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EC number: 202-571-3 | CAS number: 97-30-3
- 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
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- Flash point
- Auto flammability
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- Oxidation reduction potential
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- 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
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- Nanomaterial pour density
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- Endpoint summary
- Stability
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- 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
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- 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:
- 8.2 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 233.47 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Long term inhalation studies are not available. The long term systemic DNEL for inhalation has been derived from a combined reproduction/developmental screening study.
For derivation of the dose descriptor starting point a factor of 2 has been included for route-to-route extrapolation from oral to inhalative.
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA AF for NOAEL used as starting point.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default corrections for respiratory rate and respiratory volume have been included in route-to-route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor for remaining differences.
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor for intraspecies differences.
- AF for the quality of the whole database:
- 1
- Justification:
- The key study was conducted according to modern regulatory standards and was adequately reported. The database is not considered to contribute uncertainty, no additional factor needed.
- AF for remaining uncertainties:
- 2
- Justification:
- An additional AF of 2 has been included taking account of remaining uncertainties due to read-across.
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:
- 2.33 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Long term studies are not available. The long term systemic DNEL for dermal exposure has been derived from a combined reproduction/developmental screening study.
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA AF for NOAEL used as starting point.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default correction factor for allometric scaling.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor for remaining differences.
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor for intraspecies differences.
- AF for the quality of the whole database:
- 1
- Justification:
- The key study was conducted according to modern regulatory standards and was adequately reported. The database is not considered to contribute uncertainty, no additional factor needed.
- AF for remaining uncertainties:
- 2
- Justification:
- An additional AF of 2 has been included taking account of remaining uncertainties due to read-across.
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
Selection of the relevant dose descriptors:
Oral:
NOAEL = 1000 mg/kg bw/day: derived from a subacute reproduction/developmental screening study according to OECD 422, rat, oral (gavage); read-across to Isostearic acid, esters with methyl-α-D-glucose.
Modification of the relevant dose descriptors to the correct starting point:
Oral absorption
The physicochemical properties of Isostearic acid, esters with methyl-α-D glucose (log Kow > 6.5) and the molecular weight of(weighted mean) 690.31g/mol in general do not favour absorption from the gastro-intestinal tract subsequent to oral ingestion (molecular weight > 500 g/mol, log Kow between > 4). However, since the substance is an UVCB partial absorption cannot be fully excluded. For chemical safety assessment an oral absorption rate of 50% is assumed as a worst case default value in the absence of other data
Dermal absorption
It is generally thought that substances with a high molecular weight (> 500 g/mol) and a high log Kow (> 6.5) are not readily dermally absorbed. Thus, dermal absorption of the source substance Isostearic acid, esters with methyl-α-D-glucose is considered to be low. The target substance alpha methyl glucoside exhibits a low molecular weight (194.183 g/mol) and a low log Kow (-2.5). Due to the low partition coefficient absorption of alpha methyl glucoside is also rather unlikely.
However, in the absence of detailed dermal penetration data it has to be assumed that for both substances dermal penetration may occur.
For chemical safety assessment a dermal absorption rate of 50% is assumed as a worst case default value.
Inhalation absorption
For chemical safety assessment an inhalation absorption rate of 100% is assumed for alpha methyl glucoside as a worst case default value in the absence of other data. By default, twice as high absorption is assumed compared to oral absorption (Guidance on Information Requirements and Chemical Safety Assessment, R8).
Extrapolation oral to inhalation: AF 2
DERIVATION OF DNELs
DNELs derived from subacute reproduction/developmental screening NOAEL (OECD guideline 422)
Worker-DNEL long-term for inhalation route (systemic): 8.2 mg/m³
Start value: 1000 mg/kg bw/d
Route of original study: oral
Dose descriptor starting point after route-to-route extrapolation: 1233.47 mg/m³
For workers the corrected inhalation NOEC is calculated according to the following equation:
corrected inhalation NOAEC = oral NOAEL x 1/sRVrat x ABSoral-rat/ ABSinh-human x sRVhuman/ wRV
= 1000 x 1/0.38 x 50/100 x 6.7/10 x 1.4
The corrected inhalation NOAEC worker (8h) is therefore:
= 1233.47 mg/m³ (8h-TWA)
Overall AF: 1*6*1*2.5*5*1*2 = 150
This DNEL does not address the potential for local irritation. The risk characterisation will consider whether specific risk management measures are necessary to protect against local effects.
Worker-DNEL long-term for dermal route (systemic): 2.33 mg/kg bw/d
Start value: 1000 mg/kg bw/d
Route of original study: oral
Dose descriptor starting point after route-to-route extrapolation: 1000 mg/kg bw/d
Overall AF: 1*6*4*2.5*5*1*2 = 600
An additional factor of 2 was applied due to uncertainties from read-across.
For workers the corrected dermal NOAEL is calculated according to the following equation:
corrected dermal NOAEL = oral NOAEL x ABSoral-rat/ ABSderm-human x days per week (experimental)/days per week (human population; worker)
= 1000 x 100/100 x 7/5
The corrected dermal NOAEL worker (8h) is therefore:
= 1400 mg/kg bw/d
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.45 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 435 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Long term studies are not available. The long term systemic DNEL for inhalation has been derived from a combined reproduction/developmental screening study. An additional factor of 2 was applied due to uncertainties from read-across.
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA AF for NOAEL used as starting point.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default corrections for respiratory rate and respiratory volume have been included in route-to-route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor for remaining differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor intraspecies differences due to lack of data regarding pathways for metabolism.
- AF for the quality of the whole database:
- 1
- Justification:
- The key study was conducted according to modern regulatory standards and was adequately reported. The quality of the database is not considered to contribute uncertainty, no additional factor needed.
