Is BUTYROLACTONE safe in cosmetics?
BUTYROLACTONE has a safety rating of "GOOD" in our database. EU status: permitted. 10 toxicological study endpoint(s) are available in our database.
BUTYROLACTONE
Also known as: 1,4-Butanolide, 2(3H)-Furanone, dihydro-, 2 (3h)-furanona, dihidro -, 3-hydroxybutyric acid lactone, butyrolactone, dihydro (+15 more)
BUTYROLACTONE (CAS 96-48-0) is a cosmetic cosmetic ingredient functioning as Fragrance, Solvent. NOAEL 87.3333 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted; GHS signal word DANGER. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in pharmaceutical data.
View industrial chemical safety profile for CAS 96-48-0 →
Auto-generated CPSR Part A draft with source citations
Function
Fragrance, Solvent
Safety Rating
GOOD
Chemistry & Identifiers
IUPAC Name
oxolan-2-one
InChIKey
YEJRWHAVMIAJKC-UHFFFAOYSA-N
Regulatory Status
EU EU Status
permitted
US US Status
Not specifically regulated
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Toxicological Studies
10 study endpoints found for BUTYROLACTONE. 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 | 262 mg/kg bw/day | oral | mouse | Carcinogenicity | COSMOS_DB |
| NOAEL | 350 mg/kg bw/day | oral | mouse | Short Term Toxicity | COSMOS_DB |
| NOAEL | 450 mg/kg bw/day | oral | rat | Carcinogenicity | COSMOS_DB |
| NOAEL | 500 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
| NOAEL | 525 mg/kg bw/day | oral | mouse | Subchronic | COSMOS_DB |
| NOAEL | 600 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 900 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | =200 mg/kg bw/day | oral | Rat | Chronic toxicity | INCHEM_WHO_kemi_kemi_ah2004_07 |
| NOAEL | =200 mg/kg bw/day | oral | Rat | Chronic toxicity | INCHEM_WHO_kemi_kemi_ah2004_07 |
| NOAEL | =200 mg/kg bw/day | oral | Rat | Chronic toxicity | INCHEM_WHO_kemi_kemi_ah2004_07 |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Signal Word
DANGER
Pictograms
CorrExcl markWarn
Hazard Statements
Harmful if swallowed Causes serious eye damage May cause drowsiness or dizziness Harmful to aquatic life
Short-term Exposure Effects
The substance is severely irritating to the eyes. Ingestion could cause effects on the central nervous system. This may result in excitement and central nervous system depression. Exposure at high concentrations could cause respiratory failure, convulsions and unconsciousness. See Notes.
Routes of Exposure
The substance can be absorbed into the body by inhalation of its vapour, by ingestion and through the skin.
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for BUTYROLACTONE across SCCS product categories, with measured dermal absorption where available.
IARC Carcinogenicity
International Agency for Research on Cancer (WHO) monograph evaluation.
IARC Group
3
Volume
11, Sup 7, 71
Evaluation Year
1998
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1,000 - 10,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Safety (5)
Carcinogen Classification
3, not classifiable as to its carcinogenicity to humans. (L135)
Source: Toxin and Toxin Target Database (T3DB)
Carcinogen Classification
gamma-Butyrolactone | Group 3: Not classifiable as to its carcinogenicity to humans | Volume 11: (1976) Cadmium, Nickel, Some Epoxides, Miscellaneous Industrial Chemicals and General Considerations on Volatile Anaesthetics | Volume Sup 7: Overall Evaluations of Carcinogenicity: An Updating of IARC Monographs Volumes 1 to 42, 1987; 440 pages; ISBN 92-832-1411-0 (out of print) | Volume 71: (1999) Re
Source: International Agency for Research on Cancer (IARC)
Carcinogen Classification
gamma-Butyrolactone | TR-406: Toxicology and Carcinogenesis Studies of g-Butyrolactone (CASRN 96-48-0) in F344/N Rats and B6C3F1 Mice (Gavage Studies) (1992 ) | 07/09/91 | No Evidence | No Evidence | Equivocal Evidence | No Evidence | Under the conditions of these 2-year gavage studies, there was no evidence of carcinogenic activity of g-butyrolactone in male F344/N rats given 112 or 225
Source: NTP Technical Reports
Evidence for Carcinogenicity
Evaluation: There is inadequate evidence in humans for the carcinogenicity of 4-butyrolactone. There is evidence suggesting lack of carcinogenicity of 4-butyrolactone in experimental animals. Overall evaluation: 4-Butyrolactone is not classifiable as to its carcinogenicity to humans (Group 3).
