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

Methylparaben

Also known as: Methyl paraben (Benzoic acid, 4-hydroxy-, methyl ester), Aseptoform, BRN 0509801, Caswell No. 573PP, EINECS 202-785-7 (+15 more)

INCI: METHYLPARABEN

Methylparaben (CAS 99-76-3) is a cosmetic preservative functioning as preservative. NOAEL 374 mg/kg bw/day (PDF-verified against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: restricted, max 0.4% (as acid); mixture cap all parabens 0.8%; 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 99-76-3 →

Auto-generated CPSR Part A draft with source citations
CAS Number
99-76-3
View industrial chemical safety profile →
Function
preservative
Safety Rating
GOOD

Chemistry & Identifiers

Formula
C8H8O3
MW
152.15 g/mol
EC Number
202-785-7
PubChem CID
7456
IUPAC Name
methyl 4-hydroxybenzoate
InChIKey
LXCFILQKKLGQFO-UHFFFAOYSA-N
ChEBI: CHEBI:31835 UNII: A2I8C7HI9T Wikidata: Q229987

Regulatory Status

EU EU Status restricted
EU Max Conc. 0.4% (as acid); mixture cap all parabens 0.8%
US US Status permitted
US Notes CIR Panel concludes safe as used; no legal concentration cap 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 Methylparaben.

Calculate MoS for your specific formulation with the MoS Calculator.

Toxicological Studies

10 study endpoints found for Methylparaben. 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 =1 mg/kg/d oral rat oral toxicity CIR_vision_codex
NOAEL =1 mg/kg/d oral rat oral toxicity CIR_vision_codex
NOAEL =1 mg/kg/d oral rat oral toxicity CIR_vision_codex
NOAEL =1 mg/kg/d oral rat oral toxicity CIR_vision_codex
NOAEL =4 mg/kg bw/d oral rat oral toxicity CIR_vision_codex
NOAEL =4 mg/kg bw/d oral rat oral toxicity CIR_vision_codex
NOAEL =4 mg/kg bw/d oral rat oral toxicity CIR_vision_codex
NOAEL =4 mg/kg bw/d oral rat oral toxicity CIR_vision_codex
NOAEL =67.8 mg/kg/d - rat NOAEL study CIR_vision_codex
NOAEL =67.8 mg/kg/d - rat NOAEL study CIR_vision_codex

Safety Opinions

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

sccs SCCS/1652/23 14 December 2023
Verdict: unknown
NOAEL: 1000 mg/kg/day (oral)
Max Concentration: 0.4% in general
sccs SCCS/1652/23 14 December 2023
Verdict: unknown
NOAEL: 1000 mg/kg bw/day (not specified)
Max Concentration: 0.4% in general
sccs SCCS/1652/23 14 December 2023
Verdict: unknown
NOAEL: 250 mg/kg bw/day (not specified)
Max Concentration: 0.4% in general
sccs SCCS/1652/23 14 December 2023
Verdict: unknown
NOAEL: 300 mg/kg bw/day (not specified)
Max Concentration: 0.4% in general
sccs SCCS/1652/23 14 December 2023
Verdict: unknown
NOAEL: 300 mg/kg bw/day (oral)
Max Concentration: 0.4% in general

Pre-Calculated Safety Assessment

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

SCCS NOAEL Values

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

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/1652/23 (2023)

Sensitization Profile

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

Sensitization Rate
low
Allergen Class
preservative
EU Allergen Listed
no
Patch Test Positive Rate
0.5%
Cross-reactivity Group
paraben-group
Reaction Type
contact-dermatitis

