NOAEL Data IARC Group 3 REACH Registered Cosmetic Ingredient

4-Butyrolactone

Also known as: 1,4-Butanolide, 2(3H)-Furanone, dihydro-, 2 (3h)-furanona, dihidro -, 3-hydroxybutyric acid lactone, butyrolactone, dihydro (+15 more)

CAS 96-48-0

4-Butyrolactone (CAS 96-48-0) is a chemical substance; key hazard signal: IARC Group 3. Key regulatory status: REACH registered, 14 regulatory/inventory lists, cosmetic ingredient cross-reference; source data from EPA ToxValDB, EPA CPDat, AICIS, IARC, ECHA REACH, ILO ICSC.

View cosmetic safety profile for Butyrolactone (γ-Butyrolactone / GBL) →

Cross-Vertical Regulatory Divergence

4-Butyrolactone is classified GHS Danger (H302, H315, H318, H319, H331, H336, H371) in the chemicals database but is allowed in EU cosmetics.

SOURCE Cross-vertical comparison Cosmetics: ingredients.eu_status; Chemicals: ghs_classifications.signal_word/hazard_statement_code

SOURCE noael studies public

NOAEL studies

SOURCE chemical inventory jurisdictions

Regulatory lists

SOURCE eu clp annex vi

GHS signal

Not classified

Chemical Identity

CAS, identifiers, formula, and alternate names for the matched substance record.

SOURCE DSSTox identifiers 26 fields

Name

4-Butyrolactone

CAS Number

96-48-0

DTXSID

DTXSID6020224

Molecular Formula

C4H6O2

InChI Key

YEJRWHAVMIAJKC-UHFFFAOYSA-N

Monoisotopic Mass

86.036779

Synonyms

1,4-Butanolide2(3H)-Furanone, dihydro-2 (3h)-furanona, dihidro -3-hydroxybutyric acid lactonebutyrolactone, dihydrodihydrofuran-2(3H)-oneNIH 10540NSC 4592Agrisynth BLOgamma-BLButanoic acid, 4-hydroxy-, gamma-lactone1,2-Butanolide

IARC Carcinogen Classification

Carcinogenic hazard classification from IARC monograph evaluations.

SOURCE IARC Monographs on the Identification of Carcinogenic Hazards to Humans 1 records

Group	Meaning	Evaluated	Volume
Group 3	Not classifiable	1998	11, Sup 7, 71

ICSC Chemical Safety

International Chemical Safety Card hazard and exposure summary.

SOURCE ILO/WHO International Chemical Safety Cards 1 records

Field	Value
GHS Signal Word	DANGER
GHS Hazard Statements	Harmful if swallowed Causes serious eye damage May cause drowsiness or dizziness Harmful to aquatic life
Short-term 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.

Functional Uses

Industrial and product-use categories associated with this substance.

SOURCE EPA CPDat 9 records

SolventDeodorizerFlavouring and nutrientFragrance

Regulatory Lists

Inventory, screening, and regulatory list matches from public chemical databases.

SOURCE EPA CPDat 14 records

List	Keyword	Source
IFRA Transparency	IFRA	IFRA
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)	FDA	United States Food and Drug Administration (FDA)
consumer_product	P&G	Proctor & Gamble
Europe	European Commission	Fl@vis
artificial_saliva; detected; emissions; Europe; Other indirect contact consumer goods	Danish Environmental Protection Agency	Danish EPA
air; Cons electronics mech appliances and machinery; detected; emissions; Europe	Danish Environmental Protection Agency	Danish EPA
artificial_saliva; detected; emissions; Europe; Toys and children's products	Danish Environmental Protection Agency	Danish EPA
inert_ingredient; Pesticides	EPA	CPCat
inert_ingredient; non_food_use; Pesticides	EPA	CPCat
Canada; pharmaceutical	DrugBank	DrugBank
Europe	European Commission	Fl@vis
artificial_saliva; detected; emissions; Europe; Other indirect contact consumer goods	Danish Environmental Protection Agency	Danish EPA
air; Cons electronics mech appliances and machinery; detected; emissions; Europe	Danish Environmental Protection Agency	Danish EPA
artificial_saliva; detected; emissions; Europe; Toys and children's products	Danish Environmental Protection Agency	Danish EPA

NOAEL Studies

Toxicology endpoints rendered from public NOAEL study rows.

