OECD TG-407 Repeated Dose 28-day Oral Toxicity Study in Rodents
OECD GLP Toxicity studies of drugs and chemicals
WESHIN INSPECTION TECH CO., LTD_

OECD TG 407: Repeated Dose 28-Day Oral Toxicity Study in Rodents

 

During the intermediate stages of chemical or drug development, understanding the cumulative effects of long-term ingestion on physiological functions is essential. Following OECD TG 407 guidelines and GLP principles, we provide critical sub-acute/sub-chronic toxicity data through a 28-day repeated dosing study to help determine safe exposure levels.
 

Study Objective

 

To evaluate the toxicological profile of a test substance administered orally to rodents (typically rats) daily for 28 days. This study identifies target organs, characterizes dose-response relationships, and estimates the No-Observed-Adverse-Effect Level .
 

Service Highlights & Technical Specifications

 

  • Versatile Administration Routes: Options include dietary incorporation, drinking water, or oral gavage to suit your substance properties.

  • Comprehensive Physiological Assessment:

    • Clinical Observations: Daily monitoring of behavior, skin, fur, and neurological signs.

    • Hematology & Clinical Chemistry: Assessing liver/kidney functions, metabolic markers, and hematopoietic effects.

    • Functional Observational Battery (FOB): Including sensory reactivity, grip strength, and motor coordination.

  • Pathological Identification: Complete gross necropsy, organ weight measurements, and histopathological examinations of tissues.

  • Recovery Period Option: Including recovery groups to assess the reversibility of toxic effects after dosing cessation.
     

Study Procedure

 

  1. Dose Selection: Utilizing at least three dose levels (High, Mid, Low) and a control group.

  2. Continuous Exposure: Daily administration of the test substance for a 28-day duration.

  3. Periodic Monitoring: Weekly recording of body weight, food consumption, and clinical symptom scanning.

  4. Final Evaluation: Blood/urine sampling followed by comprehensive histopathological analysis.

  5. Reporting: Delivering formal GLP-compliant reports suitable for international regulatory submissions.
     

Targeted Industries

 

  • New Chemical Notification and Registration (REACH / TSCA)

  • Food Additives and Nutritional Ingredient Safety Assessment

  • Pre-clinical Pharmaceutical Safety Testing

  • Sub-chronic Toxicity Characterization for Pesticides




Click to Pay
BACK