MODERATE Preservative NOAEL Data Sensitization Data Dermal Penetration

Propylparaben

Also known as: Propyl-4-hydroxybenzoate, 4-10-00-00374, BRN 1103245, Caswell No. 714, EINECS 202-307-7 (+15 more)

INCI: PROPYLPARABEN

Propylparaben (CAS 94-13-3) is a cosmetic preservative functioning as Preservative. NOAEL 1000 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 0.14% (as acid). 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.

View industrial chemical safety profile for CAS 94-13-3 →

CAS Number
94-13-3
View industrial chemical safety profile →
Function
Preservative
Editorial assessment
MODERATE
Preliminary editorial note — not a computed safety verdict.

Chemistry & Identifiers

Formula
C10H12O3
MW
180.2 g/mol
EC Number
202-307-7
PubChem CID
7175
IUPAC Name
propyl 4-hydroxybenzoate
InChIKey
QELSKZZBTMNZEB-UHFFFAOYSA-N
ChEBI: CHEBI:32063 UNII: Z8IX2SC1OH Wikidata: Q511627

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. Propyl+butyl aggregate concern noted by SCCS but not reflected in US rules.

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Propylparaben. 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 100 mg/kg bw/day oral mouse Special Toxicology Study COSMOS DB
NOAEL 1000 mg/kg bw/day oral rat Developmental COSMOS DB
NOAEL 1500 mg/kg bw/day oral rat Chronic COSMOS DB
NOAEL 3000 mg/kg bw/day oral rat Special Toxicology Study COSMOS DB
NOAEL 4000 mg/kg bw/day oral rat Short Term Toxicity COSMOS DB
NOAEL 5700 mg/kg bw/day oral rat Chronic COSMOS DB
NOAEL =2 mg/kg/day - rat reproductive toxicity SCCS Opinion
NOAEL =2 mg/kg - rat repeated dose toxicity SCCS Opinion
NOAEL =2 mg/kg/day - rat reproductive toxicity SCCS Opinion
NOAEL =2 mg/kg - rat repeated dose toxicity SCCS Opinion

Pre-Calculated Safety Assessment

Conditional — safe only within SCCS limits: preservative up to 0.14%; butyl+propyl sum <=0.14%; all parabens sum <=0.8% as acid

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

SCCS NOAEL Values

NOAEL/LOAEL values cited in official SCCS opinions for Propylparaben.

NOAEL LOAEL Route Species Study DA% (SCCS) Opinion
1000 mg/kg/day - Oral Rat (Wistar) Extended one-generation reproductive (OECD 443) (~10 weeks premating + gestation + lactation) 100 SCCS/1623/20 (2021)

Sensitization Profile

Contact sensitization data for Propylparaben 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: SCCS Opinion

Dermal Penetration Profile

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

Absorption %
30-40%
Penetration Level
dermis
Penetration Depth
full dermis
Molecular Weight
180.2 Da
Log P
3.04
Systemic Absorption
yes
Topical Bioavailability
20-35%
Safety Margin Factor
very-high
Vehicle Dependent
Yes — absorption varies by formulation

Source: SCCS Opinion

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
NOAEL =1000 mg/kg-day Rat oral - ECHA
NOAEL =1000 mg/kg-day Rat oral - ECHA
NOAEL >=1000 mg/kg-day Rat oral subchronic ECHA
NOEL =2000 mg/kg-day Mouse oral acute ECOTOX
LD50 >8000 mg/kg Mouse oral - ECHA
LD50 >5000 mg/kg Rat oral - ECHA
LD50 >15000 mg/kg Rat oral - ECHA
NOAEL =1084 mg/kg-day Mouse injection - ECHA
NOAEL =1084 mg/kg-day Mouse injection - ECHA
NOAEL =1000 mg/kg-day Rat oral - ECHA

Sensitization AOP Dashboard

Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.

DPRA Cys %
4.1%
DPRA Lys %
0.05%
KeratinoSens IC50
813.17 µM
hCLAT CV75
106.7 µg/mL
LLNA EC3
25%
NESIL
6250 µg/cm²
LLNA: Weak (1B) GHS: 1B

Source: LLNA: Gerberick et al. (2005); DPRA: Bauch et al. 2012 [DOI:10.1016/j.yrtph.2012.05.013] | Gerberick et al. 2007 [DOI:10.1093/toxsci/kfm064]; KS: Emter et al. 2010 [DOI:10.1016/j.taap.2010.03.009] | Bauch et al. 2012 [DOI:10.1016/j.yrtph.2012.05.013]; hCLAT: Bauch et al. 2012 [DOI:10.1016/j.yrtph.2012.05.013] | Ashikaga et al. 2010 [DOI:10.1177/026119291003800403]

HRIPT Human Patch Test Studies

4 human repeat insult patch tests aggregated from dermatological literature.

Test Type N Sensitized Dose µg/cm² NESIL µg/cm² Potency
HRIPT - 0 174.38 - -
HRIPT - 0 871.88 - -
HRIPT - 0 6975.01 - -
HRIPT - 0 4359.38 - -

Endocrine Disruptor Evidence (Expanded)

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

Suspected Evidence: High (2015)
Health effects: Yes
Affected pathways: Estrogenic (ER agonist)
Regulatory framework: REACH

Source list: II

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

agonist (ER); antagonist (AR, TR)

Dose-Response Data Points
Endpoint Target Value Direction
NOAEL general 2 mg/kg/day -
NOAEL general 3.3 mg/kg/day -
dermal_delivery skin 1.5 µg/cm² -
ASED systemic 0.015–0.438 mg/kg/day -
Cell proliferation, ERE-CAT reporter, competitive ER binding ER EC50/IC50: EC50 (proliferation) ~10-50 uM; ERE-CAT active >=1 uM; LOEC: 1 uM; NOEC: 0.1 uM mixed agonist
SIN List ED: Suspected ED Cosmetic relevance: direct

