Is Propyl Gallate safe in cosmetics?
Propyl Gallate has a safety rating of "MODERATE" in our database. EU status: permitted. US status: permitted. 9 toxicological study endpoint(s) are available in our database.
Propyl Gallate
Also known as: PG, Gallic acid n-propyl ester, Gallic acid, propyl ester, Benzoic acid, 3,4,5-trihydroxy-, propyl ester, EINECS 204-498-2 (+6 more)
INCI: PROPYL GALLATE
Propyl Gallate (CAS 121-79-9) is a cosmetic cosmetic ingredient functioning as Antioxidant, Perfuming agent. NOAEL 135 mg/kg bw/day (cross-referenced against ToxValDB ECHA IUCLID); EU Regulation 1223/2009 status: permitted. 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 121-79-9 →
Auto-generated CPSR Part A draft with source citations
Cross-Vertical Regulatory Divergence
Propyl Gallate is classified GHS Danger (H302, H317, H318, H400, H411) in the chemicals database but is allowed in EU cosmetics.
Source: Cosmetics: ingredients.eu status; Chemicals: ghs classifications.signal word/hazard statement code
Function
Antioxidant, Perfuming agent
Safety Rating
MODERATE
Chemistry & Identifiers
IUPAC Name
propyl 3,4,5-trihydroxybenzoate
InChIKey
ZTHYODDOHIVTJV-UHFFFAOYSA-N
Regulatory Status
EU EU Status
permitted
US US Status
permitted
US Notes
Permitted; GRAS (21 CFR 184.1660); CIR assessed safe in present practices of use
For full compliance data across multiple jurisdictions, use the Substance Compliance tool.
Safety Data
Margin of Safety, dermal absorption, and sensitization profile summaries for Propyl Gallate.
Calculate MoS for your specific formulation with the MoS Calculator.
Toxicological Studies
9 study endpoints found for Propyl Gallate. 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 | 75 mg/kg bw/day | oral | mouse | Special Toxicology Study | COSMOS DB |
| NOAEL | 250 mg/kg bw/day | oral | hamster | Developmental | COSMOS DB |
| NOAEL | 500 mg/kg bw/day | oral | rat | Short Term Toxicity | COSMOS DB |
| NOAEL | 585 mg/kg bw/day | oral | rat | Carcinogenicity | COSMOS DB |
| NOAEL | 900 mg/kg bw/day | oral | mouse | Carcinogenicity | COSMOS DB |
| NOAEL | 1250 mg/kg bw/day | oral | rat | Subchronic | COSMOS DB |
| NOAEL | =250 mg/kg bw/day | oral | Hamster | developmental | ECHA |
| NOAEL | =260 mg/kg bw/day | oral | Rat | reproduction developmental | ECHA |
| NOAEL | =880 mg/kg bw/day | oral | Rat | reproduction developmental | ECHA |
Pre-Calculated Safety Assessment
Pre-calculated NOAEL → SED → MoS audit trail for Propyl Gallate across SCCS product categories, with measured dermal absorption where available.
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 | =1910 mg/kg-day | Rat | oral | subchronic | EFSA |
| NOAEL | =135 mg/kg-day | Rat | oral | subchronic | EFSA |
| LD50 | >2000 mg/kg | Mouse | oral | - | ECHA |
| LD50 | >2000 mg/kg | Rat | oral | - | ECHA |
| LD50 | >1000 mg/kg | Mouse | oral | - | ECHA |
| LD50 | <2000 mg/kg | Mouse | oral | - | ECHA |
| LEL | =25000 ppm | Rat | oral | short-term | ECHA |
| LEL | =12500 ppm | Mouse | oral | short-term | ECHA |
| LEL | =2462.5 mg/kg-day | Mouse | oral | subchronic | ECHA |
| LEL | =1152 mg/kg-day | Rat | oral | subchronic | ECHA |
EU CLP Annex VI Harmonized Classification
Legally binding harmonized classification per Regulation (EC) No 1272/2008 (CLP) Annex VI.
