acute dermal toxicity
DESCRIPTION
toxicity, OECD 402TRANSCRIPT
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By, Syed Baseeruddin Alvi
M.Pharm- pharmacology
Roll.no: 09
Acute dermal toxicity
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• Introduction
• General terminology
• Principal and test procedure• Experimental animals
• Test conditions
• Clinical examination
• Data and reporting
INDEX
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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
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General Terminology
• Acute dermal toxicity
• Dose
• The LD50
• Dosage
• Dose-response
• Dose-effect
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P R I N C I P L E O F T H E T E S T
• 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.
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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.
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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
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• How does it look like…?
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D A T A A N D R E P O R T I N G
• T r e a t m e n t o f r e s u l t s
• T e s t r e p o r t
• I n t e r p r e t a t i o n o f t h e r e s u l t s
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