ECHA REACH Registration

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

Registration Type
Full
Tonnage Band
100 - 1,000 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No

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 (6)
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
GCC restricted 0.0 Nappy/diaper area products, children <3 years
BR permitted_preservative 0.14 (sum butyl+propyl) / 0.8 (sum all) Sum butyl+propyl ≤0.14%
UK restricted - -

Expanded Dermal Absorption Data

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

EPA Dryad Skin Absorption (physics-based)
MW: 180.203
LogP: 3.03638
Kp epidermis: 0.06267 cm/h
% dose epidermis: 0.96%
% dose stratum corneum: 0.95%
% dose dermis: 0.94%

Source: EPA Dryad Skin Absorption 2024

Roberts Skin Permeation (Mendeley 2022)
MW: 180.2
Log Kow: 2.9
Log Kp: -1.853871964321762
Log Jmax: -7.268371539874078

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 0.05–0.3 0.8 CIR Safety Assessment
Body Lotion 0.05–0.3 0.8 CIR Safety Assessment

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
Saturated aqueous solutions of propylparaben are moderately irritating to the eye. Ingestion of a 0.03% propyl paraben solution causes irritation to the intestinal mucosa ... . | ... As saturated aqueous soln has been noted to be moderately irritating to the eye.
Source: Hazardous Substances Data Bank (HSDB)
Regulatory (1)
JECFA Evaluation
PROPYLPARABEN | 2006 | WITHDRAWN (2006) | In view of the adverse effects in male rats, propyl paraben (propyl p-hydroxybenzoate) should be excluded from the group ADI for the parabens used in food. This conclusion was reached on the grounds that the group ADI was originally set on a NOEL of 1000 mg/kg bw per day for a different toxicological end-point?growth depression?taken from the range of…
Source: WHO/JECFA

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Biocide Flavouring and nutrient Food preservative Fragrance No specific technical function Preservative Softener and conditioner
Regulatory List Membership (4)
EU Restricted for Children (Cosmetics) IFRA Fragrance Transparency List FDA Substances Added to Food (EAFUS) Consumer Product Chemical

Editorial summary

Preliminary editorial summary for Propylparaben — not a computed safety verdict. See the sourced toxicological data above.

Regulatory Flags

eu-restricted paraben endocrine-concern child-safety sccs-reviewed nappy-area-ban eu_children_restricted ifra_fragrance fda_food_additive jecfa_concern

NOAEL Studies Summary

View details ->

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

Studies
76
Lowest NOAEL
2
Highest NOAEL
5700

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

SCCS Opinion ECHA COSMOS DB

Dermal Absorption

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

Known Synonyms

Propyl-4-hydroxybenzoate 4-10-00-00374 BRN 1103245 Caswell No. 714 EINECS 202-307-7 EPA Pesticide Chemical Code 061203 FEMA No. 2951 FEMA Number 2951 p-Oxybenzoesaurepropylester Propylester kyseliny p-hydroxybenzoove UNII-Z8IX2SC1OH Bayer D 206 4-Hydroxybenzoic acid, propyl ester Betacide p Betacine p Chemacide PK Chemoside PK Lexgard p N-Propyl-p-hydroxybenzoate P-Hydroxybenzoic acid N-propyl ester

Chemical Function

Preservative Fragrance

Regulatory Lists

Arts and crafts/Office supplies - general arts and crafts supplies - arts and crafts paint; Europe detected; Toys and children's products detected; Toys and children's products detected; Toys and children's products detected; Toys and children's products detected; Toys and children's products detected; Toys and children's products detected; Toys and children's products active_ingredient; Europe; Pesticides Personal care; Southeast Asia inert_ingredient; Pesticides inert_ingredient; non_food_use; Pesticides IFRA Transparency food_additive; Substances Added to Food (formerly EAFUS) (2/2019) consumer_product children; WA Children's Safe Product Act (4/2020) children children

Australian Status

AICIS status: listed

Cross-Vertical Safety Context

Same-CAS public records found in pharmaceutical and food safety data.

SOURCE ChEMBL / DrugCentral / FAERS DB_PHARMA CAS match

Pharmaceutical Data

Same-CAS rows from the pharmaceutical spoke database.

Compound
PROPYLPARABEN
ChEMBL ID
CHEMBL194014
Max Phase
-1
View full pharmaceutical profile →
SOURCE EFSA / FDA GRAS food_additives

Food Safety Data

Same-CAS food additive or FDA GRAS records from the core public database.

Food Name
Propyl 4-hydroxybenzoate
E Number
E216
ADI
10 mg/kg bw
Food Category
preservative
View full food safety profile →

Frequently Asked Questions

Is Propylparaben safe in cosmetics?

Propylparaben 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.

Is Propylparaben allowed in the EU?

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

What does Propylparaben do in cosmetics?

Propylparaben functions as: Preservative. It is classified as a Preservative in our database. CAS number: 94-13-3.

What is the NOAEL for Propylparaben?

The NOAEL (No Observed Adverse Effect Level) for Propylparaben is 100 mg/kg bw/day based on a Special Toxicology Study study via oral route in mouse. A total of 10 study endpoints are available. Source: COSMOS DB.

Is Propylparaben used outside cosmetics?

Propylparaben 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.

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

Propylparaben is classified GHS Danger (H315, H319, H335, H302, H317, H370, H373, H401) in the chemicals database but is restricted in EU cosmetics at max 0.14% (as acid).

Compliance Tools

Check Propylparaben compliance across multiple jurisdictions:

Ingredient Decoder
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82 Allergen Checker
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Substance Compliance
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MoS Calculator
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Heavy Metal Limits
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