The Basics On Polyglyceryl 2 Triisostearate

What is Polyglyceryl 2 Triisostearate?

A mixture of the fatty acid Isostearic acid and a form of glycerin.

What are other names for Polyglyceryl 2 Triisostearate?

DIGLYCERYL TRIISOSTEARATE, ISOOCTADECANOIC ACID, TRIESTER WITH DIGLYCEROL, ISOOCTADECANOIC ACID, TRIESTER WITH OXYBIS(PROPANEDIOL), POLYGLYCERYL-2 TRIISOSTEARATE, TRIESTER WITH DIGLYCEROL ISOOCTADECANOIC ACID, and TRIESTER WITH OXYBIS(PROPANEDIOL) ISOOCTADECANOIC ACID

What is Polyglyceryl 2 Triisostearate used for?

How Polyglyceryl 2 Triisostearate is classified

Texture Enhancer, Emollients

Recommendations for using Polyglyceryl 2 Triisostearate during pregnancy and breastfeeding

Limited data suggests no known risk

 

Polyglyceryl 2 Triisostearate During Pregnancy

What we know about using Polyglyceryl 2 Triisostearate while pregnant or breastfeeding

Limited information available.

Acute Toxicity Acute toxicity studies are summarized in Table 12. 32,38-54 In an acute dermal toxicity study in rats, the LD50 of 1,2,3-propanetriol, homopolymer, diisooctadecanoate was>5 g/kg. Low toxicity was reported in acute oral studies. In rats, the LD50 >2 g/kg for Polyglyceryl-3 Caprate, Polyglyceryl-3 Caprylate, Polyglyceryl-4 Caprate, Diisostearoyl Polyglyceryl-3 Dimer Dilinoleate, and Polyglyceryl-8 Decabehenate/Caprate, the LD50 was estimated to be >2.5 g/kg for Glyceryl/Polyglyceryl-6 Isostearate/Behenate Esters, Macadamia Seed Oil Polyglyceryl-6 Esters Behenate, Polyglyceryl-8 Decaerucate/Decaisostearate/Decaricinoleate, and Polyglyceryl-10 Nonaisostearate, and the LD50 was >5 g/kg for Polyglyceryl-3 Isostearate, Polyglyceryl-3 Oleate, Polyglyceryl-2 Diisostearate and Polyglyceryl-3 Diisostearate. Short-Term Toxicity Animal Oral Polyglyceryl Esters – general In rats, repeated oral dosing with 10 g/kg bw polyglyceryl ester daily over 5 days caused no deaths.32 (No details were provided.) The feeding of a restricted diet consisting of 1 g of a polyglyceryl ester in 5 g basic diet/day for 3 wks to Sherman rats, followed by 8 wks feeding, ad libitum, of a diet containing 8% of the test material (8 males/group; study described in the ADME section) did not result in any microscopic abnormalities in the liver, kidneys, or ileum.34 Polyglyceryl Stearate Two groups of 4 male albino rats were administered a suspension of 1 g/kg bw/day of polyglyceryl stearate (glyceryl chain length not stated) in an aqueous solution of 0.5% carboxymethylcellulose (CMC) and 0.1% Tween 80 for 10 wks; one group was fed a basic diet, and the other a diet supplemented with 5% hydrogenated fat.55 Two untreated control groups, one fed a basal diet and one the fat-supplemented diet, were used. Polyglyceryl stearate was not toxic, and it did not have an effect on red blood cell count, white blood cell count, or hemoglobin values. Polyglyceryl-2 Diisostearate In a dietary study, 5 male and 5 female rats per group were given feed containing 0, 0.012, 0.12, or 1.2% Polyglyceryl-2 Diisostearate (for a targeted dose of 0, 10, 100, or 1000 mg/kg/day, respectively) for 28 days, and a control group was given untreated feed.38 There were no mortalities, clinical signs of toxicity, effects on body weight, clinical pathology, or gross or histopathology alterations that were considered related to the dietary administration of the test substance and/or considered to be of toxicological significance. The no observed adverse effect level (NOAEL) was 845 mg/kg/day in males and 922 mg/kg/day in females, corresponding to the highest dietary concentration tested. Human Oral Polyglyceryl Esters – general For 3 wks, 37 subjects were fed 2-20 g/day polyglyceryl ester in their diet.32 No abnormalities were detected in the hematology or clinical chemistry values or urinary or fecal parameters that were examined. Subchronic Toxicity Studies Animal Oral Polyglyceryl-10 Decaoleate Groups of 10 male and 10 female Sprague-Dawley rats were fed a diet containing 2.5, 5.0, or 10.0% Polyglyceryl-10 Decaoleate for 90 days, and the control group was fed a diet containing soybean oil as the dietary fat.37 Urine was collected from each group during wks 3 and 9, total fatty acid absorption was determined in feces collected during wks 4 and 10, and hematological studies were conducted during wks 5 and 11, and at study termination. No test article-related signs of toxicity were observed. Gross and microscopic examination of the testes and ovaries and other organs did not reveal any evidence of toxicity, and relative and absolute organ weights were unremarkable. Chronic Toxicity Studies Animal Oral Polyglyceryl Esters – general Groups of 25 male and 25 female mice were fed a diet with 5% polyglyceryl ester for 80 wks.32 No adverse effects on body weight, feed consumption, hematology values, or survival rate were noted. Carcass fat of the test group showed no polyglycerol residues. The levels of free fatty acids, unsaponifiable material, and the fatty acid composition of carcass fat were the same for the test group compared to a control group fed 5% ground nut oil in the diet. The only differences noted in organ weights were for the liver and kidneys of female mice, which were significantly higher. Microscopic examination of all major organs showed nothing remarkable. In a 2-yr study, 28 male and 28 female rats were