The Basics On Peg-12 Glyceryl Dimyristate

What is Peg-12 Glyceryl Dimyristate?

A skin-replenishing ingredient that is a polymer of ethylene oxide.

What are other names for Peg-12 Glyceryl Dimyristate?

PEG-12 GLYCERYL DIMYRISTATE

What is Peg-12 Glyceryl Dimyristate used for?

How Peg-12 Glyceryl Dimyristate is classified

Hydration, Skin-Replenishing

Recommendations for using Peg-12 Glyceryl Dimyristate during pregnancy and breastfeeding

Limited data suggests no known risk

 

Peg-12 Glyceryl Dimyristate During Pregnancy

What we know about using Peg-12 Glyceryl Dimyristate while pregnant or breastfeeding

Limited information available.

In a special report on the reproductive and developmental toxicity of ethylene glycol and its ethers, the CIR Expert Panel noted that metabolites of ethylene glycol monoalkyl ethers, such as methoxyethanol and ethoxyethanol (but not butoxyethanol) are reproductive and developmental toxicants, but not ethylene glycol monoalkyl ethers themselves (Andersen 1999c). NTP (2004) concluded that ethylene glycol itself was not a reproductive/developmental toxicant. Triethylene Glycol Triethylene glycol and two of its derivatives were evaluated for reproductive toxicity in a continuous breeding protocol with Swiss CD-1 mice (Bossert et al. 1992). Triethylene Glycol (0, 0.3, 1.5, and 3%) was administered in drinking water to breeding pairs (20 pairs per treatment group, 40 control pairs) during a 98-day cohabitation period. Reproductive function was assessed by the number of litters per pair, live pups per litter, proportion of pups born alive, and pup weights. There were no apparent effects on reproductive function in the animals receiving Triethylene Glycol at doses up to 3% in the drinking water. However, some developmental toxicity was demonstrated for Triethylene Glycol. Continuous exposure of dams to 1.5 or 3% Triethylene Glycol significantly decreased live pup weights at birth compared to control and 0.3% Triethylene Glycol. Reproductive toxicity was not demonstrated in mice receiving Triethylene Glycol at doses up to 6.78 g/kg. Union Carbide (1990d) dosed pregnant CD-1 mice with Triethylene Glycol by oral gavage daily on gestation days 6 through 15. The Triethylene Glycol doses were 0, 0.5, 5, or 10 ml/kg/day (n = 30 mice per group). The Triethylene Glycol doses were of neat undiluted Triethylene Glycol, calculated based on most recent body weight measurements, and the negative control dose was 10 ml/kg/day deionized water. Feed and water consumption as well as body weights and clinical observations were recorded throughout the study. Dams were killed on gestation day 18. At this time uteri containing fetuses were removed for evaluation, and the dams underwent gross necropsy and microscopic evaluation of certain tissues. Measures of pregnancy outcome were evaluated. Live fetuses were counted, sexed, and weighed before being fixed and stained for evaluations of visceral and skeletal morphology. Half of the live fetuses were examined by serial sections for soft-tissue craniofacial malformations. There were no treatment-related maternal deaths, and no dams aborted. Maternal body weights and body weight gains were similar between all dose groups. There were no affects of treatment on feed or water consumption. Maternal toxicity observed in the 10 ml/kg/day group included hyperactivity with audible and rapid respiration. Necropsy revealed no differences between the treated and control groups, except that relative (but not absolute) kidney weights were increased in the high dose group. Pregnancy outcomes (number of corpora lutea, viable and non-viable implantations, and sex ratio) were not affected by Triethylene Glycol treatment. The sum of fetal body weights per litter were significantly decreased in the 5 and 10 ml/kg/day groups. There were no treatment related malformations noted in the external or visceral examinations. The lowest observable effect level for skeletal abnormalities seen at gestation day 18 (cervical centra #1, #2, #3, or #4 poorly ossified; reduced number of caudal segments; unossifed proximal phlalanges of hindlimb; and poorly ossified proximal phlalanges of hindlimb) was 10 ml/kg/day and for poorly ossified frontal and supraoccipital bones was 5 ml/kg/day. The authors concluded that Triethylene Glycol exposure during organogenesis resulted in evidence of slight maternal toxicity at 10 ml/kg/day and consistent evidence of developmental delay at 5 and 10 ml/kg/day (Union