Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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