Baby Safety / Compounds / Propyl gallate

Is Propyl gallate safe for babies and kids?

Moderate risk for kids

Infants are exposed to Propyl gallate through personal care products (lotions, wipes) and food. Immature skin barrier and hepatic metabolism increase effective dose per body weight.

What is propyl gallate?

The IUPAC name is propyl 3,4,5-trihydroxybenzoate.

Also known as: propyl 3,4,5-trihydroxybenzoate, N-Propyl gallate, Progallin P, Gallic acid, propyl ester.

IUPAC name
propyl 3,4,5-trihydroxybenzoate
CAS number
121-79-9
Molecular formula
C10H12O5
Molecular weight
212.2 g/mol
SMILES
CCCOC(=O)C1=CC(=C(C(=C1)O)O)O
PubChem CID
4947

Risk for babies

Moderate risk

Infants are exposed to Propyl gallate through personal care products (lotions, wipes) and food. Immature skin barrier and hepatic metabolism increase effective dose per body weight.

Neonates and infants up to 12 months have incomplete blood-brain barrier development, immature Phase I/II metabolic enzymes (particularly CYP3A4, UGT1A1), and higher gastrointestinal permeability. Equivalent doses produce higher internal concentrations and longer residence times.

What to do: Minimize infant exposure through source control. For breastfeeding mothers: reduce maternal exposure. For formula-fed infants: use certified low-migration bottles and verified water sources. Consult pediatrician regarding any concerns.

Risk for pregnant and nursing people

Elevated risk

Prenatal exposure to Propyl gallate through personal care products and food is a concern. Some preservatives (parabens) exhibit weak estrogenic activity that may affect fetal endocrine development.

Suspected reproductive toxicant (GHS H361) or suspected endocrine disruptor. Precautionary approach warranted. Animal studies or limited human data suggest developmental toxicity potential.

What to do: Minimize exposure during pregnancy and lactation. Consult healthcare provider regarding specific risks. Consider alternative products with lower hazard profiles.

Regulatory consensus

7 regulatory and scientific bodies have classified Propyl gallate. The classifications differ — that's the data.

AgencyYearClassificationNotes
EPA CTX / Genetox—Genotoxicity: positive (Ames: negative, 3 positive / 6 negative reports)
EPA CTX / Genetox—Genotoxicity: positive (Ames: negative, 3 positive / 6 negative reports)
EPA CTX / Skin-Eye—Skin Sensitization: Skin Sens. 1 (score: high)
EPA CTX / Skin-Eye—Skin Sensitization: Category 1 (score: high)
EPA CTX / Skin-Eye—Eye Irritation: Category 6.4A (Category 2A) (score: high)
EPA CTX / Skin-Eye—Skin Irritation: Category 6.3B (Category 3) (score: moderate)
EPA CTX / Skin-Eye—Skin Sensitization: Category 6.5B (Category 1) (score: moderate)

Regulators apply different standards of evidence — animal-data weighting, exposure-pattern assumptions, epidemiological power thresholds — which is why two scientific bodies can review the same data and reach different conclusions. The disagreement is the data.

Where kids encounter propyl gallate

  • Industrial Facilities — Manufacturing plants, Chemical storage areas, Waste treatment sites
  • Occupational Environments — Factories, Warehouses, Transportation vehicles
  • Personal Care — shampoo, conditioner, lotion, cosmetics, sunscreen
  • Fragrance — perfume, cologne, scented personal care products, household fragrance products, candles
    Identified in Fragrance Ingredient Safety Priority Research database (2,325 ingredients)

Safer alternatives

Lower-risk approaches that achieve a similar outcome to Propyl gallate:

  • Fragrance-free formulations
    Trade-offs: Consumer preference for scented products
    Relative cost: Lower (ingredient elimination)
  • Essential oil-based fragrances (with disclosure)
    Trade-offs: Natural does not mean safe — many essential oils are skin sensitizers
    Relative cost: 2-5× conventional

Frequently asked questions

Is propyl gallate safe for kids?

Infants are exposed to Propyl gallate through personal care products (lotions, wipes) and food. Immature skin barrier and hepatic metabolism increase effective dose per body weight.

What products contain propyl gallate?

Propyl gallate appears in: Manufacturing plants (Industrial facilities); Chemical storage areas (Industrial facilities); Factories (Occupational environments); Warehouses (Occupational environments); shampoo (Personal care).

What should I do if my child is exposed to propyl gallate?

Minimize infant exposure through source control. For breastfeeding mothers: reduce maternal exposure. For formula-fed infants: use certified low-migration bottles and verified water sources. Consult pediatrician regarding any concerns.

Why do regulators disagree about propyl gallate?

Propyl gallate has been classified by 7 agencies including EPA CTX / Genetox, EPA CTX / Genetox, EPA CTX / Skin-Eye, EPA CTX / Skin-Eye, EPA CTX / Skin-Eye, with differing conclusions. Regulators apply different standards of evidence (animal data weighting, exposure-pattern assumptions, epidemiological power thresholds), which is why two scientific bodies can review the same data and reach different conclusions. See the regulatory consensus table on this page for the full picture.

See Propyl gallate in the baby app

Look up products containing propyl gallate, compare to alternatives, and explore the full data record.

Open in baby View raw API data

Sources (2)
  1. US FDA: Propyl Gallate — 21 CFR 172.615, Permitted Antioxidant in Fats and Oils, 0.02% Fat Content Limit, GRAS Status, JECFA ADI 3.6 mg/kg bw/day, and GI Mucosal Sensitivity Reports (2022) (2022) — regulatory
  2. EFSA Panel on Food Additives: Re-evaluation of Propyl Gallate (E310) as a Food Additive — ADI 0.5 mg/kg bw/day, Dietary Exposure Assessment Across Age Groups, Weak Estrogenicity In Vitro Data Assessment, and Gallate Ester Cross-Sensitivity (EFSA Journal 2014;12(4):3642) (2014) — regulatory

Reference data, not professional advice. Aggregates publicly available regulatory and scientific data; not a substitute for veterinary, medical, legal, or regulatory advice. Why we built ALETHEIA →