Registration Dossier
Registration Dossier
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EC number: 200-836-8 | CAS number: 75-07-0
Endpoint summary
Administrative data
Description of key information
Effects of acetaldehyde following oral administration to animals have been much less well studied than those following inhalation.
In a 28-day study in which acetaldehyde was administered to rats by the oral route, the NOEL was 125 mg/kg bw per day. At the next higher
concentration 675 mg/kg bw per day, a borderline increase in hyperkeratosis of the forestomach was oserved. In rats exposed to 0.05% acetaldehyde in drinking-water for 6 months, acetaldehyde induced synthesis of rat liver collagen, an observation that was supported by in vitro data. No other effects were examined and the toxicological significance of this observation is unknown.
In a repeated dose inhalation study, the lowest concentration at which effects were observed (degenerative changes in the olfactory epithelium in rats) was 437 mg/m3 following administration for 5 weeks. The NOELs identified for respiratory effects were 275 mg/m3 in rats exposed for 4 weeks and 700 mg/m3 in hamsters exposed for 13 weeks. Increased incidences of tumours have been observed in inhalation studies on rats and hamsters exposed to acetaldehyde. See thereto key information under IUCLID section 7.7: Carcinogenicity.
No repeated dose dermal studies were identified.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 125 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEC
- 275 mg/m³
- Study duration:
- subacute
- Species:
- rat
Additional information
These data and information are based on the sources of the IUCLID Dataset from 19 February 2000 published by the European Commission and the International Programme on Chemical Safety (IPCS) published under the joint sponsorship of the United Nations Environment Programme, the International Labour Organisation, and the World Health Organization (Environmental Health Criteria 167).
Justification for classification or non-classification
Based on the data available, acetaldehyde is not classified according to 67/548/EEC (DSD) and 1272/2008/EEC (CLP).
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