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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | CAS number: -
- 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:
- 3.8 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:
- 1 135 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Convert oral NOAEL to inhalation NOAEC : Inhalation Systemic effects - Long-term: Inhalation NOAEC = 644 x (1/0.38) x (100/100) x (6.7/10) = 1135 mg/m3
- AF for dose response relationship:
- 1
- Justification:
- No anticipated adverse effects for what is effectively a source of energy within the body.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for extrapolating from subacute to chronic duration.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required after correction to inhalation starting point.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences.
- AF for intraspecies differences:
- 5
- Justification:
- Default intraspecies factor for workers.
- AF for the quality of the whole database:
- 2
- Justification:
- Although no experimental data for repeat-dose toxicity, reproductive and developmental toxicity, little adverse toxicity is anticipated for what is effectively a source of energy within the body.
- AF for remaining uncertainties:
- 2
- Justification:
- Use of read-across
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.6 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:
- 2 576 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Convert oral NOAEL to dermal NOAEL : Dermal Systemic effects - Long-term: Dermal NOAEL = 644 mg/kg x (100/25) = 2576 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Little adverse toxicity is anticipated for what is effectively a source of energy within the body.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for extrapolating from subacute to chronic duration.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required after correction to inhalation starting point.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences.
- AF for intraspecies differences:
- 5
- Justification:
- Default intraspecies factor for workers.
- AF for the quality of the whole database:
- 2
- Justification:
- (Although no experimental data for repeat-dose toxicity, reproductive and developmental toxicity, little adverse toxicity is anticipated for what is effectively a source of energy within the body.
- AF for remaining uncertainties:
- 2
- Justification:
- Use of 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:
- medium hazard (no threshold derived)
Additional information - workers
The material would revert to glutamate and the fatty acids in the gastro-intestinal tract prior to absorption, by the action of peptidases and proteases in the stomach. Absorption of these components which are endogenous metabolites and very common dietary components can be considered to be 100%.
Dermal absorption can be considered to be no more than 25% in accordance with EFSA guidance.
In the absence of specific data to show otherwise, inhalation absorption is set to 100%.
The material was not acutely toxic via the oral or dermal route and is not anticipated to be acutely toxic via the inhalation route. It is not irritating to the skin and has no skin sensitisation potential, but it causes serious eye irritation (Cat. 2 – medium hazard), although no data on dose-response are available.
No repeat-dose toxicity study is available, and a read-across approach of the two main constituents using bespoke QSARs created in the OECD QSAR Toolbox, tailored to both the substance and the endpoint, have been used to derive expected NOELs for repeated oral exposure. The repeated dose (subacute) oral toxicity No Observed Effect Level (NOEL) of disodium hydrogen N-(1-oxohexadecyl) -L-glutamate was determined to be 803.3 mg/kg bw/day in the rat via oral gavage. The oral gavage (subacute) NOEL in rats for disodium hydrogen N-(1-oxooctadecyl) -L-glutamate was determined to be ca. 431.7 mg/kg bw/day. Considering the proportion of each component within the substance, the average expected repeat-dose NOEL for the substance as a whole, assumed for a subacute exposure as a worst-case condition, is estimated at 644 mg/kg bw/day (i.e. 803.3 x 63% + 431.7 x 32%); this value has been used as the subacute starting point for deriving the long-term systemic DNELs.
The test material was not genotoxic, and not known precedent reproductive and developmental toxic potential was found using a read-across approach of the two main constituents, using bespoke QSARs created in the OECD QSAR Toolbox.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.9 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):
- 600
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 560 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- Covert oral NOAEL to inhalation NOAEC : Inhalation Systemic effects - Long-term: Inhalation NOAEC = 644 x (1/1.15) x (100/100) = 560 mg/m3/day
- AF for dose response relationship:
- 1
- Justification:
- Little adverse toxicity is anticipated for what is effectively a source of energy within the body.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for extrapolating from subacute to chronic duration.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default intraspecies factor for the general population.
- AF for the quality of the whole database:
- 2
- Justification:
- Although no experimental data for repeat-dose toxicity, reproductive and developmental toxicity, little adverse toxicity is anticipated for what is effectively a source of energy within the body.
- AF for remaining uncertainties:
- 2
- Justification:
- Use of read across.
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.3 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:
- 2 576 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- Convert oral NOAEL to dermal NOAEL : Dermal Systemic effects - Long-term: Dermal NOAEL = 644 mg/kg x (100/25) = 2576 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Little adverse toxicity is anticipated for what is effectively a source of energy within the body.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for extrapolating from subacute to chronic duration.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required – same metabolism in mammalian species.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default intraspecies factor for the general population.
- AF for the quality of the whole database:
- 2
- Justification:
- Although no experimental data for repeat-dose toxicity, reproductive and developmental toxicity, little adverse toxicity is anticipated for what is effectively a source of energy within the body.
- AF for remaining uncertainties:
- 2
- Justification:
- Use of 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:
- 0.9 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:
- 644 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No route to route extrapolation required
- AF for dose response relationship:
- 1
- Justification:
- Little adverse toxicity is anticipated for what is effectively a source of energy within the body.
- AF for differences in duration of exposure:
- 6
- Justification:
- Default factor for extrapolating from subacute to chronic duration.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required – same metabolism in mammalian species.)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default factor for remaining differences.
- AF for intraspecies differences:
- 10
- Justification:
- Default intraspecies factor for the general population.
- AF for the quality of the whole database:
- 2
- Justification:
- Although no experimental data for repeat-dose toxicity, reproductive and developmental toxicity, little adverse toxicity is anticipated for what is effectively a source of energy within the body.
- AF for remaining uncertainties:
- 2
- Justification:
- Use of 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:
- medium hazard (no threshold derived)
Additional information - General Population
The same endpoint used for deriving long-term systemic DNELs for workers has been used for the general population. The larger AF for intraspecies sensitivity is considered to be sufficiently protective.
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.