Toxicity Studies

Complete toxicity studies were conducted on Psorolin Ointment under OECD (Organization for Economic Co-operation and Development) guidelines for Toxicity studies.

NAME OF THE STUDY	REFERENCE OECD NO	FINDINGS FOR Dr.JRK’S 777 OIL
Skin Sensitization in Guinea pig	406	Did not produce skin sensitization effect after 24 h and 48 h of removal of the patch
Effect on Mucus membrane	405	Did not produce mucus membrane irritation
In vitro Mammalian cell gene mutation test- chinese hamster ovary K1 cell line	476	Did not show any mutagenic effect
Bacterial reverse mutation test using S. typhimurium and E.coli WP2 uvr A	471	Did not show any mutagenic effect on all four strains of S. typhimurium and E.coli
Mammalian erythrocyte Micronucleus testing swiss albino mice	474	Did not produce toxic effect on bone marrow and total polychromatic/ erythrocyte ratio (P/E).
Acute lethal dose	408	No change in the viscera/ organs and in the histological parameters was observed even in the animals that received high dose of the product.
Reproduction developmental toxicity screening	421	Did not produce reproduction and developmental toxicity.Pups – did not reveal any abnormalities either at reproductive and histological level

Effect of Topical application of Psorolin ointment in management of Pityriasis versicolor

• 50 patients of age group between 13 – 35 years were selected for the study and the disease was confirmed by KOH scrapings from lesions.
• The patients were asked to apply Psorolin ointment twice a day for 4 weeks.
• Changes in their symptoms, degree of scaling, pigmentation and occurrence of any side effects and also the mycological improvement were monitored weekly.
• Reassessment after 12 weeks in a similar manner was done for recurrence.

Study findings

• All patients showed mycological cure with significant clinical improvement proving the efficacy of Psorolin ointment in treating Pityriasis versicolor.

Psorolin ointment effective in inhibition of human keratinocytes multiplication.

Psorolin ointment at various concentrations (0.2-100mg/ml) was evaluated by MTT assay using HaCaT cell line to determine its efficacy in inhibiting keratinocytes proliferation.

Study findings

• Psorolin ointment was highly effective in inhibiting the human keratinocytes proliferation at lower concentrations of 6.3mg/ml.