Moderate Preservative NOAEL Data SCCS/CIR Reviewed Sensitization Data Dermal Penetration

Butylparaben

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). Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety and pharmaceutical data.

View industrial chemical safety profile for CAS 94-26-8 →

Auto-generated CPSR Part A draft with source citations
CAS Number
94-26-8
View industrial chemical safety profile →
Function
Preservative
Safety Rating
MODERATE

Chemistry & Identifiers

Formula
C11H14O3
MW
194.23 g/mol
EC Number
202-318-7
PubChem CID
7184
IUPAC Name
butyl 4-hydroxybenzoate
InChIKey
QFOHBWFCKVYLES-UHFFFAOYSA-N
ChEBI: CHEBI:88542 UNII: 3QPI1U3FV8 Wikidata: Q3302873

Regulatory Status

EU EU Status restricted
EU Max Conc. 0.14% (as acid)
US US Status permitted
US Notes CIR concludes safe as used; no legal cap. SCCS aggregate-exposure concerns not captured in US framework.

For full compliance data across multiple jurisdictions, use the Substance Compliance tool.

Safety Data

Margin of Safety, dermal absorption, and sensitization profile summaries for Butylparaben.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

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_vision_codex
NOAEL =2 mg/kg bw/day oral mouse repeated dose toxicity SCCS_vision_codex
NOAEL =2 mg/kg bw/day oral mouse repeated dose toxicity SCCS_vision_codex
NOAEL =2 mg/kg bw/day oral mouse repeated dose toxicity SCCS_vision_codex
NOAEL =10 mg/kg bw/day - - NOAEL study SCCS_vision_codex
NOAEL =10 mg/kg bw - mouse NOAEL study SCCS_vision_codex
NOAEL =10 mg/kg bw/day - - NOAEL study SCCS_vision_codex
NOAEL =10 mg/kg bw - mouse NOAEL study SCCS_vision_codex
NOAEL =10 mg/kg bw/day - - NOAEL study SCCS_vision_codex
NOAEL =10 mg/kg bw - mouse NOAEL study SCCS_vision_codex

Safety Opinions

Official safety assessments from the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR).

sccs SCCS/1674/25 30 April 2025
Verdict: unknown
Max Concentration: 0.14% in general
sccs SCCS/1674/25 30 April 2025
Verdict: unknown
Max Concentration: 0.197% in general
sccs SCCS/1651/23 26 October 2023
Verdict: unknown
NOAEL: 325 mg/kg bw/day (not specified)
Max Concentration: 0.14% in general
sccs SCCS/1651/23 26 October 2023
Verdict: unknown
NOAEL: 325 mg/kg bw/day (not specified)
Max Concentration: 0.197% in general
sccs SCCS/1651/23 26 October 2023
Verdict: unknown
NOAEL: 325 mg/kg bw/day (not specified)
Max Concentration: 0.6% in general

Pre-Calculated Safety Assessment

Pre-calculated NOAEL → SED → MoS audit trail for Butylparaben across SCCS product categories, with measured dermal absorption where available.

SCCS NOAEL Values

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)

Sensitization Profile

Contact sensitization data for Butylparaben based on clinical patch test studies and IFRA standards.

Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.3%
Cross-reactivity Group
paraben-group
Reaction Type
contact-dermatitis

Source: ESSCA; IVDK; SCCS/1348/10

Dermal Penetration Profile

Skin absorption and penetration characteristics of Butylparaben, relevant to systemic exposure and MoS calculations.

Absorption %
35-45%
Penetration Level
dermis
Penetration Depth
full dermis/systemic
Molecular Weight
194.2 Da
Log P
3.57
Systemic Absorption
yes
Topical Bioavailability
25-40%
Safety Margin Factor
very-high
Vehicle Dependent
Yes — absorption varies by formulation

Source: SCCS/1348/10, CIR

EPA ToxValDB — Toxicity Values

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

Endocrine Disruptor Evidence (Expanded)

Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.

Confirmed Evidence: High (2019)
Health effects: Yes
Affected pathways: Estrogenic (ER agonist)
Regulatory framework: Cosmetics

Source list: I

Cosmetic-Specific Mechanism
Category: paraben
Receptor targets: ERα, ERβ, AR, TR, PPARγ
LOEC: 1 µM
EU status: restricted (max 0.14% leave-on); SVHC REACH

agonist (ER, PPARγ); antagonist (AR, TR)

Dose-Response Data Points
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)
SIN List ED: Endocrine Disruptor Cosmetic relevance: direct

ECHA REACH Registration

European Chemicals Agency REACH dossier and Substances of Very High Concern listing.