- AF for remaining uncertainties:
- 2
- Justification:
- An additional AF of 2 has been included taking account of remaining uncertainties due to read-across.
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:
- 0.833 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Long term studies are not available. The long term systemic DNEL for dermal exposure has been derived from a combined reproduction/developmental screening study. An additional factor of 2 was applied due to uncertainties from read-across.
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA AF for NOAEL used as starting point.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default corrections for respiratory rate and respiratory volume have been included in route-to-route extrapolation.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor for remaining differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor intraspecies differences due to lack of data regarding pathways for metabolism.
- AF for the quality of the whole database:
- 1
- Justification:
- The key study was conducted according to modern regulatory standards and was adequately reported. The quality of the database is not considered to contribute uncertainty, no additional factor needed.
- AF for remaining uncertainties:
- 2
- Justification:
- An additional AF of 2 has been included taking account of remaining uncertainties due to read-across.
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:
- 0.833 mg/kg bw/day
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 1 200
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Long term studies are not available. The long term systemic DNEL for oral exposure has been derived from a combined reproduction/developmental screening study. An additional factor of 2 was applied due to uncertainties from read-across.
- AF for dose response relationship:
- 1
- Justification:
- Default ECHA AF for NOAEL used as starting point.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default assessment factor for extrapolation from subacute to chronic.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default correction factor for allometric scaling
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor for remaining differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor intraspecies differences due to lack of data regarding pathways for metabolism.
- AF for the quality of the whole database:
- 1
- Justification:
- The key study was conducted according to modern regulatory standards and was adequately reported. The quality of the database is not considered to contribute uncertainty, no additional factor needed.
- AF for remaining uncertainties:
- 2
- Justification:
- An additional AF of 2 has been included taking account of remaining uncertainties due to read-across.
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
Selection of the relevant dose descriptors:
Oral:
NOAEL = 1000 mg/kg bw/day: derived from a subacute reproduction/developmental screening study according to OECD 422, rat, oral (gavage); read-across to Isostearic acid, esters with methyl-α-D-glucose.
Modification of the relevant dose descriptors to the correct starting point:
Oral absorption
The physicochemical properties of Isotearic acid, esters with methyl α D glucose (log Kow > 6.5) and the molecular weight of(weighted mean) 690.31g/mol in general do not favour absorption from the gastro-intestinal tract subsequent to oral ingestion (molecular weight > 500 g/mol, log Kow between > 4). However, since the substance is an UVCB partial absorption cannot be fully excluded. For chemical safety assessment an oral absorption rate of 50% is assumed as a worst case default value in the absence of other data
Dermal absorption
It is generally thought that substances with a high molecular weight (> 500 g/mol) and a high log Kow (> 6.5) are not readily dermally absorbed. Thus, dermal absorption of the source substance Isostearic acid, esters with methyl-α-D-glucose is considered to be low. The target substance alpha methyl glucoside exhibits a low molecular weight (194.183 g/mol) and a low log Kow (-2.5). Due to the low partition coefficient absorption of alpha methyl glucoside is also rather unlikely.
However, in the absence of detailed dermal penetration data it has to be assumed that for both substances dermal penetration may occur.
For chemical safety assessment a dermal absorption rate of 50% is assumed as a worst case default value.
Inhalation absorption
For chemical safety assessment an inhalation absorption rate of 100% is assumed for alpha methyl glucoside as a worst case default value in the absence of other data. By default, twice as high absorption is assumed compared to oral absorption (Guidance on Information Requirements and Chemical Safety Assessment, R8).
Extrapolation oral to inhalation: AF 2
DERIVATION OF DNELs
DNELs derived from subacute reproduction/developmental screening NOAEL (OECD guideline 422)
General population-DNEL long-term for inhalation route (systemic): 1.45 mg/m³
Start value: 1000 mg/kg bw/d
Route of original study: oral
Dose descriptor starting point after route-to-route extrapolation: 435 mg/m³
For general population the corrected inhalation NOEC is calculated according to the following equation:
corrected inhalation NOAEC = oral NOAEL x 1/sRVrat x ABSoral-rat/ ABSinh-human
= 1000 x 1/1.15 x 50/100
The corrected inhalation NOAEC general population (24 h) is therefore:
= 435 mg/m³ (24 h)
Overall AF: 1*2.5*10*6*1*1*2 = 300
An additional factor of 2 was applied due to uncertainties from read-across.
This DNEL does not address the potential for local irritation. The risk characterisation will consider whether specific risk management measures are necessary to protect against local effects.
general population-DNEL long-term for dermal route (systemic): 0.833 mg/kg bw/d
Start value: 1000 mg/kg bw/d
Route of original study: oral
Dose descriptor starting point after route-to-route extrapolation: 1000 mg/kg bw/d
Overall AF: 4*2.5*10*6*1*1*2 = 1200
A factor of 2 was applied due to uncertainties from read-across.
For general population the corrected dermal NOEAL is calculated according to the following equation:
corrected dermal NOAEL = oral NOAEL x ABSoral-rat/ ABSderm-human
= 1000 x 100/100
The corrected dermal NOAELgeneral population (24 h) is therefore:
= 1000 mg/m³ (24 h)
general population-DNEL long-term for oral route (systemic): 0.833 mg/kg bw/d
Start value: 1000 mg/kg bw/d
Route of original study: oral
Overall AF: 1*6*4*2.5*10*1*2 = 1200
An additional factor of 2 was applied due to uncertainties from read-across.
This DNEL does not address the potential for local irritation. The risk characterisation will consider whether specific risk management measures are necessary to protect against local effects.
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