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Polysorbate 80 or Kolliphor RH 40 as a surfactant?
I formulated a product with both non-ionic surfactants and sent it out for microbial screening. It was hard to preserve because I’m using > 10% non-ionic surfactant, and lots of traditional preservatives don’t work. The results came back, and both samples got a “total kill” rating after 7 days. Now I have the freedom to choose whether to use Polysorbate 80 or Kolliphor RH 40 as my surfactant.
I tried a large array of surfactants and these two are the only candidates. Polysorbate 80 is a polyoxyethylene sorbitan fatty acid ester. Kolliphor RH 40 (from BASF) is a polyoxyethylene hydrogenated castor oil derivative. Kolliphor RH 40 has been used at up to 22% in leave-on products and mouse models show no irritation potential at 20%. Polysorbate 80 has been used at up to 11.9% in leave-on products and 100% Polysorbate 80 in humans was non-irritating.
Given that both are well-studied and non-irritating, non-sensitizing…etc, what are some other advantages or disadvantages of using one over another? This could be stability, consumer perception, or a number of other factors I’m not aware of. Fyi, I’m aware of potential contamination by 1,4-dioxane and ethylene oxide, especially at > 10% concentration and I’m making sure to source products that meet NY regulations.
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3 Replies
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If you’re formulating hair care products, please be careful about using high amounts of non ionic surfactants. There was a case in Brazil of severe eye issues of people that used styling hair products with high amounts of ceteareth-20, which due to sweating, reached consumers eyes (https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2023/pomadas-capilares-anvisa-define-produtos-que-poderao-voltar-ao-mercado-1#:~:text=O%20Ceteareth%2D20%20%C3%A9%20amplamente,de%20mais%20de%20600%20processos
gov.br
Pomadas capilares: Anvisa define produtos que poderão voltar ao mercado
Agência autoriza a volta de uma lista restrita de pomadas capilares ao mercado. Investigações seguem com foco nos produtos relacionados aos eventos adversos graves.
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While I can’t do very much about the high levels of non-ionic surfactant in my product, you do bring up an excellent point about ocular irritation by sweating. Looking at CIR, I see a lot about PEG-35 castor oil being a non-irritant to rabbit eyes at 13.5% but not much about PEG-40. Polysorbate 80 seems to be used as a lubricant in eye drops at 0.5%, and injection of 0.4% by syringe directly into the eyes of rabbits showed no irritation. However, I don’t see much about using 10%.
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Soo surprised from the link so do you guess it is the same for Ceteareth-25? actually almost water based pomade contains more then 20%
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