PhilGeis
Forum Replies Created
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Aspergillus niger exists - and is not the fungus used in the PET challenge test. That is A. brasiliensis.
We are exposed constantly to mycotoxins in grain and nuts and products made from them. Risk assessment of topical exposure via a cosmetic is not going to be an issue. -
You need a preservative system in addition to your active - Piroctone olamine.
Assume you’re developing an antidandruff shampoo. This would be a drug product in some countries - have you addressed drug product regulations in your country?
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Not much information on specifics - that they work is enough for their suppliers and customers. Likely they have multiple killing functions, one as vitalys said re membranes.
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To your original question - all those effects can result from contamination with any bug.
As Pharma said - immunocompromised folks are at risk to microbes like these. The risk is serious as some folks have died from infections they got from contaminated cosmetics. Healthy folks can get limited infection but some infections from contaminated mascara resulted in blindness.
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PET - as in USP 51 (and its mindless reproduction in EP and ISO) are all based on old protocol (~50 years) for drug products. Cosmetics were not considered in its development. Burkholderia cepacia was recognized as such a cosmetic risk in the CTFA test.
The PET is a poor test. It is consistent in response but not validated to any quality endpoint for cosmetics. Most major companies use their own test that includes cepacia and other bugs - others use the PET but with more stringent pass fail criteria (e.g. no recovery day 7).Pharma is partially correct. Bacterial and yeast isolates were from clinical sources but have been in the lab for many decades - staph 6538 for almost 100 years. There is no Aspergillus niger - 16404 is A. brasiliensis isolated from the blueberries and has no record of carcinogenesis or aflatoxin production. That some other fungi produce alfatoxin is irrelevant to cosmetic quality. Tho 6538 still can infect skin if inoculated heavily - these are fairly innocuous bugs.
PET is better than nothing but it is not validated to consumer or manufacturing risks. Some manufacturers have developed and validated their own test (e.g. https://aem.asm.org/content/53/8/1827.short).
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Potentially all product effects for each bug - you can’t break out individual bugs for specific effect. Most health risk for staph and pseudomonas.
The most common bug is prob Burkholderia cepacia (complex) - can result in all the product effects and is a health risk for immunocompromised folks.
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Pharma said:PhilGeis said:Nasties? Please rememnber preservatives control “nasties.”
You misunderstand me. What I mean is that there’s a difference between proper skin tolerable preservation and stuff which I don’t even like in technical materials such as isothiazolinones. Sadly, these are ‘okay’ in pet products because animals are considered ‘objects’ in most legal regards.
Isothiazolinones have been used (typically as primary preservatives) in surfactant and hair conditioner products globally since ~1990. Tho’ some folks screwed up when 1st introduced, not used in leave one but for limited use of one around turn of century that provoked sensitization and was withdrawn. Not aware animals are more at risk than human “objects” exposed in historic use. Are you referring to use in leave-on products? Can you elaborate?
“Nasties” are the bugs against which we preserve. Casual slandering preservatives is the practice of uninformed activists that diminishes our ability to protect consumers and their pets. If a preservative does not satisfy safety in that use, let’s please address it in objective unemotional terms that do not jeopardize applications where it may have both efficacy and safety in use.
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Unpreserved?
Ask which drunk gets the 1st beer when “drinks are on the house” announced - whatever bugs gets to it 1st. -
YasmineR said:Thank you for replying!If your surfactant is anionic and you have enough, you prob don’t need an antifungal preservative.
Could you please clarify this part? What does an anionic surfactant have to do with antifungal activity?
Literature, FDA/EU recall and extensive experience find shampoos and other anionic surfactant products (esp. with EDTA) intrinsically resistant to fungal (esp. mold) contamination.
Euxyl 9010 is prob good for shampoo but is not a “great all-around preservative”. Alone, it leaves a gap in antifungal efficacy for relevantly susceptible products.
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Of course it gets wet - that doesn’t mean you need to preserve a film of water. You can’t preserve water pools around the bar,. Think your wasting your money on preservation.
Does the get get mushy? -
Is this a bar?
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Nasties? Please rememnber preservatives control “nasties.”
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I’m just a micro guy so hope others Perry, Microformulation) can address product formulation realities. Unless it brings a substantial bioburden or hygroscopicity elevates Aw too high, I’m ok.
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and watch your claims. FDA does not regulate pet “grooming aids” but does regulate pet drug products.
The animal counterpart of a cosmetic is commonly referred to as a “grooming aid.” The Act defines a cosmetic as pertaining only to human use (21 U.S.C. 321(i)). Therefore, products intended for cleansing or promoting attractiveness of animals are not subject to FDA control. However, if such products are intended for any therapeutic purpose or if they are intended to affect the structure or function of the animal, they are subject to regulation as new animal drugs under the Act.
https://www.fda.gov/animal-veterinary/resources-you/animal-products-fda-regulates#Grooming -
By FD&C definition, cosmetic ingredients are effectively cosmetics and a cosmetic produced with an adulterated ingredient is adulterated. Excessive/OOS micro counts establish adulteration - that they might die off over time (or the infamous - the preservative will kill it off) is irrelevant - adulterated is forever . a
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Their info prob came from Dave Steinberg’s book - Preservatives for Cosmetics. This is a very good book. https://www.amazon.com/Preservatives-Cosmetics-David-C-Steinberg/dp/193263312X/ref=sr_1_4?dchild=1&keywords=steinberg+preservatives&qid=1620126997&sr=8-4
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There is potential. Think you’re referring to info in Steinberg’s book. Dave’s info is excellent and does report there is potential. compromise.
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Check with specific suppliers - be aware, some raw materials are not physically stable at low temperature.
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Think you’re wise to study labels of products similar to those you’re developing. Major companies have access to preservative testing adequate to try different combinations in formulas. Presuming this is a limiting factor for you, try to follow their lead. But you’ll still need to confirm efficacy.
Suggest you have limited confidence in claims of broad spectrum activity - e.g. 9010 alone is not an adequate preservative vs fungi (yeast and mold). Do not consider reports of inactivation absolute, and there are plenty of substrates (food) in formulas for bugs to eat when preservation fails.
1% is more than you need for phenoxyethanol - suggest +/- 0.5%. 9010 is ~90% phenoxyethanol. If your surfactant is anionic and you have enough, you prob don’t need an antifungal preservative.
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I’d run an AET to see.
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Benzoic acid solubility can be an issue. it’s much less soluble in water than the sodium benzoate. Other than that, there is no difference.
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Effectively.
But to make it complicated - formaldehyde is a gas and formalin is a saturated solution of that gas. The gas hydrated in solution as methylene glycol.One more that you need to consider. Formalin includes methanol -maybe 10%. Please take that into consideration
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Other than the lesser concentration of the ion due to the sodium salt, there is effectively no difference - assuming you obtain solution of addition. It’s a pH driven equilibrium.
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Right - DMDm Hydantoin at 2000-2500 ppm usually gave < 500 ppm free formaldehyde. “Free” is important.