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Diss Factsheets
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EC number: 419-640-0 | CAS number: 68784-14-5 ALLYL SUCROSE
- 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:
- 13.16 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):
- 75
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 987.36 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- corrected starting point (worker, inhalative) = oral NAEL * 1/sRVrat* sRVhuman/wRV *7/5 = 400 mg/kg bw/d/0.38 m3/kg bw/d*6.7m3/10m3*7/5 = 987.36 mg/m3/d
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable
- AF for other interspecies differences:
- 2.5
- Justification:
- rat to human
- AF for intraspecies differences:
- 5
- Justification:
- worker
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 186.67 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:
- 56 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Due to the physicochemical properties of the test substance, only limited dermal absorption is expected (high molecular weight, poor water solubility and log Kow>4). Therefore a factor of 0.01 (1% absorption) was introduced for the difference in absorption . corrected starting point (worker, dermal) = oral NAEL * 7/5 /0.01 = 400mg/kg bw/d/0.01 *7/5 = 56000 mg/kg bw/d
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- Justification:
- rat to human
- AF for intraspecies differences:
- 5
- Justification:
- worker
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
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
The long-term DNELs are based on a 28 -day oral gavage study performed in rats. The NOAEL in this study was found to be 400 mg/kg bw/d for male and female rats.
Route to route extrapolation (oral to inhalative) was performed according to the ECHA guidance document R.8 (characterization of dose[concentration]-response for human health). The exposure of the test animals was based on 7 days a week. For workers, the expected exposure duration is only 5 days a week. Therefore, a factor of 7/5 was introduced for workers due to the reduced exposure duration (working time of 5 days a week).
For workers:
corrected starting point (worker, inhalative) = oral NAEL * 1/sRVrat* sRVhuman/wRV *7/5
= 400 mg/kg bw/d/0.38 m3/kg bw/d*6.7m3/10m3*7/5 = 987.36 mg/m3/d
Due to the physicochemical properties of the test substance, only limited dermal absorption is expected (high molecular weight, poor water solubility and log Kow>4). Therefore a factor of 0.01 (1% absorption) was introduced for the difference in absorption .
corrected starting point (worker, dermal) =oral NAEL * 7/5 /0.01 = 400 mg/kg bw/d/0.01 *7/5 = 5600 mg/kg bw/d
For the calculation of the DNEL, the following assessment factors were applied on the corrected starting points:
Dermal DNEL: Allometric scaling factor 4; interspecies factor 2.5; intraspecies factor 5; exposure duration factor 6; dose-response factor 1; quality of the database 1 =300
Inhalation DNEL: Interspecies factor 2.5; intraspecies factor 5; exposure duration factor 6; dose-response factor 1; quality of the database 1 =75
Taken together, the resulting dermal DNELfor workers is 186.67 mg/kg bw/d, theinhalative DNEL is 13.16 mg/m3, respectively.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.32 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:
- 347.8 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- corrected starting point (GP, inhalative) = oral NAEL * 1/sRVrat= 400 mg/kg bw/d/1.15 m3/kg/d = 347.8 mg/m3/d
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not applicable
- AF for other interspecies differences:
- 2.5
- Justification:
- rat to human
- AF for intraspecies differences:
- 10
- Justification:
- general public
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- 66.67 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:
- 40 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Due to the physicochemical properties of the test substance, only limited dermal absorption is expected. Therefore, a factor of 0.01 (1% absorption) for the difference in absorption was introduced. corrected starting point (GP, dermal) = oral NAEL/0.01 = 40000 m3/kg/d
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- Justification:
- rat to human
- AF for intraspecies differences:
- 10
- Justification:
- General public
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no DNEL required: short term exposure controlled by conditions for long-term
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:
- 0.67 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:
- 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Not applicable
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-acute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- Justification:
- rat to human
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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
The long-term DNELs are based on a 28 -day oral gavage study performed in rats. The NOAEL in this study was found to be 400 mg/kg bw/d for male and female rats.
Route to route extrapolation (oral to inhalative) was performed according to the ECHA guidance document R.8 (characterization of dose[concentration]-response for human health).
The calculation of the corrected starting points for the general population was as follows:
For the general population (GP): corrected starting point (GP, inhalative) = oral NAEL * 1/sRVrat= 400 mg/kg bw/d/1.15 m3/kg/d
= 347.8 mg/m3/dn
Due to the physicochemical properties of the test substance, only limited dermal absorption is expected. Therefore, a factor of 0.01 (1% absorption) for the difference in absorption was introduced.
corrected starting point (GP, dermal) =oral NAEL/0.01 = 40000 m3/kg/d
The DNEL calculation for the general population was performed equally as for the workers. In deviation to that, the assessment factor for intraspecies variability was set to 10 to account for more variability in the general population.
Resulting from this considerations, the DNELs calculated were 66.67 mg/kg bw/d, 0.66 mg/kg bw/d and 6.96 mg/m3for dermal exposure, oral exposure and inhalation, respectively.
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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