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Tween-80 and impurity induce anaphylactoid reaction in zebrafish
Rui Yang1, Qiao-Cong Lao, Hang-Ping Yu
1National Institutes for Food and Drug Control, China Food and Drug Administration (CFDA), No. 2 Tiantan Xili, Dongcheng District, Beijing, 100050, China.
Journal of Applied Toxicology : JAT
|October 28, 2014
Summary
Tween-80 impurities, not Tween-80 itself, may cause anaphylactoid reactions. A novel zebrafish assay identified hydrogen peroxide as a key culprit, enabling better safety assessments for injectable medicines.
Area of Science:
- Pharmacology
- Toxicology
- Zebrafish models
Background:
- Reports suggest Tween-80 in injectable medicines may cause anaphylactoid reactions.
- Assessing drug-induced anaphylactoid reactions in vitro and conventional animal models is challenging.
Purpose of the Study:
- Develop a quantitative in vivo zebrafish assay for anaphylactoid reactions.
- Investigate Tween-80 and its impurities as potential inducers of anaphylactoid reactions.
Main Methods:
- Developed a microplate-based quantitative in vivo zebrafish assay.
- Measured live whole zebrafish mast cell tryptase activity at 405 nm.
- Assessed 10 batches of Tween-80 and three impurities (ethylene glycol, 2-chloroethanol, hydrogen peroxide).
Main Results:
- Three Tween-80 batches and hydrogen peroxide induced anaphylactoid reactions in zebrafish.
- Higher hydrogen peroxide residue and peroxide values were found in reactive Tween-80 batches.
- Oxidized fatty acid residues in Tween-80, not Tween-80 itself, are implicated.
Conclusions:
- Hydrogen peroxide residue and oxidized fatty acid residues in Tween-80 may induce anaphylactoid reactions.
- The developed zebrafish assay is suitable for assessing injectable medicine safety.
- This assay can be used for screening novel mast cell-modulating drugs.
