Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 936-610-7 | 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
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
The substance Sodium Stearoyl-L-Glutamate is a multi-constituent organic substance composed by sodium hydrogen N-(1-oxooctadecyl)-L-glutamate (main component – ca. 64%) and sodium hydrogen N-(1-oxohexadecyl)-L-glutamate (ca. 33%), with a molecular weight ranging between 419 and 429.
Based on the organic nature of the components within the substance, complete oral absorption for the substance as a whole might be expected. Complete (100%) oral absorption will be used for risk assessment.
In the absence of quantitative information, for the purposes of risk assessment estimation of mammalian dermal absorption is made in accordance with principles adopted by the EFSA guidance on estimating dermal absorption of pesticide active substances (EFSA, 2012). On this basis, dermal absorption for the substance is assumed at 25%.
In the absence of quantitative information, complete absorption (100%) following inhalation is assumed for the purposes of risk assessment.
Key value for chemical safety assessment
- Absorption rate - oral (%):
- 100
- Absorption rate - dermal (%):
- 25
- Absorption rate - inhalation (%):
- 100
Additional information
The substance is a multi-constituent organic substance consisting of a major component at ca. 64% and a minor component at ca. 33%, with a molecular weight ranging between 419 and 429. It is an off-white solid powder under ambient conditions, with 77.1% of particles being less than 100 µm in size. Its water solubility was found to be related to the loading rate of the test material, with the major component being generally more water soluble than the minor component. It has surfactant properties so that it was not possible to determine an octanol-water partition coefficient. The substance is readily biodegradable.
Absorption
Nothing can be inferred from the acute oral toxicity study, because no clinical sign was observed following oral administration at the limit dose of 2000 mg/kg bw. The molecular weight not exceeding 500g/mol, and the nature of components suggest good oral absorption, with the process starting already in the stomach where peptidases are likely to cleave the peptide bond giving rise to fatty acids and glutamate. In addition,the surface-active properties could enhance intestinal absorption by affecting cell membrane, although metabolism from the intestinal flora can be expected to occur, as supported by readily biodegradability.
Based on the organic nature of the components within the substance,complete oral absorption for the substance as a whole might be expected. Complete (100%) oral absorption will be used for risk assessment.
No adverse effects, either local or systemic, were recorded in the acute dermal toxicity, the skin irritation or the skin sensitisation studies conducted with the substance, and nothing can be inferred about the dermal penetration properties of the substance from these studies.
In the absence ofquantitative information, for the purposes of risk assessment estimation of mammalian dermal absorption is made in accordance with principles adopted by the EFSA guidance on estimating dermal absorption of pesticide active substances (EFSA, 2012). On this basis, dermal absorption for the substance is assumed at 25%.
In the absence ofquantitative information, complete absorption (100%) following inhalation is assumed for the purposes of risk assessment.
Distribution
It can be expected that once absorbed the components of the substance will be widely distributed within the body. It is anticipated that the substance will be metabolised to substrates of endogenous metabolism. The acyl residues will be distributed via chylomicrons, while sodium will become part of the large physiological pool for this electrolyte existing within the body. Glutamic acid will reach the liver, and there subjected to metabolism or re-used for other metabolic processes.
Metabolism
The acyl residues and glutamate will be used as a source of energy within the citric acid cycle; in case of glutamate, it will be also used for the synthesis of peptides or other amino acids, or excreted in the form of urea.
Elimination
Most of the components deriving from metabolism/degradation of the parent compound will be re-used for other metabolic processes within the body; sodium will be eventually excreted in the urine as will be urea, resulting from the catabolism of glutamate.
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.