21-Day dermal exposure to aircraft engine oils: effects on esterase activities in brain and liver tissues, blood, plasma, and clinical chemistry parameters for Sprague Dawley rats

Mulberry extract from Fructus Mori contains an anthocyanin pigment and has been widely used as a food additive in China and other Eastern Asian countries. Only few research has been done on toxicological profiling of mulberry extract for its safety evaluation; however, the data is inconclusive. In the current study, mulberry extract of 4200, 1400, or 466 mg/kg were orally administrated to Sprague Dawley rats for 90 consecutive days followed by a recovery period of 28 days. No abnormalities were detected in body weights, food intake, ophthalmological, hematological, coagulation, clinical chemistry, and organ weights parameters. Discoloration of urine (red, purple, and brown) and feces (black), along with bedding material (purple) were observed in the 4200 mg/kg group. Further, microscopic examination revealed brown granules in the renal tubular cells for rats in 4200 and 1400 mg/kg groups. Since these changes were associated with excretory effect of the extract, the No Observed Adverse Effect Level was determined to be 4200 mg/kg, which was equivalent to the 1058.5 mg/kg of anthocyanin.

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Repeated-Dose and Subchronic Toxicity Studies of 2,2,2-Trichloroethanol in Sprague-Dawley Rats

Journal of the American College of Toxicology ◽

10.3109/10915819109078632 ◽

1991 ◽

Vol 10 (2) ◽

pp. 223-232

Author(s):

J. Peter Bercz ◽

Merrel Robinson ◽

Lucille M. Garner ◽

Norbert P. Page ◽

Greg R. Olson

Keyword(s):

Toxic Effect ◽

Clinical Symptoms ◽

Clinical Chemistry ◽

Lactic Dehydrogenase ◽

Target Organ ◽

Male Rats ◽

High Dose ◽

Sprague Dawley ◽

Sprague Dawley Rats ◽

Dose Levels

Male and female Sprague-Dawley rats were administered 2,2,2-trichloroethanol (TCE) by gavage for 14 or 90 consecutive days. The gavage solution consisted of TCE dissolved in distilled water, containing 10% Emulphor. Doses of 37.5, 75, 150, and 300 mg/kg/day in the 14-day study and 40, 80, 160, and 320 mg/kg/day for the 90-day study were employed. Evaluation of clinical symptoms, clinical chemistry, and pathology examinations did not reveal a specific toxic effect or identify a target organ. In male rats an increase of red blood cells (RBCs) and hematocrit (Hct) in both 14- and 90-day studies, as well as increased hemoglobin (Hgb) in the 90-day study was observed at the highest dose level. In the high-dose females only increase of Hgb was seen in the 14-day study. These hematopoietic indices were not accompanied by commensurate changes in reticulocytes, mean corpuscular volumes or spleen weights. Serum lactic dehydrogenase (LDH) levels were increased in males at the two highest dose levels of both studies. Other changes in chemistries were sporadic in nature and did not appear to be dose related. Collectively, there was no basis to identify a target organ. The RBC and LDH levels did not correlate with other biochemical or pathology results and did not support the hypothesis that they represent a specific toxic effect. Based on the lack of detectable toxicity of TCE at the highest doses tested in rats, the following lowest observed adverse effect levels (LOAEL) were assigned for this chemical: in the 14-day exposure, 300 mg/kg/day for both sexes; in the 90-day protocol, 320 mg/kg/day for female; and 160 mg/kg/day for male rats.

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The effect of food restriction on body weights and clinical chemistry in sprague dawley rats

Toxicology Letters ◽

10.1016/s0378-4274(96)80386-9 ◽

1996 ◽

Vol 88 ◽

pp. 107 ◽

Cited By ~ 1

Author(s):

J.L. Boiziau ◽

F. Jabes ◽

C. Deshayes

Keyword(s):

Food Restriction ◽

Clinical Chemistry ◽

Sprague Dawley ◽

Sprague Dawley Rats ◽

Body Weights ◽

Effect Of Food

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Juvenile toxicity study of Gossence™ (galactooligosaccharides) in Sprague Dawley rats

Toxicology Research and Application ◽

10.1177/2397847320913213 ◽

2020 ◽

Vol 4 ◽

pp. 239784732091321

Author(s):

Manish Jain ◽

Moninder Kaur ◽

Deepika Pandey Tiwari ◽

Chandrashekara Vishwanath ◽

Nataraju Javaregowda ◽

...