SOURCE NOAEL studies Showing 50 of 58 studies

Value	Unit	Endpoint	Route	Species	Source
range:0-1.251.25	mg/kg bw/day	ADI	-	-	INCHEM_WHO_jecfa_jecmono_v040je12
range:0-1.251.25	mg/kg bw/day	ADI	-	-	INCHEM_WHO_jecfa_jecmono_v040je12
=130	mg/m3	DNEL systemic	inhalation	Human	ToxValDB_GESTIS_DNEL
43	unitless	Draize rabbit irritation score	Ocular	Rabbit	NTP_ICE_eye_irritation
2	unitless	EPA Classification	Ocular	Rabbit	NTP_ICE_eye_irritation
OL659KIY4X	UNII	FDA UNII substance identifier	-	-	openFDA substances
OL659KIY4X	UNII	FDA UNII substance identifier	-	-	openFDA substances
OL659KIY4X	UNII	FDA UNII substance identifier	-	-	openFDA substances
OL659KIY4X	UNII	FDA UNII substance identifier	-	-	openFDA substances
3	IARC group	IARC carcinogenicity classification	-	-	IARC Monographs
3	unitless	IARC group	-	-	NTP_ICE_cancer
0.11	%/sec	Intensity	Ocular	-	NTP_ICE_eye_irritation
>5.1	mg/L	LC50	Inhalation	-	NTP_ICE_acute_inhalation
~250	mg/kg bw/day	LEL	injection	Rat	ToxValDB_ECHA_IUCLID
=262	mg/kg bw/day	LOAEL	oral	Mouse	ToxValDB_ECHA_IUCLID
60	s	Lag time	Ocular	-	NTP_ICE_eye_irritation
-	unitless	Model Score	-	-	NTP_ICE_endocrine
=112	mg/kg bw/day	NOAEL	oral	Rat	ToxValDB_EFSA
=112	mg/kg bw/day	NOAEL	oral: gavage	Rat	EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx
=112	mg/kg bw/day	NOAEL	oral: gavage	Rat	EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx
=200	mg/kg bw/day	NOAEL	oral	Rat	INCHEM_WHO_kemi_kemi_ah2004_07
=200	mg/kg bw/day	NOAEL	oral	Rat	INCHEM_WHO_kemi_kemi_ah2004_07
=200	mg/kg bw/day	NOAEL	oral	Rat	INCHEM_WHO_kemi_kemi_ah2004_07
=200	mg/kg bw/day	NOAEL	oral	Rat	INCHEM_WHO_kemi_kemi_ah2004_07
=225	mg/kg bw/day	NOAEL	oral	Rat	ToxValDB_ECHA_IUCLID
=225	mg/kg bw/day	NOAEL	-	Rat	INCHEM_WHO_kemi_kemi_ah2004_07
=225	mg/kg bw/day	NOAEL	-	Rat	INCHEM_WHO_kemi_kemi_ah2004_07
=225	mg/kg bw/day	NOAEL	-	Rat	INCHEM_WHO_kemi_kemi_ah2004_07
=225	mg/kg bw/day	NOAEL	-	Rat	INCHEM_WHO_kemi_kemi_ah2004_07
262	mg/kg bw/day	NOAEL	oral	mouse	COSMOS_DB
350	mg/kg bw/day	NOAEL	oral	mouse	COSMOS_DB
450	mg/kg bw/day	NOAEL	oral	rat	COSMOS_DB
=450	mg/kg bw/day	NOAEL	oral	Rat	ToxValDB_ECHA_IUCLID
500	mg/kg bw/day	NOAEL	oral	rat	COSMOS_DB
525	mg/kg bw/day	NOAEL	oral	mouse	COSMOS_DB
=525	mg/kg bw/day	NOAEL	oral	Mouse	ToxValDB_ECHA_IUCLID
600	mg/kg bw/day	NOAEL	oral	rat	COSMOS_DB
900	mg/kg bw/day	NOAEL	oral	rat	COSMOS_DB
>1.29	mg/kg bw/day	NOEL	-	-	INCHEM_WHO_jecfa_jecmono_v040je12
>1.29	mg/kg bw/day	NOEL	-	-	INCHEM_WHO_jecfa_jecmono_v040je12
>1.3	mg/kg bw/day	NOEL	oral	Rat	INCHEM_WHO_jecfa_jecmono_v040je12
>1.3	mg/kg bw/day	NOEL	oral	Rat	INCHEM_WHO_jecfa_jecmono_v040je12
>46	mg/kg bw/day	NOEL	oral	Rat	INCHEM_WHO_jecfa_jecmono_v040je12
>46	mg/kg bw/day	NOEL	oral	Rat	INCHEM_WHO_jecfa_jecmono_v040je12
=112	mg/kg bw/day	NOEL	oral	Rat	ToxValDB_HESS
=112	mg/kg bw/day	NOEL	-	-	INCHEM_WHO_jecfa_jecmono_v040je12
=112	mg/kg bw/day	NOEL	-	-	INCHEM_WHO_jecfa_jecmono_v040je12
=225	mg/kg bw/day	NOEL	-	-	INCHEM_WHO_jecfa_jecmono_v040je12
=225	mg/kg bw/day	NOEL	-	-	INCHEM_WHO_jecfa_jecmono_v040je12
=262	mg/kg bw/day	NOEL	-	Mouse	INCHEM_WHO_jecfa_jecmono_v040je12

