Poor Cosmetic Ingredient NOAEL Data GHS Classified

DMSO (Dimethyl Sulfoxide)

Also known as: Methyl sulfoxide, DMSO, Methane, sulfinylbis-, Caswell No. 381, Demasorb (+15 more)

INCI: DIMETHYL SULFOXIDE

DMSO (Dimethyl Sulfoxide) (CAS 67-68-5) is a cosmetic cosmetic ingredient functioning as Solvent / penetration enhancer. NOAEL 1000 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: prohibited; GHS signal word WARNING. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.

View industrial chemical safety profile for CAS 67-68-5 →

Auto-generated CPSR Part A draft with source citations

Cross-Vertical Regulatory Divergence

DMSO (Dimethyl Sulfoxide) is prohibited in EU cosmetics but has active industrial GHS classifications (H315, H319, H335, H227, H371).

Source: Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code

CAS Number

67-68-5

View industrial chemical safety profile →

Function

Solvent / penetration enhancer

Safety Rating

POOR

Chemistry & Identifiers

Formula

C2H6OS

78.14 g/mol

EC Number

200-664-3

PubChem CID

679

IUPAC Name

methylsulfinylmethane

InChIKey

IAZDPXIOMUYVGZ-UHFFFAOYSA-N

ChEBI: CHEBI:28262 UNII: YOW8V9698H Wikidata: Q407927

Regulatory Status

EU EU Status prohibited

US US Status permitted

US Notes Permitted for cosmetics — no specific 21 CFR prohibition; FDA-approved as a prescription drug (Rimso-50) for interstitial cystitis

For full compliance data across multiple jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for DMSO (Dimethyl Sulfoxide).

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

3 study endpoints found for DMSO (Dimethyl Sulfoxide). 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	=500 mg/kg bw/day	injection	Rat	repeat dose other	ToxValDB_ECHA_IUCLID
NOAEL	=1650 mg/kg bw/day	dermal	Pig	chronic	ToxValDB_ECHA_IUCLID
NOAEL	=3300 mg/kg bw/day	dermal	Monkey	chronic	ToxValDB_ECHA_IUCLID

GHS Hazard Classification

Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.

Signal Word

WARNING

Hazard Statements

Combustible liquid

Short-term Exposure Effects

The substance is mildly irritating to the eyes and skin. Exposure to high concentrations could cause lowering of consciousness. May accelerate skin absorption of other materials. See Notes.

Long-term Exposure Effects

The substance defats the skin, which may cause dryness or cracking.

Routes of Exposure

The substance can be absorbed into the body by inhalation, through the skin and by ingestion.

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for DMSO (Dimethyl Sulfoxide) across SCCS product categories, with measured dermal absorption where available.

EPA ToxValDB — Toxicity Values

10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).

Endpoint	Value	Species	Route	Duration	Source
LEL	=83083.4 mg/m3	Human	inhalation	-	DOE Protective Action Criteria
NOAEL	=1000 mg/kg-day	Rat	oral	-	EFSA
LOEL	=25 uL	Mouse	dermal	short-term	ECOTOX
NOEL	=25 uL	Mouse	dermal	short-term	ECOTOX
LOAEC	=2.783 mg/L	Rat	inhalation	subchronic	HPVIS
NOAEC	=0.964 mg/L	Rat	inhalation	subchronic	HPVIS
LD50	~40000 mg/kg	Rat	dermal	-	ECHA IUCLID
LD50	~50000 mg/kg	Mouse	dermal	-	ECHA IUCLID
LD50	=28300 mg/kg	Rat	oral	-	ECHA IUCLID
LD50	=21400 mg/kg	Mouse	oral	-	ECHA IUCLID

Sensitization AOP Dashboard

Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.

DPRA Cys %

0.4%

DPRA Lys %

1.2%

KeratinoSens IC50

2000 µM

hCLAT CV75

5000 µg/mL

LLNA EC3

72%

NESIL

46552 µg/cm²

LLNA: NC (non-sensitizer) GHS: not classified Human: positive

Source: LLNA: Gerberick et al. (2005); DPRA: Hoffmann et al., 2018; KS: No reference provided in NICEATM database; hCLAT: No reference provided in NICEATM database; HPPT: [27] Kligman AM (1966): https://doi.org/10.1038/jid.1966.160

HRIPT Human Patch Test Studies

2 human repeat insult patch tests aggregated from dermatological literature.

Test Type	N	Sensitized	Dose µg/cm²	NESIL µg/cm²	Potency
HMT	-	0	46551.72	-	-
OECD_DA_Human	-	0	-	-	Non-sensitizer

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type

Full

Tonnage Band

10,000 - 100,000 tonnes

Substance Type

SUBSTANCE

SVHC Candidate

EU CosIng Annex Listing

European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.

Annex II — Prohibited

Ref: 338

(EC) 2009/1223

Expanded Jurisdictional Detail

Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.

SA Saudi SFDA (II - Prohibited)

ASEAN Cosmetic Directive (II)

Ref: 338

BRIN Brazil/India Cosmetics

Brazil: Prohibited

India: Prohibited (GNRAS)

Additional Jurisdictional Restrictions (4)

Jurisdiction	Status	Max %	Product Type
IN	banned	-	all cosmetics
CA	banned	-	-
ASEAN	banned	-	All cosmetic products prohibited
KR	prohibited	-	-

PubChem Annotations

Safety and regulatory annotations from PubChem (NCBI) aggregated sources.

Safety (3)

Carcinogen Classification

No indication of carcinogenicity to humans (not listed by IARC).

Source: Toxin and Toxin Target Database (T3DB)

ICSC Safety Card

0459

Source: ILO-WHO International Chemical Safety Cards (ICSCs)

Skin Eye Respiratory Irritation

Skin irritation can develop at the site where DMSO is applied topically.

Source: Hazardous Substances Data Bank (HSDB)

Regulatory (5)

JECFA Number

507