Is Alitame safe for babies and kids?
Moderate risk for kidsInfants are vulnerable to Alitame through inhalation of volatile residues in household products. Immature blood-brain barrier and higher respiratory rate per body weight amplify CNS exposure.
What is alitame?
The IUPAC name is (3S)-3-amino-4-oxo-4-[[(2R)-1-oxo-1-[(2,2,4,4-tetramethylthietan-3-yl)amino]propan-2-yl]amino]butanoic acid.
Also known as: (3S)-3-amino-4-oxo-4-[[(2R)-1-oxo-1-[(2,2,4,4-tetramethylthietan-3-yl)amino]propan-2-yl]amino]butanoic acid, Alitame (Parent), RefChem:318039, DTXCID1023780.
- IUPAC name
- (3S)-3-amino-4-oxo-4-[[(2R)-1-oxo-1-[(2,2,4,4-tetramethylthietan-3-yl)amino]propan-2-yl]amino]butanoic acid
- CAS number
- 80863-62-3
- Molecular formula
- C14H25N3O4S
- Molecular weight
- 331.43 g/mol
- SMILES
- CC(C(=O)NC1C(SC1(C)C)(C)C)NC(=O)C(CC(=O)O)N
- PubChem CID
- 64763
Risk for babies
Moderate riskInfants are vulnerable to Alitame through inhalation of volatile residues in household products. Immature blood-brain barrier and higher respiratory rate per body weight amplify CNS exposure.
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.
Risk for pregnant and nursing people
Context-dependentOccupational and household exposure to Alitame during pregnancy is associated with developmental toxicity. Solvents readily cross the placenta and can cause fetal growth restriction.
No specific reproductive toxicity data identified, but pregnancy-specific safety data is limited for most chemicals. Precautionary minimization of exposure is recommended.
Regulatory consensus
1 regulatory bodyhas classified Alitame.
| Agency | Year | Classification | Notes |
|---|---|---|---|
| IARC | 2001 | Not evaluated by IARC for carcinogenicity — Alitame (CAS 80863-62-3; L-aspartyl-D-alanine-2,2,4,4-tetramethylthietane amide; a dipeptide sweetener with a novel thietane amide terminal group; no E-number — not approved in EU or USA) is approved in Australia and New Zealand (FSANZ; ADI 1 mg/kg/day), China, Mexico, and several other markets; a petition for FDA approval was filed by Pfizer in 1986 and has remained pending without final action; no IARC, EPA, or EFSA carcinogenicity classification; JECFA evaluated alitame in 1993 and 2001 but did not establish an ADI, requesting additional safety data; no EFSA opinion has been issued; alitame is approximately 2,000× sweeter than sucrose; its principal regulatory barrier has been concerns about the metabolic fate of the thietane amide tail group — specifically, the production of alanine-thietane and related sulfur-containing metabolites whose long-term safety was questioned by FDA scientific reviewers; this is not an established toxicity finding but rather a regulatory data gap |
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 alitame
- 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 Alitame:
-
Water-based systems; Bio-based solvents (ethyl lactate); Supercritical CO2
Trade-offs: Alternative solvent or process chemistry; solvency parameters (Hansen solubility, Kb value) must be matched to application; VOC content and flammability may differ; worker exposure assessment needed.Relative cost: 2-5× conventional
Frequently asked questions
Is alitame safe for kids?
Infants are vulnerable to Alitame through inhalation of volatile residues in household products. Immature blood-brain barrier and higher respiratory rate per body weight amplify CNS exposure.
What products contain alitame?
Alitame 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 alitame?
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 Alitame in the baby app
Look up products containing alitame, compare to alternatives, and explore the full data record.
Open in baby View raw API dataSources (1)
- Alitame CAS 80863-62-3 L-Aspartyl-D-Alanine 2,2,4,4-Tetramethylthietane Amide C14H25N3O4S 2000x Sucrose; No E-Number Not Approved EU USA; FSANZ Australia NZ ADI 1 mg/kg/day; China Mexico Approved; FDA Petition 1986 Pfizer Pending No Final Action 40+ Years; JECFA 1993 2001 No ADI Insufficient Thietane Metabolite Data Not Denied; Thietane 4-Membered Sulfur Ring Alanine-Thietane Urinary Metabolite No Established Toxicity; D-Alanine D-Configuration Peptidase Resistance Stability; L-Aspartate Normal Metabolism; Heat-Stable pH-Stable 2000x; Danisco Pfizer Commercial Development Discontinued; Data Gap Not Established Harm Regulatory Limbo (2001) — 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 →