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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
In rats, the oral LD50 values and 95% confidence limits were 5438 (4839-5994) mg/kg bw for males and 5565 (5083-6071) mg/kg bw for females, while the dermal LD50 value was >2000 mg/kg bw.
In mice, the oral LD50 values and 95% confidence limits were 5438 (4839-5994) mg/kg bw for males and 5565 (5083-6071) mg/kg bw for females.
No standard study on acute toxicity after inhalation is available. However, no inhalation toxicity of thermal degradation products tested at 250 °C was noted.
Key value for chemical safety assessment
Acute toxicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 534 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- mg/kg bw
Additional information
The oral acute toxicity of Acesulfame potassium was examined in rats (10 males and10 females/group).The oral LD50 values and 95% confidence limits were 5438 (4839 -5994) mg/kg bw for males and 5565 (5083 -6071) mg/kg bw for females. Major symptoms observed were a decrease in spontaneous movement, crawling, convulsions and diarrhea. The suppression of body weight gains was trendently observed at 4167 and 5000 mg/kg bw males, and at 5000 mg/kg bw females. There was no difference in body weight between the treated groups and control group at the end of observation period. The autopsy of dead animals revealed hemorrhage in the gastric mucosa, hyperemia in the small intestine and cecum, congestion in the lung, and petechial hemorrhage in the thymus. The autopsy of surviving animals exhibited no macroscopic abnormalities in any organs in either sex.
The oral acute toxicity of Acesulfame potassium was examined in mice (10 males and10 females/group).The oral LD50 values and 95% confidence limits were 6974 (6188 - 8369) mg/kg bw for males and 6713 (6103 - 7521) mg/kg bw for females. Major symptoms observed were a decrease in spontaneous movement, crawling, convulsions and sedation.
The autopsy of dead animals revealed hemorrhage in the gastric mucosa, hyperemia in the small intestine and cecum, congestion in the lung, and petechial hemorrhage in the thymus. The autopsy of surviving animals exhibited no macroscopic abnormalities in any organs in either sex.
Acesulfame potassium was investigated at a temperature of 250°C in a study of the inhalation toxicity of thermal degradation products. All test animals survived. Symptoms of intoxication were disturbance of respiration, of autonome reactionsand of body position. The investigation of CO hemoglobin did not show increased CO-Hb values immediately after exposure. Pathological examination of the animals killed immediately after the study did not show any abnormal signs.
The acute dermal toxicity study was performed with Acesulfame potassiumin Wistar rats (CRL:(WI)) in compliance with OECD Guideline No. 402,Commission Regulation (EC) No 440/2008, B.3 and OPPTS 870.1200. A limit test was carried out at 2000 mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was applied as a single dermal 24 -hour exposure followed by a 14‑day observation period. Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. Gross macroscopic examination was performed on all animals at the end of the 2-week observation period (Day 14). The test item did not cause any mortality at the dose level of 2000 mg/kg bw. No clinical signs were observed during the treatment with the test item or thereafter within the 14 day observation period. No dermal signs were observed after treatment with the test item. There were no effects on body weight or body weight gain in any animal during the study. There was no evidence of any observations at the dose level of 2000 mg/kg bw at necropsy. The median lethal dose of Acesulfame potassium after a single dermal administration was found to be greater than 2000 mg/kg bw in male and female CRL:(WI) rats.
Justification for classification or non-classification
Acesulfame potassium was non-toxic after acute oral and dermal administration.
The study results 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.
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.