OECD TG-411 Subchronic Dermal Toxicity: 90-day Study
OECD GLP Toxicity studies of drugs and chemicals
WESHIN INSPECTION TECH CO., LTD_

OECD TG 411: Subchronic Dermal Toxicity: 90-Day Study

 

Short-term studies may not fully reveal potential health risks for products involving chronic or repeated skin contact. Following OECD TG 411 guidelines and GLP principles, we offer a 90-day subchronic dermal toxicity assessment to thoroughly investigate cumulative physiological effects, ensuring your product meets the highest international regulatory standards.
 

Study Objective

 

To characterize the toxicological profile of a test substance administered via the dermal route (typically 6 hours per day, at least 5 days a week, for 90 days). This study identifies target organs, observes potential cumulative toxicity, and provides essential data for establishing long-term safety limits, such as the No-Observed-Adverse-Effect Level .
 

Service Highlights & Technical Specifications

 

  • Chronic Exposure Simulation: Rigorous dosing protocols that precisely control skin contact area and application pressure to simulate real-world long-term exposure scenarios.

  • In-depth Clinical Analysis:

    • Clinical Pathology: Detailed hematology and biochemistry at various intervals to assess the integrity of hepatic, renal, hematopoietic, and endocrine systems.

    • Urinalysis: Monitoring the impact of substance metabolism on the urinary system.
       

  • Expert Histopathology: Comprehensive gross necropsy and microscopic tissue examination of major internal organs and treated skin sites by senior pathologists.

  • Functional Assessment: Recording sensory reactivity, motor activity, and behavioral changes to detect potential signs of neurotoxicity.
     

Study Procedure

 

  1. Dose Level Selection: Establishing appropriate dose levels for the 90-day study based on results from 28-day preliminary tests.

  2. Continuous Dosing Phase: Daily dermal applications maintained over a 90-day period within a GLP-controlled environment.

  3. Dynamic Monitoring: Continuous tracking of body weight fluctuations, food consumption efficiency, and clinical signs.

  4. Comprehensive Reporting: Integrating all physiological, chemical, and pathological data into a formal toxicological report compliant with international regulatory standards.
     

Targeted Industries

 

  • Safety Assessment of High Production Volume (HPV) Chemicals

  • Registration of Long-term Contact Pesticides and Agrochemicals

  • Environmental Health Risk Identification for Specialized Industrial Materials

  • International Regulatory Submissions (e.g., EU REACH, US TSCA)



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