Signal Word
Warning
Pictograms
Harmful / IrritantEnvironmental Hazard
Hazard Class and Category
Acute Tox. 4; Skin Sens. 1; Aquatic Acute 1; Aquatic Chronic 1
Hazard Statements
- H302 Harmful if swallowed
- H317 May cause an allergic skin reaction
- H400 Very toxic to aquatic life
- H410 Very toxic to aquatic life with long lasting effects
Specific Concentration Limits / M-factors
oral: ATE = 1700.0 mg/kg bw; M = 1; M = 1
Inserted via ATP: ATP22
Sensitization AOP Dashboard
Adverse Outcome Pathway data across 5 assays (DPRA, KeratinoSens, hCLAT, LLNA, NESIL) aggregated from public sources.
DPRA Cys %
59.2%
DPRA Lys %
26.6%
KeratinoSens IC50
650.3 µM
hCLAT CV75
125 µg/mL
LLNA EC3
0.32%
NESIL
80 µg/cm²
LLNA: Strong (1A)
GHS: 1A
Source: LLNA: Basketter and Scholes (1992); DPRA: Bauch et al. 2012 [DOI:10.1016/j.yrtph.2012.05.013] | Gerberick et al. 2007 [DOI:10.1093/toxsci/kfm064]; KS: Natsch et al. 2013 [DOI:10.1002/jat.2868] | Joint Research Centre of the European Union 2014; hCLAT: Ashikaga et al. 2010 [DOI:10.1177/026119291003800403] | Bauch et al. 2012 [DOI:10.1016/j.yrtph.2012.05.013]
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: other
Receptor targets: ERα, ERβ, AR
LOEC: 30 µM
EU status: allowed (food + cosmetics)
agonist (ER at 30 µM); antagonist in presence of E2
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
Hazard classification: Restricted (Annex XVII)
Additional Ingredient Properties
6 property records from structured ingredient metadata.
anti_pollution
{"cas_number": "121-79-9", "ingredient_class": "antioxidant_pollution_shield", "primary_mechanism": "chain_breaking", "pollution_types_targeted": "PM2_5", "IR_A_protection": "no", "visible_light_protection": "no", "digital_screen_protection_claim": "no", "PAH_neutralization": "no", "ozone_protection": "no", "mitochondrial_protection": "no", "Nrf2_activation": "no", "AhR_pathway_modulation": "no", …
baby_pediatric
{"cas_number": "CAS-FUNC-27", "ingredient_class": "other", "pediatric_safety_rating": "caution", "minimum_age_months": "12", "neonatal_safe": "no", "premature_infant_safe": "insufficient_data", "skin_barrier_maturity_consideration": "Synthetic antioxidant - scrutiny, limit babies", "transepidermal_absorption_risk_pediatric": "low", "systemic_exposure_concern_pediatric": "low", "dose_per_kg_body_we…
pediatric_safety
{"safe_for_newborn_0_6m": "caution", "safe_for_infant_6_12m": "caution", "safe_for_toddler_1_3y": "yes", "safe_for_child_3_12y": "yes", "safe_for_teen_12_18y": "yes", "pediatric_max_concentration_pct": "0.1", "adult_max_concentration_pct": "0.1", "pediatric_dermal_absorption_factor": "moderate", "immature_skin_barrier_risk": "low", "oral_ingestion_risk": "low", "eye_irritation_risk": "low", "diape…
preservative
{"preservative_class": "Phenol derivative", "antimicrobial_spectrum_bacteria_gp": "Good", "antimicrobial_spectrum_bacteria_gn": "Good", "antimicrobial_spectrum_yeast": "Yes", "antimicrobial_spectrum_mold": "Yes", "mic_staph_aureus_ppm": "600", "mic_e_coli_ppm": "800", "mic_pseudomonas_ppm": "1000", "mic_candida_albicans_ppm": "1500", "mic_aspergillus_niger_ppm": "2000", "challenge_test_pass_concen…
regulatory
{"eu_status": "allowed", "us_status": "allowed"}
solubility_hlb
{"water_soluble": "partial", "oil_soluble": "yes", "soluble_in": "oils, ethanol", "insoluble_in": "water, glycerin", "log_p": "1.4", "melting_point_c": "148-150", "appearance": "cream to white powder", "source": "Jiurui"}
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)
Carcinogen Classification
