The Basics On Polyisobutene
What is Polyisobutene?
A polymer of the hydrocarbon isobutylene obtained from petroleum oil.
What are other names for Polyisobutene?
1-PROPENE, 2-METHYL-, HOMOPOLYMER; 1-PROPENE, 2-METHYL-, HOMOPOLYMER(C4H8)X, X = 17; 1-PROPENE, 2-METHYL-, HOMOPOLYMER(C4H8)X, X = 17, 1-PROPENE,-2-METHYL-, HOMOPOLYMER, 1PROPENE, 2METHYL, HOMOPOLYMER, 2-METHYL-1-PROPENE, HOMOPOLYMER, HOMOPOLYMER 1-PROPENE,-2-METHYL-, HOMOPOLYMER 2-METHYL-1-PROPENE, ISOBUTENE HOMOPOLYMER, ISOBUTYLENE HOMOPOLYMER, PERMETHYL 108A, POLYISOBUTENE, and POLYISOBUTYLENE
What is Polyisobutene used for?
In cosmetics and personal care products, Polyisobutene is used as a binder , film former and viscosity increasing agent – nonaqueous . Hydrogenated Polyisobutene functions as a skin conditioning agent – emollient and a viscosity increasing agent – nonaqueous in cosmetics and personal care products.
How Polyisobutene is classified
Texture Enhancer
Recommendations for using Polyisobutene during pregnancy and breastfeeding
Limited data suggests no known risk
Polyisobutene During Pregnancy
What we know about using Polyisobutene while pregnant or breastfeeding
Limited information available.
No teratogenic effects were found when polybutene was fed to rats at 1% or 10% in the diet for six months.4 A three-generation reproductive study in Charles River albino rats that ingested polybutene up to 20,000 ppm 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 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 oral gavage (average molecular weight not specified). 6 (See 90-day repeated dose study of hydrogenated polydecene in Sprague-Dawley rats described in the above Repeated Dose Toxicity section). 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 NOAEL for parental systemic effects, parental reproductive effects, and offspring effects in this one generation rat study is 1000 mg/kg bw/day. Hydrogenated Polydodecene The reproductive effects of the trimer of hydrogenated polydodecene (analog of hydrogenated polydodecene) were studied in one generation of rats that received the test material via gavage.6 (See repeated dose study of the trimer of hydrogenated polydodecene in Sprague-Dawley rats described in the above Repeated Dose Toxicity section). 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. Two non-treatment related mortalities occurred during the study, one in the control group and the other in the 250 mg/kg/day dose group. No treatment-related effects were observed on clinical signs, body weight, feed and water consumption, or fertility and mating performance in the parental rats. Hematological and clinical chemistry measurements were within normal parameters. 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 adult toxicity and reproductive and development toxicity in this rat study is 1000 mg/kg/day. GENOTOXICITY In vitro Polyethylene Genotoxicity testing of polyethylene was negative in two bacterial studies.2 Average molecular weights were not specified in these studies. Polyisobutene In a study to determine the ability of various insulating fluids to induce transformation in the Syrian hamster embryo (SHE) cell transformation assay and to enhance 3-methylcholanthrene (MCA)-induced transformation of C3H/10T1/2 cells, a low-viscosity polyisobutene-based oil did not induce transformation activity and was slightly cytotoxic.3 In the two-stage transformation assay of C3H/10T1/2 cells, the polyisobutene oil had promoter activity. Average molecular weights werenot specified in these studies. Hydrogenated Polydecene Hydrogenated polydecene was not mutagenic in a reverse gene mutation assay in Salmonella typhimurium strains TA1535, TA1537, TA98, and TA100 and Escherichia coli strain WP2uvrA (average molecular weight not specified). 6 The test material was incorporated in emulsions with sorbitan stearate and polysorbate 60 at concentrations of 156.25, 312.5, 625, 1250, 2500, or 5000 Œºg/plate, with and without metabolic activation using the pre-incubation method. The positive controls yielded expected results. In reverse mutation assays, S. typhimurium strains TA98, TA100, TA1535 and TA1537 were treated with hydrogenated polydecene at concentrations up to 10 mg/plate (average molecular weight not specified). 