Diligent profiling of preclinical safety of the silk protein sericin

Farogh Ahsan; Tarique Mahmood; Mohammed Haris Siddiqui; Shazia Usmani; Paramdeep Bagga; Arshiya Shamim; Ritesh Kumar Srivastav

doi:10.1515/jbcpp-2019-0272

Article

Diligent profiling of preclinical safety of the silk protein sericin

Farogh Ahsan , Tarique Mahmood , Mohammed Haris Siddiqui , Shazia Usmani , Paramdeep Bagga , Arshiya Shamim and Ritesh Kumar Srivastav

Published/Copyright: March 5, 2020

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From the journal Journal of Basic and Clinical Physiology and Pharmacology Volume 32 Issue 5

Abstract

Background

Sericin is a widely used protein in the pharmaceutical industry derived from the silkworm, Bombyx mori, and used for the treatment of various diseases and pathological conditions. It is the main ingredient of the Unani preparation khameera abresham. The study was conducted to evaluate the preclinical toxicity of the silk protein sericin in mice.

Methods

In the acute toxicity study, sericin was administered once orally to different groups of animals at doses of 500, 1000, and 2000 mg/kg. Animals were observed for 14 days. In the sub-acute toxicity study, sericin was administered in mice for 4 weeks in the toxic group at doses of 500, 1000, and 2000 mg/kg, while in the recovery group it was administered for 4 weeks at doses of 500 and 2000 mg/kg followed by 2 weeks of distilled water administration.

Results

In the acute toxicity study, the observed parameters showed no significant difference, and no mortality was reported. In the sub-acute toxicity study, there were no toxicological effects in any of the estimated parameters, while histopathological analysis showed inflammation in vital organs at the dose of 2000 mg/kg.

Conclusions

Results of our acute toxicity study suggest that sericin is safe at all administered doses, while the sub-acute study suggests that the NOAEL (no-observed-adverse-effect level) of sericin is below 2000 mg/kg, at which it can be considered safe.

Keywords: acute toxicity; Bombyx mori ; mortality; sericin; sub-acute toxicity

Acknowledgments

We thank Prof. Syed Waseem Akhtar, Hon. Chancellor, and Prof. Aqil Ahmad, Hon. Vice Chancellor, for providing excellent research facilities at the University. We also extend our gratitude to Prof. Syed Misbahul Hasan, Dean, for reviewing the manuscript and providing valuable suggestions. The University has provided a manuscript communication number for further communication (IU/R&D/2019-MCN000625).

Research funding: This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.
Author contributions: TM, SU, and MHS designed the study, FA performed the experiment and analyzed the data, and AS and RKS helped in drafting the manuscript. PB helped in performing the statistical analysis. All authors have equally contributed, read, and approved the manuscript before submission.
Competing interests: The authors declare no conflicts of interest with respect to the research, authorship, and/or publication of this article.
Ethical approval: The study protocol was also reviewed and approved by Institutional Animal Ethical Committee (IAEC), Faculty of Pharmacy, Integral University, Lucknow, India (Reg no. 1213/PO/Re/S/08/CPCSEA, 5 June 2008), approval no. IU/IAEC/17/01.

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Received: 2019-09-26

Accepted: 2019-11-30

Published Online: 2020-03-05

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Articles in the same Issue

https://doi.org/10.1515/jbcpp-2019-0272

Keywords for this article

acute toxicity; Bombyx mori; mortality; sericin; sub-acute toxicity