Baby Safety / Compounds / N-Nitrosodiethylamine (NDEA)

Is N-Nitrosodiethylamine (NDEA) safe for babies and kids?

Very high risk for kids

Infants accumulate N-Nitrosodiethylamine (NDEA) through breast milk (bioconcentration), placental transfer, and dust ingestion. Persistent pollutants concentrate in fatty tissues with extended half-lives in developing organisms.

What is n-nitrosodiethylamine (ndea)?

The IUPAC name is N,N-diethylnitrous amide.

Also known as: N,N-diethylnitrous amide, N-NITROSODIETHYLAMINE, Diethylnitrosamine, NDEA.

IUPAC name: N,N-diethylnitrous amide
CAS number: 55-18-5
Molecular formula: C4H10N2O
Molecular weight: 102.14 g/mol
SMILES: CCN(CC)N=O
PubChem CID: 5921

Risk for babies

Very high risk

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

Very high risk

N-Nitrosodiethylamine (NDEA) persists in maternal adipose tissue and is mobilized during pregnancy and lactation. Lipophilic pollutants concentrate in breast milk and cross the placenta during critical developmental windows.

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

8 regulatory and scientific bodies have classified N-Nitrosodiethylamine (NDEA). The classifications differ — that's the data.

Agency	Year	Classification	Notes
IARC	1987	Group 2A (probably carcinogenic to humans)	IARC Supplement 7 (1987), originally Monograph 17 (1978). Sufficient evidence of carcinogenicity in multiple animal species across multiple routes; limited evidence in humans. Produces hepatocellular carcinoma, esophageal carcinoma, and nasal tumors in rodents at low doses. Potent alkylating agent forming O6-ethylguanine DNA adducts — a highly mutagenic and carcinogenic lesion.
US EPA	1987	likely to be carcinogenic to humans	EPA classified NDEA as likely to be carcinogenic to humans based on animal evidence. Oral slope factor 150 per mg/kg-day (one of the highest IRIS potency values). NDEA has been identified as a contaminating nitrosamine impurity in pharmaceuticals including ranitidine (Zantac) — the primary driver of the 2019–2020 ranitidine recall affecting millions of patients globally.
EPA CTX / IRIS	—	B2 (Probable human carcinogen - based on sufficient evidence of carcinogenicity in animals)
EPA CTX / NTP RoC	—	Reasonably Anticipated to be a Human Carcinogen
EPA CTX / IARC	—	Group 2A - Probably carcinogenic to humans
EPA CTX / CalEPA	—	Known human carcinogen
EPA CTX / Genetox	—	Genotoxicity: positive (Ames: positive, 29 positive / 8 negative reports)
EPA CTX / Genetox	—	Genotoxicity: positive (Ames: positive, 29 positive / 8 negative reports)

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 n-nitrosodiethylamine (ndea)

Industrial Facilities — Manufacturing plants, Chemical storage areas, Waste treatment sites
Occupational Environments — Factories, Warehouses, Transportation vehicles

Safer alternatives

Lower-risk approaches that achieve a similar outcome to N-Nitrosodiethylamine (NDEA):

Exposure reduction (environmental contaminant)
Trade-offs: Removes 95-99% of dissolved contaminants including metals, PFAS, nitrates; wastes 2-4 gallons per gallon produced (improving with newer systems); removes beneficial minerals; $0.05-0.25/gallon; requires pre-treatment for longevity.

Relative cost: 1.2-2×

Frequently asked questions

Is n-nitrosodiethylamine (ndea) safe for kids?

What products contain n-nitrosodiethylamine (ndea)?

N-Nitrosodiethylamine (NDEA) appears in: Manufacturing plants (Industrial facilities); Chemical storage areas (Industrial facilities); Factories (Occupational environments); Warehouses (Occupational environments).

What should I do if my child is exposed to n-nitrosodiethylamine (ndea)?

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 n-nitrosodiethylamine (ndea)?

N-Nitrosodiethylamine (NDEA) has been classified by 8 agencies including IARC, US EPA, EPA CTX / IRIS, EPA CTX / NTP RoC, EPA CTX / IARC, 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 N-Nitrosodiethylamine (NDEA) in the baby app

Look up products containing n-nitrosodiethylamine (ndea), compare to alternatives, and explore the full data record.

Open in baby View raw API data

Sources (3)

IARC Monographs Volume 17: N-Nitrosodiethylamine (updated Supplement 7, 1987) (1987) — regulatory
US EPA IRIS: N-Nitrosodiethylamine — Carcinogenicity Assessment (1987) — regulatory
US FDA: Laboratory Testing of Ranitidine — NDEA Levels and Recall (Market Withdrawal) (2020) — 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 →