6 The positive controls yielded expected results. Hydrogenated polydecene was not mutagenic with or without S9 metabolic activation at all tested doses. Hydrogenated Polydodecene The genotoxic potential of the trimer of hydrogenated polydodecene (an analog of hydrogenated polydodecene) was assayed in a chromosome aberration study using human lymphocyte cultures in 2 experiments.6 In the first experiment, the test material was cultured at concentrations of 0, 39, 78.1, 156.25, 31 2.5, 625, 1250, 2500 and 5000 Œºg/mL. In the second experiment, the test material was cultured at concentrations of 625, 1250, 2500 and 5000Œºg/mL for 20 hours or 1250, 2500, and 5000 Œºg/mL for a 44 hour harvest time. All experiments were conducted in duplicate, with and without S9 metabolic activation. Cytotoxicity was not observed in a range finding test conducted prior to the main assay at concentrations ‚â§ 5000 ¬µg/ml. The test material did not induce chromosomal aberrations or polyploidy cells, with or without metabolic activation. Positive controls, ethyl methanesulfonate in the absence of S9, and cyclophosphamide in the presence of S9, yielded expected results. The authors concluded that the trimer of hydrogenated polydodecene was not clastogenic to human lymphocytes in vitro when tested at concentrations ‚â§ 5000 ¬µg/mL. In a mammalian cell gene mutation assay (HGPRT locus), Chinese hamster ovary (CHO) cells cultured in vitro were exposed to the trimer of hydrogenated polydodecene in ethanol at concentrations of 0, 313, 625, 1250, 2500, or 5000 Œºg/mL with and without metabolic activation for 4 hours.6 In the range-finding test, relative cloning frequencies (RCEs) ranged from 97% to 73% for doses ranging from 0.5 to 5000 ¬µg/mL without metabolic activation. RCEs were 122% to 80% for the same dose range with metabolic activation. RCEs in the first mutation assay were 92% to 77% and 111% to 89% for doses ranging 313 to 5000 ¬µg/mL with and without metabolic activation, respectively. The activated portion of the first mutation assay was repeated and RCE was 100% to 71% for the same dose range. In the confirmatory assay, the RCEs among the test material-treated cultures ranged from 50% to 23% and 89% to 52% for the concentrations of 313 to 5000 ¬µg/mL with and without metabolic activation, respectively. A significant response was observed at 625 Œºg/mL when compared to the solvent control data in the repeat definitive mutation assay with activation; however, the increase was not significant when it was compared to the historical, cumulative solvent control data. The same was true at 2500 ¬µg/mL, with activation, in the confirmatory mutation assay. The increase in the number of mutants was not significant when compared to historical, cumulative solvent control data. The response seen in the definitive mutation assay at 625 Œºg/mL was not reproduced in the confirmatory assay. Controls were within the historical negative control values. The trimer of hydrogenated polydodecene was not mutagenic in this mammalian cell gene mutation assay. CARCINOGENICITY Polyethylene Numerous investigations on the tumor production of polyethylene implantation have produced mixed results.2 Polyethylene causes tumors in rats implanted with squares of the test substance; however, testing involving implanting coverslips and powdered polyethylene suggest that tumors are caused by the physical reaction to imbedded plastic films and not the polyethylene itself. IARC lists polyethylene as “not classifiable as to carcinogenicity in humans.” Average molecular weights were not specified. Polyisobutene In a carcinogenicity study conducted to determine the skin tumorigenicity effects of certain oils used for impregnation of paper-insulated power cables and their synthetic alternatives, including polyisobutene oil, no evidence of a direct tumorigenic or carcinogenic effect was reported and polyisobutene oil (average molecular weight 250) appeared to reduce the number of 7,12-dimethylbenz[a]anthracene (DMBA)-induced tumors.3 Polypropylene IARC determined that polypropylene is not classifiable as to its carcinogenicity to humans (Group 3).23
General safety info about Polyisobutene from CIR
No report found.
Use this, not that!
Products where you might find Polyisobutene
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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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