Showing 50 of 58 studies

REACH Registration

Registration status from the ECHA REACH registered substances database.

SOURCE ECHA (EU) 1 records

Status	Name	EC Number	Link
Registered	γ-butyrolactone	202-509-5	ECHA overview →

Australian Status (AICIS)

Australian industrial chemicals inventory status and applicable conditions.

SOURCE AICIS inventory 1 records

Inventory Status

listed

Cosmetic Safety Profile

Same-CAS cosmetic ingredient record for cross-vertical context.

SOURCE CosIng / Ingredients DB

EU Status

permitted

Max

Pharmaceutical Data

Same-CAS pharmaceutical records from drug and bioactivity sources.

SOURCE EMBL-EBI ChEMBL BUTYROLACTONE

ChEMBL Phase

Not listed

Adverse Events

Bioactivity

View full pharmaceutical profile →

Food Safety Data

Same-CAS food additive, ADI, and GRAS records where available.

SOURCE EFSA / FDA GRAS 1 records

1 food-safety record found.

View full food safety profile →

Cannabis Data

Same-CAS cannabis compliance and lab records where available.

SOURCE Cannabis regulatory / lab data efsa substances

1 cannabis record found in efsa substances.

View full cannabis profile →

Frequently Asked Questions

What is the NOAEL for 4-Butyrolactone?

4-Butyrolactone has 58 NOAEL studies in the database. The lowest reported value is 0 unitless. Source: NTP_ICE_endocrine.

What regulatory lists include 4-Butyrolactone?

4-Butyrolactone appears on 10 regulatory/inventory lists including IFRA Transparency, food_additive; Substances Added to Food (formerly EAFUS) (2/2019), consumer_product, and 7 more. Source: EPA CPDat.

Is 4-Butyrolactone a carcinogen according to IARC?

4-Butyrolactone is classified by IARC as Group 3 — not classifiable as to its carcinogenicity to humans (evaluated 1998). Source: IARC Monographs on the Identification of Carcinogenic Hazards to Humans.

Is 4-Butyrolactone used in cosmetics?

Yes, 4-Butyrolactone is also indexed as a cosmetic ingredient under the name Butyrolactone (γ-Butyrolactone / GBL). View the full cosmetic safety profile on the ingredient page for detailed safety data, SCCS opinions, and regulatory status.

Where does the safety data for 4-Butyrolactone come from?

Safety data is sourced from EPA ToxValDB, EPA CPDat, AICIS (Australian Industrial Chemicals Introduction Scheme), EPA DSSTox, IARC Monographs, ECHA REACH, ILO/WHO ICSC, CosIng / Ingredients DB, ChEMBL / DailyMed, EFSA / FDA GRAS, cannabis regulatory/lab databases. All data traces to primary regulatory sources and is updated from official government databases.

Does 4-Butyrolactone have different safety status in cosmetics vs industrial chemicals?

4-Butyrolactone is classified GHS Danger (H302, H315, H318, H319, H331, H336, H371) in the chemicals database but is allowed in EU cosmetics.

Is 4-Butyrolactone used outside industrial chemicals?

4-Butyrolactone also appears in cosmetics, pharmaceutical, food safety, cannabis databases.