|
|
Toxicity of 90-Day Repeated Ingastric Administration of Cetilistat Impurity A in Rats
DU Jiancai, YAO Fangfang, LIU Ruoxun, ZHAO Yun, LI Guochao, QIU Deyang, LI Bin, YAO Jingchun
2026, 23(2):
147-154.
DOI: 10.19803/j.1672-8629.20250632
Objective To assess the potential toxicity of 90-day consecutive ingastric administration of cetilistat impurity A in SD rats. Methods A total of 120 SPF-grade SD rats were randomly assigned to four groups: the low-dose, medium-dose, and high-dose(20.0, 80.0, and 320.0 mg·kg-1·d-1) treatment groups and a solvent control group that received 0.5% sodium carboxymethyl cellulose solution. There were 30 rats in each group (half male and half female). The volume of administration was 10 mL·kg-1·d-1, once daily and for 90 days, followed by a 28-day recovery period. During the study, health status of these rats was observed daily, food intake was measured weekly, and body weight was recorded twice. At the end of dosing and recovery periods, indexes related to ophthalmology, urine, hematology, coagulation, serum biochemistry, and electrolytes were detected, along with bone marrow smears and histopathological examination. Results No significant changes in health status, food intake, body weight, ophthalmology, urine, or coagulation parameters were observed in any of the dose groups (P>0.05). Minor changes were observed in neutrophil percentages (NEU%) of alanine aminotransferase, total bilirubin, total protein, and urea (P<0.05), but all the values remained within normal limits. Histopathological examination revealed mild pathological changes in such organs as the heart, kidney, liver, and prostate. However, the incidence and severity of these changes were similar across these groups (P>0.05), suggesting that these alterations were likely spontaneous. Conclusion No significant toxic effects are observed in SD rats administered with cetilistat impurity A ingastricly at doses of 20.0, 80.0, and 320.0 mg·kg-1·d-1 for 90 days.
References |
Related Articles |
Metrics
|