Table

Studies on Toxicity and Safety of Colorants Exempt from Certification

Color

Titanium dioxide

Annatto

Model

Cats

Dogs

Guinea pigs Rabbits Tissue culture, rat liver epithelial cell

Canthaxanthin Dog

Rabbit

Mice

Rat and mice

Conditions

Tissue culture, Chinese hamster ovary K-1 cells

Results

1.5 g/kg/day/390 days No effects

900 mg/kg bw/day/ 390 days 800 mg/kg/day/390 days 1.5 g/kg/day/390 days 5, 10, and 20 ^g/cm2 with and without ultraviolet (UV) exposure

20% water-soluble annatto/16 weeks followed by 10%/36 weeks in the diet and 10% in gelatin capsules 250-500 mg/kg bw/three generations, provided in water 2% fat-soluble or 2% water-soluble annatto in the diet for 13 weeks 500 mg/kg bw/day/13 or 15 wk 100, 200, or 400 mg/kg bw/day on days 7-19 of pregnancy Up to 1000 mg/kg bw/day/90 wk 1000 mg/kg bw/day/ 104 wk or 98 wk, respectively

No effects

No effects No effects

TiO2 does not exhibit cell toxicity; a slight but significant cell growth inhibition has been observed at the highest concentrations; micronucleated cells are not increased by effect of TiO2 independently of UV exposure; and, interestingly, the lowest treatments produce a reduction in the number of micronuclei; it is concluded that carcinogenic potential of TiO2 is not due to chromosomal damaging effects Sister chromatid exchange increases in dose-dependent fashion, being 1.59 higher at 5 ^ M than control; color was not cytotoxic in the range evaluated; induction of micronuclei production has been found Growth inhibition and reduced food intake

No adverse effects No abnormalities No effect

No maternal or fetal alterations

Increased blood cholesterol and microscopic changes in the liver No carcinogenic effect

TABLE 4.5 (continued)

Studies on Toxicity and Safety of Colorants Exempt from Certification

TABLE 4.5 (continued)

Studies on Toxicity and Safety of Colorants Exempt from Certification

Color

Model

Conditions

Results

Canthaxanthin

Rat

250 mg or more/kg

Increased liver enzyme activity and

(continued)

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