Baby Safety / Compounds / Chlorobutanol

Is Chlorobutanol safe for babies and kids?

Moderate risk for kids

Infants have immature drug-metabolizing enzymes (CYP450 ontogeny), reduced renal clearance, and different volume of distribution. Accidental exposure or breast milk transfer of Chlorobutanol poses heightened risk.

What is chlorobutanol?

The IUPAC name is 1,1,1-trichloro-2-methylpropan-2-ol.

Also known as: 1,1,1-trichloro-2-methylpropan-2-ol, Chlorbutol, CHLORETONE, 1,1,1-Trichloro-2-methyl-2-propanol.

IUPAC name
1,1,1-trichloro-2-methylpropan-2-ol
CAS number
57-15-8
Molecular formula
C4H7Cl3O
Molecular weight
177.45 g/mol
SMILES
CC(C)(C(Cl)(Cl)Cl)O
PubChem CID
5977

Risk for babies

Moderate risk

Infants have immature drug-metabolizing enzymes (CYP450 ontogeny), reduced renal clearance, and different volume of distribution. Accidental exposure or breast milk transfer of Chlorobutanol poses heightened 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

Moderate risk

Chlorobutanol crosses the placenta based on its lipophilic nature and low molecular weight. It is also excreted in breast milk. Chronic exposure during pregnancy (from ophthalmic or topical preparations) results in low-level fetal exposure. The CNS-depressant properties of chlorobutanol at higher concentrations could potentially affect fetal CNS development with chronic exposure, though specific teratogenicity data are limited. The primary concern is for neonates exposed through breast milk from mothers using chlorobutanol-preserved preparations — neonatal plasma concentrations from breast milk consumption could contribute to accumulation given the neonatal's slow elimination. Chlorobutanol-preserved parenteral preparations should be avoided when alternative preservative systems are available during pregnancy and lactation.

Regulatory consensus

1 regulatory bodyhas classified Chlorobutanol.

AgencyYearClassificationNotes
WHO (pharmaceutical preservative assessment)2019no carcinogenicity classification; assessed as pharmaceutical preservative (eye drops, parenteral preparations, cosmetics); maximum concentration limits established by WHO and pharmacopoeias; CNS depressant at high doses; not classified for carcinogenicity by IARC, NTP, US EPA, or EFSA

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 chlorobutanol

  • 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 Chlorobutanol:

  • Alternative drug class; Non-pharmacological therapy; Lowest effective dose
    Trade-offs: Direct chemical substitution requires verification that the replacement does not introduce new hazards (regrettable substitution). Conduct full hazard assessment of proposed alternative before adoption.
    Relative cost: 1.2-2×

Frequently asked questions

Is chlorobutanol safe for kids?

Infants have immature drug-metabolizing enzymes (CYP450 ontogeny), reduced renal clearance, and different volume of distribution. Accidental exposure or breast milk transfer of Chlorobutanol poses heightened risk.

What products contain chlorobutanol?

Chlorobutanol 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 chlorobutanol?

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.

See Chlorobutanol in the baby app

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

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Sources (1)
  1. WHO Pharmaceutical Preservative Chlorobutanol Assessment 2019: Max Concentration 0.5%; Neonatal Accumulation Toxicity NICU CNS Depression Acidosis; Half-life ~10 days Adults Longer Neonates; Hydrolysis Chloroform Acetone; No Carcinogenicity Classification IARC NTP (2019) — 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 →