Source: ESSCA; IVDK; SCCS/1348/10

Dermal Penetration Profile

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

Absorption %
20-30%
Penetration Level
dermis
Penetration Depth
epidermis/dermis
Molecular Weight
152.1 Da
Log P
1.96
Systemic Absorption
yes
Topical Bioavailability
15-25%
Safety Margin Factor
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 >1030 mg/kg-day Rat oral - ECHA IUCLID
NOAEL =1030 mg/kg-day Rat oral subchronic EFSA
LD50 =3000 mg/kg Dog oral - ECHA IUCLID
LD50 =2100 mg/kg Rat oral - ECHA IUCLID
LD50 >8000 mg/kg Mouse oral - ECHA IUCLID
LD50 ~8000 mg/kg Mouse oral - ECHA IUCLID
LD50 =3000 mg/kg Guinea Pig oral - ECHA IUCLID
LD50 >15000 mg/kg Rat oral - ECHA IUCLID
LD50 >8000 mg/kg Mouse oral - ECHA IUCLID
NOAEL =550 mg/kg-day Rat oral - ECHA IUCLID

Sensitization AOP Dashboard

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

DPRA Cys %
3.6%
DPRA Lys %
0%
KeratinoSens IC50
2000 µM
LLNA EC3
50%
NESIL
174 µg/cm²
LLNA: Weak (1B) GHS: 1B Human: positive

Source: LLNA: Ryan et al. (2000); DPRA: Urbisch et al. 2015 [DOI:10.1016/j.yrtph.2014.12.008]; KS: Urbisch et al. 2015 [DOI:10.1016/j.yrtph.2014.12.008]; HPPT: [228] Marzulli FN and Maibach HI (1973): https://library.scconline.org/v024n07/

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: Moderate (2014)
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: 10 µM
EU status: restricted (max 0.4% single; 0.8% mixture)

agonist (ER); antagonist (AR, TR)

Dose-Response Data Points
Endpoint Target Value Direction
EC_threshold_ER ERα >10⁻⁵ M M agonist
IC_threshold_AR AR >10⁻⁵ M M antagonist
NOAEL general 1000 mg/kg/day -
NOAEL general 11.2 mg/kg/day -
dermal_delivery skin 2.0 µg/cm² -
ASED systemic 0.0181–0.6611 mg/kg/day -

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 (8)
Jurisdiction Status Max % Product Type
CN permitted_preservative 0.4 All cosmetics
IN permitted_preservative 0.8 all cosmetics (mixture of paraben esters)
IN permitted_preservative 0.4 all cosmetics (single paraben ester)
AU restricted - preservatives
GCC restricted 0.4 All cosmetics
GCC restricted 0.0 Nappy/diaper area products, children <3 years
BR permitted_preservative 0.4 (individual) / 0.8 (sum with ethyl) 0.4% each individually; 0.8% as sum of methyl+ethyl esters and salts
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: 152.149
LogP: 1.95803
Kp epidermis: 0.03141 cm/h
% dose epidermis: 0.98%
% dose stratum corneum: 0.95%
% dose dermis: 0.91%

Source: EPA_Dryad_Skin_Absorption_2024

Roberts Skin Permeation (Mendeley 2022)
MW: 152.1
Log Kow: 1.87
Log Kp: -2.0339433523068373
Log Jmax: -6.92

