Toxicological Evaluation of Isobutyl Paraben: A Combined Repeated Dose and Reproductive/Developmental Study in Rats

Abstract

Background: The chemical isobutyl paraben, used in the cosmetic, pharmaceutical, and food industries, has garnered attention as a potential hormonal disruptor. Its chemical structure, which includes an estrogen-like component and lipophilic properties, leads to widespread toxicities and hormonal disorders. The available toxicological data on IBP offers insufficient information regarding its long-term effects and developmental risks.

Methodology: This study analyzed the impact of oral IBP administration on the systemic health and reproductive and developmental systems of Wistar rats. Following the OECD Test Guidelines, Wistar rats received IBP orally via a corn oil vehicle. 

Results: Assessments of organ weights and tissue investigations revealed multiple organ toxicities in both male and female rats. Male rats given higher doses of IBP exhibited reduced food intake and weight loss, while female rats gained weight across all treatment groups. Biochemical tests on male subjects indicated that the drug dose directly influenced changes in blood glucose, cholesterol, and urea levels. Female rats showed significant alterations in both red and white blood cells, impacting their overall hematological profile. Researchers employed organ weight measurements together with histopathological results to identify specific toxic effects affecting individual organs in both male and female test subjects. 

Conclusion: This study provides essential preclinical data necessary18 for regulatory agencies to assess the safety of consumer products containing IBP. The findings will aid regulatory bodies in evaluating the safety of IBP for consumer use.

Major Findings: IBP decreased food intake and weight in males, increased weight in females, and caused systemic biochemical, hematological, and organ toxicities.