Is Ethylparaben safe in cosmetics?
Ethylparaben has a safety rating of "GOOD" in our database. EU status: restricted. US status: permitted. 2 toxicological study endpoint(s) are available in our database.
Ethylparaben
Also known as: ethyl 4-hydroxybenzoate, 4-10-00-00367, BRN 1101972, Carbethoxyphenol, Caswell No. 447 (+7 more)
INCI: ETHYLPARABEN
Ethylparaben (CAS 120-47-8) is a cosmetic preservative functioning as preservative. NOAEL 900 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 0.4% as acid in finished product; 0.8% cap for total paraben mixture. 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 120-47-8 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Ethylparaben is classified GHS Danger (H304, H315, H317, H319, H401) in the chemicals database but is restricted in EU cosmetics at max 0.4% as acid in finished product; 0.8% cap for total paraben mixture.
Source: Cosmetics: ingredients.eu_status/eu_max; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
preservative
Safety Rating
GOOD
Chemistry & Identifiers
IUPAC Name
ethyl 4-hydroxybenzoate
InChIKey
NUVBSKCKDOMJSU-UHFFFAOYSA-N
Regulatory Status
EU EU Status
restricted
EU Max Conc.
0.4% as acid in finished product; 0.8% cap for total paraben mixture
US US Status
permitted
US Notes
CIR Panel: safe as used. No legal concentration caps under FDA/MoCRA.
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Ethylparaben.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
2 study endpoints found for Ethylparaben. 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 | =1030 mg/kg bw/day | - | Rat | subchronic | EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx |
| NOAEL | =1030 mg/kg bw/day | - | Rat | subchronic | EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Ethylparaben across SCCS product categories, with measured dermal absorption where available.
Sensitization Profile
Contact sensitization data for Ethylparaben 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 Ethylparaben, relevant to systemic exposure and MoS calculations.
Absorption %
25-35%
Penetration Level
dermis
Penetration Depth
epidermis/dermis
Molecular Weight
166.2 Da
Log P
2.47
Systemic Absorption
yes
Topical Bioavailability
18-30%
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 |
|---|---|---|---|---|---|
| NOAEL | =1043 mg/kg-day | Rat | oral | subchronic | EFSA |
| NOEL | =2000 mg/kg-day | Mouse | oral | acute | ECOTOX |
| LD50 | >8000 mg/kg | Mouse | oral | - | ECHA IUCLID |
| LD50 | >3100 mg/kg | Rat | oral | - | ECHA IUCLID |
| LD50 | =6008 mg/kg | Mouse | oral | - | ECHA IUCLID |
| LD50 | =2000 mg/kg | Guinea Pig | oral | - | ECHA IUCLID |
| LD50 | =4300 mg/kg | Rat | oral | - | ECHA IUCLID |
| LOAEL | =4000 mg/kg-day | Rabbit | oral | short-term | ECHA IUCLID |
| NOAEL | >300 mg/kg-day | Hamster | oral | - | ECHA IUCLID |
| NOAEL | >=300 mg/kg-day | Hamster | oral | - | ECHA IUCLID |
Endocrine Disruptor Evidence (Expanded)
Cross-referenced EDC classifications, mechanism data, and dose-response evidence from EDLists, SIN List, and cosmetic-specific detail sources.
