Acute toxicity of 18F-NaF in mice

  • That Nguyen Khac 108 Military Central Hospital
  • Dung Nguyen Thi Kim 108 Military Central Hospital
  • Linh Nguyen Tran 108 Military Central Hospital
  • Ha Le Ngoc 108 Military Central Hospital
  • Duong Nguyen Thuy Hanoi University of Pharmacy

Main Article Content

Keywords

18F-NaF, acute toxicity, mice

Abstract

Objective: To evaluate the acute toxicity of 18F-NaF produced on self-manufactured module of Cyclotron Center at 108 Military Central Hospital. The experiments were conduced on Swiss white mice with 100 times of human dose according to the single-dose toxicity test method for the active ingredients at very small doses in the guidance of the European Pharmaceutical Administration (EMA), incorporating general principles in acute toxicity studies following OECD guidelines. Result: After 24 hours and 14 days of 17.1mCi/kg 18F-NaF  injection, the weight, blood tests such as WBC, RBC, HGB, PLT, AST, ALT… of mices did not affect by the 18F-NaF and the histopathologic fearures of mices were not also affected by 18F-NaF. Conclusion: 18F-NaF radiopharmaceutical prepared by the self-manufactured module of Cyclotron Center at 108 Military Central Hospital had no acute toxicity in the mice model.

Article Details

References

1. Shukla AK, Kumar U (2006) Positron emission tomography: An overview. J. Med. Phys 31: 13-21.
2. Taylor K, Jenifer AL, Douglas RB (2014) Radiation-induced DNA damage and the ralative biological effectiveness of 18F-FDG in wild-type mice. Mutagenesis 29: 279-287.
3. Frush DP, Perez MDR (2017) Children, medical radiation and the en vironment: An important dialogue. Environ. Res. 156: 358-363.
4. Prasad A, Visweswaran S, Kanagaraj K et al (2019) 18F-FDG PET/CT scanning: Biological effects on patients: Entrance surface dose, DNA damage, and chromosome aberrations in lymphocytes. Mutat. Res 838: 59-66.
5. Chen YK, Ding HJ, Su CT, Shen YY, Liao AC, Hung TZ, Hu FL, Kao CH (2004) Application of PET and PET/CT imaging for cancer screening. Anticancer. Res 24: 4103-4108.
6. Gilbert ES (2009) Ionising radiation and cancer risks: What have we learned from epidemiology? Int. J. Radiat. Biol 85: 467-482.
7. Mullenders L, Atkinson M, Paretzke H, Sabatier L, Bouffler S (2009) Assessing cancer risks of low-dose radiation. Nat. Rev. Cancer 9: 596-604.
8. European Medicines Agency (2009) Non-clinical safety studies for the conduct of human clinical trials and marketing authorization for pharmceuticals. ICH guideline M3(R2).
9. OECD (2002) Test no. 420: Acute oral toxicity - fixed dose procedure. OECD Guidelines for the Testing of Chemicals, Section 4, OECD Publishing,
Paris.DOI:http://dx.doi.org/10.1787/9789264070943-en.
10. OECD (2002) Test no. 423: Acute oral toxicity-acute toxic class method. OECD Guidelines for the Testing of Chemicals, Section 4, OECD
Publishing, Paris.DOI:http://dx.doi.org/10.1787/9789264071001-en.
11. OECD (2008) Test no. 425: Acute oral toxicity: Up-and-down procdure. OECD Guidelines for the Testing of Chemicals, Section 4, OECD Publishing,
Paris. DOI: http://dx.doi.org/10. 1787/978926x4071049-en.
12. Ziessman HA, O'Malley JP (2014) Nuclear medicine: The requisites. 4th Edition. Fourth ed. New York: Saunders: 412.
13. WHO (2016) The international pharmacopoeia. Sixth Edition.
14. Bastawrous S, Bhargava P, Behnia F, Djang DSW, Haseley DR (2014) Newer PET application with an old tracer: Role of 18F-NaF Skeletal PET/CT in Oncologic Practice. RadioGraphics 34(5): 1295-1316.
15. Tanmoy M, Amit N (2019) 18F-FDG-induced DNA damage, chromosomal aberations, and toxicity in V79 lung fibroblast cells. Elsevier 847: 503105.
16. Danielle MD, João AO (2013) Acute and subacute toxicity of 18F-FDG. International Nuclear Atlantic Conference-INAC 2013.
17. Jha SK, Mishra VK, Sharma DK, Damodaran T (2011) Fluoride in the environment and its metabolism in humans anonymous reviews of environmental contamination and toxicology. New York: Springer: 121-142.
18. Ponikvar M (2008) Exposure of humans to fluorine and its assessment. Fluorine Health 7: 487-549.
19. Martínez-Mier EA (2012) Fluoride: Its metabolism, toxicity, and role in dental health. J Evid Based Complement Alternat Med 17: 28-32.
20. Smith FA (2012) Fluoride toxicity. New York: Handbook of Hazardous Materials: 277-283.
21. Whitford GM (2011) Acute toxicity of ingested fluoride. Monogr Oral Sci 22: 66-80.