title: Evaluation of 90 day repeated dose oral toxicity and reproductive/developmental toxicity of 3'-hydroxypterostilbene in experimental animals.
abstract: 3'-Hydroxypterostilbene (3'-HPT) is one of the active constituents of Sphaerophysa salsula and Pterocarpus marsupium. Despite many proposed therapeutic applications, the safety profile of 3'-HPT has not been established. The present work investigated 90 day repeated oral dose and reproductive (developmental) toxicity of 3'-HPT as a test substance in rats as per OECD guidelines. 90 day toxicity was conducted in sixty Sprague Dawley rats of each sex (120 rats), grouped into six dosage groups of 0 (control), 0 (control recovery), 20 (low dose), 80 (mid dose), 200 (high dose) and 200 (high dose recovery) mg/kg bwt/day (body weight/day) respectively. For the reproductive toxicity study forty Wistar rats of each sex (80 rats) divided into four dosage groups received 0 (vehicle control), 20 (low dose), 100 (mid dose) and 200 (high dose) mg/kg bwt/day of 3'-HPT respectively for a period of two weeks while pre-mating, mating, on the day before sacrifice, in females during pregnancy and four days of lactation period. Results showed no significant differences in body weight, food intake, absolute organ weight, haematology, with no adverse effects (toxicity) on biochemical values nor any abnormal clinical signs or behavioural changes were observed in any of the control/treatment groups, including reproductive and developmental parameters, gross and histopathological changes. In conclusion, the results suggested a No-Observed-Adverse-Effect-Level (NOAEL) of 200 mg/kg bwt/day in rats after oral administration, implying 3'-HPT did not exhibit any toxicity under the study conditions employed.
authors.affiliation: Sami Labs Limited, Bangalore, Karnataka, India.
authors.forename: Muhammed
authors.initials: M
authors.lastname: Majeed
authors.affiliation: Biological Research Department, Sami Labs Limited, Bangalore, Karnataka, India.
authors.forename: Sarang
authors.initials: S
authors.lastname: Bani
authors.affiliation: Research and Development Center, Sami Labs Limited, Bangalore, Karnataka, India.
authors.forename: Sankaran
authors.initials: S
authors.lastname: Natarajan
authors.affiliation: Biological Research Department, Sami Labs Limited, Bangalore, Karnataka, India.
authors.forename: Anjali
authors.initials: A
authors.lastname: Pandey
authors.affiliation: ClinWorld, ClinWorld Private Limited, Bangalore, Karnataka, India.
authors.forename: Naveed
authors.initials: N
authors.lastname: S
mesh_terms: D000284:Administration, Oral; D000818:Animals; D001835:Body Weight; D004305:Dose-Response Relationship, Drug; D004435:Eating / Q000187:drug effects; D005260:Female; D006801:Humans; D007774:Lactation / Q000187:drug effects* / Q000502:physiology; D010936:Plant Extracts / Q000008:administration & dosage / Q000009:adverse effects* / Q000737:chemistry; D011247:Pregnancy; D035721:Pterocarpus / Q000737:chemistry; D051381:Rats; D012098:Reproduction / Q000187:drug effects* / Q000502:physiology; D013267:Stilbenes / Q000008:administration & dosage / Q000009:adverse effects*
chemical_list: C505072:3'-hydroxypterostilbene; D010936:Plant Extracts; D013267:Stilbenes