fed 5% polyglyceryl ester in the diet.32 No adverse effects on body weight, feed consumption, hematology values, or survival rate were noted. Organ weights were similar in control and test groups. Liver function tests and renal function tests performed at 59 and 104 wks of the study were comparable between the test group and a control group fed 5% ground nut oil. The carcass fat contained no polyglycerol, and the levels of free fatty acid, unsaponifiable residue and fatty acid composition of carcass fat were not different from the controls. A complete histological examination of major organs showed nothing remarkable. In the ADME study described previously, in which Wistar rats (number of animals per group not specified) were fed a diet containing 5 or 10% polyglyceryl ester (prepared mostly with stearic and oleic acid; duration of dosing not specified, however some animals were fed the test diet for up to 14 mos, and some were maintained through 3 generations), no abnormalities were observed upon microscopic examination of tissues (details not provided).33 DEVELOPMENTAL AND REPRODUCTIVE TOXICITY STUDIES Oral Polyglyceryl Esters – general A test group of 22 rats was fed a diet containing 1.5% polyglyceryl ester for 3 generations.32 A group of 28 rats was used as a control. The animals were kept for over 1 year without significant variation in fertility or reproductive performance. Gross and microscopic examination of the third generation revealed no consistent abnormality attributable to the test substance. No details were provided. Polyglyceryl-3 Diisostearate A combined repeated dose oral toxicity study with a reproduction/developmental toxicity screening test (OECD Guideline 422) was conducted in Wistar rats. 39 The animals were dosed once daily by gavage with 0, 100, 300, or 1000 mg/kg bw/day 1,2,3-propanetriol, homopolymer, diisooctadecanoate (n not defined; this substance is most likely Polyglyceryl-3 Diisostearate) in corn oil. Initially, the groups consisted of 12 males and 12 females. However, because a disturbance of the light/dark cycle was believed to cause a reduction in mating rate of the females of the first delivery, additional male and female rats were added in a second delivery for breeding to meet guideline requirements for the number of gravid females per group. All (1st and 2nd delivery) animals were subjected to the same conditions of the study, with the exception that the males of the second delivery were necropsied on day 24 after mating, not on day 16 of mating. Therefore, Polyglyceryl-3 Diisostearate was administered to male rats for up to 28 days (first delivery) and up to 41 days (second delivery) and to female rats for 14 days prior to mating, through the mating and gestation periods, and until the F1 generation reached day 4 post-partum. Because an impact caused by the light/dark cycle disturbance could not be excluded (i.e., a prolonged duration of gestation and an increased post-implantation loss at the high dose), the study was repeated with a third delivery with control and highdose groups under proper light conditions. The test article was administered to12 male rats/group for 33 days and to12 female rats/group for 14 days prior to mating, through mating and gestation, and until day 4 post-partum. Five males and 5 females/group killed at the end of the study were selected for hematology and clinical chemistry examinations, and some additional organs were weighed. The NOEL and NOAEL for systemic effects were ‚â•300 mg/kg bw/day and ‚â•1000 mg/kg bw/day 1,2,3-propanetriol, homopolymer, diisooctadecanoate, respectively, in both males and females. No adverse effects on body weights and body weight gains, feed consumption, hematology, clinical chemistry, neurobehavior, or gross or microscopic lesions were observed. Statistically significant increases in absolute and relative liver and kidney weights in males and females of the 1000 mg/kg bw/day were not considered to be adverse effects because there was no evidence for an impairment of organ function by clinical pathology and histopathology. Additionally, increases in the absolute and relative heart weights in high-dose females were without histopathological correlation and considered to be incidental.

General safety info about Polyglyceryl 2 Triisostearate from CIR

The Cosmetic Ingredient Review (CIR) Expert Panel assessed the safety of 274 polyglyceryl fatty acid esters. Each of the esters in this group is a polyether comprising 2 to 20 glyceryl residues, end-capped by esterification with simple carboxylic acids, such as fatty acids. Most of these ingredients are reported to function in cosmetics as skin-conditioning agents and/or surfactants. The Panel reviewed the available data and considered conclusions from relevant previous CIR reports, and determined that these ingredients are safe in cosmetics in the present practices of use and concentration described in this safety assessment when formulated to be non-irritating

Use this, not that!

Products where you might find Polyglyceryl 2 Triisostearate

The Ordinary AHA 30% + BHA 2% Peeling Solution; The Ordinary Hyaluronic Acid 2% + B5; Drunk Elephant T.L.C. Sukari Babyfacial 25% AHA + 2% BHA Mask

 

 

 

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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