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Diss Factsheets
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EC number: 208-288-1 | CAS number: 520-26-3
- 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:
- 52.89 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):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 322 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The oral NOAEL of 750 mg/kg bw/d is converted to a NOAEC by dividing by 0.38 and multiplying by 0.67 according to ECHA Guidance
- AF for dose response relationship:
- 1
- Justification:
- NOAEC is used as a starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- based on an oral 200 days feeding study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- no substance specific data are available.
- AF for intraspecies differences:
- 5
- Justification:
- for workers the default factor of 5 is used
- 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:
- 52.89 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:
- 7.5 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- oral to dermal extrapolation as no dermal study is available
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as a starting point.
- AF for differences in duration of exposure:
- 2
- Justification:
- based on an oral 200-day 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 substance-specific data are available.
- AF for intraspecies differences:
- 5
- Justification:
- for worker, a default AF of 5 is to be used.
- 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:
- 7.5 mg/kg bw/day
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
According to the results of toxicokinetic assessment, as there is no quantitative data available for dermal adsorption of test material, 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%. The inhalation route is not considered further as exposure scenarios for test article do not indicate inhalative exposure to be the likely route of exposure to human in regular use.
As basis for DNEL derivation the result from a sub-chronic feeding study with rats was used, published by R.A. Wilson et al. In this study hesperidin was dosed up to 1% in food over 200 days and no evidence of cumulative injury, blood sugar levels, weights of important viscera or macroscopic and microscopic tissues has been observed. Hence this study is chosen as basis for DNEL derivation, applying the highest applied dose as NOAEL value (750 mg/kg bw/d) in this study in line with a worst case approach. By Lina et al. a sub-chronic 90-day oral toxicity test was conducted in the rats with neohesperidin dihydrochalcone as structural surrogates for test article. It was indicated that no object adverse effect level (NOAEL) was of 750 mg/kg. bw/day supporting this approach. Based on the above description, the basis for the DNEL therefore is this oral NOAEL (750 mg/kg bw/day), and NOAELcorr for the dermal route is still 750 mg/kg.bw/day. According to ECHA guidance document the oral NOAEL is converted to an inhalative NOAECWorker by dividing through 0.38 m3/kg and multiplied by 0.67 resulting in a NOAEC of 1322 mg/m3.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 13.04 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):
- 50
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 652 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The oral NOAEL of 750 mg/kg bw/d is converted to a NOAEC by dividing by 1.15 according to ECHA Guidance
- AF for dose response relationship:
- 1
- Justification:
- NOAEC is used as a starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- based on an oral 200 days feeding study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- AF not used for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- no substance specific data are available.
- AF for intraspecies differences:
- 10
- Justification:
- for general population the default factor of 10 is used
- 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:
- 13.04 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:
- 3.75 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):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 750 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- oral to dermal extrapolation as no dermal study is available
- AF for dose response relationship:
- 1
- Justification:
- NOAEL is used as starting point
- AF for differences in duration of exposure:
- 2
- Justification:
- based on oral 200 days study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats had been used as test animals
- AF for other interspecies differences:
- 2.5
- Justification:
- no substance-specific data are available.
- AF for intraspecies differences:
- 10
- Justification:
- default value for general population
- AF for the quality of the whole database:
- 1
- Justification:
- Available data fromsubstance 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:
- low 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:
- 3.75 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):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 750 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:
- NOAEL is used as a starting point.
- AF for differences in duration of exposure:
- 2
- Justification:
- DNEL is based on an oral 200-day study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rats were used in the animal study.
- AF for other interspecies differences:
- 2.5
- Justification:
- No substance-specific data is available.
- AF for intraspecies differences:
- 10
- Justification:
- For general population, a default AF of 10 is to be used.
- AF for the quality of the whole database:
- 1
- Justification:
- Available data from substance fulfilling scientific principle.
- 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
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
As basis for DNEL derivation the result from a sub-chronic feeding study with rats was used, published by R.A. Wilson et al. In this study hesperidin was dosed up to 1% in food over 200 days and no evidence of cumulative injury, blood sugar levels, weights of important viscera or macroscopic and microscopic tissues has been observed. Hence this study is chosen as basis for DNEL derivation, applying the highest applied dose as NOAEL value (750 mg/kg bw/d) in this study in line with a worst case approach. By Lina et al. a sub-chronic 90-day oral toxicity test was conducted in the rats with neohesperidin dihydrochalcone as structural surrogates for test article. It was indicated that no object adverse effect level (NOAEL) was of 750 mg/kg. bw/day supporting this approach. Based on the above description, the basis for the DNEL therefore is this oral NOAEL (750 mg/kg bw/day), and NOAELcorr for the dermal route is still 750 mg/kg.bw/day. According to ECHA guidance document the oral NOAEL is converted to an inhalative NOAECWorkerby dividing through 1.15 m3/kg resulting in a NOAEC of 652 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.