Source: Hazardous Substances Data Bank (HSDB)
ICSC Safety Card
1020
Source: ILO-WHO International Chemical Safety Cards (ICSCs)
Regulatory (3)
JECFA Number
219
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
JECFA Evaluation
4-HYDROXYBUTYRIC ACID LACTONE | 1997 | No safety concern at current levels of intake when used as a flavouring agent | TRS 884-JECFA 49/42 | FAS 40-JECFA 49/231
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
JECFA Evaluation
gamma-BUTYROLACTONE | 1998 | No safety concern at current levels of intake when used as a flavouring agent | TRS 891-JECFA 51/96 | FAS 42-JECFA 51/335
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Deodorizer
Flavouring and nutrient
Fragrance
Solvent
Regulatory List Membership (3)
IFRA Fragrance Transparency List
FDA Substances Added to Food (EAFUS)
Consumer Product Chemical
Expert Verdict
Expert safety assessment and concern-level summary for BUTYROLACTONE.
Regulatory Flags
cosing-sourced
eu-permitted
fragrance
needs-enrichment
ifra_fragrance
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to BUTYROLACTONE by CAS number or substance name.
Studies
18
Lowest NOAEL
200 mg/kg bw/day
Highest NOAEL
900 mg/kg bw/day
COSMOS_DB
ToxValDB_ECHA_IUCLID
INCHEM_WHO_kemi_kemi_ah2004_07
Known Synonyms
1,4-Butanolide
2(3H)-Furanone, dihydro-
2 (3h)-furanona, dihidro -
3-hydroxybutyric acid lactone
butyrolactone, dihydro
dihydrofuran-2(3H)-one
NIH 10540
NSC 4592
Agrisynth BLO
gamma-BL
Butanoic acid, 4-hydroxy-, gamma-lactone
1,2-Butanolide
Butyric acid, 4-hydroxy-, gamma-lactone
Butyryl lactone
Butyrylactone
Caswell No. 132B
Dihydro-2-furanone
EINECS 202-509-5
EPA Pesticide Chemical Code 122303
FEMA No. 3291
Chemical Function
Solvent
Deodorizer
Flavouring and nutrient
Fragrance
Regulatory Lists
IFRA Transparency
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
consumer_product
Europe
artificial_saliva; detected; emissions; Europe; Other indirect contact consumer goods
air; Cons electronics mech appliances and machinery; detected; emissions; Europe
artificial_saliva; detected; emissions; Europe; Toys and children's products
inert_ingredient; Pesticides
inert_ingredient; non_food_use; Pesticides
Canada; pharmaceutical
Europe
artificial_saliva; detected; emissions; Europe; Other indirect contact consumer goods
air; Cons electronics mech appliances and machinery; detected; emissions; Europe
artificial_saliva; detected; emissions; Europe; Toys and children's products
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
BUTYROLACTONE
ChEMBL ID
CHEMBL95681
Frequently Asked Questions
Is BUTYROLACTONE allowed in the EU?
BUTYROLACTONE EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does BUTYROLACTONE do in cosmetics?
BUTYROLACTONE functions as: Fragrance, Solvent. It is classified as a cosmetic ingredient in our database. CAS number: 96-48-0.
What is the NOAEL for BUTYROLACTONE?
The NOAEL (No Observed Adverse Effect Level) for BUTYROLACTONE is 262 mg/kg bw/day based on a Carcinogenicity study via oral route in mouse. A total of 10 study endpoints are available. Source: COSMOS_DB.
Is BUTYROLACTONE classified as hazardous under GHS?
BUTYROLACTONE carries a GHS signal word of "DANGER". Hazard statements: Harmful if swallowed Causes serious eye damage May cause drowsiness or dizziness Harmful to aquatic life. This classification is based on the ILO/WHO International Chemical Safety Card and ECHA C&L inventory data. Note: GHS classification applies to the pure substance — at cosmetic use concentrations, hazard thresholds may not be met.
Is BUTYROLACTONE used outside cosmetics?
BUTYROLACTONE also appears in pharmaceutical data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Compliance Tools
Check BUTYROLACTONE 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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