Reference Data of the Main Physiological Parameters in Control Sprague-Dawley Rats from Pre-clinical Toxicity Studies

Han, Zhong; Xu, Hao; Kim, Kwang Ho; Ahn, Tae Hwan; Bae, Jin Sook; Lee, Ji Young; Lee, Joo Young; Woo, Su Jung; Yoo, Hyun Jung; Lee, Hyun Kul; Kim, Kap Ho; Park, Chan Koo; Zhang, Hu Song; Song, Si Whan

doi:10.5625/lar.2010.26.2.153

Cited by 91 publications

(56 citation statements)

References 23 publications

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“…In addition, the dose-response in the other groups was slight and no increases in ALP were noted in females. All of the mean serum ALP values in the control and treated groups of both sexes were within the historical reference ranges (Han et al, 2010). Also, there were no other concomitant changes that could be suggestive of hepatocellular (i.e., AST and ALT) or hepatobiliary (i.e., bilirubin) toxicity (Davies, 1992).…”

Section: Parametermentioning

confidence: 73%

“…The slight decreases in WBC count and percent neutrophils in males administered squid oil, while not statistically significant relative to control values, showed a dose-response and consequently cannot be readily dismissed as unrelated to treatment. However, the findings are considered of no biological significance, given the minor magnitude of the change (not attaining statistical significance), with the values in the treated groups all within historical reference ranges for rats of this age and strain at this facility (Han et al, 2010). This conclusion is further supported by the lack of such findings in females, the absence of changes in WBC differential counts, and the lack of histopathological changes in organs associated with WBC formation and function.…”

Section: Parametermentioning

confidence: 82%

“…It is possible that the slight, non significant decreases in the absolute and/or relative weights of the thymus and spleen in the male groups may be related to the decrease in WBC. Again, however, these findings were ascribed as having no toxicological significance, given the minor character of the effects, consistency with reference ranges of all groups (Han et al, 2010), lack of occurrence in females, and lack of histopathological findings in these or any other organs indicative of a functional impairment of the immune system.…”

Section: Parametermentioning

confidence: 87%

“…Dose of squid oil (ll/kg bw/day) Control (0) (n = 10) 250 (n = 10) 500 (n = 10) 1000 (n = 10) historical reference values available for the testing facility (Han et al, 2010). No significant differences in the measures of plasma clotting were observed in either male or female rats administered squid oil as compared to the male and female rats administered corn oil.…”

Section: Parametermentioning

confidence: 99%

“…All values represent the mean ± SD. a Han et al (2010). ⁄ Represents a significant difference at p < 0.05 relative to the control group.…”

Section: Parametermentioning

confidence: 99%

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13-Week oral toxicity study of oil derived from squid (Todarodes pacificus) in Sprague-Dawley rats

Park

Musa-Veloso

Lynch

et al. 2012

Regulatory Toxicology and Pharmacology

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Section: Parametermentioning

confidence: 73%

Section: Parametermentioning

confidence: 82%

Section: Parametermentioning

confidence: 87%

Section: Parametermentioning

confidence: 99%

“…All values represent the mean ± SD. a Han et al (2010). ⁄ Represents a significant difference at p < 0.05 relative to the control group.…”

Section: Parametermentioning

confidence: 99%

See 3 more Smart Citations

13-Week oral toxicity study of oil derived from squid (Todarodes pacificus) in Sprague-Dawley rats

Park

Musa-Veloso

Lynch

et al. 2012

Regulatory Toxicology and Pharmacology

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Evaluation of the acute toxicity and 28‐days subacute toxicity of the alcoholic extract from Ganoderma leucocontextum

Deng

AGA

Xie

et al. 2022

Food Science & Nutrition

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Ganoderma leucocontextum is a well‐known traditional medicine in Tibet Autonomous Region, which has benefits, such as anti‐hypoxia, neurotrophic action on nerves, easing coughs and relieving asthma, strengthening the body and prolonging life. However, few research have focused on its negative effects, possibly jeopardizing its safety. The purpose of this study is to evaluate the acute and subacute toxicity of an alcoholic extract from G. leucocontextum (GLA) in vivo. The phytochemical characterization analysis showed that alcoholic extract from G. leucocontextum were rich in polysaccharides, triterpenoids. Then, in acute oral toxicity, male and female mice from Institute of Cancer Research (ICR) were orally administered with 16 g/kg GLA and were observed for 14 days. In the subacute toxicity, male and female Sprague–Dawley (SD) rats were orally administered with 2, 4, and 8 g/kg doses of GLA for 28 days. There was no death or clinical changes in male and female mice in the acute toxicity test. During the subacute toxicity test, the difference in body weights, food consumption, biochemical and hematological parameters, and organ coefficients between treated and control groups were unrelated to GLA treatment. The obtained data show that the GLA had no significant toxic effects when administered orally to male and female rats in acute and subacute toxicity.

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

Kim

Oh³

et al. 2019

J of Applied Toxicology

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Herbal medicines are widely utilized for disease prevention and health promotion. GHX02 consists of mixtures including Gwaruin (Trichosanthes kirilowii), Haengin (Prunus armeniaca), Hwangryeon (Coptis japonica) and Hwangkeum (Scutellaria baicalensis). It has been purported to have therapeutic effectiveness in cases of severe bronchitis. Non‐clinical safety testing comprised a single‐dose oral toxicity study and a 28‐day repeated‐dose oral toxicity study with a 14‐day recovery period, and genotoxicity was assessed by a bacterial reverse mutation test, in vitro chromosomal aberration test, in vivo mouse bone marrow micronucleus test and single cell gel electrophoresis assay (comet assay). In the single‐dose oral toxicity study, the approximate lethal dosage is estimated to be higher than 5000 mg/kg in rats. Thus, the dosage levels were set at 0, 1250, 2500 and 5000 mg/kg/day in the 28‐day repeated‐dose oral toxicity study, and 10 male rats and 10 female rats/dose were administered GHX02. No clinical signs of toxicological significance were recorded in any animal during the dosing and the observation period in the single‐dose study. The no‐observed‐adverse‐effect level of GHX02 was 5000 mg/kg/day when administered orally for 28 days to male and female Sprague‐Dawley rats. Despite increases in the frequencies of cells with numerical chromosomal aberration in the in vitro test, the increases were not considered relevant to the in vivo genetic risk. Except for the increase of in vitro numerical chromosomal aberration, clear negative results were obtained from other genetic toxicity studies.

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Reference Data of the Main Physiological Parameters in Control Sprague-Dawley Rats from Pre-clinical Toxicity Studies

Cited by 91 publications

References 23 publications

13-Week oral toxicity study of oil derived from squid (Todarodes pacificus) in Sprague-Dawley rats

13-Week oral toxicity study of oil derived from squid (Todarodes pacificus) in Sprague-Dawley rats

Evaluation of the acute toxicity and 28‐days subacute toxicity of the alcoholic extract from Ganoderma leucocontextum

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

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