Material Safety Data Sheet POLYSORBATE 80 MSDS
October 29, 2012 – Assessment report Immunological differences of pandemic vaccines (review of hypothesis on Pandemrix and development of narcolepsy) “The authors suggest that their data show that children who developed narcolepsy after Pandemrix vaccination developed an altered immune response, and that polysorbate 80 is an immunologically active substance in the H1N1 antigen suspension of Pandemrix. They hypothesize that polysorbate 80 in H1N1 antigen suspension of Pandemrix revealed new epitope(s) in the viral protein(s), and the antibodies against these epitopes cross-reacted with narcolepsy associated autoantigens.”
May 2012 – Hypersensitivity reaction to human papillomavirus vaccine due to polysorbate 80. “A 17-year-old girl reported generalized urticaria, eyelid angioedema, rhino-conjunctivitis, dyspnea and wheezing 1 hour after third intramuscular administration (injection) of quadrivalent human papillomavirus vaccine (Gardasil). She was treated with antihistamine, and corticosteroids with prompt relief of rhinitis and dyspnoea, while urticaria and angioedema lasted 24 hours. Intradermal test with Gardasil, which contains polysorbate 80 (PS80), resulted positive, while skin tests with the bivalent vaccine were negative. Prick test performed with PS80 resulted positive in the patient and negative in ten healthy controls. The CD203 basophil activation test result was negative for PS80 at all the tested dilutions and specific IgE was not found. As flu vaccine was recommended, the authors' skin tested two flu vaccine, one containing PS80 (Fluarix, GSK), which resulted positive and another flu vaccine with no adjuvant or preservative (Vaxigrip, Sanofi Pasteur MSD), which gave negative results. The patient then received Vaxigrip without adverse reactions.”
September 1, 2008 – Anaphylaxis following quadrivalent human papillomavirus vaccination (pdf) “Quadrivalent HPV (Gardasil) vaccine contains polysorbate 80 as a stabilizer. Polysorbates are commonly used as solubilizers, stabilizers and emulsifiers in cosmetics and medical preparations. Polysorbate 80 could be a potential trigger of nonallergic (“anaphylactoid”) anaphylaxis. There have been a number of reports of anaphylaxis or generalized hypersensitivity reactions occurring following the receipt of drugs that have implicated polysorbate 80 as the cause.
August 30, 2008 – Polysorbate 80 and Histidine, a marriage of disaster by Cynthia Janak. (many scientific links).
January 2008 – Evaluation of developmental neurotoxicity of polysorbate 80 in rats. “The developmental neurotoxicity of polysorbate 80 (PS80) was evaluated. Rats were given drinking water containing polysorbate 80 (PS80) [at a range of concentrations] on day 0 of pregnancy through day 21 after delivery. Pregnant rats were allowed to deliver spontaneously. Potential adverse effects of pre- and post-natal exposure on the development and function of the nervous system in offspring of rats given PS80 were examined. Maternal body weight was lowered at 7.5%. The number of pups born was lowered at 7.5%. Histopathological examinations of the brain revealed no toxicological changes. Lowered body weight was observed in male and female offspring.
February 2007 – Alternative drug formulations of docetaxel: a review “Docetaxel (trade name Taxotere) is a chemotherapy medication used mainly for the treatment of breast, ovarian, prostate, and non-small cell lung cancer. Docetaxel is associated with the occurrence of unpredictable (acute) hypersensitivity reactions and cumulative fluid retention. These side-effects have been attributed, in part, to the presence of polysorbate 80 and have consequently initiated research focused on the development of a less-toxic, better-tolerated polysorbate 80-free formulation of docetaxel.” Comment: Polysorbate 80 causes serious side effects in oral medications and a substitute is sought. But when it causes serious reactions in a vaccine, the association is ignored.
December 2005 – Polysorbate 80 in medical products and nonimmunologic anaphylactoid reactions “Polysorbate 80 is a widely used solubilizing agent that can cause severe nonimmunologic anaphylactic reactions.”
September 2003: Specific role of polysorbate 80 coating on the targeting of nanoparticles to the brain (full text)- It was reported that nanoparticles with polysorbate 80 (Tween 80, PS80, T-80) coating represented tools used for delivering drugs into the brain. The presence of a complex composed by the model loading, PS80 and nanoparticles were found in the preparation of nanoparticles. Partial coverage was enough for PS80 coating to play a specific role in brain targeting. Therefore, the specific role of PS80 coating on nanoparticles in brain targeting was confirmed.
March 1993 – Delayed effects of neonatal exposure to Tween 80 on female reproductive organs in rats. “Neonatal female rats were injected intraperitoneally (0.1 ml/rat) with Tween 80 in 1, 5 or 10% aqueous solution on days 4-7 after birth. Treatment with Tween 80 accelerated maturation, prolonged the oestrus (mentrual) cycle, and induced persistent vaginal oestrus. The relative weight of the uterus and ovaries was decreased relative to the untreated controls. Squamous cell metaplasia of the epithelial lining of the uterus and cytological changes in the uterus were indicative of chronic oestrogenic stimulation. Ovaries were without corpora lutea, and had degenerative follicles.
April 1, 1986 – Polysorbate 80 and E-Ferol Toxicity “Because a mixture of polysorbate 80 and polysorbate 20 is used as a carrier in E-Ferol, these components were also tested and were found to be responsible for the suppression, especially the polysorbate 80. Concurrent with this suppression of PHA-induced mitogenesis was a decrease in the percentage of T11 lymphocytes.”
March 1977 – Cardiovascular effects of radioactive microsphere suspensions and Tween 80 solutions “Thus, care must be exercised in application of microsphere techniques to organ blood flow measurements when Tween 80 is used to prevent microsphere aggregation, since this surface-active agent causes profound alterations in cardiac dynamics in concentrations normally employed in experiments involving microsphere techniques.”
Polysorbate 20
Material Safety Data Sheet Polysorbate 20 MSDS Tween 20 Tween (full name Tween 20 or Polysorbate 20) is a common detergent used in biology used in cell lysis and membrane protein solubilisation among other uses. “The polysorbates have been reported to be incompatible with alkalis, heavy metal salts, phenols, and tannic acid. Polysorbates may reduce the activity of many preservatives.”
February 2010 – Fluorescent Molecular Rotors as Dyes to Characterize Polysorbate-Containing IgG Formulations (full text) “Almost 70% of the marketed monoclonal antibody formulations contain polysorbate 20 or polysorbate 80 as stabilizing excipients. Within those commercial preparations, the polysorbate concentrations range between 0.001% (w/v) polysorbate 80 (Reopro) and 0.16% (w/v) polysorbate 20 (Raptiva), with most formulations containing about 0.005 to 0.02% polysorbate 20 or 80.”
1989 – Polysorbate 20 “On repeated intravenous administration, effects on the liver, spleen and kidneys were seen in premature babies exposed to a mixture of polysorbate 80 and polysorbate 20, some fatalities occurred.”
April 1, 1986 – Polysorbate 80 and E-Ferol Toxicity “Because a mixture of polysorbate 80 and polysorbate 20 is used as a carrier in E-Ferol, these components were also tested and were found to be responsible for the suppression, especially the polysorbate 80. Concurrent with this suppression of PHA-induced mitogenesis was a decrease in the percentage of T11 lymphocytes.”