145
Views
0
CrossRef citations to date
0
Altmetric
Research Articles

Acute, repeated inhalation toxicity, respiratory system irritation, and mutagenicity studies of 1,1,2,2-tetrafluoroethane (HFC-134) as the impurity in the pharmaceutical propellant 1,1,1,2-tetrafluoroethane (HFA-134a)

, , &
Pages 841-850 | Received 17 Mar 2022, Accepted 17 Jul 2022, Published online: 03 Aug 2022

References

  • Alexander, D.J., et al., 1995. An overview of the toxicology of HFA-134a (1,1,1,2-tetrafluoroethane). Human & Experimental Toxicology, 14 (9), 715–720.
  • Araki, A., et al., 1994. Improved method for mutagenicity testing of gaseous compounds by using a gas sampling bag. Mutation Research, 307 (1), 335–344.
  • Brock, T.P., et al., 2006. Readability of brochure about phase-out of chlorofluorocarbons in metered-dose inhalers. American Journal of Health-System Pharmacy, 63 (9), 807–808.
  • Brock, W.J., 1996. Acute, subchronic, and developmental toxicity and genotoxicity of 1,1,1-trifluoroethane (HFC-143a). Fundamental and Applied Toxicology, 31 (2), 200–209.
  • Chinese Pharmacopeia, 2020. Pharmacopoeia of the People's Republic of China (ChP). Beijing: China Medical Science and Technology Press.
  • [ECETOC] European Center for Ecotoxicology and Toxicology of Chemicals, 1990. Joint Assessment of Commodity Chemicals No. 14 1-chloro-2,2,2,-trifluoroethane (HFA-133a). CAS:75-88-7. Brussels: ECETOC.
  • [ECETOC] European Center for Ecotoxicology and Toxicology of Chemicals, 2006. Joint Assessment of Commodity Chemicals No. 50 1,1,1,2-tetrafluoroethane (HFC-134a). CAS:75-88-7. 2nd ed. Brussels: ECETOC.
  • [EP] European Pharmacopeia, 2016. European Pharmacopeia. 9th ed. Strasbourg: Council of Europe.
  • Gehring, D.G., et al., 1992. Chlorofluorocarbons alternatives analysis, part I: the determination of HFC-134a purity by gas chromatography. Journal of Chromatographic Science, 30 (7), 280–284.
  • Kawano, T., 1995. Toxicological evaluation of 1,1,1,2,2-pentafluoroethane (HFC-125). Fundamental and Applied Toxicology, 28 (2), 223–231.
  • Maron, D.M. and Ames, B.N., 1983. Revised methods for the Salmonella mutagenicity test. Mutation Research/Environmental Mutagenesis and Related Subjects, 113 (3–4), 173–215.
  • [NMPA] National Medical Products Administration, 2014a. Guidance for single dose acute toxicity testing for pharmaceuticals. Beijing: NMPA.
  • [NMPA] National Medical Products Administration, 2014b. Guidance for irritation, sensitization and hemolysis testing of drug products. Beijing: NMPA.
  • [NMPA] National Medical Products Administration, 2014c. Guideline for repeated dose toxicity of drug products. Beijing: NMPA.
  • [NRC] National Research Council, 2002. Acute exposure guideline levels for selected airborne chemicals. Vol. 2. Washington (DC): National Academies Press.
  • [OECD] Organization for Economic Cooperation and Development, 2009. Test no. 403: acute inhalation toxicity, OECD guidelines for the testing of chemicals, section 4. Paris: OECD.
  • [OECD] Organization for Economic Cooperation and Development, 2018. Test no. 412: subacute inhalation toxicity: 28-day study, section 4. Paris: OECD.
  • [OECD] Organization for Economic Cooperation and Development, 2020. Test no. 471: bacterial reverse mutation test, section 4. Paris: OECD.
  • Ritchie, G.D., et al., 2001. Acute neurobehavioral effects in rats from exposure to HFC 134a or CFC 12. Neurotoxicology, 22 (2), 233–248.
  • Rusch, G.M., et al., 1999. The acute, genetic, developmental, and inhalation toxicology of 1,1,1,3,3-pentafluoropropane (HFC 245fa). Toxicological Sciences, 52 (2), 289–301.
  • Rusch, G.M., et al., 2013. The acute, genetic, developmental and inhalation toxicology of trans-1,3,3,3-tetrafluoropropene (HFO-1234ze). Drug and Chemical Toxicology, 36 (2), 170–180.
  • Stein, S.W. and Thiel, C.G., 2017. The history of therapeutic aerosols: a chronological review. Journal of Aerosol Medicine and Pulmonary Drug Delivery, 30 (1), 20–41.
  • The Kigali Amendment, 2016. The Montreal Protocol on substances that deplete the ozone layer. Kigali: The Kigali Amendment: The amendment to the Montreal Protocol agreed by the Twenty-Eighth Meeting of the Parties.
  • [USP] The United States Pharmacopeia, 2018. USP41-NF36 S1. New York: United States Pharmacopeial Convention, Inc.
  • Thoolen, B., et al., 2010. Proliferative and nonproliferative lesions of the rat and mouse hepatobiliary system. Toxicologic Pathology, 38 (7 Suppl.), 5S–81S.
  • Tveit, A., et al., 2013. The acute, developmental, genetic and inhalation toxicology of 2,3,3,3-tetrafluoropropene (HFO-1234yf). Drug and Chemical Toxicology, 36 (4), 412–420.
  • [CDER] U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, 2018. Metered dose inhaler (MDI) and dry powder inhaler (DPI) products-quality considerations guidance for industry (DRAFT GUIDANCE). Rockville: CDER.
  • Workplace Environmental Exposure Level, 2019. 1,1,2,2-Tetrafluoroethane (HFC-134) (2018). Toxicology and Industrial Health, 35 (3), 196–203.

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.