Baby Safety / Compounds / Melphalan

Is Melphalan safe for babies and kids?

Context-dependent for kids

(Babies-specific data is limited; this page draws from human pregnant context.) Pregnancy alters the metabolism and distribution of Melphalan, potentially increasing fetal exposure. The developing embryo/fetus is vulnerable during organogenesis (weeks 3-8) and neurological development. Placental transfer should be assumed.

What is melphalan?

The IUPAC name is (2S)-2-amino-3-[4-[bis(2-chloroethyl)amino]phenyl]propanoic acid.

Also known as: (2S)-2-amino-3-[4-[bis(2-chloroethyl)amino]phenyl]propanoic acid, Melfalan, L-PAM, L-Sarcolysine.

IUPAC name
(2S)-2-amino-3-[4-[bis(2-chloroethyl)amino]phenyl]propanoic acid
CAS number
148-82-3
Molecular formula
C13H18Cl2N2O2
Molecular weight
305.2 g/mol
SMILES
C1=CC(=CC=C1CC(C(=O)O)N)N(CCCl)CCCl
PubChem CID
460612

Risk for babies

Context-dependent

Pregnancy alters the metabolism and distribution of Melphalan, potentially increasing fetal exposure. The developing embryo/fetus is vulnerable during organogenesis (weeks 3-8) and neurological development. Placental transfer should be assumed.

No specific reproductive toxicity data identified, but pregnancy-specific safety data is limited for most chemicals. Precautionary minimization of exposure is recommended.

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

Risk for pregnant and nursing people

Context-dependent

Pregnancy alters the metabolism and distribution of Melphalan, potentially increasing fetal exposure. The developing embryo/fetus is vulnerable during organogenesis (weeks 3-8) and neurological development. Placental transfer should be assumed.

No specific reproductive toxicity data identified, but pregnancy-specific safety data is limited for most chemicals. Precautionary minimization of exposure is recommended.

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

Regulatory consensus

10 regulatory and scientific bodies have classified Melphalan. The classifications differ — that's the data.

AgencyYearClassificationNotes
IARC2012Group 1
US EPA2000carcinogenic to humans
EPA CTX / NTP RoC—Known Human Carcinogen
EPA CTX / IARC—Group 1 - Carcinogenic to humans
EPA CTX / CalEPA—Known human carcinogen
EPA CTX / Genetox—Genotoxicity: positive (Ames: positive, 20 positive / 0 negative reports)
EPA CTX / Genetox—Genotoxicity: positive (Ames: positive, 20 positive / 0 negative reports)
EPA CTX / Skin-Eye—Skin Irritation: SkinIrr2 (score: high)
EPA CTX / Skin-Eye—Skin Sensitization: SkinSens1 (score: high)
EPA CTX / Skin-Eye—Skin Irritation: Category 2 (score: high)

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 melphalan

  • 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 Melphalan:

  • Bendamustine
    Trade-offs: Alkylating agent with better tolerability profile for some hematologic malignancies. Less myelosuppression than melphalan in some regimens. Not interchangeable for all indications.
    Relative cost: 1.2-2×
  • Lenalidomide + dexamethasone
    Trade-offs: Non-alkylating immunomodulatory regimen for multiple myeloma. Different mechanism (no direct DNA alkylation). Oral administration. Teratogenic — requires REMS program.
    Relative cost: 1.2-2×

Frequently asked questions

What products contain melphalan?

Melphalan appears in: Manufacturing plants (Industrial facilities); Chemical storage areas (Industrial facilities); Factories (Occupational environments); Warehouses (Occupational environments).

Why do regulators disagree about melphalan?

Melphalan has been classified by 10 agencies including IARC, US EPA, EPA CTX / NTP RoC, EPA CTX / IARC, EPA CTX / CalEPA, 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 Melphalan in the baby app

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

Open in baby View raw API data

Sources (2)
  1. IARC Monographs Volume 100A: Pharmaceuticals — Melphalan Group 1; AML in Multiple Myeloma Patients; Bifunctional Guanine N7 Alkylation; del(5q)/del(7q) Alkylator-AML Karyotype; High-dose Transplant Conditioning (2012) — iarc_monograph
  2. US EPA Melphalan: Carcinogenic to Humans; NIOSH Hazardous Drug; Isolated Limb Perfusion Melanoma/Sarcoma; MP Regimen Elderly Myeloma Historical AML Risk; Hydrolytic Instability Environmental Mitigation (2000) — 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 →