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Diss Factsheets
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EC number: 616-824-4 | CAS number: 800392-66-9
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: expert statement
- Adequacy of study:
- key study
- Study period:
- 2011-02-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study
Data source
Materials and methods
- Principles of method if other than guideline:
- The attached Toxicokinetic Assessment is meant to fulfill the requirement as defined in the REGULATION (EC) No 1907/2006 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 18 December 2006 requests in Annex VIII, point 8.8.1:
"Assessment of the toxicokinetic behaviour of the substance to the extent that can be derived from therelevant available information."
Results and discussion
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: no bioaccumulation potential based on study results.
Sodium cocoyl apple amino acids is a colourless liquid and a mixture of N-acetylated amino acids. It is an anionic detergent with a water solubility of 395.4g/L. Based on the available data sodium cocoyl apple amino acids will probably be absorbed to a low extent via the skin and via inhalation and to a significant extent via the gastro-intestinal-tract. Actually, classical surfactants are reported to reversibly damage and alter the physiological nature of the stratum corneum reducing then its diffusional resistance. Thus, in a weight of evidence dermal absorption rate of Sodium cocoyl apple amino acids is assumed to be to be low considering the adverse effect noted in skin irritation test. Due to their high water solubility and their resemblance to amino acids the ingredients of the mixture (and their metabolites) can reach every tissue of the organism. In repeated dose toxicity study (OECD 422), the observed clinical, clinicochemical and (histo) pathological effects demonstrate bioavailability from the gastro-intestinal tract with report to the control group. However, there was no indication of a cumulative toxicity in this study.
Concerning metabolism, a significant metabolism of Sodium cocoyl apple amino acids in the liver can be expected when being absorbed from the gastrointestinal tract. Considering the chemical structure of Sodium cocoyl apple amino acids the metabolism may consist of:
- Hydrolysis of the ester binding by N-aminoacetylases, present in all cells of mammals and other eucariotic organisms, will hydrolyse the N-acetylated amino acids to acetate and the respective amino acid. These common metabolites will be included in the physiologic processes and metabolised accordingly.
- Oxidation of both hydrolysis products by cytochrome P450-dependent monooxygenases
- Cytochrome P450-dependent decarboxylation
- Glucurono/sulfo or GSH-conjugations of metabolic oxidation products.
Concerning excretion, an extensive metabolisation, leading to polar metabolites with low molecular weights, followed by renal excretion is to be expected
Therefore there is no potential of bioaccumulation of the constituents of this mixture.
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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