1. ‘Safety Evaluation Of Microalgae
In Rodents.’
Presented By;
Mr. Sharad D.Khune
(M. Pharm Sem-III)
Guided by;
Dr. A.D. Kshirsagar
Associate and Head (Department of Pharmacology)
Padm. Dr. D. Y. Patil Institute of Pharmaceutical Sciences & Research,
Pimpri, Pune-411018

2. Introduction;
 Toxicology-
is a science of posions their source,chemical
composition,action,test for detectionand antitodes
 Toxicologists talk about the target of a toxicant, they
are referring to the particular macromolecule, cell,
organ or biochemical process that the toxicant
disrupts.
 The way the toxicant is able to disrupt that process is
called the mechanisnm of action the toxicant. Not all
toxicants are lethal. They may alsocause disease,
tissue damage,genetic alterations, cancer, etc.

3. Continued….

4. Safety pharmacology-
 Definition- Saftey pharmacology is defined as those
studies that investigate the potential undesirable
pharmacodynamic effects of substance on physiological
functions in relation to exposure in theraputic range and
above.
On the basis of hierarchical systems of human body it is
divided in three category;
1.Core battery 2. follow up study
3. Supplemental study.

5. Microalgae-
Microalgae are prokaryotic or eukaryotic photosynthetic
micro organism that grow rapidly and live in harsh
conditions due to their unicellular or simple multicellular
structure. Ex. eukaryotic microalgae is green algae
Chlorophyta.

6. Literature survey;
 The theraputic use of algae has a long history with
records dating back to the chinese ‘Ben cao’ , ayurveda
medicine and materia medica of Discurides (approx 70
AD)This use continues today.
 The application of algae derived compounds in modern
medicine is still limited,however in last 15 years
compounds from microalgae such as caratenoids ,long
chain poly unsaturated fatty acids ,proteins are sold as
neutraceuticals.
 for example spirulina plantesis is a good source of protein.

7. Algal pigments….

8. Continued……
 Algae are proving to be a source of many potential new
drug and bioactive molecules with diverse
pharmacological activities.
 Biological activities in algal natural compounds have wide
effect such as antibacterial,antifungal,antiviral,and
antioxidant activities.

9. Applications of algae..

10. Need of work……
 Thus, as we have seen in literature survey there is need
of more use and commercial applications of microalgae to
satisfy the demands of increasing world population.
 But, it is prime important to asses the pre-clinical
evaluation of new test substance on rodents before
practicized on humans.

11. Aim and objective…
A] To Study single dose acute oral toxicity study of Microlagea;
1. Cladophora ,
2. Spirogyra,
3. Sirogonium,
4. Chlorella ,
5. Scendesmus ,
B] To Study repeated dose oral toxicity (28 days)of Microlagea;
1. Cladophora .
C]To Study repeated dose oral toxicity (28 days)of Microlagea;
1. Spirogyra

12. Material and methods…..
Collection of algal biomass
Selection of laboratory animal
Housing and diet of laboratory animal
Acclimatization of laboratory animal
Preparation of doses.
Number of animals and dose levels.
Procedure to be followed.
Observations and interpretation of results.

13. Material and methods……..
A] study of single dose (14 Days) acute oral toxicity of algae and in
rats.(OECD guidelines 423);
 The acute oral toxicity of algae and will be performed according to
OECD guidelines 423.
 The dose of 2000 mg/kg will be administered in female rats. Control
group will be administered with 1 ml/kg vehicle.
 The effect of the extract on body weight and food water
consumption of the test group will be done in comparison with the
control group.
 Various parameters such as body weight, Food and water
consumption FOB will be determined on the 0th, 7th, 14th day and
relative organ weight of the control and treated group will also be
determined. (OECD guidelines, 423) Histopathology if available.

14. Material and method…….
B] study of the sub-acute (28 days)oral toxicity of algae Cladophora ;
(OECD guidelines, 407).
 Depending on the submaximal dose from single dose oral acute
toxicity different doses of the algae will be selected for sub acute
oral toxicity study and administered to the test group. period.Both
the male and female rat will be selected for the study.
 Toxicity and mortality will be observed during the experimental
period.
 Physiological ,FOB parameters will be evaluated on 0th, 7th, 14th,
21st, 28th and 42ndday For control,test and reserved group.
 Hematological, biochemical and Histopathology study will be
carried to study the effect of the drug on the major organs. (OECD
guidelines, 407).

15. Continued………
C] Study of the sub-acute (28 days)oral toxicity of algae Spirogyra; (OECD
guidelines, 407).
 Depending on the submaximal dose from single dose oral acute
toxicity different doses of the algae will be selected for sub acute
oral toxicity study and administered to the test group.Both the male
and female rat will be selected for the study.
 Toxicity and mortality will be observed during the experimental
period.
 Physiological ,FOB parameters will be evaluated on 0th, 7th, 14th,
21st, 28th and 42ndday For control,test and reserved group.
 Hematological, biochemical and Histopathology study will be
carried to study the effect of the drug on the major organs. (OECD
guidelines, 407).

16. STATISTICAL ANALYSIS…..
 Statistical analysis will be done by one way ANOVA followed
by Dunnett’s test.
 Data will be express as Mean ± SEM.

17. Hypothesis….
 The aim of present work is to check the toxicity of algal
species and If,they are toxic they will be discarded.
 Depending on results If they are safe ,we can proceed
further and use them as a animal feed, neutraceuticals,
feed additives,pharmacologically active biomolecules and
theraputic agents respectively.

18. Continued……..

19. REFERENCES……..
 F.S.k .Barar Essentials of pharmacotherapeutics, Edition 5
th, page no 1
 Satish kumar , CNS safety pharmacology, CRIPS vol. 8 no.1
,2007
 Teresam, et al microalgae for biodiesel production and
other application.Renewable and sustainable energy review
14(2010)217-232
 Sushil kumar etal , International journal of pharmcy and
pharmaceutical sciences, vol 4, suppl. 2, 2012.
 Michael borowitzka, pharmaceuticals from algae, journal
of biotechnology.vol-2

20.  El–barky et al, characterisation of neutraceutical
compound in blue green algae spirulina maxima, journal of
medicinal plant and research , vol 2(10),page no 292-300,
oct 2008
 M salzar et al, subchronic toxicity study in mice fed
spirulina maxima , journal of ethnopharmacology, 62(1998)
235- 241.
 OECD Guideline for the testing of chemicals: Acute oral
toxicity (2001); 423
 OECD Guideline for the testing of chemicals: Repeated
dose 28 day oral toxicity study in rodents (2008); 407