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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 700-887-0 | 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
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
For both main components of the reaction mass of L-alanyl-L-glutamine and potassium chloride either a suitable study (L-alanyl-L-glutamine) for the determination of sensitizing properties has been conducted or a sound scientifical justification for endpoint waiving (potassium chlroide) are available. For both main components and the registered reaction mass of them based on the available information no evidence for skin sensitizing properties is given.
Justification for selection of skin sensitisation endpoint:
Potassium chloride:
After an intensive literature search it has to be concluded that there is no adequate data available covering the skin sensitization potency of potassium chloride. On the other hand potassium and chloride are essential constituents and 2 of the most abundant ions in all humans as in all animal species. In adult humans, the body potassium is approx. 3.5 mol (135 g); the total body chloride in adult humans is approx. 2.1 mol (75 g). KCl is essential for intracellular osmotic pressure and buffering, cell permeability , acid-base balance, muscle contraction and nerve function
Due to the low vapor pressure (5.73 hPa) and the low calculated octanol-water partition coefficient (Log POW: -0.46) of the substance, the potential for dermal absorption is low.
Based on the above considerations, it is not anticipated that potassium chloride has any sensitizing potential. This is confirmed by the lack of evidence for skin sensitization potential despite the wide dispersive use (see UNEP 2003) and no testing was proposed in the OECD HPV program.
L-alanyl-L-glutamine:
For L-alanyl-L-glutamine a guideline (OECD 406) and GLP compliant study for skin sensitizating properties has been conducted. Based on this study the substance does not have to be classified for the endpoint skin sensitization.
Overall assessment for reaction mass of L-alanyl-L-glutamine and potassium chloride:
Based on the data available for one of the main components L-alany-L-glutamine and the scientifically justified waiving for the testing on senitizing properties for potassium chlroide and considering the absence of synergistic or antagonistic properties, the substance raction mass of L-alanyl-L-glutamine and potassium chloride is considered to be not sensitizing.
Justification for classification or non-classification
For both main components of the reaction mass of L-alanyl-L-glutamine and potassium chloride either a suitable study (L-alanyl-L-glutamine) for the determination of sensitizing properties has been conducted or a sound scientifical justification for endpoint waiving (potassium chlroide) are available. For both main components and the registered reaction mass of them based on the available information no evidence for skin sensitizing properties is given.
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.