Polysilicone-11

The Basics On Polysilicone-11

What is Polysilicone-11?

Specialized, synthetic crosslinked siloxane that functions as a film-forming agent and polymer.

What are other names for Polysilicone-11?

POLYSILICONE-11

What is Polysilicone-11 used for?

How Polysilicone-11 is classified

Silicones, Texture Enhancer

Recommendations for using Polysilicone-11 during pregnancy and breastfeeding

Limited data suggests no known risk

 

Polysilicone-11 During Pregnancy

What we know about using Polysilicone-11 while pregnant or breastfeeding

Limited information available.

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General safety info about Polysilicone-11 from CIR

This is a safety assessment of Polysilicone-11 as used in cosmetics. According to the Dictionary, Polysilicone-11 is a crosslinked dimethyl siloxane formed by the reaction of bis-vinyldimethicone and hydrogen peroxide, and is reported to function as a film former in cosmetics. According to 2019 VCRP data, Polysilicone-11 is reported to be used in 420 formulations, 412 of which are leaveon formulations. The majority of these uses are in face and neck (excluding shave) products, moisturizing products, eye lotions, and foundations. The result of the 2018 concentration of use survey conducted by the Council indicate Polysilicone11 is used at a maximum concentration of up to 35% in face and neck products (not spray). An LD50 of > 5 g/kg was established in an acute oral toxicity study performed on Sprague-Dawley rats given a test substance consisting of 6% Polysilicone-11 and 94% cyclotetrasiloxane. No mutagenicity was reported in an Ames assay performed using a mixture consisting of 14% Polysilicone-11, 47% dimethicone, and 39% cyclopentasiloxane. The test substance was tested on S. typhimurium (TA98 and TA100) at concentrations of up to 5000 µg/plate. No irritation was observed in a skin irritation study performed on New Zealand white albino rabbits using a test substance consisting of 6% Polysilicone-11 and 94% cyclotetrasiloxane. A 48-hour patch test performed was performed on 50 subjects using a lipstick containing 1.8% Polysilicone-11. No irritation was observed. In addition, no dermal irritation was observed in a 7-day dermal irritation study performed on 38 subjects using a face cream containing 1.6% Polysilicone11. No sensitization was observed in multiple HRIPTs using the following test materials: a facial product containing 9.68% Polysilicone-11, a 10% dilution of a facial product containing 19.83% Polysilicone-11, a mixture of 11% Polysilicone11 and 89% cyclopentasiloxane, or a product containing 1.45% Polysilicone-11. In a sensitization study performed on 27 subjects using a pre-treatment with SLS, the test substance (24% Polysilicone-11) was considered to be non-sensitizing. An in vitro tissue equivalent assay was performed in order to evaluate the ocular irritation potential of a face cream containing 1.6% Polysilicone-11. The t50s for Polysilicone-11 and the positive control were 18.2 h and 30.3 minutes, respectively. A MatTek EpiOcular™ MTT viability assay was also performed to evaluate the ocular irritation potential of a test substance containing 98.5% Polysilicone-11. The ET50 was 725.9 min, and the ocular irritancy classification for this test substance was “non-irritating, minimal.” In an ocular irritation study in New Zealand white rabbits, a test substance consisting of 6% Polysilicone-11 and 94% cyclotetrasiloxane applied to the eyes was considered to be minimally irritating.

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Products where you might find Polysilicone-11

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