Also known as: Butyl 4-hydroxybenzoate, Butyl p-hydroxybenzoate, n-Butyl-p-hydroxybenzoate, 4-Hydroxybenzoic acid butyl ester, BRN 1103741 (+10 more)
INCI: BUTYLPARABEN
Butylparaben (CAS 94-26-8) is a cosmetic preservative functioning as Preservative. NOAEL 24.5 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 0.14% (as acid); 5 safety opinions reviewed (SCCS Opinion). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety, pharmaceutical, and food safety data.
Butylparaben is classified GHS Danger (H315, H318, H319, H335, H412) in the chemicals database but is restricted in EU cosmetics at max 0.14% (as acid).
Source: Cosmetics: ingredients.eu status/eu max; Chemicals: ghs classifications.signal word/hazard statement code
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Margin of Safety, dermal absorption, and sensitization profile summaries for Butylparaben.
Calculate MoS for your specific formulation with the MoS Calculator.
10 study endpoints found for Butylparaben. 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 | =2 mg/kg bw/day | oral | mouse | repeated dose toxicity | SCCS Opinion |
| NOAEL | =2 mg/kg bw/day | oral | mouse | repeated dose toxicity | SCCS Opinion |
| NOAEL | =2 mg/kg bw/day | oral | mouse | repeated dose toxicity | SCCS Opinion |
| NOAEL | =2 mg/kg bw/day | oral | mouse | repeated dose toxicity | SCCS Opinion |
| NOAEL | =10 mg/kg bw/day | - | - | NOAEL study | SCCS Opinion |
| NOAEL | =10 mg/kg bw | - | mouse | NOAEL study | SCCS Opinion |
| NOAEL | =10 mg/kg bw/day | - | - | NOAEL study | SCCS Opinion |
| NOAEL | =10 mg/kg bw | - | mouse | NOAEL study | SCCS Opinion |
| NOAEL | =10 mg/kg bw/day | - | - | NOAEL study | SCCS Opinion |
| NOAEL | =10 mg/kg bw | - | mouse | NOAEL study | SCCS Opinion |
Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).
Pre-calculated NOAEL → SED → MoS audit trail for Butylparaben across SCCS product categories, with measured dermal absorption where available.
NOAEL/LOAEL values cited in official SCCS opinions for Butylparaben.
| NOAEL | LOAEL | Route | Species | Study | DA% (SCCS) | Opinion |
|---|---|---|---|---|---|---|
| 1000 mg/kg/day | - | Oral | Rat (Wistar) | Extended one-generation reproductive (OECD 443) (Multi-generation) | 100 | SCCS/1651/23 (2023) |
Contact sensitization data for Butylparaben based on clinical patch test studies and IFRA standards.
Source: SCCS Opinion
Skin absorption and penetration characteristics of Butylparaben, relevant to systemic exposure and MoS calculations.
Source: SCCS Opinion
10 toxicity values from EPA ToxValDB (aggregated from CCTE, HPV, ToxRefDB, IRIS, and other regulatory dossiers).
| Endpoint | Value | Species | Route | Duration | Source |
|---|---|---|---|---|---|
| NOEL | =2000 mg/kg-day | Mouse | oral | acute | ECOTOX |
| LD50 | =13200 mg/kg | Mouse | oral | - | ChemIDplus |
| LEL | =7 mg/kg-day | Mouse | injection | short-term | Uterotrophic Hershberger DB |
| LEL | =21 mg/kg-day | Mouse | injection | short-term | Uterotrophic Hershberger DB |
| LEL | =50 mg/kg-day | Mouse | injection | short-term | Uterotrophic Hershberger DB |
| LEL | =70 mg/kg-day | Mouse | injection | short-term | Uterotrophic Hershberger DB |
| LEL | =100 mg/kg-day | Rat | injection | short-term | Uterotrophic Hershberger DB |
| LEL | =200 mg/kg-day | Rat | injection | short-term | Uterotrophic Hershberger DB |
| LEL | =210 mg/kg-day | Rat | injection | short-term | Uterotrophic Hershberger DB |
| LEL | =400 mg/kg-day | Rat | injection | short-term | Uterotrophic Hershberger DB |
Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.
