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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 448-060-0 | CAS number: 727678-39-9
- 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:
- 11.75 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:
- 1 763.2 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No study on long-term inhalation toxicity available
- AF for dose response relationship:
- 1
- Justification:
- Default value for NOAEL as starting point for DNEL calculation
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is not necessary for the inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value for additional interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 2
- Justification:
- Remaining uncertainties due to data waiving for toxicity to reproduction
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Workers - 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:
- No study on long-term dermal toxicity available
- AF for dose response relationship:
- 1
- Justification:
- Default value for NOAEL as starting point for DNEL calculation
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value for additional interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Default value for workers
- AF for the quality of the whole database:
- 2
- Justification:
- Remaining uncertainties due to data waiving for toxicity to reproduction
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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
No DNELs have been derived for the short-term dermal and inhalation exposure of UY-330 for workers, as the assessment of hazard is considered to be sufficiently covered by deriving the respective DNELs for long-term exposure.
In a repeated dose oral toxicity study according to OECD 407, 5 Wistar rats per sex and dose were treated for 28 d with UY-330 (van Otterdijk, 2004). The test substance was applied in doses of 50, 150 and 1000 mg/kg bw/d as suspension in propylene glycol via oral gavage.
All animals survived the treatment period and no effects on body weight, body weight gain and food consumption were observed. No test substance related findings were noted on clinical signs, haematology, clinical chemistry, neurobehavioural examinations, gross pathology, organ weights and histopathology. Based on the results of this study, the NOAEL is ≥ 1000 mg/kg bw/d for males and females.
This study was chosen as the starting point for deriving the long-term worker DNELs for inhalation and dermal systemic effects since there are no inhalation and dermal repeated dose toxicity studies available.
For deriving the long-term worker DNEL for inhalation systemic effects according to the “Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health” (ECHA, 2012), the oral NOAEL has to be converted into an inhalatory NAEC: the oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (0.38 m³/kg for 8 h exposure). Additionally, it should be taken into account that during 8 hours light activity at work the respiratory rate becomes higher (10 m³/person) than standard (6.7 m³/person). Based on the water insolubility and the high log Pow, absorption of UY-330 is not likely to occur (refer to Toxicokinetics, metabolism and distribution). Therefore, absorption via the inhalation route is considered to be comparable to absorption via the oral route. Taken toghether, the corrected starting point is a NOAEC of 1763.2 mg/m³.
To convert the oral NOAEL [mg/kg bw/d] into a dermal NOAEL [mg/kg bw/d], the differences in absorption between routes, the differences in duration of exposure as well as differences in dermal absorption between rats and humans have to be accounted for (Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health, ECHA, 2012).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.9 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):
- 300
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 869.6 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No study on long-term inhalation toxicity available
- AF for dose response relationship:
- 1
- Justification:
- Default value for NOAEL as starting point for DNEL calculation
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic exposure
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Allometric scaling is not necessary for the inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value for additional interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 2
- Justification:
- Remaining uncertainties due to data waiving for toxicity to reproduction
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.83 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):
- 1 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No study on long-term dermal toxicity available
- AF for dose response relationship:
- 1
- Justification:
- Default value for NOAEL as starting point for DNEL calculation
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value for additional interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 2
- Justification:
- Remaining uncertainties due to data waiving for toxicity to reproduction
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
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:
- 0.83 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):
- 1 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Default value for NOAEL as starting point for DNEL calculation
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic exposure
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Allometric scaling rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default value for additional interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default value for general population
- AF for the quality of the whole database:
- 2
- Justification:
- Remaining uncertainties due to data waiving for toxicity to reproduction
- AF for remaining uncertainties:
- 1
- Justification:
- No remaining uncertainties
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
No DNELs have been derived for the short-term oral, dermal and inhalation exposure of UY-330 for consumers, as it is considered that the assessment of hazard is sufficiently covered by deriving the respective DNELs for long-term exposure.
In a repeated dose oral toxicity study according to OECD 407, 5 Wistar rats per sex and dose were treated for 28 d with UY-330 (van Otterdijk, 2004). The test substance was applied in doses of 50, 150 and 1000 mg/kg bw/d as suspension in propylene glycol via oral gavage.
All animals survived the treatment period and no effects on body weight, body weight gain and food consumption were observed. No test substance related findings were noted on clinical signs, haematology, clinical chemistry, neurobehavioural examinations, gross pathology, organ weights and histopathology. Based on the results of this study, the NOAEL is ≥ 1000 mg/kg bw/d for males and females.
This study was chosen as the starting point for deriving the long-term DNELs for the general population for inhalation and dermal systemic effects since there are no inhalation and dermal repeated dose toxicity studies available. The long-term DNEL for the general population oral systemic effects was derived directly from the oral repeated dose toxicity study.
For deriving the long-term consumer DNEL for inhalation systemic effects according to the “Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health” (ECHA, 2012), the oral NOAEL has to be converted into an inhalatory NOAEC: the oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m³/kg for 24 h exposure).
Based on the water insolubility and the high log Pow, absorption of UY-330 is not likely to occur (refer to Toxicokinetics, metabolism and distribution). Therefore, absorption via the inhalation route is considered to be comparable to absorption via the oral route. Taken toghether, the corrected starting point is a NOAEC of 869.6 mg/m³.
To convert the oral NOAEL [mg/kg bw/d] into a dermal NOAEL [mg/kg bw/d], the differences in absorption between routes, the differences in duration of exposure as well as differences in dermal absorption between rats and humans have to be accounted for (Guidance on information requirements and chemical safety assessment. Chapter R.8: Characterisation of dose [concentration]-response for human health, ECHA, 2012).
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.