Hi Muthu

Toxicity testing of new compounds is essential for drug development process. The preclinical toxicity testing on various biological systems reveals the species-, organ- and dose- specific toxic effects of an investigational product. The toxicity of substances can be observed by (a) studying the accidental exposures to a substance (b) in vitro studies using cells/ cell lines (c) in vivo exposure on experimental animals. This review mainly focuses on the various experimental animal models and methods used for toxicity testing of substances. The pre-clinical toxicity testing helps to calculate “No Observed Adverse Effect Level” which is needed to initiate the clinical evaluation of investigational products.

Regards

Article Toxicological screening

Hi..You need to toxicity studies as mentioned in the guidelines OECD 402 and 404 as an acute phase. Based on the results of the acute phase, repeated dose dermal toxicity should be performed as mentioned in the OECD 407 However, exact duration of the cream/oniment treatment should be selected after considering its application to humans. 

Thanks for your suggestions Dr. Ali and Dr. Pandya