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A one year feeding study with carmoisine in rats
Toxicology
|June 1, 1978
Summary
Carmoisine dye (C.I. 14720) did not cause adverse effects in rats over 52 weeks. The maximum no-effect level was determined to be 0.8% dietary intake, approximately 400 mg/kg daily.
Area of Science:
- Toxicology
- Food Science
- Animal Studies
Background:
- Carmoisine (C.I. 14720) is a synthetic azo dye commonly used in food products.
- Assessing the long-term safety of food additives is crucial for public health.
Purpose of the Study:
- To evaluate the chronic toxicity of carmoisine dye in a rat model.
- To determine the maximum no-effect level (NOEL) of carmoisine after prolonged dietary exposure.
Main Methods:
- Rats were fed diets containing carmoisine at concentrations of 0.35%, 0.8%, or 2.0% for 52 weeks.
- Comprehensive monitoring included mortality, weight gain, hematology, organ weights, and histopathology.
- Control groups received a standard diet without carmoisine.
Main Results:
- No significant adverse effects were observed in rats fed up to 0.8% carmoisine compared to controls.
- Mortality, weight gain, hematological parameters, and relative organ weights remained comparable across groups.
- Male rats at 2.0% carmoisine showed increased incidence of mild subclinical conditions like bronchitis and tracheal inflammation.
Conclusions:
- The maximum no-effect level (NOEL) for carmoisine in rats after 52 weeks of exposure is 0.8% in the diet.
- This corresponds to an estimated daily intake of approximately 400 mg/kg body weight.
- Carmoisine appears safe at levels below 0.8% in the diet for long-term consumption in rats.