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01.12.2018 | Research article | Ausgabe 1/2018 Open Access

BMC Complementary and Alternative Medicine 1/2018

Assessment of acute, 14-day, and 13-week repeated oral dose toxicity of Tiglium seed extract in rats

Zeitschrift:
BMC Complementary and Alternative Medicine > Ausgabe 1/2018
Autoren:
Jun-Won Yun, Euna Kwon, Yun-Soon Kim, Seung-Hyun Kim, Ji-Ran You, Hyoung-Chin Kim, Jin-Sung Park, Jeong-Hwan Che, Sang-Koo Lee, Ja-June Jang, Hyeon Hoe Kim, Byeong-Cheol Kang
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1186/​s12906-018-2315-5) contains supplementary material, which is available to authorized users.
Jun-Won Yun and Euna Kwon contributed equally to this work.

Abstract

Background

Seed of mature Croton tiglium Linne, also known as Tiglium seed (TS), has been widely used as a natural product due to its several health beneficial properties including anti-tumor and antifungal activities. Despite its ethnomedicinal beneficial properties, toxicological information regarding TS extract, especially its long-term toxicity, is currently limited. Therefore, the objective of the present study was to evaluate acute and subchronic toxicity of TS extract in rats after oral administration following test guidelines of the Organization for Economic Cooperation and Development (OECD).

Methods

Toxicological properties of TS extract were evaluated by toxicity assays to determine its single-dose acute toxicity (125, 250, 500, 1000, or 2000 mg/kg), 14-day repeated-dose toxicity (125, 250, 500, 1000, or 2000 mg/kg) and 13-week repeated-dose toxicity (31.25, 62.5, 125, 250, and 500 mg/kg) in Sprague-Dawley rats and F344 rats. Hematological, serum biochemical, and histopathological parameters were analyzed to determine its median lethal dose (LD50) and no-observed-adverse-effect-level (NOAEL).

Results

Oral single dose up to 2000 mg/kg of TS extract resulted in no mortalities or abnormal clinical signs. In 13-week toxicity study, TS extract exhibited no dose-related changes (mortality, body weight, food/water consumption, hematology, clinical biochemistry, organ weight, or histopathology) at dose up to 500 mg/kg, the highest dosage level suggested based on 14-day repeat-dose oral toxicity study.

Conclusion

Acute oral LD50 of TS extract in rats was estimated to be greater than 2000 mg/kg. NOAEL of TS extract administered orally was determined to be 500 mg/kg/day in both male and female rats. Results from these acute and subchronic toxicity assessments of TS extract under Good Laboratory Practice regulations indicate that TS extract appears to be safe for human consumption.
Zusatzmaterial
Additional file 1: Survival of male and female F344 rats orally administered with Tiglium seed extract for 14 days. (TIF 630 kb)
12906_2018_2315_MOESM1_ESM.tif
Additional file 2: Summary incidence of gross findings of F344 rats orally administered with Tiglium seed extract for 14 days. (DOCX 17 kb)
12906_2018_2315_MOESM2_ESM.docx
Additional file 3: Organ weights of male and female F344 rats orally administered with Tiglium seed extract for 14 days. (DOCX 30 kb)
12906_2018_2315_MOESM3_ESM.docx
Additional file 4: Effects of Tiglium seed extract on the daily food intake and water consumption after oral administration in male and female rats for 13 weeks. (TIF 806 kb)
12906_2018_2315_MOESM4_ESM.tif
Additional file 5: Summary incidence of gross findings of F344 rats orally administered with Tiglium seed extract for 13 weeks. (DOCX 18 kb)
12906_2018_2315_MOESM5_ESM.docx
Literatur
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