Is 1,4-Butanediol safe in cosmetics?
1,4-Butanediol has a safety rating of "POOR" in our database. EU status: restricted. US status: prohibited. 3 toxicological study endpoint(s) are available in our database.
1,4-Butanediol
Also known as: 4-01-00-02515, Agrisynth B1D, BRN 1633445, EINECS 203-786-5, UNII-7XOO2LE6G3 (+3 more)
INCI: 1,4-BUTANEDIOL
1,4-Butanediol (CAS 110-63-4) is a cosmetic cosmetic ingredient functioning as Solvent, humectant, viscosity controlling agent. Reported NOAEL =50 mg/kg bw/day in Rat (ECHA); EU Regulation 1223/2009 status: restricted. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.
Function
Solvent, humectant, viscosity controlling agent
Editorial assessment
POOR
Preliminary editorial note — not a computed safety verdict.
Regulatory Status
EU EU Status
restricted
US US Status
prohibited
US Notes
FDA Class I Health Hazard. FDA has issued warnings; CIR Panel concluded it is not safe for cosmetic use based on in-vivo conversion to GHB (gamma-hydroxybutyrate). Metabolized to GHB, a CNS depressant. FDA reported adverse health effects including decreased respiration and deaths linked to 1,4-Butanediol-containing products.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for 1,4-Butanediol.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
3 study endpoints found for 1,4-Butanediol. 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 | =50 mg/kg bw/day | oral | Rat | short-term | ECHA |
| NOAEL | =400 mg/kg bw/day | oral | Rat | developmental | ECHA |
| NOAEL | =800 mg/kg bw/day | oral | Rat | reproduction developmental | ECHA |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Short-term Exposure Effects
The substance may cause effects on the central nervous system. This may result in narcosis.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its vapour and by ingestion.
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
100,000 - 1,000,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Binder
Plasticizer
Processing aids not otherwise specified
Solvent
Regulatory List Membership (1)
FDA Indirect Food Contact Additives
Editorial summary
Preliminary editorial summary for 1,4-Butanediol — not a computed safety verdict. See the sourced toxicological data above.
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to 1,4-Butanediol by CAS number or substance name.
Studies
3
Lowest NOAEL
50 mg/kg bw/day
Highest NOAEL
800 mg/kg bw/day
ECHA
Known Synonyms
4-01-00-02515
Agrisynth B1D
BRN 1633445
EINECS 203-786-5
UNII-7XOO2LE6G3
1,4-BD
HO(CH2)4OH
HOCH2CH2CH2CH2OH
Chemical Function
Solvent
Binder
Processing aids not otherwise specified
Plasticizer
Regulatory Lists
detected; Europe; Toys and children's products
detected; Europe; Toys and children's products
detected; Toys and children's products
Canada; pharmaceutical
CEDI
Indirect additives food contact (10/2018)
inert_ingredient; non_food_use; Pesticides
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
1,4-BUTANEDIOL
ChEMBL ID
CHEMBL171623
Frequently Asked Questions
Is 1,4-Butanediol allowed in the EU?
1,4-Butanediol EU regulatory status: restricted. This is based on EU Regulation 1223/2009 and its amendments.
What does 1,4-Butanediol do in cosmetics?
1,4-Butanediol functions as: Solvent, humectant, viscosity controlling agent. It is classified as a cosmetic ingredient in our database. CAS number: 110-63-4.
What is the NOAEL for 1,4-Butanediol?
The NOAEL (No Observed Adverse Effect Level) for 1,4-Butanediol is =50 mg/kg bw/day based on a short-term study via oral route in Rat. A total of 3 study endpoints are available. Source: ECHA.
Is 1,4-Butanediol used outside cosmetics?
1,4-Butanediol also appears in industrial chemical safety and pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check 1,4-Butanediol compliance across multiple jurisdictions:
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Substance Compliance
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MoS Calculator
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Heavy Metal Limits
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