Subchronic toxicity study of Caramel Colour II in F344 rats

Area of Science:

• Food Science
• Toxicology
• Animal Studies

Background:

• Caramel Colour II is a sulfite-based colorant with a reddish hue, used in foods and beverages.
• It offers functional properties like high alcohol solubility, beneficial for natural flavorings.
• Despite its uses, it constitutes a small fraction of total caramel color production.

Purpose of the Study:

• To evaluate the toxicity of Caramel Colour II in Fischer-344 (F344) rats.
• To determine the no-observed-adverse-effect level (NOAEL) for Caramel Colour II.

Main Methods:

• Fischer-344 rats (20/sex/group) were administered Caramel Colour II in drinking fluid at doses of 0, 4, 8, 12, or 16 g/kg for 13 weeks.
• Food consumption, body weight, fluid intake, hematology, blood chemistry, and pathology were monitored.
• Dose levels were adjusted to achieve target daily intake per kilogram of body weight.

Main Results:

• No deaths occurred in any treatment group.
• Soft feces and reduced fluid consumption were observed, attributed to palatability issues.
• Minor changes in body weight and urine parameters were linked to reduced water intake, not toxicity.
• No significant treatment-related alterations in hematology, blood chemistry, or pathology were found.

Conclusions:

• Caramel Colour II was not toxic in F344 rats following 13 weeks of administration.
• The highest dose tested (16 g/kg) was identified as the no-observed-adverse-effect level (NOAEL).
• The observed effects were not considered toxicologically significant.