Silicone

The Basics On Silicone

What is Silicone?

Substance derived from silica (sand is a silica) with unique fluid properties.

What are other names for Silicone?

SILICON

What is Silicone used for?

Form a barrier-like coating on the skin that’s resistant to both water and air.

How Silicone is classified

Silicones, Slip Agents, Emollients

Recommendations for using Silicone during pregnancy and breastfeeding

Limited data suggests no known risk

 

Silicone During Pregnancy

What we know about using Silicone while pregnant or breastfeeding

Limited information available.

Oral Dimethicone The Food and Drug Research Labs (1966) tested Dimethicone-containing fluids in oral studies to investigate possible atrophic changes in rat seminal vesicles. The test material was administered directly into the stomach of 10 male Sprague-Dawley rats at a dose of 3.3 ml/kg/day for 6 days. A control group received saline. Feed and water were available ad libitum. Rats were killed at the end of dosing and necropsy was performed. Final body weight and the weight of the seminal vesicles were measured. A Dimethicone sample (TX-158F) produced a significant reduction in the average seminal vesicle to body weight ratio but not in absolute organ weight. Two other Dimethicone samples had no adverse effect. Atlas Chemical Industries (1970) reported a study in which a medical grade antifoam compound (93% Dimethicone) was given orally to pregnant Wistar rats on gestational days (GDs) 6 to 15 at doses of 0.38, 1.20, and 3.80 g/kg/day. The highest dose was selected to represent 70 times the recommended clinical dose for the treatment of intestinal gas and 1000 times that recommended to treat peptic ulcers. A control group received tap water. Rats were examined by laparotomy on GD 20 at which time fetuses were removed from the uterus. Dams were killed and the ovaries were examined for corpora lutea. The authors concluded that Dimethicone at any dose did not induce significant differences in fetal viability at laparotomy, resorptions, average weight, and gross external, soft tissue, and skeletal anomalies. Siddiqui (1994) fed an antifoam compound (food-grade Dimethicone) to time-mated New Zealand white rabbits at concentrations of 0%, 0.5%, 1.0%, and 2.5% on GDs 6 to 19. Females were observed daily for clinical signs of toxicity. On gravid day 29, confirmed-pregnant females (20 to 22 per group) were evaluated for gestational outcome. Each live fetus was examined for external, visceral, and skeletal malformations. No overt signs of toxicity in the dams, and no statistically significant differences in feed consumption were observed between treated and control rabbits. No adverse effects were noted in mean maternal body weight or liver weight. The incidence of resorptions among the total fetal population was not altered by feeding the antifoam compound. Male and female pup weights were not affected by the maternal treatment. No significant treatment related adverse effects in the incidence of external, visceral, or skeletal abnormalities were observed. Dermal Dimethicone Kennedy et al. (1976) applied 200 mg/kg Dimethicone (medical grade fluid, 350 cs; suspended in either com oil or sesame oil in a 1 :5 ratio) to the shaved backs of groups of15 pregnant rabbits on GDs 6 to 18. Other groups received subcutaneous injections of 20, 200, or 1000 mg/kg Dimethicone (diluted in sesame oil, or undiluted at the highest dose). Vehicle control groups were treated with com oil or sesame oil. Litters were delivered by cesarean section on day 29. The uterus and other genital organs of each dam were inspected. Implantation sites and live and dead pups were counted. Live pups were incubated for 24 h and then killed. Dead pups and two thirds of those killed were cleared and stained for skeletal examination. The remaining pups were necropsied. The investigators considered that the vehicles, com, and sesame oil had an effect on the incidence of resorptions. No treatment-related fetal abnormalities were found. The incidence of talipes varus in the 200-mg/kg group was at or above the upper limit for historical controls, but the abnormality was not detected at the 1000 mg/kg dose. Following the same protocol, these authors applied Dimethicone (225 fluid, 10 cs) suspended in com oil ( 1 :5) (200 mg/kg) to the shaven backs of groups of 15 pregnant rabbits on GDs 6 to 18. Treatment did not affect maternal body weight, weight gains, number of implantation or resorption sites, or viable fetuses. Umbilical hernia was noted in one pup each of the treated and control group; one treated pup had talipes varus. No other abnormalities were observed and 24-h survival was comparable between treated and control pups (Kennedy et al. 1976). In a study by an unknown author, retrieved from the National Technical Information Service (NTIS 1987 a), motor oil containing an unspecified amount ofDimethicone was applied undiluted to the shaved backs of the parental (P1) and first (Fi) generation of Sprague-Dawley rats, 7 days a week for an 8 week premating period; 3-week mating period, and throughout gestation and lactation. Doses applied were 0.1, 0.4, and 1.5 ml/kg. Twenty pregnant P1 females from each dose group underwent natural parturition; the remaining 20 were killed on GD 13 and the uteri content was examined for implants. A single male and female were selected from each FI litter to produce the F2 generation; dermal treatment began one day after weaning. All F1 females were allowed a natural parturition. P1 and F 1 males were killed at the end of mating. F2 rats were not treated and were killed aJ weaning. No statistically significant difference was detected in the mortality or survival rates in F1 litters on day O (parturition). However, mortality after day O was significantly decreased in the Distributed for Comment Only — Do Not Cite or Quote DIMETHICONE AND METHICONE 29 0.4- and 1.5-ml/kg groups. In contrast, mortality in the F2 litter was significantly increased in the 0.4-ml/kg group on day 0. Body weights and weight gains were significantly reduced in adult F1 male rats of the 1.5-ml/kg group beginning on week 7 and continuing throughout the mating period. Absolute testes weight was also significantly reduced in these males, but the relative testes to body weight ratio was not significantly different from controls. Gestating dam body weights were significantly increased in the 0.1- and 0.4-ml/kg group compared to sham controls. No significant differences were noted in F 1 or F2 litter body weight or body weight gains. External appearance and microscopic features of the F1 and F2 skeletal systems were comparable to controls. Mild dermal irritation was observed in P1 and F1 rats. Mild epidermal acanthosis was observed in P1 and F1 rats of the 1.5-ml/kg group. According to the authors, the motor oil did not induce any significant alterations in the reproductive performance of either the P1 or F1 generation (NTIS 1987a). In a study by an unknown author, retrieved from the National Technical Information Service (NTIS 1987b), motor oil containing an unknown concentration of Dimethicone was applied undiluted (1.5 ml/kg) to the shaved back of 20 timed-pregnant Sprague-Dawley rats on GDs 6 to 15. A sham-control was maintained. No deaths occurred during the study. Mean dam and litter body weight, pup viability, incidence of external, soft tissue, and skeletal abnormalities were comparable between treated and control animals.

General safety info about Silicone from CIR

No report found.

Use this, not that!

Products where you might find Silicone

Wrinkles Schminkles Eye Smoothing Kit (6 count); Wrinkles Schminkles Neck Smoothing Kit (41 g.); FOREO Silicone Cleaning Spray (2 fl. oz.); The Ordinary High-Adherence Silicone Primer; The Ordinary Vitamin C Suspension 30% in Silicone; HUDA BEAUTY Fender Blender Dual-Ended Sponge & Silicone Eyeshadow Brush