Is Sodium Ethylparaben safe in cosmetics?
Sodium Ethylparaben has a safety rating of "GOOD" in our database. EU status: permitted. US status: permitted. 4 toxicological study endpoint(s) are available in our database.
Sodium Ethylparaben
Also known as: EINECS 252-487-6, Ethyl p-hydroxybenzoate, sodium salt, UNII-Z0D00IVA10
INCI: SODIUM ETHYLPARABEN
Sodium Ethylparaben (CAS 35285-68-8) is a cosmetic cosmetic ingredient functioning as Preservative (antimicrobial). Reported NOAEL =1030 mg/kg bw/day in Rat (EFSA_OpenFoodTox_OpenFoodToxTX22809_2023.xlsx); EU Regulation 1223/2009 status: permitted, max 0.4%. Industrial safety data is also available in the chemical safety database. Same-CAS public records also appear in industrial chemical safety data.
View industrial chemical safety profile for CAS 35285-68-8 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Sodium Ethylparaben is classified GHS Danger (H318, H319) in the chemicals database but is allowed in EU cosmetics at max 0.4%.
Source: Cosmetics: ingredients.eu_status/eu_max; Chemicals: ghs_classifications.signal_word/hazard_statement_code
Function
Preservative (antimicrobial)
Safety Rating
GOOD
Chemistry & Identifiers
InChIKey
HLEKLAHSVAPCPF-UHFFFAOYSA-N
Regulatory Status
EU EU Status
permitted
EU Max Conc.
0.4%
US US Status
permitted
US Notes
Permitted; CIR safe as used; FDA allows in cosmetics with ongoing monitoring
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Sodium Ethylparaben.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
4 study endpoints found for Sodium 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_OpenFoodToxTX22809_2023.xlsx |
| NOAEL | =1030 mg/kg bw/day | - | Rat | subchronic | EFSA_OpenFoodTox_OpenFoodToxTX22809_2023.xlsx |
| NOAEL | =1043 mg/kg bw/day | - | Rat | subchronic | EFSA_OpenFoodTox_OpenFoodToxTX22809_2023.xlsx |
| NOAEL | =1043 mg/kg bw/day | - | Rat | subchronic | EFSA_OpenFoodTox_OpenFoodToxTX22809_2023.xlsx |
Sensitization Profile
Contact sensitization data for Sodium Ethylparaben based on clinical patch test studies and IFRA standards.
Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.2%
Cross-reactivity Group
paraben-group
Reaction Type
contact-dermatitis
Source: ESSCA; IVDK; SCCS/1348/10
ECHA REACH Registration
European Chemicals Agency REACH dossier and Substances of Very High Concern listing.
Registration Type
Full
Tonnage Band
1 - 10 tonnes
Substance Type
SUBSTANCE
SVHC Candidate
No
Additional Ingredient Properties
1 property record from structured ingredient metadata.
allergen_detail
{"eu_allergen_listed": "no", "allergen_class": "preservative", "cross_reactivity_group": "paraben-group", "patch_test_frequency_pct": "0.2", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "ESSCA; IVDK; SCCS/1348/10"}
PubChem Annotations
Safety and regulatory annotations from PubChem (NCBI) aggregated sources.
Regulatory (1)
EU Food Improvement
Food additives
Source: EU Food Improvement Agents
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Preservative
Expert Verdict
Expert safety assessment and concern-level summary for Sodium Ethylparaben.
Regulatory Flags
preservative
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Sodium Ethylparaben by CAS number or substance name.
Studies
4
Lowest NOAEL
1030 mg/kg bw/day
Highest NOAEL
1043 mg/kg bw/day
EFSA_OpenFoodTox_OpenFoodToxTX22809_2023.xlsx
Known Synonyms
EINECS 252-487-6
Ethyl p-hydroxybenzoate, sodium salt
UNII-Z0D00IVA10
Chemical Function
Preservative
Regulatory Lists
active_ingredient; Europe; Pesticides
inert_ingredient; non_food_use; Pesticides
Australian Status
AICIS status: listed
Frequently Asked Questions
Is Sodium Ethylparaben allowed in the EU?
Sodium Ethylparaben EU regulatory status: permitted. Maximum allowed concentration: 0.4%. This is based on EU Regulation 1223/2009 and its amendments.
What does Sodium Ethylparaben do in cosmetics?
Sodium Ethylparaben functions as: Preservative (antimicrobial). It is classified as a cosmetic ingredient in our database. CAS number: 35285-68-8.
What is the NOAEL for Sodium Ethylparaben?
The NOAEL (No Observed Adverse Effect Level) for Sodium Ethylparaben is =1030 mg/kg bw/day based on a subchronic study via oral route in Rat. A total of 4 study endpoints are available. Source: EFSA_OpenFoodTox_OpenFoodToxTX22809_2023.xlsx.
Is Sodium Ethylparaben used outside cosmetics?
Sodium Ethylparaben also appears in industrial chemical safety data. The cross-vertical cards on this page render same-CAS public rows from the matched databases.
Does Sodium Ethylparaben have different safety status in cosmetics vs industrial chemicals?
Sodium Ethylparaben is classified GHS Danger (H318, H319) in the chemicals database but is allowed in EU cosmetics at max 0.4%.
Compliance Tools
Check Sodium Ethylparaben compliance across multiple jurisdictions:
Ingredient Decoder
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82 Allergen Checker
Check for EU declarable fragrance allergens
Substance Compliance
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MoS Calculator
Calculate Margin of Safety using SCCS methodology
Heavy Metal Limits
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