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Multigeneration reproduction studies with carmoisine in rats
Toxicology
|June 1, 1978
Summary
Carmoisine, a food dye, showed no adverse effects on rat reproduction across multiple generations. The maximum no-effect level was determined to be 2% in the diet, with potential for an even higher safe level.
Area of Science:
- Toxicology
- Food Science
- Reproductive Biology
Background:
- Carmoisine (C.I. No. 14720) is a synthetic azo dye widely used in food products.
- Assessing the safety of food additives is crucial for public health and regulatory approval.
Purpose of the Study:
- To evaluate the reproductive toxicity of Carmoisine in rats through a multigeneration study.
- To determine the no-observed-adverse-effect level (NOAEL) of Carmoisine in the diet.
Main Methods:
- A multigeneration reproduction study was conducted with rats fed diets containing 0, 0.35, 0.8, and 2.0% Carmoisine.
- A nine-week feeding study with dietary Carmoisine levels of 0, 2, 4, 6, and 8% was also performed.
Main Results:
- Carmoisine did not cause any adverse effects on the reproductive capacity of any generation studied.
- Fertility, lactation, and viability indices remained statistically similar to control groups across all tested Carmoisine concentrations.
- Rats tolerated up to 4% dietary Carmoisine in a shorter-term study without overt toxicity, suggesting a high NOAEL.
Conclusions:
- The maximum no-effect level for Carmoisine in the diet of rats is at least 2% based on multigeneration studies.
- Further studies suggest the safe dietary level of Carmoisine may exceed 4%, indicating a favorable safety profile for reproductive parameters.