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 0.1–0.4 0.8 CIR (IJT 39:2020)
Body Lotion 0.1–0.4 0.8 CIR (IJT 39:2020)
Shampoo 0.1–0.3 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": "0.5", "sensitization_rate": "low", "common_reaction_type": "contact-dermatitis", "ifra_restricted": "no", "source": "ESSCA; IVDK; SCCS/1348/10"}
comedogenicity_detail
{"comedogenicity_rating": "0", "irritancy_rating": "1", "skin_type_suitability": "all,oily,combination,normal", "acne_safe": "yes", "source": "Paraben preservative"}
concentration
{"min_concentration_pct": "0.1", "max_concentration_pct": "0.4", "typical_concentration_pct": "0.2", "product_type": "Cleanser", "function_at_concentration": "Preservative", "source": "CIR Safety Assessment; EU Annex V"}
dermal_absorption
{"molecular_weight_da": "152.1", "log_p_value": "1.96", "skin_penetration_level": "dermis", "penetration_depth": "epidermis/dermis", "absorption_pct": "20-30", "systemic_absorption": "yes", "penetration_enhancer": "no", "occlusion_effect": "no", "vehicle_dependent": "yes", "skin_barrier_effect": "neutral", "bioavailability_topical_pct": "15-25", "safety_margin_factor": "high", "source": "SCCS/1348…
ecotoxicity
{"biodegradable": "yes", "biodegradation_days": "28-60", "bioaccumulative": "no", "aquatic_toxicity_level": "low", "coral_reef_safe": "yes", "marine_toxicity": "EC50 91 mg/L algae", "freshwater_toxicity": "LC50 59.5 mg/L fish", "endocrine_disruptor": "suspected", "persistent_organic_pollutant": "no", "microplastic": "no", "nano_particle": "no", "hawaii_banned": "no", "eu_restricted_environmental":…
interactions
{"ingredient_2": "Propylparaben", "interaction_type": "synergistic", "severity": "beneficial", "effect": "Broader antimicrobial spectrum than either alone", "recommendation": "Classic paraben combination if parabens used", "data_source": "Formulation science literature, dermatological research, cosmetic chemistry best practices", "last_updated": "2026-03-05"}
microbiome_impact
{"microbiome_effect": "negative", "prebiotic": "no", "probiotic_compatible": "no", "antimicrobial_spectrum": "broad", "preservative_effect_on_microbiome": "Reduces beneficial commensal diversity; strongly inhibits S. epidermidis at >0.4%", "skin_flora_disruption": "moderate", "gut_microbiome_risk": "low", "microbiome_recovery_time": "7-10 days", "selective_antimicrobial": "no", "pathogen_inhibitio…
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…

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
Methylparaben ... as saturated aq soln ... noted to be moderately irritating to eye ... .
Source: Hazardous Substances Data Bank (HSDB)
Regulatory (2)
JECFA Evaluation
METHYL p-HYDROXYBENZOATE | 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
Biocide Flavouring and nutrient 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 Methylparaben.

Regulatory Flags

eu-restricted paraben endocrine-concern sccs-reviewed eu_children_restricted ifra_fragrance fda_food_additive

NOAEL Studies Summary

View details ->

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

Studies
58
Lowest NOAEL
0.105
Highest NOAEL
1180

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

COSMOS_DB ToxValDB_ECHA_IUCLID CIR_vision_codex SCCS_vision_codex

Dermal Absorption

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

Known Synonyms

Methyl paraben (Benzoic acid, 4-hydroxy-, methyl ester) Aseptoform BRN 0509801 Caswell No. 573PP EINECS 202-785-7 EPA Pesticide Chemical Code 061201 FEMA Number 2710 Methylester kyseliny p-hydroxybenzoove UNII-A2I8C7HI9T E 218 E218 FEMA No. 2710 INS No. 218 INS number 218 Methyl ester of p-hydroxybenzoic acid Methyl p-oxybenzoate Methyl parahydroxybenzoate Methyl-p-hydroxybenzoate P-Hydroxybenzoic acid, methyl ester P-Hydroxybenzoic methyl ester

Chemical Function

Preservative Fragrance

Regulatory Lists

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

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
METHYLPARABEN
ChEMBL ID
CHEMBL325372
Max Phase
-1
View full pharmaceutical profile →

Frequently Asked Questions

Is Methylparaben safe in cosmetics?

Methylparaben has a safety rating of "GOOD" 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 Methylparaben allowed in the EU?

Methylparaben EU regulatory status: restricted. Maximum allowed concentration: 0.4% (as acid); mixture cap all parabens 0.8%. This is based on EU Regulation 1223/2009 and its amendments.

What does Methylparaben do in cosmetics?

Methylparaben functions as: preservative. It is classified as a Preservative in our database. CAS number: 99-76-3.

What is the NOAEL for Methylparaben?

The NOAEL (No Observed Adverse Effect Level) for Methylparaben is =1 mg/kg/d based on a oral toxicity study via oral route in rat. A total of 10 study endpoints are available. Source: CIR_vision_codex.

Is Methylparaben used outside cosmetics?

Methylparaben 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.

Compliance Tools

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