Carbide 1990d). Union Carbide (1991) dosed pregnant Sprague-Dawley rats with Triethylene Glycol by oral gavage on gestation days 6 through 15. The doses were 0, 1, 5, or 10 ml/kg/day (n = 55 rats per group). The Triethylene Glycol doses were of neat undiluted Triethylene Glycol, calculated based on most recent body weight measurements, and the negative control dose was 10 ml/kg/day deionized water. Feed and water consumption as well as body weights and clinical observations were recorded throughout the study. Dams were killed on gestation day 21. At this time uteri containing fetuses were removed for evaluation, and the dams underwent gross necropsy and microscopic evaluation of certain tissues. Measures of pregnancy outcome were evaluated. Live fetuses were counted, sexed, and weighed before being fixed and stained for evaluations of visceral and skeletal morphology. Half of the live fetuses were examined by serial sections for soft-tissue craniofacial malformations. 19 There were no maternal deaths and no aborted pregnancies. In the 10 ml/kg/day group maternal body weights were decreased on gestation days 9 through 18, feed consumption was decreased on gestation days 6 through 15, and water consumption was increased on gestation days 6 through 18. Clinical observations in the 10 mg/kg/day group included audible respiration, urine stains, periocular encrustation, and perioral wetness. Dams in the 5 ml/kg/day group had decreased body weights on gestation day 18, decreased feed consumption on gestation days 6 through 9, and increased water consumption on gestation days 6-15. Animals treated with 1 ml/kg/day had no observations different from controls. At necropsy maternal body weights (adjusted for gravid uterine weight) were decreased and relative (but not absolute) kidney weights were increased in the high-dose group compared to controls. There were no treatment-related effects on pregnancy outcome with the exception of a decrease in the sum of fetal body weights per litter in the 10 ml/kg/day. There were no significant increases in the incidence of external, visceral or skeletal malformations. There was an increase in the incidence of one skeletal variation (bilobed thoracic centrum # 10) in the high-dose group. While there was some evidence of maternal toxicity, no biologically significant embryotoxiciy or teratogenicity was observed at the doses administered in this study (Union Carbide 1991). PEG-6, PEG-32, and PEG-75 Smyth et al. (1947) investigated the reproductive toxicity of PEG-6, PEG-32 and PEG-75 during the 2-year oral toxicity studies (described earlier in this report). The animals at each dose (0.015, 0.059, 0.27, and 1.69 g/kg/day PEG-6, PEG-32; and 0.00085, 0.0036, 0.017, and 0.062 g/kg/day PEG-75) were allowed to breed during the study and records were kept of the F1 and F2 generations. No changes or adverse responses to either compound occurred in the three generations. In the 90-day oral toxicity study conducted by Smyth et al. (1942) described earlier, the authors reported that rats drinking dosages of 0.23 g/kg/day or more of PEG-75 had testicular tubule degeneration and scant or degenerated sperm. They noted that although none of their control rats had these conditions, historical control rats have had such changes.

General safety info about Peg-12 Glyceryl Dimyristate from CIR

The safety of Polyethylene Glycols (PEGs) as used in cosmetics was reviewed. In general, PEGs are not oral toxicants, exhibit little ocular irritation, and have minimal dermal irritation and sensitization. PEGs are not genotoxic or carcinogenic. PEGs are not reproductive or developmental toxicants. Use of antimicrobial creams with a PEG vehicle was associated with renal toxicity when applied to burned skin, but studies of extensively tape stripped skin demonstrated that the levels of PEGs that could penetrate in a worst case analysis are >100 times less than the renal toxicity no observable effect level, providing a margin of safety. Triethylene Glycol and PEGs ‚â• 4 are considered safe for use in cosmetics in the present practices of use and concentration.

Use this, not that!

Products where you might find Peg-12 Glyceryl Dimyristate

Beautycounter Counter+ All Bright C Serum; Bumble and bumble Thickening Dryspun Volume Texture Spray; Farmacy Very Cherry Bright 15% Clean Vitamin C Serum with Acerola Cherry

 

 

 

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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