By, Syed Baseeruddin Alvi

M.Pharm- pharmacology

Roll.no: 09

Acute dermal toxicity

• Introduction

• General terminology

• Principal and test procedure• Experimental animals

• Test conditions

• Clinical examination

• Data and reporting

INDEX

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

General Terminology

• Acute dermal toxicity

• Dose

• The LD50

• Dosage

• Dose-response

• Dose-effect

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.

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.

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

• How does it look like…?

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