My topic is OECD guidelines for the testing of chemicals. Thank You Kanchan gupta

1. OECD GUIDELINES FOR THE TESTING OF
CHEMICALS INHALATION TOXICITY STUDY
INHALATION TOXICITY STUDY
 This test guidelines is designed to fully characterised test
chemicals toxicity by inhalation route for acute duration (14
days), sub acute (28 days), and chronic duration(90 days).
 This test guidelines also suggests additional investigation,
such as toxicokinectics and systemic toxicity study to better
characterize the toxicity of test chemical.
 This inhalation toxicity study can be used for quantitative risk
assessment.

2.  Acute inhalation studies can be found in the guidelines
Documents No. 39.
 Acute inhalation toxicity guidelines – 403.
 Sub- acute inhalation toxicity guidelines- 412.
 Chronic inhalation toxicity guidelines- 413.

3. ( ACUTE TOXICITY OR SINGLE DOSE STUDIES)
PRELIMINARY
 single dose tested in 2 rodents species.
 Observation for 14 days after dosing
 Sign, and symptoms reported
 microscopic and macroscopic evaluation.

4. DEFINITIVE-
 Group of 20 animal of either sex
 5 animals of each sex are observed for 48 hrs.
 Remaining 5 animals of each sex are 14 days.
 Changes in body wt.
 Pathological changes
 Macroscopic and microscopic evalution.

5. REPEATED DOSE STUDIES/ SUB-ACUTE TOXICITY
 2 mammalian species(one should be non rodents)
 Long duration studies.
 Parameters observed and recorded are..
 Behavioral
 Physiological
 Biochemicals
 Microscopic observation

6. CHRONIC TOXICITY STUDIES
 To evaluate the toxicity of chemicals.
 2 species required- rodents and non- rodents
 Rodents- 6-24 months
 Non- rodents- 12 months or longer
 Parameter monitored and recorded are-
 Mortality
 Pathology and histopathology
 Wt. change

7. Description of the method
Selection of species…
 Rodents species is rat.
 Rodents species is used.
 One male and one female animals may be performed for the
study.
 Healthy young adults animal of laboratory strains should be
used.
 If female are used they should be non- pregnant.
 Should be b/w 8 and 12 weeks old.
 Weight should be 20% of the mean body wt.

8. Housing and feeding condition
 The temperature of the experimental animal room should be
22 degree celcius.
 The relative humidity should be at least 30% and not exceed
70%.
 Lighting should be artificial, being 12 hours dark,light
Preparation of animals
 The animals are acclimatised to the laboratory conditions for
at least 5 days prior to the start of exposure.
 Animals are selected for used in the study and provide
individual identification.

9. Main study
No. of animals and concentration levels..
 5 animals of one sex will be used for each concentration.
 Each group consists of max. of 5 male and 5 female rodents
are exposed to the test chemicals for 6 hrs per day on 5 day
per week for a periods of 4 weeks (14 days for acute, 28 days
for subacute, and 90 days for chronic).

10. Exposure condition
Administration of concentration
 Animal are exposed to test chemicals as a gas, vapours,
aerosol or a mixture.
 Hygroscopic and chemical reactive test chemical should be
tested under dry air condition.
Test chemical preparation in a vehicle-
 Test chemical should be tested without vehicle.
 If it is necessary to use a vehicle to generate an appropriate
test chemical concentration and particle size, water should be
used whenever possible.

11. Monitoring of exposure conditions
Chamber air flow
 The flow of air through exposure chamber should be carefully
controlled.
 Oxygen concentration Should be at least 19% and carbon di
oxide concentration should not exceed 1%.
 If measurement on the 1st day of exposure show that these
gases are at proper levels, no further measurement should be
necessary.

12. Chamber temp. and relative humidity
 The air temp. in the animal breathing room should be
monitored continuously and recorded at least 3 times during
each exposure, chamber temp. should be maintain at 22
degree celcius.
 The relative humidity should be maintain in the range of 30 to
70%.
Particle size distribution
 Particle size distribution of fine aerosols should be determined
by cascade impactor.

13. Observation
 The animal should be clinically observed before, during and after
each exposure periods as well as during the post exposure periods.
 When animals are sacrified, time of death should be recorded.
 Change in the skin , fur, eyes , mucous membrane, change in
respiratory and circulatory system are observed and recorded.
Body wt.
 Individual animal wt. should be recorded before the first
exposure(day 0), twice weekly or at the time of death or
euthansia.
Food and water consumption
 Food and water consumption may also be measured weekly.

14. Data and reporting
Data
 Individual animal data should be provided.
 All data should be summarised in tabular form….
 No. of animal used
 No. of animal displaying sign of toxicity
 No. of animal dead during the test.
 Time of death
 Discription

15. Test report
Test report should include the following information…
 Source
 Lot no.
 Stability of test chemicals
 Solubility of the test chemical in solvent, if known.
 Measurement of PH and osmolality.
 Physical appearance, water solubility and physicochemical
properties.
 Chemical identification such as IUPAC or CAS name , CAS no.
 Purity

16. Vehicle
 Use of vehicle and justification for choice of vehicle(if other
than water).
Test animal
 Species/strain used
 Microbiological status of the animal.
 Acclimatised period.
 No. ,age and sex of animal
 Source housing condition.
 Diet.

17. Test condition
 Details of test chemical preparation.
 Equipment used to monitor chamber temperature humidity
and airflow.
 Equipment used to collect sample for determination of
chamber concentration and particle size distribution.
 Details of food and water quality.
Result
 Tabulation of chamber temperature, humidity and airflow.
 Tabulation of chamber nominal and actual concentration data.
 Tabulation of response data and concentration level for each
animal.

18. THANK
YOU
KANCHAN GUPTA
M.PHARM(Pharmacology)
Advance institute of biotech and paramedical sciences