PMID- 23803717 OWN - NLM STAT- MEDLINE DCOM- 20140210 LR - 20240404 IS - 1420-3049 (Electronic) IS - 1420-3049 (Linking) VI - 18 IP - 7 DP - 2013 Jun 26 TI - Study on the potential toxicity of a thymoquinone-rich fraction nanoemulsion in Sprague Dawley rats. PG - 7460-72 LID - 10.3390/molecules18077460 [doi] AB - Toxicological studies constitute an essential part of the effort in developing an herbal medicine into a drug product. A newly developed thymoquinone-rich fraction nanoemulsion (TQRFNE) has been prepared using a high pressure homogenizer. The purpose of this study was to investigate the potential acute toxicity of this nanoemulsion in Sprague Dawley rats. The acute toxicity studies were conducted as per the OECD guidelines 425, allowing for the use of test dose limit of 20 mL TQRFNE (containing 44.5 mg TQ)/kg. TQRFNE and distilled water (DW) as a control were administered orally to both sexes of rats on Day 0 and observed for 14 days. All the animals appeared normal, and healthy throughout the study. There was no observed mortality or any signs of toxicity during the experimental period. The effects of the TQRFNE and DW groups on general behavior, body weight, food and water consumption, relative organ weight, hematology, histopathology, and clinical biochemistry were measured. All the parameters measured were unaffected as compared to the control (DW) group. The administration of 20 mL TQRFNE /kg was not toxic after an acute exposure. FAU - Tubesha, Zaki AU - Tubesha Z AD - Laboratory of Molecular Biomedicine, Institute of Bioscience, Universiti Putra Malaysia, 43400 Serdang, Selangor Darul Ehsan, Malaysia. FAU - Imam, Mustapha Umar AU - Imam MU FAU - Mahmud, Rozi AU - Mahmud R FAU - Ismail, Maznah AU - Ismail M LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20130626 PL - Switzerland TA - Molecules JT - Molecules (Basel, Switzerland) JID - 100964009 RN - 0 (Benzoquinones) RN - 0 (Emulsions) RN - 0 (Plant Preparations) RN - O60IE26NUF (thymoquinone) SB - IM MH - Administration, Oral MH - Animals MH - Benzoquinones/*adverse effects/chemistry/*pharmacology MH - Body Weight/drug effects MH - Dose-Response Relationship, Drug MH - Drug Discovery MH - Drug Evaluation, Preclinical MH - Emulsions/adverse effects/chemistry/pharmacology MH - Female MH - Male MH - Nigella sativa/*metabolism MH - Organ Size/drug effects MH - Plant Preparations/adverse effects/chemistry/pharmacology MH - Rats MH - Rats, Sprague-Dawley PMC - PMC6270347 EDAT- 2013/06/28 06:00 MHDA- 2014/02/11 06:00 PMCR- 2013/06/26 CRDT- 2013/06/28 06:00 PHST- 2013/05/27 00:00 [received] PHST- 2013/06/18 00:00 [revised] PHST- 2013/06/19 00:00 [accepted] PHST- 2013/06/28 06:00 [entrez] PHST- 2013/06/28 06:00 [pubmed] PHST- 2014/02/11 06:00 [medline] PHST- 2013/06/26 00:00 [pmc-release] AID - molecules18077460 [pii] AID - molecules-18-07460 [pii] AID - 10.3390/molecules18077460 [doi] PST - epublish SO - Molecules. 2013 Jun 26;18(7):7460-72. doi: 10.3390/molecules18077460.