PhilGeis
Forum Replies Created
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Love to see the ‘concrete reason.”
To your question - the relevant OTC drug monographs establish data requirements needed you need to market.
https://www.fda.gov/drugs/otc-drug-review-process-otc-drug-monographs
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Pretty sure that would not be a drug claim - but give me break. That’s BS.
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Agree - the solution is at risk for contamination. You could get a rough idea by comparing ZOI - before and after autclaving.
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Makes to difference - it’s a poor preservative system at an y concentration.
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At best “broad spectrum” is based on an existing MIC (at any concentration) for each of the bugs representing the groups: Gram + and -, yeast and molds. While in-formula efficacy data establish practical the definition, we know the mythical creature does not exist - as seen on labels with major brands.
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Why would you autoclave?
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Inactivation? Test it.
COSMOS/Ecocert confines your efforts to options limited in efficacy. Your package may limit consumer contamination but magnifies risk (via inhalation) if there is contamination. What is the quality of your production - water, raw materials, sanitization, etc.? Major manufacturers work on a 3 year product life.
To ketchito’s question - efficacy (hair growth and anti dandruff) - add safety, esp. via inhalation. How do you answer these?
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That’s a stretch - “soap” a single factor of product formulation - and maybe EO - is “hurdle. Suppose a bottle of chlorine bleach is hurdle.
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What’s your packaging?
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For shampoo - use isothiazolinone (as suggested), Na benzoate (2500 ppm) and EDTA (1000 ppm). Anionic surfactants raise the effective pKa for Benzoate.
Vs. isothiazolinone, Phenoxy is not as good but DMDM Hydantoin (2500 ppm) would be a replacement..
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I understand some may not be familiar with antimicrobial efficacy of benzoate/benzoic acid at near neutral pH. Here’s a ref - https://www.sofw.com/en/sofw-journal/articles-en/47-home-care/1703-enhancing-antimicrobial-efficacy-of-sodium-benzoate
and You’ll find it with isothiazolinones in many mass market shampoos.
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In concept, preservation by a combination of factors none of which has a primary antimicrobial effect - e.g. mildly acidic or basic pH, Aw <0.9, low % alcohol, etc. Maybe toss in a pump packaged.
Shampoos? Don’t bet on it. Don’t waste your time
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Good point Mike - as a scientific question -safety in any aspect is and will always be open for discovery. Parabens have been the most investigated of preservatives and SCCS is reportedly in process of addressing additional data that offered in support of methyl paraben safety.
It’s also worth noting that many of the replacement preservatives are not approved and the subjects of limited to no safety testing.
chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://health.ec.europa.eu/system/files/2022-02/sccs2022_q_001.pdf
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Mike, whereas the scare mongering may have made the question academic, what do you see as the open question re. parabens that current risks assessments have not addressed?
https://www.sciencedirect.com/science/article/abs/pii/S027323002100146X
https://www.cir-safety.org/sites/default/files/paraben_web.pdf
https://journals.sagepub.com/doi/full/10.1177/1091581820925001
https://www.fda.gov/cosmetics/cosmetic-ingredients/parabens-cosmetics
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Analogous - one can find >750,000 citations for combined search terms formaldehyde and cancer. Yet the same sources CIR, FDA, SCCS have determined and confirmed safety in use for formaldehyde releasing preservatives in cosmetics. As correctly noted by J&J researchers when they grudgingly removed Dowicil from their baby shampoo - there’s more formaldehyde in a plum than their product.
Be aware- CIR, SCCS, FDA work on risk assessment rather than an attempt at risk elimination - consistent with Paracelsus caution - the poison is in the dose.
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That two terms are associated in a publication does not mean they report or confirm cause and effect. You might also research to meaning of endocrine disruption. The working definition (binding to estrogen receptors) would find many phytoestrogens such as are commonly found in diets profoundly more effective. Lastly - take anything authored by Darbre with caution - tho’ as a scientist you might enjoy her profoundly flawed methodologies.
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Amber doesn’t control evaporation - perhaps oxidation. and leaching.
For sprays, you should have a stronger system as, if present, contamination will be inhaled. Mere presence of a nonionic line Tween in formula does not mean it will neutralize but 221 is a weak preservative in any context. Perhaps phenoxyethanol?
What is pH?
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“Saponified oils” - it’s simply soap. “Hurdle ” here is pretentious.
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Not sure I’d call hurdle - reliance on soap formulation. Were there other factors?
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Have a beer!
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Ever tested product after condumer use? What is your package?
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Here’s the book https://drive.google.com/file/d/0B8A98zYzLCDRb2xadjU2MnlkQXM/view?resourcekey=0-VOuv7UH-bSJiN_jaQhb3Q\\
says “optimal activity” below 5, little above 8. That’s what I understand. My comment re benzoic acid with surfactants up to 7 is data based.
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Can you describe your hurdle technology? Is this in context of the soap base you mentioned before.
“In-use” as in the articles below. The major manufacturers put product in hands of consumers to confirm the basic efficacy of their systems . This has been shown generally conventional systems and would be esp important with hurdle. “Compliance” is rudimentary - gov folks know crap all about cosmetic microbiology and as I think you noted before -your guys did not ask for data.
https://academic.oup.com/jambio/article-abstract/128/2/598/6714996
https://journals.asm.org/doi/abs/10.1128/aem.53.8.1827-1832.1987
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Gram + and fungi generally ~5 or less. Dave Steinberg liked it up to 7 - for me 7 and broader efficacy (some v. Gram neg) with benzoic acid in surfactants.
What is ref 16?
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Your soap solutions? Do you have in-use data?