Assessment of the 4‐week repeated‐dose oral toxicity and genotoxicity of GHX02

Sharbat-e-Deenar (SDR) is a compound Unani pharmacopoeial formulation recommended for the treatment of Waram-e-Kabid (hepatitis), Waram-e-Rahem (uterine inflammation/ Pelvic Inflammatory Diseases), Yarqan-e-Suddi (obstructive jaundice), and Istisqa (ascites). The current study was carried out to investigate repeated dose oral toxicity study of SDR for 90 days in Sprague dawley (SD) rats. SDR was orally administered (gavage) at the doses of 4, 10 and 20 mL/kg bw/day. A periodic observation was performed for mortality, morbidity and any clinical sign of toxicity. Changes in body weight and feed consumption were observed weekly throughout study duration. After the treatment duration of three months, animals were anaesthetized and blood samples were subjected to haematological investigation and serum was subjected to different biochemical estimation. Gross necropsy was performed and internal organs/ tissues were processed for histopathological investigation. Treatment with SDR showed no incidence of mortality and no clinical sign of systemic toxicity. Body weight showed pattern of weight gain except significance decrease at mid and high dose at 13th week of study duration. Feed consumption exhibited a significant decrease as compare to control. Haematology and biochemistry profile found normal except certain isolated changes which was considered toxicologically not significant as the values lies in the normal physiological range. There were no changes observed in the gross necropsy and relative organ weight data of control and SDR treated rats. It is reported that few of the animals showed changes in liver at mid (2.5 times of therapeutic equivalent dose) and high dose (5 times of therapeutic equivalent dose) in SDR treated animals that may be attributed to SDR treatment, however, associated liver function parameters like ALT, AST and ALP did not show any alteration of liver function. Based on the results of this study, it may be indicated that liver may be the target organ for toxicity if SDR is used above recommended therapeutic dose for longer duration.

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Erratum to: Single- and repeated-dose oral toxicity tests of deep sea water mineral extracts in ICR mice

Journal of Applied Biological Chemistry ◽

10.3839/jabc.2016.064 ◽

2016 ◽

Vol 59 (4) ◽

pp. 379-379

Author(s):

Min Hee Hwang ◽

Miju Cho ◽

Dong Gun Lee ◽

Eun Byeol Go ◽

Young Sig Park ◽

...

Keyword(s):

Deep Sea ◽

Sea Water ◽

Repeated Dose ◽

Toxicity Tests ◽

Oral Toxicity ◽

Deep Sea Water ◽

Icr Mice ◽

Dose Oral

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Safety evaluation of Bifidobacterium breve MCC1274 via oral toxicity tests in rats

Toxicology Research and Application ◽

10.1177/2397847318807373 ◽

2018 ◽

Vol 2 ◽

pp. 239784731880737

Author(s):

Satoshi Arai ◽

Jun-ichi Minami ◽

Masamichi Muto ◽

Noriyuki Iwabuchi ◽

Koji Yamauchi ◽

...

Keyword(s):

Single Dose ◽

Daily Intake ◽

Clinical Signs ◽

Blood Chemistry ◽

Repeated Dose ◽

Toxicity Tests ◽

Control Group ◽

Oral Toxicity ◽

Bifidobacterium Breve ◽

Dose Oral

In this study, the safety of Bifidobacterium breve MCC1274, a probiotic bifidobacterial strain, was assessed by single-dose and 90-day repeated-dose oral toxicity studies. In the single-dose oral toxicity assay using 6000 mg/kg of B. breve MCC1274 corresponding to 8.4 × 1011 colony-forming unit (CFU)/kg, mortality and adverse effects were not observed. Furthermore, the administration of 1000 mg/kg of B. breve MCC1274 by oral gavage in saline for 90 days did not induce any signs of toxicity, such as changes in clinical signs, body weight (BW), food consumption, ophthalmoscopy, urinalysis, hematology, blood chemistry, organ weight, gross pathology, and histopathology compared to the control group given cornstarch in saline (10/sex/group). The no-observed-adverse-effect-level of B. breve MCC1274 in the 90-day repeated-dose toxicity study was greater than 1000 mg/kg corresponding to 1.3 × 1011 CFU/kg. Based on the findings of this study, the acceptable daily intake of B. breve MCC1274 was calculated to be 1.3 × 109 CFU/kg BW/day.

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