Baby Safety / Compounds / Chlorambucil

Is Chlorambucil 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 Chlorambucil, 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 chlorambucil?

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

Also known as: 4-[4-[bis(2-chloroethyl)amino]phenyl]butanoic acid, Chloroambucil, Ambochlorin, Leukeran.

IUPAC name
4-[4-[bis(2-chloroethyl)amino]phenyl]butanoic acid
CAS number
305-03-3
Molecular formula
C14H19Cl2NO2
Molecular weight
304.2 g/mol
SMILES
C1=CC(=CC=C1CCCC(=O)O)N(CCCl)CCCl
PubChem CID
2708

Risk for babies

Context-dependent

Pregnancy alters the metabolism and distribution of Chlorambucil, 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 Chlorambucil, 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

9 regulatory and scientific bodies have classified Chlorambucil. 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, 22 positive / 0 negative reports)
EPA CTX / Genetox—Genotoxicity: positive (Ames: positive, 22 positive / 0 negative reports)
EPA CTX / Skin-Eye—Skin Irritation: SkinIrr2 (score: high)
EPA CTX / Skin-Eye—Skin Sensitization: SkinSens1 (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 chlorambucil

  • 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 Chlorambucil:

  • Safer process chemistry; Green chemistry alternatives; Exposure controls
    Trade-offs: Requires R&D investment to redesign synthesis routes; may reduce yield or throughput initially; long-term benefits include reduced waste treatment costs, regulatory compliance, and worker safety; 12 Principles of Green Chemistry framework available.
    Relative cost: 2-5×

Frequently asked questions

What products contain chlorambucil?

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

Why do regulators disagree about chlorambucil?

Chlorambucil has been classified by 9 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 Chlorambucil in the baby app

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

Open in baby View raw API data

Sources (2)
  1. IARC Monographs Volume 100A: Pharmaceuticals — Chlorambucil Group 1; AML in CLL/Lymphoma Patients; Nitrogen Mustard Bifunctional Alkylation; del(5q)/del(7q) Secondary AML Karyotype; Cumulative Dose-Response (2012) — iarc_monograph
  2. US EPA Chlorambucil: Carcinogenic to Humans; NIOSH Hazardous Drug; Iatrogenic AML Historical Documentation; CLL Treatment Context; Elderly Patient Risk; Hydrolytic Instability in Aquatic Environment (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 →