DIMETHICONE

Antifoaming Agent; Skin-Conditioning Agent - Occlusive; Skin Protectant; EMOLLIENT; SKIN CONDITIONING; SKIN PROTECTING  

SCORE

2

low hazard to moderate hazard depending on product usage

3

 

74%

data gap

(why scores have changed)

Also listed as

DIMETHYL SILICONE; HIGHLY POLYMERIZED METHYL POLYSILOXANE; METHYL POLYSILOXANE; SILICONE L-45; DIMETHICONE COPOLYOL; DC 1664; DIMETHICONE 350; DIMETICONE; DOW CORNING 1664; MIRASIL DM 20; VISCASIL 5M


Given the incomplete information made available by companies and the government, EWG provides additional information on personal care product ingredients from the published scientific literature. The chart below indicates that research studies have found that exposure to this ingredient -- not the products containing it -- caused the indicated health effect(s) in the studies reviewed by Skin Deep researchers. Actual health risks, if any, will vary based on the level of exposure to the ingredient and individual susceptibility -- information not available in Skin Deep.

This ingredient:
noCancer
noDevelopmental/reproductive toxicity
yes, moderateViolations, restrictions & warnings
noAllergies/immunotoxicity
noContamination concerns
noOther moderate concerns for this ingredient:
Organ system toxicity (non-reproductive)
noLesser or emerging concerns for this ingredient:
Ecotoxicology, Data gaps
 
See products containing DIMETHICONE

About DIMETHICONE: Dimethicone is a mixture of fully methylated linear siloxane polymers end blocked withtrimethylsiloxy units. It conforms generally to the formula: In the United States, Dimethicone may be used as an active ingredient in OTC drug products. When used as an active drug ingredient, the established name is Dimethicone. See "Regulatory and Ingredient Use Information," regarding the labeling names for U.S . OTC Drug Ingredients in Volume 1, Introduction, Part A.

DIMETHICONE has reported used in the following product types: moisturizer (1540); facial moisturizer/treatment (1524); foundation (1099); anti-aging (924); sunscreen: makeup (658); conditioner (619); eye shadow (593); sunscreen: SPF 15-30 (516); hair color and bleaching (506); nail polish (392)


Violations, restrictions & warnings

type of concern product conditions reference
Recommended restricted in cosmetics - use, concentration, or manufacturing restrictions - Product type restrictions or differences noted in safety assessment by industry panel   Cosmetic Ingredient Review Assessments

Organ system toxicity (non-reproductive)

type of concern product conditions reference
Classified as expected to be toxic or harmful     Environmental Canada Domestic Substance List
show more

Ecotoxicology

type of concern product conditions reference
Suspected to be an environmental toxin and be persistent or bioaccumulative     Environmental Canada Domestic Substance List
show more

Data gaps

type of concern product conditions reference
Risk assessment method deficiencies and data gaps - Maximum reported "as used" concentration is basis of safety assessment by industry safety panel (Cosmetic Ingredient Review, CIR) - implicit safe concentration limit in product   Cosmetic Ingredient Review Assessments
54 studies on toxicity in PubMed see search results ->   PubMed

Multiple, additive exposure sources

type of concern product conditions reference
Designated as safe for general or specific, limited use in food   FDA Everything Added to Food
Designated as safe for general or specific, limited use in food   FDA Food Additive Status

Persistence and bioaccumulation

type of concern product conditions reference
Not suspected to be bioaccumulative     Environmental Canada Domestic Substance List
show more



Government, industry, academic studies and classifications

government/industry list/academic study appears on list as classification(s)
FDA Food Additive StatusDIMETHYLPOLYSILOXANE• Food additive: antifoaming (or defoaming) agent
• Food additive: food additive for which a petition has been filed and a regulation issued
• ZERO - In milk -173.340
• 110 parts per million - In dry gelatin dessert mixes
• 250 parts per million In salt for cooking purposes
• 10 parts per million - In other food in its ready-for-consumption state
• 145.180(a)
• Cnd Pineapple
• 146.185(a)
• Cnd Pineapple Juice
Cosmetic Ingredient Review AssessmentsDIMETHICONE•Safe as used in cosmetics according to industry panel (Cosmetic Ingredient Review, CIR)
•Maximum reported "as used" concentration is basis of safety assessment by industry safety panel (Cosmetic Ingredient Review, CIR) - implicit safe concentration limit in product
•Product type restrictions or differences noted in safety assessment by industry panel
FDA Everything Added to FoodDIMETHYLPOLYSILOXANE• Fully up-to-date toxicology information has been sought.
Cosmetic Ingredient Review AssessmentsDIMETHICONE COPOLYOL•Safe as used in cosmetics according to industry panel (Cosmetic Ingredient Review, CIR)
•Maximum reported "as used" concentration is basis of safety assessment by industry safety panel (Cosmetic Ingredient Review, CIR) - implicit safe concentration limit in product
Environmental Canada Domestic Substance ListDIMETHICONE•This chemical was flagged for further attention by CEPA due to suspected aquatic toxicity and persistence.
Environmental Canada Domestic Substance ListSILOXANES AND SILICONES, DI-ME, HYDROXY-TERMINATED, ETHOXYLATED PROPOXYLATED•This chemical was NOT flagged by CEPA for further attention.

references

government/industry list/academic study reference
FDA Food Additive StatusFDA (U.S. Food and Drug Administration) 2006. Food Additive Status List. Downloaded from http://www.cfsan.fda.gov/%7Edms/opa-appa.html, Oct 16, 2006.
Cosmetic Ingredient Review AssessmentsCIR (Cosmetic Ingredient Review). 2006. CIR Compendium, containing abstracts, discussions, and conclusions of CIR cosmetic ingredient safety assessments. Washington DC.
FDA Everything Added to FoodFDA (U.S. Food and Drug Administration). 2008. EAFUS [Everything Added to Food]: A Food Additive Database. FDA Office of Food Safety and Applied Nutrition.
Environmental Canada Domestic Substance ListEC (Environment Canada). 2008. Domestic Substances List Categorization. Canadian Environmental Protection Act (CEPA) Environmental Registry.

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