Registration Type
Full
Tonnage Band
Ceased manufacture
Substance Type
SUBSTANCE
SVHC Candidate
Yes (since 25-Jun-2020)
Hazard classification: Restricted (Annex XVII)
SVHC reason: Endocrine disrupting properties (Article 57(f) - human health)
Substance of Very High Concern (SVHC)
Included: 25-Jun-2020
Endocrine disrupting properties (Article 57(f) - human health)

Expanded Jurisdictional Detail

Additional regulatory detail beyond the 7-jurisdiction summary: Saudi SFDA, Korea MFDS, ASEAN ACD, Japan/Korea, Brazil/India, and cross-jurisdictional restriction entries.

JPKR Japan/Korea Cosmetics
Japan (Positive (Preservative)): max 1.0
Korea (Restricted): max 0.4
Additional Jurisdictional Restrictions (5)
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 - -

Expanded Dermal Absorption Data

Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.

Roberts Skin Permeation (Mendeley 2022)
MW: 194.23
Log Kow: 3.57
Log Kp: -0.9812995013337567
Log Jmax: -6.85464246352923

Source: Roberts_Cheruvu_Mendeley_2022

Aggregated DA Values (1 records across 5 sources)
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)

Typical Use Concentrations

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 (IJT 39:2020)

Additional Ingredient Properties

10 property records from structured ingredient metadata.

allergen_detail
{"eu_allergen_listed": "no", "allergen_class": "preservative", "cross_reactivity_group": "paraben-group", "patch_test_frequency_pct": "0.3", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "ESSCA; IVDK; SCCS/1348/10"}
baby_pediatric
{"cas_number": "94-26-8", "ingredient_class": "preservative_baby_safe", "pediatric_safety_rating": "avoid", "minimum_age_months": "0", "neonatal_safe": "no", "premature_infant_safe": "no", "skin_barrier_maturity_consideration": "BANNED DIAPER: EU ban leave-on nappy area <3yr; endocrine concern", "transepidermal_absorption_risk_pediatric": "moderate", "systemic_exposure_concern_pediatric": "low", "…
comedogenicity_detail
{"comedogenicity_rating": "0", "irritancy_rating": "1", "skin_type_suitability": "all,combination,normal", "acne_safe": "yes", "source": "Paraben preservative"}
dermal_absorption
{"molecular_weight_da": "194.2", "log_p_value": "3.57", "skin_penetration_level": "dermis", "penetration_depth": "full dermis/systemic", "absorption_pct": "35-45", "systemic_absorption": "yes", "penetration_enhancer": "no", "occlusion_effect": "yes", "vehicle_dependent": "yes", "skin_barrier_effect": "weakens", "bioavailability_topical_pct": "25-40", "safety_margin_factor": "very-high", "source": …
ecotoxicity
{"biodegradable": "yes", "biodegradation_days": "60-90", "bioaccumulative": "yes", "aquatic_toxicity_level": "moderate", "coral_reef_safe": "yes", "marine_toxicity": "moderate aquatic toxicity", "freshwater_toxicity": "bioaccumulative", "endocrine_disruptor": "yes", "persistent_organic_pollutant": "no", "microplastic": "no", "nano_particle": "no", "hawaii_banned": "no", "eu_restricted_environmenta…
microbiome_impact
{"microbiome_effect": "negative", "prebiotic": "no", "probiotic_compatible": "no", "antimicrobial_spectrum": "broad", "preservative_effect_on_microbiome": "Highest lipophilicity among parabens; severe commensal disruption", "skin_flora_disruption": "severe", "gut_microbiome_risk": "low", "microbiome_recovery_time": "14-21 days", "selective_antimicrobial": "no", "pathogen_inhibition": "C. acnes, S.…
pediatric_safety
{"safe_for_newborn_0_6m": "avoid", "safe_for_infant_6_12m": "avoid", "safe_for_toddler_1_3y": "caution", "safe_for_child_3_12y": "caution", "safe_for_teen_12_18y": "yes", "pediatric_max_concentration_pct": "0.028", "adult_max_concentration_pct": "0.14", "pediatric_dermal_absorption_factor": "higher", "immature_skin_barrier_risk": "moderate", "oral_ingestion_risk": "low", "eye_irritation_risk": "lo…
ph_stability
{"optimal_ph_min": "4.0", "optimal_ph_max": "8.0", "stable_ph_min": "3.5", "stable_ph_max": "8.5", "degrades_above_ph": "9.0", "degrades_below_ph": "3.0", "ph_dependent_function": "Function best pH 5-8; hydrolyze >pH 8.5", "formulation_note": "Most lipophilic paraben", "source": "Alfa Chemistry 2025"}

PubChem Annotations

Safety and regulatory annotations from PubChem (NCBI) aggregated sources.

