Is Dimethicone safe in cosmetics?
Dimethicone has a safety rating of "EXCELLENT" in our database. EU status: permitted. US status: permitted. 10 toxicological study endpoint(s) are available in our database.
Dimethicone
Also known as: Dow Corning 365 Dimethicone NF Emulsion, Dimeticone, Dow Corning 5-7139, Gransil 530, Silicone Fluid 350 (+3 more)
INCI: DIMETHICONE
Dimethicone (CAS 9006-65-9) is a cosmetic emollient functioning as emollient, skin-conditioning, film-forming, skin protectant, occlusive. Reported NOAEL =0.2 mg/kg bw/day (WHO/JECFA); EU Regulation 1223/2009 status: permitted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical data.
Function
emollient, skin-conditioning, film-forming, skin protectant, occlusive
Editorial assessment
EXCELLENT
Preliminary editorial note — not a computed safety verdict.
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
FDA OTC skin protectant active ingredient at 1–30% under Monograph M016 (21 CFR §347.10); CIR Final Amended Report March 2022 concludes safe for 30 methicone/dimethicone polymers as used
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Dimethicone.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
10 study endpoints found for Dimethicone. NOAEL (No Observed Adverse Effect Level) values are used to calculate the Margin of Safety per SCCS methodology.
| Endpoint | Value | Route | Species | Study Type | Source |
|---|---|---|---|---|---|
| NOAEL | =0.2 mg/kg bw/day | - | - | Toxicology study | WHO/JECFA |
| NOAEL | =0.2 mg/kg bw/day | - | - | Toxicology study | WHO/JECFA |
| NOAEL | =0.2 mg/kg bw/day | - | - | Toxicology study | WHO/JECFA |
| NOAEL | =4.28571428571429 mg/kg bw/day | - | - | Toxicology study | WHO/JECFA |
| NOAEL | =4.28571428571429 mg/kg bw/day | - | - | Toxicology study | WHO/JECFA |
| NOAEL | =4.28571428571429 mg/kg bw/day | - | - | Toxicology study | WHO/JECFA |
| NOAEL | =30 mg/kg bw/day | - | - | Toxicology study | WHO/JECFA |
| NOAEL | =30 mg/kg bw/day | - | - | Toxicology study | WHO/JECFA |
| NOAEL | =246 mg/kg bw/day | - | - | Subchronic toxicity | WHO/JECFA |
| NOAEL | =246 mg/kg bw/day | - | - | Subchronic toxicity | WHO/JECFA |
Dermal Penetration Profile
Skin absorption and penetration characteristics of Dimethicone, relevant to systemic exposure and MoS calculations.
Absorption %
0%
Penetration Level
surface
Penetration Depth
surface only
Molecular Weight
7500-9000 Da
Log P
6.8
Systemic Absorption
no
Topical Bioavailability
0%
Safety Margin Factor
none
Source: SCCS Opinion
EPA ToxValDB — Toxicity Values
1 toxicity value from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| LD50 | >20000 mg/kg | Mouse | oral | - | ChemIDplus |
Typical Use Concentrations
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Face Cream | 0.5–5 | 15 | CIR Safety Assessment |
| Body Lotion | 0.5–5 | 15 | CIR Safety Assessment |
| Shampoo | 0.5–3 | 5 | CIR Safety Assessment |
| Primer | 1–10 | 15 | CIR Safety Assessment |
| Hair Serum | 1–5 | 20 | CIR Safety Assessment |
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Anti-stain agent
Chemical reaction regulator
Defoamer
Emulsifier
Film former
Humectant
Lubricating agent
Processing aids not otherwise specified
Softener and conditioner
Stabilizing agent
Regulatory List Membership (2)
EU Regulated in Personal Care
EU Restricted for Children (Cosmetics)
Editorial summary
Preliminary editorial summary for Dimethicone — not a computed safety verdict. See the sourced toxicological data above.
Regulatory Flags
cir-approved
fda-otc-active
skin-protectant
non-volatile-silicone
non-comedogenic
scar-management
high-molecular-weight
genotoxicity-negative
carcinogenicity-negative
cosmos-prohibited
airbrush-insufficient-data
eu_children_restricted
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Dimethicone by CAS number or substance name.
Studies
16
Lowest NOAEL
0.2 mg/kg bw/day
Highest NOAEL
500 mg/kg bw/day
WHO/JECFA
Known Synonyms
Dow Corning 365 Dimethicone NF Emulsion
Dimeticone
Dow Corning 5-7139
Gransil 530
Silicone Fluid 350
Polydimethyl siloxane
DIMETHICONE 350
EC No.: 618-433-4
Chemical Function
Defoamer
Lubricating agent
Softener and conditioner
Humectant
Regulatory Lists
inert_ingredient; non_food_use; Pesticides
active_ingredient; animal_products; Europe; pharmaceutical; residue
children; Europe; Personal care
children; Europe; Personal care - specialized bath products - bath salts
children; Europe; Personal care - general moisturizing - hand/body lotion
Europe; Personal care - hair styling and care - shampoo-dandruff
consumer_product; Europe
Europe; Personal care
Europe; Personal care
Canada; pharmaceutical
Cleaning products and household care - dishwasher and dishes - automatic dishwashing detergent; Europe
Cleaning products and household care; Europe
Cleaning products and household care; Europe
Europe; Personal care - oral and dental care - teeth whitener
Europe; Personal care - make-up and related
Australian Status
AICIS status: listed
Cross-Vertical Safety Context
Same-CAS public records found in pharmaceutical data.
SOURCE
ChEMBL / DrugCentral / FAERS
DB_PHARMA CAS match
Pharmaceutical Data
Same-CAS rows from the pharmaceutical spoke database.
Compound
dimethicone
ChEMBL ID
CHEMBL1200838
Adverse Event Associations
2534
Frequently Asked Questions
Is Dimethicone allowed in the EU?
Dimethicone EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Dimethicone do in cosmetics?
Dimethicone functions as: emollient, skin-conditioning, film-forming, skin protectant, occlusive. It is classified as a Emollient in our database. CAS number: 9006-65-9.
What is the NOAEL for Dimethicone?
The NOAEL (No Observed Adverse Effect Level) for Dimethicone is =0.2 mg/kg bw/day based on a Toxicology study study via oral route in rat. A total of 10 study endpoints are available. Source: WHO/JECFA.
Is Dimethicone used outside cosmetics?
Dimethicone also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check Dimethicone compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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