Selection of appropriate parameters, use of a quality control concept, and suitable statistical analyses for clinical pathology examination of animals in toxicity studies: Results of a current survey by the Japanese pharmaceutical manufacturers association

Matsuzawa, Toshiaki; Nomura, Mamoru; Yonezawa, Hiroe; Unno, Takashi

doi:10.1007/bf00368044

Cited by 12 publications

(8 citation statements)

References 5 publications

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“…Similarly, the serum electrolyte levels were found to be well within the clinical range of rats which reflects that NK has no adverse effect on ionic homeostasis. Histopathological studies provide supportive evidence for biochemical and haematological observations [24]. The relative organ weights were found to be non-significant between the control and NK treated rats.…”

Section: Discussionmentioning

confidence: 64%

Acute toxicity and the 28-day repeated dose study of a Siddha medicine Nuna Kadugu in rats

Ramaswamy

Prathyusha

Saranya

et al. 2012

BMC Complement Altern Med

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BackgroundNuna Kadugu (NK), a Siddha medicine prepared from leaves and fruits of Morinda Pubescens, used for the treatment of various skin diseases. Though NK has been widely used for several decades, no scientific report was available on its safety. Present study was undertaken to demonstrate the oral toxicity of NK in Sprague Dawley rats.MethodsAcute and 28-day repeated oral toxicity studies were performed following OECD test guidelines 423 and 407, respectively, with minor modifications. In acute oral toxicity study, NK was administered at 2000mg/kg b.wt., p.o and animals were observed for toxic signs at 0, 0.5, 1, 4, 24 h and for next 14 days. Gross pathology was performed at the end of the study. In repeated dose, the 28- day oral toxicity study, NK was administered at 300, 600 and 900 mg/kg b.wt./p.o/day. Two satellite groups (control and high dose) were also maintained to determine the delayed onset toxicity of NK. Animals were observed for mortality, morbidity, body weight changes, feed and water intake. Haematology, clinical biochemistry, electrolytes, gross pathology, relative organ weight and histopathological examination were performed.ResultsIn acute toxicity study, no treatment related death or toxic signs were observed with NK administration. In the repeated dose study, no significant differences in body weight changes, food / water intake, haematology, clinical biochemistry and electrolytes content were observed between control and NK groups. No gross pathological findings and difference in relative organ weights were observed between control and NK treated rats. Histopathological examination revealed no abnormalities with NK treatment.ConclusionAcute study reveals that the LD50 of NK is greater than 2000mg/kg, b.wt. in fasted female rats and can be classified as Category 5. 28-day repeated oral toxicity demonstrates that the No Observed Adverse Effect Level of NK is greater than 900 mg/kg b.wt./day, p.o in rats. There were no delayed effects in NK satellite group. In conclusion, NK was found to be non-toxic in the tested doses and experimental conditions.

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Section: Discussionmentioning

confidence: 64%

Acute toxicity and the 28-day repeated dose study of a Siddha medicine Nuna Kadugu in rats

Ramaswamy

Prathyusha

Saranya

et al. 2012

BMC Complement Altern Med

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“…These changes could be regarded as tissue morphology (detected by histopathological evaluation) and/or alterations in a series of in vivo analyzed parameters. Dose-related changes were also of crucial importance [29]. Among these parameters, clinical chemistry and hematology data were of great importance for determining effects induced by treatment.…”

Section: Hematology and Clinical Chemistry Of Ccam In Vivomentioning

confidence: 99%

Biocompatibility and characteristics of chitosan/cellulose acetate microspheres for drug delivery

et al. 2011

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In this work, chitosan/cellulose acetate microspheres (CCAM) were prepared by the method of W/O/W emulsion with no toxic reagents. The microspheres were spherical, free flowing, and non-aggregated, which had a narrow size distribution. More than 90% of the microspheres had the diameter ranging from 200 to 280 µm. The hemolytic analysis indicated that CCAM was safe and had no hemolytic effect. The implanted CCAM did not produce any significant changes in the hematology of SpragueDawley (SD) rats, such as white blood cell, red blood cell, platelet, and the volume of hemoglobin. In addition, the levels of serum alanine aminotransferase, blood urea nitrogen, and creatinine had no obvious changes in SD rats implanted with CCAM, surger thread, or normal SD rats without any implantation. Thus, the CCAM had good blood compatibility and had no hepatotoxicity or renal toxicity to SD rats. Furthermore, CCAM with or without the model drug had good tissue compatibility with respect to the inflammatory reaction in SD rats and showed no significant difference from that of SD rats implanted with surgery thread. CCAM shows promise as a long-acting delivery system, which had good biocompatibility and biodegradability.

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“…Experimental animal modelling is used to evaluate the safety of test components; any abnormal treatment‐related values represent changes relevant to its pharmacological or toxicological effects thus must be documented through serum biochemical evaluation (Matsuzawa et al. , 1995).…”

Section: Introductionmentioning

confidence: 99%

Biological quality and safety assessment of rice bran protein isolates

Khan¹,

Butt

Sharif

2011

International Journal of Food Science &Amp; Technology

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Three stabilisation techniques, microwave, dry heat and parboiling were applied to bran followed by enzymatic extraction, biological quality through growth and nitrogen balance study and safety assessment through 45 days feeding trial. Traits linked with protein bio-evaluation were affected significantly by the test diets (P < 0.05), growth study parameters during the experimental remained as; PER from 1.97 to 2.18 with higher value for microwave stabilised protein isolates, net protein ratio of 4.43-5.14. Nitrogen balance study parameters too were better in microwave and dry heat stabilised protein isolates, while the lowest values were observed for parboiled protein isolates; true digestibility was within the range of 76.0-86.11% and biological value of extracted isolates was within the upper and lower limit of 78.57-88.23. No general ill effects were observed during the safety evaluation trial as the serum biochemical profile and organ to body weight ratio exhibited normal metabolic activity. Findings of current study are supportive for the suggestion that these extracted isolates can be safely used for variety of foods especially the designed formulations for protein deficient vulnerable groups especially from low socio-economic countries.

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Selection of appropriate parameters, use of a quality control concept, and suitable statistical analyses for clinical pathology examination of animals in toxicity studies: Results of a current survey by the Japanese pharmaceutical manufacturers association

Cited by 12 publications

References 5 publications

Acute toxicity and the 28-day repeated dose study of a Siddha medicine Nuna Kadugu in rats

Acute toxicity and the 28-day repeated dose study of a Siddha medicine Nuna Kadugu in rats

Biocompatibility and characteristics of chitosan/cellulose acetate microspheres for drug delivery

Biological quality and safety assessment of rice bran protein isolates

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