This document discusses acute dermal toxicity testing. It provides an introduction stating that dermal toxicity testing assesses the toxic effects of a substance applied to skin. Key terminology is defined, such as LD50. The test procedure involves applying graduated doses of a test substance to animal skin and observing for signs of toxicity. Animals are clinically examined and necropsied to determine cause of death or signs of distress. Data is reported on treatment results, including LD50 values.

1. Acute dermal toxicity
By, Syed Baseeruddin Alvi
M.Pharm- pharmacology
Roll.no: 09

2. INDEX
• Introduction
• General terminology
• Principal and test procedure
• Experimental animals
• Test conditions
• Clinical examination
• Data and reporting

3. INTRODUCTION
• Dermal toxicity involves the assessment and
evaluation of the toxic characteristics of a
substance. It is useful where the exposure to
dermal route is likely.
• Data from an acute dermal toxicity study may
serve as a basis for classification and labelling.
•
It is an initial step in establishing a dosage
regimen in subchronic and other studies

4. General Terminology
• Acute dermal toxicity
• Dose
• The LD50
• Dosage
• Dose-response
• Dose-effect

5. PRINCIPLE OF THE TEST
• The test substance is applied to the skin in
graduated
doses
to
several
groups
of
experimental animals.
• Animals which die during the test are necropsied
and surviving animals are also done the same at
the conclusion..
• Animals showing severe and enduring signs of
distress and pain may need to be humanely
killed.

6. THE TEST PROCEDURE
• Healthy young adult animals are acclimatised to the
laboratory conditions for at least 5 days prior to the
test.
• 24 hours before the test fur should be removed
• Not less than 10% of the body surface area should
be clear & weight of the animal should be taken into
account
• A suitable vehicle to ensure good contact with the
skin. The influence of the vehicle should also be
considered.

7. Experimental a n i m a l s
• Selection of species
• Number and sex
• Housing and feeding conditions
 Test c o n d i t i o n s:
• Dose levels
• Limit test
• Observation period
• Clinical examination & pathology

8. • How does it look like…?

9. DATA AND REPORTING
• Treatment of results
• Test report
• Interpretation of the results