Under investigation
Evidence: Limited
(2022)
Health effects: Yes
Affected pathways: Estrogenic (ER agonist)
Regulatory framework: REACH
Source list: II (former)
Cosmetic-Specific Mechanism
Category: paraben
Receptor targets: ERα, ERβ, AR, TR
LOEC: 10 µM
EU status: restricted (max 0.4% single)
agonist (ER); antagonist (AR, TR)
Dose-Response Data Points
| Endpoint | Target | Value | Direction |
|---|---|---|---|
| NOAEL | general | 1000 mg/kg/day | - |
| NOAEL | general | 250 mg/kg/day | - |
| ASED | systemic | 0.0005–0.5162 mg/kg/day | - |
| Cell proliferation, ERE reporter, pS2 gene | ER | EC50/IC50: Active >=10^-6 M (partial); LOEC: 1 uM; NOEC: 0.1 uM mixed | agonist |
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 (4)
| Jurisdiction | Status | Max % | Product Type |
|---|---|---|---|
| CN | permitted_preservative | 0.4 | All cosmetics |
| AU | restricted | - | preservatives |
| GCC | restricted | 0.4 | All cosmetics |
| BR | permitted_preservative | 0.4 (individual) / 0.8 (sum with methyl) | 0.4% each; sum ≤0.8% |
Expanded Dermal Absorption Data
Cross-database dermal penetration: EPA Dryad physics-based, Roberts Mendeley permeation, and SCCS-aggregated measured values.
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 (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"}
dermal_absorption
{"molecular_weight_da": "166.2", "log_p_value": "2.47", "skin_penetration_level": "dermis", "penetration_depth": "epidermis/dermis", "absorption_pct": "25-35", "systemic_absorption": "yes", "penetration_enhancer": "no", "occlusion_effect": "no", "vehicle_dependent": "yes", "skin_barrier_effect": "neutral", "bioavailability_topical_pct": "18-30", "safety_margin_factor": "very-high", "source": "SCCS…
ecotoxicity
{"biodegradable": "yes", "biodegradation_days": "28-60", "bioaccumulative": "no", "aquatic_toxicity_level": "low", "coral_reef_safe": "yes", "marine_toxicity": "low aquatic toxicity", "freshwater_toxicity": "moderate toxicity", "endocrine_disruptor": "suspected", "persistent_organic_pollutant": "no", "microplastic": "no", "nano_particle": "no", "hawaii_banned": "no", "eu_restricted_environmental":…
pediatric_safety
{"safe_for_newborn_0_6m": "caution", "safe_for_infant_6_12m": "caution", "safe_for_toddler_1_3y": "caution", "safe_for_child_3_12y": "yes", "safe_for_teen_12_18y": "yes", "pediatric_max_concentration_pct": "0.4", "adult_max_concentration_pct": "0.4", "pediatric_dermal_absorption_factor": "higher", "immature_skin_barrier_risk": "low", "oral_ingestion_risk": "low", "eye_irritation_risk": "low", "end…
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": "Similar to methylparaben", "source": "Alfa Chemistry 2025"}
pregnancy_detail
{"pregnancy_safe": "avoid", "breastfeeding_safe": "avoid", "trimester_restriction": "all", "risk_category": "not-rated", "reason": "Potential endocrine disruptor", "alternative_ingredient": "Phenoxyethanol; Sodium Benzoate", "source": "ACOG; dermatology literature"}
preservative
{"preservative_class": "Paraben", "antimicrobial_spectrum_bacteria_gp": "Yes", "antimicrobial_spectrum_bacteria_gn": "Moderate", "antimicrobial_spectrum_yeast": "Yes", "antimicrobial_spectrum_mold": "Yes", "mic_staph_aureus_ppm": "500", "mic_e_coli_ppm": "900", "mic_pseudomonas_ppm": "1400", "mic_candida_albicans_ppm": "250", "mic_aspergillus_niger_ppm": "600", "challenge_test_pass_concentration_p…
regulatory
{"eu_status": "allowed", "us_status": "allowed", "eu_max_concentration": "0.4", "regulation_reference": "Annex V/12"}
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
... when tested using Human Patch tests (undiluted material) only a limited number of people developed mild skin irritation.
