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Establishment of Rat Models Mimicking Gender-affirming Hormone Therapies
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A new sighting study for the fixed concentration procedure to allow for gender differences.

Nigel Stallard1, Charlotte Price, Stuart Creton

  • 1Warwick Medical School, University of Warwick, Coventry, UK. n.stallard@warwick.ac.uk

Human & Experimental Toxicology
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PubMed
Summary

A revised sighting study for the fixed concentration procedure (FCP) uses both male and female animals. This modification improves the accuracy of acute inhalation toxicity assessments, ensuring reliable classification regardless of gender-specific sensitivity.

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Area of Science:

  • Toxicology
  • Inhalation Toxicology
  • Regulatory Science

Background:

  • The fixed concentration procedure (FCP) is a proposed alternative to the traditional median lethal concentration (LC50) test (OECD TG 403) for acute inhalation toxicity.
  • Current FCP protocols utilize a sighting study with a single gender (typically female) to determine the starting concentration for the main study.
  • Potential gender-based differences in toxicity may impact the reliability of single-gender FCP assessments.

Purpose of the Study:

  • To propose and evaluate a modified sighting study for the fixed concentration procedure (FCP).
  • To assess the impact of using both male and female animals in the FCP sighting study on toxicity classification accuracy.
  • To ensure the FCP remains a robust alternative test method for acute inhalation toxicity, minimizing gender-related biases.

Main Methods:

  • Proposed a modification to the FCP sighting study, incorporating both male and female animals.
  • Conducted statistical analyses to compare the performance of the revised sighting study against the original single-gender approach.
  • Evaluated classification outcomes under varying conditions of gender-specific sensitivity (females more sensitive, males more sensitive, or no difference).

Main Results:

  • The revised sighting study is likely to yield the same classification as the original FCP when females are more sensitive.
  • If males exhibit higher sensitivity, the modified procedure significantly reduces the risk of incorrect classification into a less toxic category.
  • When no gender difference in LC50 exists, the revised procedure shows a slight tendency towards classifying into a more stringent toxicity category.

Conclusions:

  • The proposed modification to the FCP sighting study effectively mitigates the impact of gender-specific sensitivity differences on toxicity assessment.
  • The revised procedure enhances the reliability and accuracy of the FCP as an alternative method for evaluating acute inhalation toxicity.
  • This supports the broader adoption of the FCP, aligning with the principles of reducing, refining, and replacing animal testing in toxicology.