Establishment of Historical Control Data on Rats and Mice for Preclinical Studies
105 / 23
Authors
-
Venkatesan, P.S.
-
S.Sundaresan
-
M.Eswarya
-
S.Sowmiya
-
M.Madhavaselvi
Keywords:
Rodents, Haematology, Biochemistry, Reference range valueAbstract
Toxicology studies and other biomedical research can only be interpreted when adequate reference ranges established from healthy control animals are available. Each animal species being evaluated requires a unique set of reference values for various hematology and biochemical parameters. The stock animals were selected from Mass Biotech, Chengalpet, Tamil Nadu, India, during the years 2019 to 2023. The selected animals were found to be healthy under veterinary examination. Wistar rats (Rattus norvegicus) and Swiss albino mice (Mus musculus) were selected from the age group of 5-12 weeks. Heamatology, biochemistry, feed consumption and body weight were estimated and mean reference range was tabulated with standard deviation. The mean SGPT value of male rat was 70.16; the female rat was 41.14. The mean SGOT value of the male rat was 124.49, and that of the female rat was 95.3. The mean SGPT value of female mice was 31.14, and that of male mice was 46.72. The mean SGOT was 64.31 in female mice and 170.83 in male mice. The mean ALP value of female mice is 147.7. The mean haemoglobin value of male mice is 9.22, and the mean RBC and WBC count is 3.30 and 6.39, respectively. Other hematology and biochemical parameters of both sexes were estimated. The estimated variations in each parameter, with wider ranges, might be due to animal sources, geographical variations in terms of environment and genetic factors. So, the estimated values could be comparable with the data generated in similar geographical regions.
Downloads
References
Brereton, M., R.McCafferty, K.Marsden, Y.Kawai, J.Etzell and A.Ermens (2016), Recommendation for standardization of haematology reporting units used in the extended blood count, Inter. J. Lab. Hematology, 38(5): 472–82.
De Kort, Marlies, Klaus Weber, Björn Wimmer, Katharina Wilutzky, Patricia Neuenhahn, Philip Allingham and Anne-Laure Leoni (2020), Historical control data for hematology parameters obtained from toxicity studies performed on different Wistar rat strains: Acceptable value ranges, definition of severity degrees, and vehicle effects, Toxicology Research and Application, 4.
Ema, Makoto, Katsumi Endoh, Ryou Fukushima, Sakiko Fujii, Hiroaki Hara, Mutsuko Hirata‐Koizumi and Akihiko Hirose (2014), Historical control data on developmental toxicity studies in rodents, Congenital Anomalies. 54(3): 150–61.
Geerlofs, Lotte, Zhiyong He, Sa Xiao and Zhi-Cheng Xiao (2020), Repeated dose (90 days) oral toxicity study of ursolic acid in Han-Wistar rats, Toxicology Reports, 7: 610–23.
Hayakawa, Kazuhiro, Yuichi Mimura, Shigehiro Tachibana, Mami Furuya, Terutaka Kodama, Toyohiko Aoki, Satoru Hosokawa (2013), A Study for collecting background data on Wistar Hannover [Crl:WI(Han)] rats in general toxicity studies - comparative data to Sprague Dawley rats, J. Toxi. Sci., 38(6): 855–73.
Keenan, Charlotte, Susan Elmore, Sabine Francke-Carroll, Ramon Kemp, Roy Kerlin, Shyamal Peddada and John Pletcher (2009), Best practices for use of historical control data of proliferative rodent lesions, Toxicologic Pathology, 37(5): 679–93.
Lee, Jung-Min, Min-Ah Lee, Hyeon-Nam Do, Yun-Ik Song, Re-Ji-Na Bae, Hye-Yeong Lee, Sun Hee Park, Jin Seok Kang and Jong-Koo Kang (2012), Historical control data from 13-week repeated toxicity studies in Crj:CD (SD) rats, Lab. Anim. Res., 28(2): 115.
Ochiai, Yuichiro, Atushi Baba, Mio Hiramatsu, Naoto Toyota, Toshihiko Watanabe, Kazuto Yamashita, Hiroshi Yokota and Hidetomo Iwano (2017), Blood biochemistry and hematological changes in rats after administration of a mixture of three anesthetic agents, J. Vet. Med. Sci., 80(2): 387–94.
Okamura, Toshiya, Saori Suzuki, Tatsuya Ogawa, Junichi Kobayashi, Osamu Kusuoka, Kazuhisa Hatayama, Masahiro Mochizuki, Toru Hoshiya, Shuzo Okazaki and Kazutoshi Tamura (2011), Background data for general toxicology parameters in RCCHANTM:WIST rats at 8, 10, 19 and 32 weeks of age, J. Toxi. Path., 24(4): 195–205.
Petterino, Claudio and Alberta Argentino-Storino (2005), Clinical chemistry and haematology historical data in control Sprague-Dawley rats from pre-clinical toxicity studies, Exp. and Toxi. Path., 57(3): 213–19.
Restell, Tamy Ingrid, Lenir Cardoso Porfirio, Albert Schiaveto De Souza and Iandara Schettert Silva (2014), Hematology of Swiss mice (Mus musculus) of both genders and different ages, Acta Cirúrgica Brasileira, 29(5): 306–12.
Silva‐Santana, Giorgio, Juliet Cunha Bax, Débora Cristina Silva Fernandes, Daniela Tendler Leibel Bacellar, Cleber Hooper, Alexandre Alves Souza Oliveira Dias and Cristina Barbosa Silva (2020), Clinical hematological and biochemical parameters in Swiss, BALB/c, C57BL/6 and B6D2F1 Mus musculus, Anim. Models and Exp. Med., 3(4): 304–15.
Spinelli, Marilda Osti, Milena Coutinho da Motta, Robson José Cruz and C M Godoy (2014), Reference intervals for hematological parameters of animals bred and kept at the vivarium of the Faculty of Medicine of the State University of São Paulo, Acta Scientiarum Health Science, 36: 1-4.