Determining safety of betacarboclomet cream in epidermal delivery to the body of animals

Authors

  • G. M. Voytenko
  • Aram Dullah
  • I. O. Vlasenko
  • L. L. Davtyan

DOI:

https://doi.org/10.14739/2409-2932.2015.2.45104

Keywords:

Ointments, Toxicity Tests, Drug Evaluation, Predinical

Abstract

Aim. The article is devoted to safety determining of newly developed drug as one of the important stages of preclinical evaluation in the organization of industrial manufacturing.  

Methods and results. The study of safety of newly developed Betacarboclomet cream in epidermal delivery to the body showed that the LD50 of Betacarboclomet exceeds to 2000 mg/kg. Significant changes in body mass the animals after dermal application of cream and in control group animals have not been determined. A post-mortem examination of internal organs and tissues of animals after dermal application of Betacarboclomet at a dose of 2000 mg/kg revealed no signs of pathological changes, hemocirculatory disorders or inflammatory reactions.

Conclusion. The results of the study allow referring Betacarboclomet to toxicity Class V (virtually non-toxic substance).

References

Stephanov, A. V. (Ed.) (2002) Doklinicheskie issledovaniya lekarstvennykh sredstv [Preclinical studies of drugs]. Кyiv: Аvicena. [in Ukrainian].

OECD GUIDELINE FOR TESTING OF CHEMICALS. OECD GUIDELINE 402 «Acute Dermal Toxicity», adopted: 24 Feb 1987. Retrieved from www.oecd.org.

Volkova, O. V., & Eleckij, Y. K. (1982). Osnovy gistologii s gistologicheskoj tekhnikoj [Fundamentals of histology with histological technique]. Moscow: Mеdicina. [in Russian].

Reznikov, A. G. (2010) Bioe`ticheskie aspekty e`ksperimentov na zhivotnykh [Bioethical aspects of animal experiments]. Klinichna khirurhiia, 6, 8–13. [in Ukrainian].

(2001) Derzavna pharmacopeia Ukrainy. Kharkiv: RIREH. [in Ukrainian].

A Guide to the Globally Harmonized Sys of Classification and Labelling of Chemicals (GHS). Retrieved from www.osha.gov/dsg/hazcom/ghs.html#3.2

(1976) Vrednye veschestva. Klassifikaciya i obschie trebovaniya bezoposnosti [Hazardous substances. Classification and general safety requirements]. [in Russian].

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How to Cite

1.
Voytenko GM, Dullah A, Vlasenko IO, Davtyan LL. Determining safety of betacarboclomet cream in epidermal delivery to the body of animals. Current issues in pharmacy and medicine: science and practice [Internet]. 2015Jul.14 [cited 2024Apr.23];(2). Available from: http://pharmed.zsmu.edu.ua/article/view/45104

Issue

No. 2 (2015)

Section

Experimental and clinical pharmacology

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