Propyl gallate | TR-240: Carcinogenesis Bioassay of Propyl Gallate (CASRN 121-79-9) in F344/N Rats and B6C3F1 Mice (Feed Study) (1982 ) | 12/16/81 | Equivocal Evidence | No Evidence | Equivocal Evidence | No Evidence | Under the conditions of this bioassay, propyl gallate was not considered carcinogenic for F344/N rats, although there was evidence of an increased proportion of low-dose ma
Source: NTP Technical Reports
Skin Eye Respiratory Irritation
/LABORATORY ANIMALS: Acute Exposure/ Guinea pig: 10% /propyl gallate/ in propylene glycol applied to shaved skin for 48 hours /resulted in/ no local lesions or primary irritation. /from table/ | /LABORATORY ANIMALS: Acute Exposure/ Rabbit: <1 percent /propyl gallate/ in a lipstick. Primary skin irritation test - applied to intact and abraded skin, three 24-hour applications. Not a primary irritant
Source: Hazardous Substances Data Bank (HSDB)
Regulatory (2)
JECFA Evaluation
PROPYL GALLATE | 1996 | 0-1.4 mg/kg bw (1993) | The 1993 ADI was maintained at the forty-sixth meeting (1996) | TRS 868-JECFA 46/15 | FAS 32/JECFA 41/3 (1993)
Source: WHO/JECFA
EU Food Improvement
Food additives
Source: EU Food Improvement Agents
Function Categories & List Membership
Cosmetic/Chemical Function Categories
Antioxidant
Flavouring and nutrient
Fragrance
Regulatory List Membership (3)
IFRA Fragrance Transparency List
FDA Substances Added to Food (EAFUS)
Consumer Product Chemical
Expert Verdict
Expert safety assessment and concern-level summary for Propyl Gallate.
Regulatory Flags
potential-allergen
fragrance-component
ifra_fragrance
fda_food_additive
NOAEL Studies Summary
View details ->Public NOAEL study rows linked to Propyl Gallate by CAS number or substance name.
Studies
9
Lowest NOAEL
75 mg/kg bw/day
Highest NOAEL
1250 mg/kg bw/day
COSMOS DB
ECHA
Known Synonyms
PG
Gallic acid n-propyl ester
Gallic acid, propyl ester
Benzoic acid, 3,4,5-trihydroxy-, propyl ester
EINECS 204-498-2
FEMA No. 2947
NCI-C505888
3,4,5-Trihydroxybenzene-1-propylcarboxylate
3,4,5-Trihydroxybenzoic acid n-propyl ester
Propylester kyseliny gallove
UNII-8D4SNN7V92
Chemical Function
Antioxidant
Fragrance
Regulatory Lists
inert_ingredient; non_food_use; Pesticides
animal_products
IFRA Transparency
food_additive; Substances Added to Food (formerly EAFUS) (2/2019)
Canada; pharmaceutical
consumer_product
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
PROPYL GALLATE
ChEMBL ID
CHEMBL7983
Max Phase
1
Frequently Asked Questions
Is Propyl Gallate allowed in the EU?
Propyl Gallate EU regulatory status: permitted. This is based on EU Regulation 1223/2009 and its amendments.
What does Propyl Gallate do in cosmetics?
Propyl Gallate functions as: Antioxidant, Perfuming agent. It is classified as a cosmetic ingredient in our database. CAS number: 121-79-9.
What is the NOAEL for Propyl Gallate?
The NOAEL (No Observed Adverse Effect Level) for Propyl Gallate is 75 mg/kg bw/day based on a Special Toxicology Study study via oral route in mouse. A total of 9 study endpoints are available. Source: COSMOS DB.
Is Propyl Gallate used outside cosmetics?
Propyl Gallate 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 Propyl Gallate have different safety status in cosmetics vs industrial chemicals?
Propyl Gallate is classified GHS Danger (H302, H317, H318, H400, H411) in the chemicals database but is allowed in EU cosmetics.
Compliance Tools
Check Propyl Gallate 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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