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Toxicity Study Report Outline

1.

Summary

2.

Guidelines

3.

Objectives

4.

Materials and methods

4.1.

Preparation of dose

4.2.

Test system

4.2.1.

Rationale for selection of test system

4.2.2.

Justification for Route of administration, indicated dosage & duration of therapy

4.3.

Preparation of animals

5.

Experimental procedure

6.

Observations

7.

Evaluation of results

8.

Results

8.1.

Skin Reaction

8.2.

Clinical signs of intoxication

8.3.

Table A: Body weight

8.4.

Table B: Dermal Irritation

8.5.

Table C: clinical signs of intoxication

9.

Conclusion

10.

Appendix: Draize evaluation of skin reactions



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