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Diss Factsheets
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EC number: 422-930-1 | CAS number: 780759-89-9 JAUNE TZ 4210
- 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:
- 47 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:
- 3 526 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 (1000 mg/kg bw/d, derived from the oral OECD407 study) is converted to an inhalatory NOAEC Worker as follows: 1000 mg/kg bw /d / 0.38 m3/kg/d * 6.7 m3/10m3 * 20/10 = 3526 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 higher absorption via inhalative route compared to oral route (i.e. 20% for oral absorption, and 10% 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:
- DNEL (Derived No Effect Level)
- Value:
- 47 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:
- 6.67 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:
- 2 000 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 10% and the absorption by oral route 20% according to TK assessment. Thus, the NOAEL from the OECD 407 study being 1000 mg/kg bw/d * 20/10 = 2000 mg/kg bw/d is used 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 available toxicity data concerning test substance on human.
In the sub-acute toxicity study, 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 adverse treatment-related effects were noted on any parameter observed during the study, except of discoloration of urine and slightly higher bilirubin concentrations, considered being treatment related but not of toxicological significance. 1000 mg/kg body weight/day of the test item was established as the no-observed-adverse-effect-level (NOAEL).
FAT40549 is expected to be absorbed in human via different routes - oral, dermal and inhalation route due to the physico-chemical properties (i.e., high molecular weight, highly water solubility, particle size is 66 µm (D50 value), low 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 being 10% and the absorption rate by as oral route being 20%. Therefore, NOAELcorr for the dermal route is 2000 mg/kg bw/day. According to ECHA guidance document the oral NOAEL is converted to an inhalation NOAECworker of 3526 mg/m3 (0.38 m3/kg in case of 8 h exposure/d for worker), a factor of 6.7 m3/10m3 taking account of light work activities and a default factor of 2 was assumed in the case of oral-to-inhalation extrapolation (i.e. 20% for oral absorption, and 10% for inhalation).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 11.6 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:
- 1 739 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 (1000 mg/kg bw/d, derived from the OECD 407 study) is converted to an inhalatory NOAEC General Population as follows: 1000 mg/kg bw /d / 1.15 m3/kg/d * 20/10 = 1739 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 oral route compared to inhalation route (i.e. 2% for oral absorption, and 10% 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:
- DNEL (Derived No Effect Level)
- Value:
- 11.6 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:
- 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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 000 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 10% an for oral route 20%. Hence, the NOAEL is corrected by a factor of 2.
- 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:
- 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
- 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:
- 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
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 test substance on human.
In the sub-acute toxicity study, 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 discoloration of urine and slightly increased bilirubin levels, considered being treatment related but not of toxicological significance. 1000 mg/kg body weight/day of the test item was established as the no-observed-adverse-effect-level (NOAEL).
FAT40549 is expected to be absorbed in human via different routes - oral, dermal and inhalation route due to the physico-chemical properties (i.e., high molecular weight, highly water solubility, particle size is 66 µm on average, low 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 10% and for oral route assumed to be 20%. Therefore, NOAELcorr for the dermal route is 2000 mg/kg bw/day. According to ECHA guidance document the oral NOAEL is converted to an inhalation NOAEC general population of 1739 mg/m3 (1.15 m3/kg in case of 24 h exposure/d for general population), and a default factor of 2 was assumed in the case of oral-to-inhalation extrapolation (i.e. 20% for oral absorption, and 10% 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.
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