Source: Hazardous Substances Data Bank (HSDB)
Regulatory (2)
JECFA Evaluation
ETHYL p-OXYBENZOATE | 1973 | 0-10 mg/kg bw | Group ADI as the sum of the ethyl and methyl esters of p-hydroxybenzoic acid. In view of the adverse effects in male rats, propyl paraben (propyl p-hydroxybenzoate) was excluded from the group ADI for the parabens used in food (TRS 940-JECFA 67/30, 2006) | NMRS 53/TRS 539-JECFA 17/17 | FAS 5/NMRS 53A-JECFA 17/81
Source: Joint FAO/WHO Expert Committee on Food Additives (JECFA)
EU Food Improvement
Food additives
Source: EU Food Improvement Agents
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Flavouring and nutrient
Food preservative
Fragrance
Preservative
Regulatory List Membership (3)
EU Restricted for Children (Cosmetics)
IFRA Fragrance Transparency List
FDA Indirect Food Contact Additives
Expert Verdict
Expert safety assessment and concern-level summary for Ethylparaben.
Regulatory Flags
paraben
restricted
eu-annex-v
sccs-edc-assessed
estrogenic-activity
eu_children_restricted
ifra_fragrance
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Ethylparaben by CAS number or substance name.
Studies
2
Lowest NOAEL
1030 mg/kg bw/day
Highest NOAEL
1030 mg/kg bw/day
EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx
Dermal Absorption
View details ->| Absorption % | Method | Vehicle |
|---|---|---|
| 3.7 | In vitro — Franz cells (multiple studies) | Cream / lotion |
Known Synonyms
ethyl 4-hydroxybenzoate
4-10-00-00367
BRN 1101972
Carbethoxyphenol
Caswell No. 447
EINECS 204-399-4
EPA Pesticide Chemical Code 061202
Ethyl p-oxybenzoate
Ester etylowykwasu p-hydroksybenzoesowego
Ethylester kyseliny p-hydroxybenzoove
p-Oxybenzoesaeureaethylester
UNII-14255EXE39
Chemical Function
Preservative
Fragrance
Flavouring and nutrient
Food preservative
Regulatory Lists
active_ingredient; Europe; Pesticides
IFRA Transparency
Europe
Personal care; Southeast Asia
inert_ingredient; non_food_use; Pesticides
air; detected; emissions; Europe; Vehicle - car interior
detected; Europe; Vehicle - car interior
children; WA Children's Safe Product Act (4/2020)
children
children
detected; Toys and children's products
nondetect; Toys and children's products
detected; Toys and children's products
detected; Toys and children's products
nondetect; Toys and children's products
detected; Toys and children's products
nondetect; Toys and children's products
children
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
ETHYLPARABEN
ChEMBL ID
CHEMBL15841
Max Phase
-1
Frequently Asked Questions
Is Ethylparaben allowed in the EU?
Ethylparaben EU regulatory status: restricted. Maximum allowed concentration: 0.4% as acid in finished product; 0.8% cap for total paraben mixture. This is based on EU Regulation 1223/2009 and its amendments.
What does Ethylparaben do in cosmetics?
Ethylparaben functions as: preservative. It is classified as a Preservative in our database. CAS number: 120-47-8.
What is the NOAEL for Ethylparaben?
The NOAEL (No Observed Adverse Effect Level) for Ethylparaben is =1030 mg/kg bw/day based on a subchronic study via oral route in Rat. A total of 2 study endpoints are available. Source: EFSA_OpenFoodTox_EFSA_ReferencePoints.xlsx.
Is Ethylparaben used outside cosmetics?
Ethylparaben 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 Ethylparaben have different safety status in cosmetics vs industrial chemicals?
Ethylparaben is classified GHS Danger (H304, H315, H317, H319, H401) in the chemicals database but is restricted in EU cosmetics at max 0.4% as acid in finished product; 0.8% cap for total paraben mixture.
Compliance Tools
Check Ethylparaben compliance across multiple jurisdictions:
Ingredient Decoder
Paste a full ingredient list for instant analysis
82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
Check compliance across multiple jurisdictions
MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
Compare limits across jurisdictions
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