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OECD 423 - Acute Oral Toxicity Study: 6. Describe Details of Study Plan To Justify The Use of Animals

The document outlines an Acute Oral Toxicity Study (OECD 423) involving Wistar female rats to determine the acute oral toxicity of a test item and classify it according to GHS criteria. The study will be initiated after IAEC approval and is expected to be completed within one year, following a fixed dose procedure with a stepwise dosing approach. Observations will include mortality and signs of toxicity over a 14-day period, with all surviving animals undergoing necropsy at the end of the study.

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879 views2 pages

OECD 423 - Acute Oral Toxicity Study: 6. Describe Details of Study Plan To Justify The Use of Animals

The document outlines an Acute Oral Toxicity Study (OECD 423) involving Wistar female rats to determine the acute oral toxicity of a test item and classify it according to GHS criteria. The study will be initiated after IAEC approval and is expected to be completed within one year, following a fixed dose procedure with a stepwise dosing approach. Observations will include mortality and signs of toxicity over a 14-day period, with all surviving animals undergoing necropsy at the end of the study.

Uploaded by

68Rajiv Tejani
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOCX, PDF, TXT or read online on Scribd

OECD 423 - Acute Oral Toxicity Study

a. Date of initiation (Proposed): After IAEC approval

b. Date of completion (Proposed): Within 1 year from date of approval

6. Describe details of study plan to justify the use of animals


Study Title Acute Oral Toxicity Study in Rodents using
Fixed Dose Procedure
Objective To determine the acute oral toxicity and
classify the test item according to GHS
criteria.
Guideline 423

Animal Details
Species and Strain Wistar Female Rat
Housing Polypropylene cages with bedding material
Acclimatisation 5 days
Identification Tattoo or Cage Card
Age 8 to 12 weeks
Environmental Conditions Temperature: 22 ± 3°C, Humidity: 30-70%
Light Cycle 12 hours light and 12 hours dark
Diet and Water: Standard laboratory diet and water ad libitum

Study Design
Group Treatment Dose Number of Observation Remarks
(mg/kg) Animals Period

1 Vehicle 0 3 14 Days -
Control
2 Test Item 5 3 14 Days If no
mortality,
proceed to
Next dose
3 Test Item 50 3 14 Days If no
mortality,
proceed to
next dose
4 Test Item 300 3 14 Days If no
mortality,
proceed to
next dose
5 Test Item 2000 3 14 Days If mortality
observed,
classification
based on
response
and go to
lower dose

Other Study Details


Duration of treatment Single Dose
Route of administration Oral gavage
Formulation Solution/Suspension
Analytical Validation If required
Formulation analysis To confirm concentration and homogeneity

Investigation Details
Clinical Observation Animals observed for mortality, signs of
toxicity at 30 min, 1, 2, 4, 6 hours post-dose
and daily for 14 days.
Body Weight Measured on Day 0, 7, and 14.
Termination All surviving animals sacrificed at the end
of the observation period.
Necropsy Gross pathology examination of major
organs.
Statistical Analysis Descriptive statistics, if required.
LD50 = Median Lethal Dose, GHS = Globally Harmonized System

Note: The study follows a stepwise dosing approach to classify the toxicity level.

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