CIR Safety Review: The CIR Expert Panel noted that Poloxamers injected intravenously are rapidly excreted in the urine, with some accumulation in lung, liver, brain and kidney tissue. In humans treated intravenously, the plasma concentration of Poloxamer 188 reached a maximum at 1 hour, then reached a steady state. Poloxamers generally were ineffective in wound healing, but were effective in reducing post-surgical adhesions in several test systems. Short-term intravenous doses up to 4 g/kg of Poloxamer 108 produced no change in body weights, but did result in diffuse hepatocellular vacuolization, renal tubular dilation in kidneys, and dose-dependent vacuolization of epithelial cells in the proximal convoluted tubules. A short-term inhalation toxicity study of Poloxamer 101 in air at 97 mg/m³ identified slight alveolitis after two weeks of exposure which subsided in the 2 week post-exposure observation period. A short-term dermal toxicity study of Poloxamer 184 at doses up to 1000 mg/kg produced slight erythema and slight intradermal inflammatory response in histological examination, but no dose-dependent body weight, hematology, blood chemistry, or organ weight changes. A 6 month feeding study of Poloxamer 188 at exposures up to 5% in the diet produced no adverse effects. Likewise, Poloxamer 331 (tested up to 0.5 g/kg/day), Poloxamer 235 (tested up to 1.0 g/kg/day), and Poloxamer 338 (at 0.2 or 1.0 g/kg/day) produced no adverse effects. Poloxamer 338 (at 5.0 g/kg/day) produced slight transient diarrhea. Poloxamer 188 at levels up to 7.5% in diet in a 2 year feeding study produced diarrhea at 5% and 7.5% levels, a small decrease in growth at the 7.5% level, but no change in survival. Doses up to 0.5 mg/kg/day for 2 years produced yellow discoloration of the serum, and increased levels of liver enzymes in the serum.

Poloxamers were minimal ocular irritants, but were not dermal irritants or sensitizers. A test in bacteria did not identify any mutagenic activity of Poloxamer 407. Several studies suggested anti-carcinogenic effects of Poloxamers. Poloxamers appear to increase the sensitivity to anti-cancer drugs of multidrug resistant cancer cells. Clinical tests of dermal irritation and sensitization were uniformly negative. The CIR Expert Panel did note the absence of reproductive and developmental toxicity data, but, based on molecular weight and solubility, there should be little skin penetration.

Small amounts of 1,4-dioxane, a by-product of ethoxylation, may be found in the Poloxamer ingredients. The potential presence of this material is well known and can be controlled through purification steps to remove it from the ingredients before blending into cosmetic formulations.

Link to more information about what the Food and Drug Administration (FDA) is doing to assure that cosmetics do not contain unsafe levels of 1,4-dioxane.
http://www.fda.gov/Cosmetics/ProductandIngredientSafety/Pote...

Link to FDA Code of Federal Regulation and Federal Register for Poloxamers (Polyoxyethylene-Polyoxypropylene block polymers)
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRS...
http://www.fda.gov/cder/otcmonographs/Antimicrobial/antimicr...

Poloxamers may be used in cosmetics and personal care products marketed in Europe according to the general provisions of the Cosmetics Directive of the European Union.
Link to the EU Cosmetics Directive: http://ec.europa.eu/consumers/sectors/cosmetics/documents/di...

Poloxamers are polyoxyethlyene, polyoxypropylene block polymers. A block polymer is made of blocks of different polymerized monomers. The benzoate esters are formed from a reaction of benzoic acid and the particular Poloxamer. In cosmetics and personal care products, most Poloxamers function as surfactants (emulsifying, cleansing and/or solubilizing agents). Poloxamer 188 is used as an antimicrobial agent and Poloxamer 182 Dibenzoate functions as a skin conditioning agent - emollient.