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Acute and short-term toxicity studies on orange II
Veterinary and Human Toxicology
|August 1, 1987
Summary
Orange II, a widely used food colorant, demonstrated a high oral LD50 in rats. While high doses caused splenomegaly and iron deposition, key organs and reproductive functions remained unaffected in short-term studies.
Area of Science:
- Food toxicology
- Chemical safety assessment
- Animal studies
Background:
- Orange II is frequently used as a food colorant despite not being officially approved.
- Understanding the toxicological profile of Orange II is crucial for public health and regulatory bodies.
Purpose of the Study:
- To evaluate the toxicological effects of Orange II in a rodent model.
- To assess the impact of Orange II on hematology, organ function, and reproductive parameters.
Main Methods:
- Oral LD50 determination in male and female rats.
- 90-day subchronic toxicity study with varying dietary concentrations of Orange II (0.1%, 0.5%, 3.0%).
- Comprehensive analysis including hematological tests, serum biochemistry, liver function tests, and histopathological examination of multiple organs.
Main Results:
- Oral LD50 was greater than 10.56 g/kg body weight.
- Slight decreases in erythrocyte count and hemoglobin were observed at the highest dose, but other hematological parameters remained normal.
- No significant changes in liver function, serum biochemistry, or histopathology of major organs were noted, except for splenomegaly and iron pigment deposition in the spleen at 3.0% Orange II.
- Reproductive parameters, including testicular function and androgenic status, were unaffected.
Conclusions:
- Orange II exhibits low acute oral toxicity.
- While high doses may induce splenomegaly and iron accumulation, short-term exposure does not appear to cause significant systemic toxicity or affect reproductive health in rats.