Keyword(s):

Clinical Chemistry ◽

Pediatric Population ◽

Recovery Period ◽

Clinical Signs ◽

Weighted Average ◽

Organ Weight ◽

High Dose ◽

Average Dose ◽

Sprague Dawley ◽

Sprague Dawley Rats

Gossence™ (galactooligosaccharide; GOS) is a prebiotics and used as one of the major constituents in infant milk formulas that act as a functional food. Gossence is manufactured by Tata Chemicals Ltd, India, through a patented process of biotransformation of lactose. A toxicology study in juvenile rats was carried out to assess the safety profile of Gossence intended for pediatric population. The objective of this study is to assess the potential systemic toxicity of Gossence when administered through gavage at dose levels of 1000, 2000, or 5000/3000 mg/kg/day (equivalent to 1347, 2694, and 6735/4041 mg/kg/day of GOS, respectively) to juvenile Sprague Dawley rats from postnatal day (PND) 4 to PND 52 (i.e. total 49 days of dosing period). A separate group of animals were treated with vehicle (purified Milli Q water) for a similar duration. The following parameters were evaluated during the study period: morbidity/mortality check, clinical signs, body weights, body weight changes, food consumption, functional observational battery, motor activity, postnatal developmental observations, hematology, clinical chemistry, urinalysis, organ weight, gross pathology, and histopathology. During dosing phase, the high-dose group, 5000 mg/kg/day, was reduced to 3000 mg/kg/day (equivalent to 4041 mg/kg/day dose of GOS) from day 16 (PND 19) onward, due to clinical signs of watery feces and yellow color stains at urogenital region and mortality in two animals on day 15 (PND 18) of the study. Time-weighted average dose for 5000 mg/kg/day was equivalent to 3600 mg/kg/day. No further deaths or clinical signs were noticed in animals at 3000 mg/kg/day from day 18 (PND 21) of dosing phase to until terminal euthanization. At the terminal euthanization, there were no test item-related gross changes observed in all surviving rats except for, an increased cecum size in some of the rats at 5000/3000 mg/kg/day, which correlated with the increased weights of cecum with contents during organ weight recording, but this had no correlating light microscopic changes during histological examination. The cecal enlargement was completely recovered following the 14-day recovery period. The no-observedadverse-effect level is 3000 mg/kg/day for Gossence, which is equivalent to 4041 mg/kg/day of GOS in both sexes.

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A Subchronic Toxicity Study of Phosflex 51B in Sprague-Dawley Rats

International Journal of Toxicology ◽

10.1080/109158101753253009 ◽

2001 ◽

Vol 20 (5) ◽

pp. 269-274 ◽

Cited By ~ 1

Author(s):

Ralph I. Freudenthal ◽

David Brandwene ◽

Welmoed Clous

Keyword(s):

Food Consumption ◽

Clinical Chemistry ◽

Female Rats ◽

Male Rats ◽

High Dose ◽

Sprague Dawley ◽

Significant Treatment ◽

Sprague Dawley Rats ◽

The Mean ◽

Microscopic Pathology

Phosflex 51B is a flame retardant plasticizer that is blended with polyvinyl chloride films to effectively control product flammability. Its composition places it in the butylated triphenyl phosphate category. Previous studies have shown Phosflex 51B to have low acute toxicity, to lack teratogenic and mutagenic activity, and to not induce delayed peripheral neuropathy. The present study was conducted to determine the toxicity of Phosflex 51B after repeated dietary exposure. Four groups, each consisting of 20 male and 20 female Sprague-Dawley rats, received rodent diet containing either 0, 100, 400, or 1600 ppm for 90 days. Parameters measured include body weight, food consumption, clinical observations, hematology, clinical chemistry, and cholinesterase activity. Tissues were examined at necropsy for gross changes and were processed for microscopic pathology. There were no significant treatment-related effects on body weights, food consumption, hematology and clinical chemistry, or cholinesterase values. A significant increase was observed in the absolute and relative mean weights of livers in high-dose male rats, the mean relative fiver weights of the high-dose female animals, the mean relative kidney weights of the high-dose male rats, and the mean absolute weights of the adrenal glands from high-dose female rats. Neither gross nor microscopic pathology examinations revealed tissue changes in these organs or in any other organs. Although increases in fiver, kidney, and adrenal weights were observed in certain animals in the 1600-ppm high-dose group, the administration of Phosflex 51B did not result in significant treatment-related adverse effects at dietary dose levels of 100 and 400 ppm. The no-observable-effect level (NOEL) in this study is 400 ppm.

