Oral Toxicity Profile of a Novel Silk Lutein Extract and Assessment of Its Cardiovascular Benefits in Rodents

Silk Lutein (SL), a novel protein-bound lutein complex derived from <i>Bombyx mori</i> cocoons, offers an intriguing alternative to traditional sources. This study aimed to establish the complete toxicological profile of SL. Evaluations of the acute oral toxicity of SL (LD₅₀ > 2000 mg/kg body weight (BW)) were conducted in female Wistar rats and ICR mice. In the chronic toxicity trial, male and female Wistar rats were administered daily oral dosages of SL (5, 25, 50 mg/kg BW) for a duration of six months. The results indicated a robust safety profile for SL, with no treatment-related adverse effects detected. Apart from demonstrating its foundational safety, this study found that prolonged SL administration possessed significant, beneficial bioactive properties. Following four months of treatment, both male and female Wistar rats administered SL exhibited a significant hypotensive effect, maintaining their systolic blood pressure at approximately 120 mmHg and thereby averting the age-related hypertension observed in control subjects. Additionally, SL significantly reduced serum triglyceride levels in both sexes. The findings of this study confirm SL's potential as a multipurpose nutraceutical by demonstrating that it is a safe constituent with a favorable toxicological profile and notable cardiovascular effects.