Source list: I
agonist (ER, PPARγ); antagonist (AR, TR)
| Endpoint | Target | Value | Direction |
|---|---|---|---|
| IC_threshold_AR | AR | >10⁻⁵ M M | antagonist |
| EC_threshold_adipogenic | PPARγ | 10⁻⁴ M M | agonist |
| NOAEL | general | 2 mg/kg/day | - |
| ASED | systemic | 0.0017–0.3124 mg/kg/day | - |
| Cell proliferation, PR expression, pS2 upregulation | ER | EC50/IC50: Significant proliferation >=10 uM; EC50 ~30 uM; LOEC: 10 uM; NOEC: 1 uM mixed | agonist |
| Displacement of [3H]-estradiol (RBA) | ERa | EC50/IC50: IC50 >>10^-4 M; 86% displacement at 10^6-fold molar excess; LOEC: 100 uM (binding detectable); NOEC: 10 uM mixed | agonist (low affinity) |
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | permitted_preservative | 0.14 | All cosmetics (restricted for body lotion/infant) |
| AU | restricted | - | preservatives |
| GCC | restricted | 0.14 | All cosmetics |
| BR | permitted_preservative | 0.14 (sum butyl+propyl) / 0.8 (sum all) | Sum butyl+propyl parabens ≤0.14%; total sum all parabens ≤0.8%; NOT in leave-on products for children <3 yrs in diaper area |
| UK | restricted | - | - |
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
Source: Roberts Cheruvu Mendeley 2022
| Type | DA % | Method | Skin Model | SCCS Ref |
|---|---|---|---|---|
| measured_in_vitro | 3.7 | In vitro — Franz cells (multiple studies) | - | SCCS/1348/10; SCCS/1481/12 (2010) |
Reported concentration ranges per product category from SCCS/CIR/industry sources.
| Product Category | Typical Range | Max Reported | Source |
|---|---|---|---|
| Face Cream | 0.01–0.1 | 0.5 | CIR Safety Assessment |
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Preliminary editorial summary for Butylparaben — not a computed safety verdict. See the sourced toxicological data above.
Public NOAEL study rows linked to Butylparaben by CAS number or substance name.
Units vary across source rows: mg/kg bw/day, mg/kg bw, mg/kg/day
| Absorption % | Method | Vehicle |
|---|---|---|
| 3.7 | In vitro — Franz cells (multiple studies) | Cream / lotion |
Same-CAS public records found in pharmaceutical and food safety data.
Same-CAS rows from the pharmaceutical spoke database.
Same-CAS food additive or FDA GRAS records from the core public database.
Butylparaben has a safety rating of "MODERATE" in our database. EU status: restricted. US status: permitted. 10 toxicological study endpoint(s) are available in our database. This ingredient has been reviewed by SCCS Opinion.
Butylparaben EU regulatory status: restricted. Maximum allowed concentration: 0.14% (as acid). This is based on EU Regulation 1223/2009 and its amendments.
Butylparaben functions as: Preservative. It is classified as a Preservative in our database. CAS number: 94-26-8.
The NOAEL (No Observed Adverse Effect Level) for Butylparaben is =2 mg/kg bw/day based on a repeated dose toxicity study via oral route in mouse. A total of 10 study endpoints are available. Source: SCCS Opinion.
Butylparaben also appears in industrial chemical safety, pharmaceutical, and food safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Butylparaben is classified GHS Danger (H315, H318, H319, H335, H412) in the chemicals database but is restricted in EU cosmetics at max 0.14% (as acid).
Check Butylparaben compliance across multiple jurisdictions:
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