Hershberger Test for Separation and Destruction Procedure
The Hershberger Assay is a well-established in vivo androgenic activity bioassay, utilising castrated male rats to measure the weights of androgen-dependent tissues after the administration of test substances. This method is used to evaluate androgenic or antiandrogenic effects, providing crucial data in the field of toxicology and endocrine disruptor bioassays.
The Standard Evaluation Procedure (SEP) for the Hershberger Assay
The SEP serves as a comprehensive guide for standardising the experimental steps and criteria, ensuring consistent and reliable assay performance. Key elements include:
- Animal Preparation: Male rats are surgically castrated, typically at 42-60 days of age, to eliminate endogenous androgens, allowing exogenous androgenic or antiandrogenic effects to be isolated.
- Dosing Regimen: Animals are treated with test substances daily, usually for 10 consecutive days, with or without a reference androgen such as testosterone propionate.
- Tissue Dissection: After treatment, androgen-responsive tissues are dissected and weighed. These include the ventral prostate, seminal vesicles (with coagulating glands), levator ani plus bulbocavernosus muscles, glans penis, and Cowper’s glands.
- Endpoints: The primary endpoint is the change in weight of these androgen-dependent tissues compared to vehicle control or reference androgen controls.
- Data Analysis: Tissue weights are often normalized to body weight. Statistical analysis determines significance, indicating androgenic or antiandrogenic activity.
- Quality Controls: Use of positive and negative controls ensures assay sensitivity and specificity.
The Data Entry Spreadsheet Table (DEST) for the Hershberger Assay
The DEST is a standardised data recording and reporting template, designed to:
- Record Animal Information: ID, body weight, castration status, health observations.
- Record Dosing Details: Test substance dose, vehicle, duration.
- Enter Raw Tissue Weights: Individual weights of each androgen-dependent tissue per animal.
- Calculate Derived Endpoints: Tissue weight to body weight ratios and percentage changes relative to controls.
- Statistical Results: Means, standard deviations, p-values for treatment vs control comparisons.
- Summary and Interpretation: Clear presentation of any androgenic or antiandrogenic effects observed.
This spreadsheet facilitates data consistency across laboratories and supports regulatory submissions by organising and standardising critical data points.
In conclusion, the SEP offers detailed, stepwise guidance on conducting the Hershberger Assay to ensure consistency and reproducibility, while the DEST is the structured format where all experimental and analytical data are systematically recorded for evaluation and reporting. For official Standard Operating Procedures (SOPs) or templates, these are typically available from regulatory bodies such as the Organisation for Economic Co-operation and Development (OECD) Test Guideline 441 or from toxicology study organisations. Unfortunately, the current search results did not include these documents explicitly.
In the context of the Hershberger Assay, the science of androgenic activity bioassays utilizes medical-conditions such as castration of male rats to measure the effects of test substances on health-and-wellness parameters like the weights of androgen-dependent tissues. Data on these experiments, including animal information, dosing details, and tissue weights, is systematically recorded and analyzed using the Data Entry Spreadsheet Table (DEST), providing crucial insights into the androgenic or antiandrogenic effects that could impact health-and-wellness.
