The Basics On Polybutene

What is Polybutene?

Polymer derived from mineral oil and used as a thickener and lubricant.

What are other names for Polybutene?

1-BUTENE, HOMOPOLYMER, HOMOPOLYMER 1-BUTENE, and POLYBUTENE

What is Polybutene used for?

Polybutene is a light colored, nondrying, sticky liquid. In cosmetics and personal care products, it is used in the formulation of lipstick, eye makeup and skin care products. Polybutene functions as a binder , epilating agent and viscosity increasing agent – nonaqueous

How Polybutene is classified

Texture Enhancer

Recommendations for using Polybutene during pregnancy and breastfeeding

Limited data suggests no known risk

 

Polybutene During Pregnancy

What we know about using Polybutene while pregnant or breastfeeding

Limited information available.

Polybutene No teratogenic effects were found when polybutene was fed to rats at 1% or 10% in the diet for six months.3 A three-generation reproductive study in Charles River albino rats that ingested up to 20,000 ppm polybutene demonstrated that, except for the test (F2) male parental animals that were fed 20,000 ppm polybutene, none of the animals in successive generations differed from controls with regard to weight gains. The F2 male parental animals showed slight weight gain depression, although their growth patterns were still within the normal range. In all three generations, there were no significant differences between test and control animals with regard to litter size, the number of stillborn, and the number of viable pups during lactation. The survival, body weights, and reactions of test animals were comparable to those of controls. Average molecular weights were not specified in these studies. Hydrogenated Polydecene The reproductive effects of hydrogenated polydecene were studied in rats that received the test material via gavage (average molecular weight not specified). 5 Groups of 30 male and 30 female Sprague-Dawley rats received 0, 100, 500, or 1000 mg/kg bw/day hydrogenated polydecene in polyethylene glycol daily for 4 weeks prior to mating and through mating. At the end of mating, males were sacrificed. Females were treated through gestation and until lactation day 21. No treatment-related effects were observed on clinical signs, body weight, or gross pathology in the parental generation or in the pups through lactation day 21. There were no treatment related effects on reproduction or pup viability. The NOAELs for parental systemic effects, parental reproductive effects, and offspring effects in this one generation rat study are each 1000 mg/kg bw/day. Polyisobutene In a 3-generation reproductive toxicity study, an unreported number of Charles River rats received 0, 800, or 20,000 ppm 100% polyisobutene in their feed (molecular weight range 654-2168).37,38 No further details about dosing were provided. Weight gain was slightly reduced in the second generation high-dose male rats, but the changes were within normal control ranges. No other effects on body weights, clinical signs, organ weights or histopathology were observed. No treatment-related reproductive effects were noted in any of the parameters measured (no furthered details provided). No differences were observed in offspring survival, litter size, number of stillborn pups, and number of viable pups in any generation of the treated groups when compared to controls. No remarkable post-mortem findings were reported. Hydrogenated Polydodecene The reproductive effects of the trimer of hydrogenated polydodecene were studied in one generation of rats that received the test material via gavage.5 Groups of 24 male and 24 female Sprague-Dawley rats received 0, 50, 250, or 1000 mg/kg/day of the test material in arachis oil daily for 20 weeks (during maturation, mating, gestation, and lactation). No treatment-related effects on offspring growth or development were observed. Litter sizes were comparable to controls in all dose groups. No adverse effects were observed during gross necropsy or histopathological examination. The NOAEL for reproductive and development toxicity in this rat study is 1000 mg/kg/day.

General safety info about Polybutene from CIR

The Cosmetic Ingredient Review (CIR) Expert Panel reviewed the safety of polyenes, which function in cosmetics primarily as film formers and viscosity increasing agents. The Panel reviewed relevant data related to these ingredients, noting gaps in the available safety data for some of the polyenes in this safety assessment. The data available for many of the ingredients are sufficient, and can be extrapolated to support the safety of the entire group because of the similarities in the chemical structures, physicochemical properties, use concentrations, and reported functions across the group. The Panel concluded that polyenes were safe in cosmetics in the present practices of use and concentration described in this safety assessment.

Use this, not that!

Products where you might find Polybutene

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List of References

General sources: Drugs and Lactation Database (LactMed) [Internet]. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/

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Disclaimer: This material is provided for educational purposes only and is not intended for medical advice, diagnosis, or treatment. Consult your healthcare provider with any questions.

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