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Comparison of haematology, coagulation and clinical chemistry parameters in blood samples from the sublingual vein and vena cava in Sprague–Dawley rats

Laboratory Animals ◽

10.1258/la.2010.009049 ◽

2010 ◽

Vol 44 (4) ◽

pp. 344-351 ◽

Cited By ~ 11

Author(s):

J Seibel ◽

K Bodié ◽

S Weber ◽

D Bury ◽

M Kron ◽

...

Keyword(s):

Clinical Chemistry ◽

Vena Cava ◽

Sprague Dawley ◽

Blood Samples ◽

Sprague Dawley Rats

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Toxicological evaluation of isopropylparaben and isobutylparaben mixture in Sprague–Dawley rats following 28 days of dermal exposure

Regulatory Toxicology and Pharmacology ◽

10.1016/j.yrtph.2015.08.005 ◽

2015 ◽

Vol 73 (2) ◽

pp. 544-551 ◽

Cited By ~ 10

Author(s):

Min Ji Kim ◽

Seung Jun Kwack ◽

Seong Kwang Lim ◽

Yeon Joo Kim ◽

Tae Hyun Roh ◽

...

Keyword(s):

Dermal Exposure ◽

Sprague Dawley ◽

Toxicological Evaluation ◽

Sprague Dawley Rats

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Safety assessment of Gossence™ (galactooligosaccharides): Genotoxicity and general toxicity studies in Sprague Dawley rats

Toxicology Research and Application ◽

10.1177/2397847319860375 ◽

2019 ◽

Vol 3 ◽

pp. 239784731986037 ◽

Cited By ~ 1

Author(s):

Manish Jain ◽

S Narayanan ◽

Deepika Pandey Tiwari ◽

Bibhuti Ranjan ◽

Avinash Jadhav ◽

...

Keyword(s):

Chromosomal Aberration ◽

Clinical Chemistry ◽

Clinical Signs ◽

Feed Consumption ◽

Prolonged Treatment ◽

Sprague Dawley ◽

Toxicity Studies ◽

Sprague Dawley Rats ◽

Chromosomal Aberration Test ◽

Dose Levels

Galactooligosaccharides (GOS) used as prebiotics are one of the major constituents of the infant milk formulas. GOS (Gossence™) is produced by a patented process of biotransformation of lactose; hence toxicology studies were carried out to assess its safety. The objective of the present study was to evaluate the general and genetic toxicity of Gossence™. In 14-day and subchronic (90-day) oral toxicity studies in Sprague Dawley rats, daily administration of GOS at dose levels of 1000, 2000, or 5000 mg/kg (equivalent to 1347, 2694, and 6735 mg/kg/day of Gossence™, respectively) did not cause any mortality, or clinical signs, and changes in body weights, feed consumption, hematology, clinical chemistry, and urinalysis. In 90-day study, no changes in ophthalmological and neurological findings were observed. Significant increases in the cecum weights (with and/or without content) at dose levels of ≥2000 mg/kg were observed in both 14-day and 90-day studies. Based on the results of 90-day study, the no-observed-adverse-effect-level for GOS is 5000 mg/kg/day which is equivalent to 6735 mg Gossence™/kg/day. In the bacterial reverse mutation test, there was no significant increase in the mean numbers of revertants at the tested concentrations. Gossence™ was not mutagenic up to 5000 µg/plate. In chromosomal aberration test, there was no statistically significant increase in the number of percent aberrant metaphase for the Gossence™. Gossence™ is non-clastogenic (negative) in the in vitro chromosomal aberration test using human peripheral blood lymphocyte during short and prolonged treatment.

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