title: Clinical chemistry and haematology historical data in control Sprague-Dawley rats from pre-clinical toxicity studies.
abstract: The purpose of this paper is to provide historical data pertaining to clinical chemistry and haematology parameters, obtained from control Sprague-Dawley rats, used in pre-clinical toxicity studies. Mean, standard deviation, minimum and maximum values for haematological and coagulative profiles, haemato-biochemistry and urine analysis data, and the differences per sex and study duration, 4 versus 13 weeks, are presented. The studies were conducted in agreement with the GLP (Good Laboratory Practice) regulations. Statistically significant differences, at the confidence level of 99%, for the red blood cell (RBC) parameters, the white blood cell (WBC) series parameters, plasmatic albumin/globulin (A/G), alanine amino-transferase (ALT), alkaline phosphatase (ALP), creatinine, globulin, glucose, sodium, total protein, tryglycerides, urea and urine volume were observed in males, when 4-week study values were compared with those obtained from 13-week studies. Female rats showed statistically significant variations, at the confidence level of 99% for RBC number and mean corpuscular haemoglobin (MCH), mean red blood cell volume (MCV), WBCs count and lymphocytes percentage, A/G, albumin, ALT, AST, ALP, creatinine, globulin, and sodium, when 4-week study values were compared to 13-week studies. Similar differences were observed comparing the female with male haematological and biochemical data for the two different times of the sample collection. These data could be useful as a reference for evaluation of background pathology in Sprague-Dawley rats, when used in studies performed to evaluate the toxicological profile of a new chemical entity (NCE) in agreement with requirements from international regulatory agencies.
authors.affiliation: claudio.petterino@tiscali.it
authors.forename: Claudio
authors.initials: C
authors.lastname: Petterino
authors.forename: Alberta
authors.initials: A
authors.lastname: Argentino-Storino
mesh_terms: D000818:Animals; D001774:Blood Chemical Analysis / Q000706:statistics & numerical data*; D005260:Female; D008297:Male; D051381:Rats; D017207:Rats, Sprague-Dawley / Q000502:physiology*; D012016:Reference Values; D018675:Toxicity Tests / Q000706:statistics & numerical data*