Butyrolactone (Gamma-Butyrolactone / GBL)
INCI: BUTYROLACTONE
Regulatory Status
For full compliance data across 55 jurisdictions, use the Substance Compliance tool.
Safety Data
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
8 study endpoints found for Butyrolactone (Gamma-Butyrolactone / GBL). 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 | oral | rat | Developmental | COSMOS_DB |
| NOAEL | 600 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS_DB |
| NOAEL | 350 mg/kg bw/day | oral | mouse | Short Term Toxicity | COSMOS_DB |
| NOAEL | 900 mg/kg bw/day | oral | rat | Subchronic | COSMOS_DB |
| NOAEL | 525 mg/kg bw/day | oral | mouse | Subchronic | COSMOS_DB |
| NOAEL | 450 mg/kg bw/day | oral | rat | Carcinogenicity | COSMOS_DB |
| NOAEL | 262 mg/kg bw/day | oral | mouse | Carcinogenicity | COSMOS_DB |
| dose_tested | 500 mg/kg bw/day | oral | rat | Developmental | COSMOS_DB |
GHS Hazard Classification
Globally Harmonized System classification per ECHA C&L inventory and ILO/WHO International Chemical Safety Cards.
Expert Verdict
Prohibited in the US despite EU permission; high safety concern due to poor safety profile and high absorption.
Regulatory Flags
Frequently Asked Questions
Is Butyrolactone (Gamma-Butyrolactone / GBL) safe in cosmetics?
Prohibited in the US despite EU permission; high safety concern due to poor safety profile and high absorption. The EU classifies Butyrolactone (Gamma-Butyrolactone / GBL) as "permitted". Safety rating: POOR. 8 toxicological study endpoint(s) are available in our database.
Is Butyrolactone (Gamma-Butyrolactone / GBL) allowed in the EU?
Butyrolactone (Gamma-Butyrolactone / GBL) EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Butyrolactone (Gamma-Butyrolactone / GBL) do in cosmetics?
Butyrolactone (Gamma-Butyrolactone / GBL) functions as: Solvent. It is classified as a cosmetic ingredient in our database. CAS number: 96-48-0.
What is the Margin of Safety for Butyrolactone (Gamma-Butyrolactone / GBL)?
not established The Margin of Safety (MoS) is calculated using SCCS methodology. A MoS above 100 is generally considered safe. Use the MoS Calculator tool to calculate MoS for your specific formulation and product category.
What is the NOAEL for Butyrolactone (Gamma-Butyrolactone / GBL)?
The NOAEL (No Observed Adverse Effect Level) for Butyrolactone (Gamma-Butyrolactone / GBL) is 500 mg/kg bw/day based on a Developmental study via oral route in rat. A total of 8 study endpoints are available. Source: COSMOS_DB.
Is Butyrolactone (Gamma-Butyrolactone / GBL) classified as hazardous under GHS?
Butyrolactone (Gamma-Butyrolactone / GBL) 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.
Compliance Tools
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