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Long Term Toxicity
Tests
(Teratogenicity, Oncogenicity, Mutagenicity & Allergenicity)
RVS Chaitanya Koppala
ALLERGENICITY/HYPERSENSITIVITY
TOXICOLOGY STUDIES
Guinea Pig Maximization
test
Local lymph node assay
Determination of Maximum non irritant or
minimum irritant dose
Evaluation of Erythema and oedema
Mice of one sex(either male or female)
Drug treatment given on ear skin
Auricular lymph node dissection after 5 days
Increase in 3h-thymidine used for evaluation
GENOTOXICITY STUDIES
To detect early tumorigenic effects in cases of chronic illness
In vitro tests:
Test for gene mutation in Bacteria
Cytogenetic evaluation of chromosomal damage in
mammalian cells
E.g.; Ames’s Salmonella Assay detects increased number of
aberrations in metaphase chromosomes
DNA strand breaks, DNA repair or recombination,
Measurements of DNA adducts
IN VIVO TESTS
 In vivo test for chromosomal damage using mammalian hematopoietic
cells.
 Chromosome damage in rodent hematopoietic cells
E.g.; Micronucleus Assay
CARCINOGENICITY/ ONCOGENICITY STUDIES
life-time bioassays
carcinogenicity studies are performed on:
drug used for >6 months or frequent intermittent use for chronic
diseases
chemical structure of drug indicates carcinogenic potential
therapeutic class of drugs which have produced positive
carcinogenicity
TERATOGENICITY
 Capacity of a drug to cause foetal abnormalitites when administered to
the pregnant mother.
 Placenta does not consider a strict barrier and any drug can cross it to a
greater or lesser extent.
 The embryo is one of the most dynamic biological systems
 Drugs can affect the foetus at 3 stages
1. Fertilization and implantation- conception to 17 days (unnoticed failure
of pregnancy)
2. Organogenesis- 18-55 days of gestation most vulnerable period,
deformaties are produced.
3. Growth and development-56days onward developmental and funcitonal
abnormalities can occur e.g. ACE inhibitors can cause hypoplasia of
organs lungs, kidneys.
 The type of malformation depends upon the drug as well as the
stage at which exposure to the teratogen occurred.
 Foetal exposure depends on the blood level and duration for
which the drugs remains in maternal ciruclation.
 The teratogenic potential of a drug is to be considered against
the background of congenital abnormalities
Teratogenicity oncogenicity mutagenicity and allergenicity
Teratogenicity oncogenicity mutagenicity and allergenicity
 Therefore wise to avoid all the drugs during pregnancy unless compelling
reasons, exist for their use regardless of the assigned pregnancy category.
 Frequency of spontaneous as well as drug induced malformations.
Especially neural tube defects may be reduced by folate therapy during
pregnancy.

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Teratogenicity oncogenicity mutagenicity and allergenicity

  • 1. Long Term Toxicity Tests (Teratogenicity, Oncogenicity, Mutagenicity & Allergenicity) RVS Chaitanya Koppala
  • 2. ALLERGENICITY/HYPERSENSITIVITY TOXICOLOGY STUDIES Guinea Pig Maximization test Local lymph node assay Determination of Maximum non irritant or minimum irritant dose Evaluation of Erythema and oedema Mice of one sex(either male or female) Drug treatment given on ear skin Auricular lymph node dissection after 5 days Increase in 3h-thymidine used for evaluation
  • 3. GENOTOXICITY STUDIES To detect early tumorigenic effects in cases of chronic illness In vitro tests: Test for gene mutation in Bacteria Cytogenetic evaluation of chromosomal damage in mammalian cells E.g.; Ames’s Salmonella Assay detects increased number of aberrations in metaphase chromosomes DNA strand breaks, DNA repair or recombination, Measurements of DNA adducts
  • 4. IN VIVO TESTS  In vivo test for chromosomal damage using mammalian hematopoietic cells.  Chromosome damage in rodent hematopoietic cells E.g.; Micronucleus Assay
  • 5. CARCINOGENICITY/ ONCOGENICITY STUDIES life-time bioassays carcinogenicity studies are performed on: drug used for >6 months or frequent intermittent use for chronic diseases chemical structure of drug indicates carcinogenic potential therapeutic class of drugs which have produced positive carcinogenicity
  • 6. TERATOGENICITY  Capacity of a drug to cause foetal abnormalitites when administered to the pregnant mother.  Placenta does not consider a strict barrier and any drug can cross it to a greater or lesser extent.  The embryo is one of the most dynamic biological systems
  • 7.  Drugs can affect the foetus at 3 stages 1. Fertilization and implantation- conception to 17 days (unnoticed failure of pregnancy) 2. Organogenesis- 18-55 days of gestation most vulnerable period, deformaties are produced. 3. Growth and development-56days onward developmental and funcitonal abnormalities can occur e.g. ACE inhibitors can cause hypoplasia of organs lungs, kidneys.
  • 8.  The type of malformation depends upon the drug as well as the stage at which exposure to the teratogen occurred.  Foetal exposure depends on the blood level and duration for which the drugs remains in maternal ciruclation.  The teratogenic potential of a drug is to be considered against the background of congenital abnormalities
  • 11.  Therefore wise to avoid all the drugs during pregnancy unless compelling reasons, exist for their use regardless of the assigned pregnancy category.  Frequency of spontaneous as well as drug induced malformations. Especially neural tube defects may be reduced by folate therapy during pregnancy.