Acute Toxicity Studies - Study Design of OECD Guideline 405: Acute Eye Irritation/Corrosion Study in Rabbits

The OECD Guideline 405 outlines a standardized test for assessing the potential of a substance to irritate or corrode the eyes of rabbits. This information is crucial for ensuring the safety of chemicals before they reach the market. Here’s a breakdown of the key aspects:

Objectives:

  • Determine the degree of irritation/corrosion caused by a single ocular application of the test substance.
  • Classify the substance according to its irritation/corrosion potential based on the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).
  • Provide initial information for further safety testing, if necessary.
Acute Toxicity Studies - Study Design of OECD Guideline 405: Acute Eye Irritation/Corrosion Study in Rabbits

Test System:

  • Healthy young adult albino rabbits (at least 3 per dose group) are used.

Dose Levels and Application:

  • The test substance is applied to the conjunctival sac of one eye of each animal.
  • The other eye remains untreated as a control.
  • The amount of test substance applied depends on its expected severity:
    • Liquids:1 mL
    • Solids: 10 mg
  • Occlusion of the eyelids may be used for certain types of substances.

Observation Period:

  • Animals are observed for at least 72 hours after application.
  • Detailed observations are made at specific intervals, including:
    • Immediate: Redness, chemosis, corneal opacity.
    • 1, 24, 48, and 72 hours: Discharge, iritis, conjunctival swelling, corneal opacity.

Scoring System:

  • A scoring system is used to quantify the severity of observed effects, including redness, chemosis, corneal opacity, and other relevant factors.
  • The scores for each animal and each observation time point are summed to provide an overall irritation score.

Data Analysis:

  • The mean irritation score for each dose group is calculated.
  • The substance is classified according to GHS criteria for irritation/corrosion categories (e.g., Category 1: irreversible damage, Category 2: reversible damage).

Benefits:

  • Standardized protocol for international harmonization.
  • Provides a quick and reliable assessment of eye irritation/corrosion potential.
  • Relatively simple and cost-effective compared to other in vivo tests.

Limitations:

  • Requires animal use, raising ethical concerns.
  • Does not assess all potential eye effects (e.g., sensitization).
  • May not be suitable for all types of substances (e.g., volatile or highly reactive chemicals).

Additional Resources:

 

 

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