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Acute toxicity of subcutaneously administered vitamin E isomers delta- and gamma-tocotrienol in mice
Sibyl N Swift1, Roli L Pessu1, Kushal Chakraborty1
1Armed Forces Radiobiology Research Institute (AFRRI), Uniformed Services University of the Health Sciences, Bethesda, MD, USA.
Abstract:
The toxicity of parenterally administered vitamin E isomers, delta-tocotrienol (DT3) and gamma-tocotrienol (GT3), was evaluated in male and female CD2F1 mice. In an acute toxicity study, a single dose of DT3 or GT3 was administered subcutaneously in a dose range of 200 to 800 mg/kg. A mild to moderately severe dermatitis was observed clinically and microscopically in animals at the injection site at doses above 200 mg/kg. The severity of the reaction was reduced when the drug concentration was lowered. Neither drug produced detectable toxic effects in any other tissue at the doses tested. Based on histopathological analysis for both DT3 and GT3, and macroscopic observations of inflammation at the injection site, a dose of 300 mg/kg was selected as the lowest toxic dose in a 30-day toxicity study performed in male mice. At this dose, a mild skin irritation occurred at the injection site that recovered completely by the end of the experimental period. At a dose of 300 mg/kg of DT3 or GT3, no adverse effects were observed in any tissues or organs.
Insights
Parenterally administered vitamin E isomers, delta-tocotrienol (DT3) and gamma-tocotrienol (GT3), showed mild injection site dermatitis in mice at doses above 200 mg/kg. No other toxic effects were observed, indicating a good safety profile for these vitamin E compounds.
Area of Science:
- Biomedical Sciences
- Toxicology
- Pharmacology
Background:
- Vitamin E isomers, delta-tocotrienol (DT3) and gamma-tocotrienol (GT3), are being investigated for potential therapeutic applications.
- Parenteral administration routes require thorough toxicity assessments.
Purpose of the Study:
- To evaluate the toxicity of parenterally administered DT3 and GT3 in CD2F1 mice.
- To determine the lowest toxic dose (LTD) and identify potential target organs for toxicity.
Main Methods:
- Acute toxicity study with single subcutaneous injections of DT3 and GT3 (200-800 mg/kg).
- 30-day toxicity study in male mice at the determined LTD (300 mg/kg).
- Clinical, macroscopic, and histopathological evaluations of tissues and injection sites.
Main Results:
- Mild to moderately severe dermatitis observed at injection sites for doses >200 mg/kg.
- Dermatitis severity decreased with lower drug concentrations.
- No detectable toxic effects in other tissues at tested doses.
- 300 mg/kg was identified as the LTD, causing transient mild skin irritation that resolved completely.
- No adverse effects in any tissues or organs at 300 mg/kg in the 30-day study.
Conclusions:
- Parenteral administration of DT3 and GT3 at doses up to 300 mg/kg is well-tolerated in mice.
- Local skin irritation is the primary toxicity concern at higher doses.
- DT3 and GT3 exhibit a favorable safety profile for parenteral use at the studied concentrations.
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