Historical control data from 13-week repeated toxicity studies in Crj:CD (SD) rats

Area of Science:

• Toxicology
• Laboratory Animal Science
• Pharmacology

Background:

• Standard experimental parameter reference ranges are vital for toxicological comparisons.
• Crl:CD (SD) rats are a widely utilized strain for toxicity and efficacy research.
• Establishing domestic reference values is essential for consistent research outcomes.

Purpose of the Study:

• To compile and analyze data from 13-week repeated toxicity studies in Crl:CD (SD) rats.
• To establish domestic reference values for key physiological and biochemical parameters.
• To provide a reliable historical control dataset for future toxicological assessments.

Main Methods:

• Data collection from 11 toxicity studies involving 220 Crl:CD (SD) rats (110 males, 110 females).
• Inclusion of parameters such as body weight, food consumption, urinalysis, hematology, clinical biochemistry, and organ weights.
• Studies conducted at a single facility over five years, using animals from a single breeder.

Main Results:

• Compiled data included means, standard deviations, percentages, and ranges for all parameters.
• Parameters with high variability (standard deviation ≥ 30%) identified: urine volume, uterus weight, eosinophil and basophil counts, triglyceride, total bilirubin, and gamma-glutamyl transpeptidase.
• Comprehensive dataset generated for various physiological and biochemical markers.

Conclusions:

• The compiled historical control data are valuable for interpreting test substance effects in routine toxicity studies.
• These reference values enhance the reliability and comparability of toxicological and efficacy research.
• The study provides a foundation for robust scientific interpretation in preclinical research using Crl:CD (SD) rats.