route is available)
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as the starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- based on the 28-day toxicity study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats are used in the animal test
- 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 further uncertainties to be taken into account.
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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
There is no available toxicity data concerning the test substance on humans.
In an available sub-acute toxicity study, FAT 41029/A was administered daily by oral gavage to SPF-bred Wistar rats of both sexes at dose levels of 50, 200 and 1000 mg/kg body weight/day for a period of 28 days. Oral administration of FAT 41'029/A to Wistar rats at doses of 50, 200 and 1000 mg/kg/day, for 28 days was generally well tolerated and did neither produce early mortality or treatment-related signs of toxicological relevance (daily, weekly or functional observational battery) nor effects upon fore- and hind limb grip strength. Test item-related findings were generally restricted to only slight effects on loco motor activity at 1000 mg/kg/day. These effects were considered to be non-adverse. Based on the results of this study, 1000 mg/kg body weight/day of FAT41'029/A is the no-observed-adverse-effect-level (NOAEL).
Based on the mentioned above, it was reasonable to choose the oral NOAEL of 1000 mg/kg/day as the starting point for the purpose of DNEL derivation.
As there is no quantitative data available for dermal adsorption of the chemical, a worst case scenario is assumed in which the absorption rate from dermal route is considered to be same as oral route.
FAT41029 is expected to be absorbed in human via different routes - oral (assumed 10%), dermal (assumed 10%) and inhalation route (assumed 10% only if human is exposed in dusts directly) due to the physico-chemical properties (i.e., moderate molecular weight, poor water solubility, particle size is rather course with a mass median diameter of 236 µm, Log Pow of 3.6).
According to ECHA guidance document the oral NOAEL (1000 mg/kg bw/d) is converted to an inhalatory NOAECWorker of 1763 mg/m3, considering division by 0.38 m3/kg in case of 8 h exposure/d for worker as well as a factor of 6.7 m3/10 m3 for light weight work adjustment.
As the substance FAT 41029 is a weak skin sensitiser (positive in maximisation test but negative in Buehler test) a medium hazard (no threshold derived) for acute inhalation and dermal exposure is set, to be addressed qualitatively in the exposure scenarios.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.8 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:
- NOAEC
- Value:
- 870 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- oral to inhalation (no direct data for inhalation route is available)
- AF for dose response relationship:
- 1
- Justification:
- NOAEC 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:
- 10
- Justification:
- default factor for general population
- 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:
- Available data from substance fulfilling scientific principle is used
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- oral to dermal (no direct data for dermal route is available)
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as the starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- based on the sub-acute toxicity
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats are used in the animal test
- 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 from substance fulfilling scientific principle is used .
- AF for remaining uncertainties:
- 1
- Justification:
- No further uncertainties to be taken into account
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
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:
- 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- no route to route
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as the starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- based on the sub-acute toxicity
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats are used in the animal tests
- 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 from substance fulfilling scientific principle is used
- AF for remaining uncertainties:
- 1
- Justification:
- No further uncertainties to be taken into account
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.67 mg/kg bw/day
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
There is no available toxicity data concerning the test substance on humans.
In an available sub-acute toxicity study, FAT 41029/A was administered daily by oral gavage to SPF-bred Wistar rats of both sexes at dose levels of 50, 200 and 1000 mg/kg body weight/day for a period of 28 days. Oral administration of FAT 41'029/A to Wistar rats at doses of 50, 200 and 1000 mg/kg/day, for 28 days was generally well tolerated and did neither produce early mortality or treatment-related signs of toxicological relevance (daily, weekly or functional observational battery) nor effects upon fore- and hind limb grip strength. Test item-related findings were generally restricted to only slight effects on loco motor activity at 1000 mg/kg/day. These effects were considered to be non-adverse. Based on the results of this study, 1000 mg/kg body weight/day of FAT41'029/A is the no-observed-adverse-effect-level (NOAEL).
Based on the mentioned above, it was reasonable to choose the oral NOAEL of 1000 mg/kg/day as the starting point for the purpose of DNEL derivation.
As there is no quantitative data available for dermal adsorption of the chemical, a worst case scenario is assumed in which the absorption rate from dermal route is considered to be same as oral route.
FAT41029 is expected to be absorbed in human via different routes - oral (assumed 10%), dermal (assumed 10%) and inhalation route (assumed 10% only if human is exposed in dusts directly) due to the physico-chemical properties (i.e., moderate molecular weight, poor water solubility, particle size is rather course with a mass median diameter of 236 µm, Log Pow of 3.6).
According to ECHA guidance document the oral NOAEL (1000 mg/kg bw/d) is converted to an inhalatory NOAECConsumer of 870 mg/m3, considering division by 1.15 m3/kg in case of 24 h exposure/d for consumer.
As the substance FAT 41029 is a weak skin sensitiser (positive in maximisation test but negative in Buehler test) a medium hazard (no threshold derived) for acute inhalation and dermal exposure is set, to be addressed qualitatively in the exposure scenarios.
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.