Lack of potential carcinogenicity for acesulfame potassium - Systematic evaluation and integration of mechanistic data into the totality of the evidence.
Food Chem Toxicol
; 141: 111375, 2020 Jul.
Article
in En
| MEDLINE
| ID: mdl-32360221
ABSTRACT
The safety of low- and no-calorie sweeteners remains a topic of general interest. Substantial evidence exists demonstrating a lack of carcinogenicity of the no-calorie sweetener acesulfame potassium (Ace K). The objective of this evaluation was to conduct a systematic assessment of available mechanistic data using a framework that quantitatively integrates proposed key characteristics of carcinogens (KCCs) into the totality of the evidence. Over 800 KCC-relevant endpoints from a variety of in vitro and in vivo assays were assessed for quality, relevance, and activity, and integrated to determine the overall strength of the evidence for plausibility that Ace K acts through the KCC. Overall, there was a lack of activity across the KCCs (overall integrated score <0 and no "strong" categorization for evidence of activity) in which data were identified. Together with the absence of treatment-related tumor effects in rodent bioassays, these results support the conclusion that Ace K is unlikely to induce a carcinogenic response. This assessment employed a weight of the evidence analysis that includes the consideration of factors such as reliability, strength of the model system, activity, and dose in a complex and heterogeneous dataset, and the ultimate integration of multiple data streams in the cancer hazard evaluation.
Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Sweetening Agents
/
Thiazines
Type of study:
Prognostic_studies
/
Systematic_reviews
Limits:
Animals
/
Humans
Language:
En
Journal:
Food Chem Toxicol
Year:
2020
Document type:
Article