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Diss Factsheets
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EC number: 430-500-8 | CAS number: 204277-61-2
- 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:
- 4.7 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:
- 352.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Inhalation is a likely route for exposure to the substance in regular use. According to ECHA guidance document the oral NOAEL (200 mg/kg bw/d, derived from the oral OECD407 study) is converted to an inhalatory NOAEC Worker as follows: 200 mg/kg bw /d / 0.38 m3/kg/d * 6.7 m3/10m3 * 100/100 = 352.6 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 absorption via inhalative route compared to oral route (i.e. 100% for oral absorption, and 100% for inhalation).
- 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:
- 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:
- 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:
- 0.67 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
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- As there is no direct information regarding dermal route for the substance, a worst case scenario is assumed in which the absorption rate via dermal route is considered to be same as oral route (both 100% as worst case). Thus, the NOAEL from the OECD 407 study being 200 mg/kg bw/d is used for the dermal route accordingly.
- 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 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
There is no toxicity data available concerning the test substance on humans.
In a sub-acute toxicity study, the test article was administered daily by oral 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. No treatment-related effects were noted on any parameter observed during the study, except of microscopic effects to kidneys (hyaline droplets), considered being treatment related. 200 mg/kg body weight/day of the test item was established as the no-observed-adverse-effect-level (NOAEL).
FAT41024 is expected to be absorbed in human via different routes - oral, dermal and inhalation route due to the physico-chemical properties (i.e., molecular weight approx.. 550 Dalton, low water solubility, mean particle size greater than 10 µm, high Log Pow).
As there is no direct information for the dermal route for the substance, except from acute toxicity studies, a worst case scenario is assumed in which the absorption rate via dermal route is considered to be same as oral route, and for both routes assumed to be 100% as worst case. Therefore, NOAELcorr for the dermal route is still 200 mg/kg bw/day. According to ECHA guidance document the oral NOAEL is converted to an inhalation NOAECworker of 352.6 mg/m³ (0.38 m³/kg in case of 8 h exposure/d for worker), consideration of light work activity by a factor of 6.7 m³ air inhaled divided by 10 m³ air and a default factor of 1 was assumed in the case of oral-to-inhalation extrapolation (i.e. 100% for oral absorption, and 100% for inhalation).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.16 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:
- 174 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Inhalation is a likely route for exposure to the substance in regular use. According to ECHA guidance document the oral NOAEL (200 mg/kg bw/d, derived from the OECD 407 study) is converted to an inhalatory NOAEC General Population as follows: 200 mg/kg bw /d / 1.15 m3/kg/d * 100/100 = 174 mg/m3, whereas the first factor accounts for different respiratory volume from rats to humans and the second factor considers an anticipated absorption via inhalative route compared to oral route (i.e. 100% for oral absorption, and 100% for inhalation).
- 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 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:
- 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:
- 0.33 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- A worst case scenario is assumed in which the absorption rate from dermal route is considered to be same as oral route, and for both routes assumed to be 100%.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL 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:
- 0.33 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 200 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- none applied
- 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 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:
- 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
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
There is no toxicity data available concerning the test substance on humans.
In a sub-acute toxicity study, the test article was administered daily by oral 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. No treatment-related effects were noted on any parameter observed during the study, except of microscopic effects to kidneys (hyaline droplets), considered being treatment related. 200 mg/kg body weight/day of the test item was established as the no-observed-adverse-effect-level (NOAEL).
FAT41024 is expected to be absorbed in human via different routes - oral, dermal and inhalation route due to the physico-chemical properties (i.e., molecular weight approx.. 550 Dalton, low water solubility, mean particle size greater than 10 µm, high Log Pow).
As there is no direct information of dermal route for substance, a worst case scenario is assumed in which the absorption rate via dermal route is considered to be same as oral route, and for both routes assumed to be 100%. Therefore, NOAELcorr for the dermal route is still 200 mg/kg bw/day. According to ECHA guidance document the oral NOAEL is converted to an inhalation NOAECgeneral population of 174 mg/m³ (1.15 m³/kg in case of 24 h exposure/d for general population), and a default factor of 1 was assumed in the case of oral-to-inhalation extrapolation (i.e. 100% for oral absorption, and 100% for inhalation).
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.