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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 259-715-3 | CAS number: 55589-62-3
- 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:
The potential of Acesulfame potassium to induce dermal sensitization was investigated in groups of four female CBA/J Rj mice treated with: 25, 10 and 5% (w/v) in DMSO. The negative control group received DMSO and the positive control group received 25 %a-Hexylcinnamaldehyde (HCA) in DMSO.
No mortality or sign of systemic toxicity or local irritation were observed during the study. No treatment body weight loss was observed during the study. Stimulation index values of the test item were 1.3, 1.4, and 1.5 at treatment concentrations of 25, 10 and 5% (w/v), respectively.
Thus, Acesulfame potassium tested for its sensitizing potential according to OECD 429 under GLP conditions was shown to have no sensitization potential in the murine Local Lymph Node Assay.
In addition, Acesulfame potassium was examined for possible antigenicity in an active systemic anaphylaxis test performed in guinea pigs. Animals sensitized with bovine serum albumin (BSA) served as positive control. Untreated guinea pigs were used as negative control. A further group of animals received Freund's adjuvant (FCA) as a reference substance. Only the guinea pigs sensitized with BSA (positive control) showed anaphylactic reactions. Acesulfame potassium showed no antigenic effect in this study.
Migrated from Short description of key information:
Acesulfame Potassium tested in dimethyl sulphoxide as vehicle, was shown to have no sensitization potential in the Local Lymph Node Assay in female CBA/J Rj mice .
According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, Acesulfame Potassium does not require classification as a skin sensitiser.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Acesulfame potassium tested for its sensitizing potential according to OECD 429 under GLP conditions was shown to have no sensitization potential in the murine Local Lymph Node Assay.
The study result triggers the following classification/labelling:
EU Directive 1999/45/EC (as amended): none
Regulation (EC) No 1272/2008 (CLP): none
GHS (rev. 4) 2011: unclassified
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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