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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 939-201-1 | 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
It is likely that the test substance forms two physiological cleavage products: fatty acids and glutamic acid.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Metabolism
In the following, the available information on the toxicokinetic properties for the target substanceReaction mass of sodium hydrogen N-(1-oxooctadecyl)-L-glutamate and stearic acid (EC 939-201-1)and the source substancesL-Glutamic acid, N-coco acyl derivs., disodium salts (CAS 68187-30-4) and L-Glutamic acid, N-coco acyl derivs., disodium salts (CAS 68187-32-6)is assessed. Both substances are amino acid alkyl amides. A likely metabolic pathway for these substances includes reactions catalyzed by amidases resulting in the release of the amino acid glutamic acid and the fatty acid (stearic acid or coconut acid) (CIR 2013) which are both part of the daily dietand are consumed by humans on a gram scale.
Glutamic acid will be then degraded via transamination, in which the amino group of the amino acid is transferred to a ketoacid, typically catalyzed by a transaminase.Transamination can thus be linked to deamination, effectively allowing nitrogen from the amine groups of amino acids to be removed, via glutamate as an intermediate, and finally excreted from the body in the form of urea.
Fatty acids, like stearic acid and coconut acid, will be metabolized via ß-oxidation which is the catabolic process to break down fatty acids in the mitochondria to generate acetyl-CoA finally entering in the citric acid cycle (CIR 1987).
It can be concluded that the metabolism of both substances should be comparable due to the structural similarity.
Absorption, distribution and excretion
The bioavailability of the target and the source substances is related to the efficiency of absorption which depends on pancreatic function, biliary secretion to form mixed micelles with the hydrolysed fat, and the transfer across intestinal membranes. Both substances have a low log Pow and a good water solubility.
Oral absorption
Due to the high water solubility and the low log Pow of the substances, systemic uptake via passive diffusion is possible within the gastrointestinal (GI) tract. Furthermore, water soluble substances will readily dissolve in the GI fluids, which enhance the contact with the intestinal mucosa. Following oral intake, and once in contact with the digestive fluids of the stomach and uptake in the body, it is assumed that the target and source substance will comparably degrade into fatty acid and glutamic acid. For this reason, a studywas performed to investigate the hydrolytic degradation of the two test substances “L-Glutamic acid, N-coco acyl derivs. disodium salts” and “Reaction mass of sodium hydrogen N-(1-oxooctadecyl)-l-glutamate and stearic acid” in gastric juice simulant and liver S9 fraction of different species (see IUCLID chapter 7.1.1). As glutamic acid is the most likely hydrolysis product for the target and the source substance, the glutamic acid concentration was measured in the respective samples.There was no indication for the formation of glutamic acid during incubation in gastric juice simulant for both substances. When using liver S9 fraction from different species (rat, rabbit, human), it is concluded that the target and the source substance demonstrate a comparable glutamic acid formation in the different S9 liver fractions.
Dermal absorption
Based on the good water solubility of the reaction product, dermal uptake is negligible. It is commonly known that substances with a good water solubility are too hydrophilic to cross the lipid rich environment of the stratum corneum.
Distribution
Once absorbed it is expected that the reaction products and its metabolites are distributed within the blood stream. Here the transport efficiency to the body tissues is limited by the rate at which the highly water soluble substances cross cell membranes. More specifically, access to the central nervous system or the testes is likely to be restricted by the blood-brain and blood-testes barriers (Rozman and Klaassen 1996). Due to the high water solubility and the low log Pow accumulation is unlikely (see Bioaccumulation assessment).
Excretion
Based on the expected biotransformation reactions, molecular size and water solubility, it is most likely that the final metabolites are excreted via the urine.
Conclusion
It is expected that both amino acid alkyl amides after oral intake behave similar. A dermal intake is not expected for both target and source substances due to their physico-chemical properties.
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.