Safety (3)
Carcinogen Classification
No indication of carcinogenicity to humans (not listed by IARC).
Source: Toxin and Toxin Target Database (T3DB)
Endocrine Disruptors
Potential endocrine disrupting compound
Source: NORMAN Suspect List Exchange
Skin Eye Respiratory Irritation
Butylparaben was a skin irritant in man.
Source: Hazardous Substances Data Bank (HSDB)
Regulatory (2)
JECFA Number
870
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
JECFA Evaluation
BUTYLPARABEN | 2002 | No safety concern at current levels of intake when used as a flavouring agent | TRS 913-JECFA 59/112 | FAS 48-JECFA 57/273 (2001)
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Deodorizer Flavouring and nutrient Food preservative Fragrance Preservative
Regulatory List Membership (3)
EU Restricted for Children (Cosmetics) IFRA Fragrance Transparency List FDA Substances Added to Food (EAFUS)

Expert Verdict

Expert safety assessment and concern-level summary for Butylparaben.

Regulatory Flags

eu-restricted paraben endocrine-disruptor child-safety sccs-reviewed nappy-area-ban avoid-in-children high-aggregate-exposure-risk eu_children_restricted ifra_fragrance fda_food_additive

NOAEL Studies Summary

View details ->

Public NOAEL study rows linked to Butylparaben by CAS number or substance name.

Studies
120
Lowest NOAEL
2
Highest NOAEL
1504

Units vary across source rows: mg/kg/day, mg/kg bw/day, mg/kgbw/day

SCCS_vision_codex

Dermal Absorption

View details ->
Absorption % Method Vehicle
3.7 In vitro — Franz cells (multiple studies) Cream / lotion

Known Synonyms

Butyl 4-hydroxybenzoate Butyl p-hydroxybenzoate n-Butyl-p-hydroxybenzoate 4-Hydroxybenzoic acid butyl ester BRN 1103741 n-Butyl hydroxybenzoate n-Butyl parahydroxybenzoate Butyl-Parasept Caswell No. 130A EINECS 202-318-7 EPA Pesticide Chemical Code 061205 FEMA No. 2203 FEMA Number 2203 UNII-3QPI1U3FV8 Butylparaben (TN)

Chemical Function

Preservative Deodorizer Fragrance Flavouring and nutrient Food preservative

Regulatory Lists

active_ingredient; Europe; Pesticides active_ingredient; animal_products; Europe; pharmaceutical; residue Europe Personal care; Southeast Asia IFRA Transparency inert_ingredient; non_food_use; Pesticides food_additive; Substances Added to Food (formerly EAFUS) (2/2019) air; detected; emissions; Europe; Vehicle - car interior detected; Europe; Vehicle - car interior children; WA Children's Safe Product Act (4/2020) children children Europe; restricted children artificial_sweat; detected; emissions; Europe; Toys and children's products Europe; pharmaceutical detected; Personal care; Southeast Asia Europe; Personal care - body hygiene - hand soap

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
BUTYLPARABEN
ChEMBL ID
CHEMBL459008
Max Phase
-1
View full pharmaceutical profile →

Frequently Asked Questions

Is Butylparaben safe in cosmetics?

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.

Is Butylparaben allowed in the EU?

Butylparaben EU regulatory status: restricted. Maximum allowed concentration: 0.14% (as acid). This is based on EU Regulation 1223/2009 and its amendments.

What does Butylparaben do in cosmetics?

Butylparaben functions as: Preservative. It is classified as a Preservative in our database. CAS number: 94-26-8.

What is the NOAEL for Butylparaben?

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_vision_codex.

Is Butylparaben used outside cosmetics?

Butylparaben 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.

Does Butylparaben have different safety status in cosmetics vs industrial chemicals?

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).

Compliance Tools

Check Butylparaben compliance across multiple jurisdictions:

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MoS Calculator
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