Acute Toxicity Studies - Study Design of OECD GLP TG 404 - Acute Dermal Irritation/Corrosion Study In Rabbits

The Acute Dermal Irritation/Corrosion Study in Rabbits (OECD 404) is a crucial test employed to assess the potential of a substance to cause skin irritation or corrosion. Here’s a breakdown of its key aspects:

Objectives:

  • Determine the degree of skin irritation or corrosion caused by a single dermal application of a test substance.
  • Classify the substance according to its irritation/corrosion potential based on GHS criteria.
  • Provide initial information for further safety testing, if necessary.
Acute Toxicity Studies - Study Design of OECD GLP TG 404 - Acute Dermal Irritation/Corrosion Study In Rabbits

Test System:

  • Healthy young adult albino rabbits of at least two sexes are used.
  • A minimum of three animals per dose group are required.

Dose Levels and Application:

  • The test substance is applied to a shaved or clipped area of intact skin on the back of the animals.
  • Two dose levels are used:
    • 5 mL (liquid) or 0.5 g (solid): This is the standard dose for assessing irritation.
    • 0 mL (liquid) or 3.0 g (solid): This higher dose is used to identify potential corrosivity.
  • Occlusive dressings 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, edema, eschar formation.
    • 1, 24, 48, and 72 hours: Erythema, edema, eschar formation, and other signs of irritation.

Scoring System:

  • A scoring system is used to quantify the severity of observed effects, including erythema, edema, eschar formation, 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 score for each dose group is calculated.
  • The substance is classified according to GHS criteria based on the severity and reversibility of skin lesions (e.g., Category 1: corrosive, Category 2: irreversible irritation, Category 3: reversible irritation, Category 4: practically non-irritating).

Benefits:

  • Relatively simple and cost-effective compared to other toxicity tests.
  • Standardized protocol for international harmonization.
  • Provides quick initial assessment of dermal irritation/corrosion potential.

Limitations:

  • Requires animal use, raising ethical concerns.
  • Only assesses acute effects and may miss delayed or chronic toxicity.
  • Can be subjective due to the scoring system.
  • Not suitable for all types of substances (e.g., highly volatile or corrosive).

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