Poor Cosmetic Ingredient NOAEL Data Sensitization Data

Benzylparaben

Also known as: Benzyl 4-hydroxybenzoate, Benzoic acid, 4-hydroxy-, phenylmethyl ester, Benzyl Parasept, Benzyl Tegosept, Benzyl-Parasept (+8 more)

INCI: BENZYLPARABEN

Benzylparaben (CAS 94-18-8) is a cosmetic cosmetic ingredient functioning as Preservative (antimicrobial). Reported NOAEL =10 mg/kg bw/day in Mouse (ToxValDB_ECHA_IUCLID); EU Regulation 1223/2009 status: prohibited. 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 94-18-8 →

Auto-generated CPSR Part A draft with source citations
Function
Preservative (antimicrobial)
Safety Rating
POOR

Chemistry & Identifiers

EC Number
202-311-9

Regulatory Status

EU EU Status prohibited
US US Status restricted
US Notes Not specifically banned by FDA; however, CIR Expert Panel noted the EU ban and flagged insufficient safety data

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

Safety Data

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

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

2 study endpoints found for Benzylparaben. 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 =10 mg/kg bw/day dermal Mouse short-term ToxValDB_ECHA_IUCLID
NOAEL =3000 mg/kg bw/day oral Mouse short-term ToxValDB_ECHA_IUCLID

Sensitization Profile

Contact sensitization data for Benzylparaben 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

Endocrine Disruptor Evidence (Expanded)

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

Cosmetic-Specific Mechanism
Category: paraben
Receptor targets: ERα
LOEC: 1 µM
EU status: restricted (≤0.4%)

agonist

Dose-Response Data Points
Endpoint Target Value Direction
Displacement of T4/estrogen from AFP carrier protein ER (indirect via AFP) EC50/IC50: IC50 0.012 uM AFP binding (most potent paraben for AFP); LOEC: 0.01 uM; NOEC: 0.001 uM mixed agonist

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
No

EU CosIng Annex Listing

European Commission CosIng database Annex references per Regulation (EC) No 1223/2009.

Annex II — Prohibited
Ref: 1377
(EU) 2014/358

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.

SA Saudi SFDA (II - Prohibited)
ASEAN Cosmetic Directive (II)
Ref: 1377
BRIN Brazil/India Cosmetics
Brazil: Prohibited
India: Prohibited (GNRAS)

Additional Ingredient Properties

3 property records from structured ingredient metadata.

allergen_detail
{"eu_allergen_listed": "no", "allergen_class": "preservative", "cross_reactivity_group": "paraben-group", "patch_test_frequency_pct": "0.2", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "ESSCA; IVDK; SCCS/1348/10"}
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": "dermatology literature"}
regulatory
{"eu_status": "banned", "us_status": "restricted", "eu_max_concentration": "0", "restricted_in": "all products", "ban_date": "2014-10-30", "regulation_reference": "Annex II/1116"}

Function Categories & List Membership

Cosmetic/Chemical Function Categories
Biocide Food preservative
Regulatory List Membership (2)
EU Banned in Cosmetics EU CosIng Cosmetics Ingredient Database

Expert Verdict

Expert safety assessment and concern-level summary for Benzylparaben.

Regulatory Flags

preservative eu_banned_cosmetics eu_cosing_listed

NOAEL Studies Summary

View details ->

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

Studies
2
Lowest NOAEL
10 mg/kg bw/day
Highest NOAEL
3000 mg/kg bw/day
ToxValDB_ECHA_IUCLID

Known Synonyms

Benzyl 4-hydroxybenzoate Benzoic acid, 4-hydroxy-, phenylmethyl ester Benzyl Parasept Benzyl Tegosept Benzyl-Parasept EINECS 202-311-9 p-Hydroxybenzoic acid benzyl ester Nipabenzyl NSC 8080 Parosept Solbrol Z UNII-8Y41DYV4VG Benzyl parahydroxybenzoate

Chemical Function

Biocide Food preservative

Regulatory Lists

banned; Europe; Personal care active_ingredient; animal_products; Europe; pharmaceutical; residue detected; Personal care; Southeast Asia detected; MN Chemical Screening; surface_water Canada; pharmaceutical Canada; pharmaceutical

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.

ChEMBL ID
CHEMBL447861
View full pharmaceutical profile →

Frequently Asked Questions

Is Benzylparaben safe in cosmetics?

Benzylparaben has a safety rating of "POOR" in our database. EU status: prohibited. US status: restricted. 2 toxicological study endpoint(s) are available in our database.

Is Benzylparaben allowed in the EU?

Benzylparaben EU regulatory status: prohibited. This is based on EU Regulation 1223/2009 and its amendments.

What does Benzylparaben do in cosmetics?

Benzylparaben functions as: Preservative (antimicrobial). It is classified as a cosmetic ingredient in our database. CAS number: 94-18-8.

What is the NOAEL for Benzylparaben?

The NOAEL (No Observed Adverse Effect Level) for Benzylparaben is =10 mg/kg bw/day based on a short-term study via dermal route in Mouse. A total of 2 study endpoints are available. Source: ToxValDB_ECHA_IUCLID.

Is Benzylparaben used outside cosmetics?

Benzylparaben 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 Benzylparaben have different safety status in cosmetics vs industrial chemicals?

Benzylparaben is prohibited in EU cosmetics but has active industrial GHS classifications (H315, H319, H335).

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