Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

Data concerning the reproductive effects of in vivo administration of acetaldehyde (conducted using physiologically relevant routes of exposure) are limited to the results of one subchronic investigation in which an assessment of ovary weights, testicular weights and other testicular parameters was conducted in hamsters exposed by inhalation. Based on the results of this study, reduced gonad weights have been observed at 1340 ppm (2412 mg/m3) acetaldehyde and higher (Kruysse et al., 1975). [cited from Canadian Environmental Protection Act 1999, Priority substance list assessmnet report on Acetaldehyde]

Effects on developmental toxicity

Additional information

Literature data

Most research on the developmental toxicity of Acetaldehyde was done because of the fact that Acetaldehyde is a direct metabolite of ethanol, and ethanol caused at high doses developmental effects. To receive a similar bioavailabilty of Acetaldehyde as in the case of direct ethanol exposure experimental data was aquired mainly after intraperitoneal injection. Since this is not an appropriate route of exposure to acetaldehyde and the application itself can cause secondary developmental effects the reported data could not be used for the evaluation of the hazard. The only report available in literature that examined the developmental effects of acetaldehyde after oral exposure is only available as meeting abstract with no detailed data. For details see endpoint record.

Developmetal screening study

A non-GLP study similar to OECD guideline 414 examined the teratogenic potential of acetaldehyde in 22 rats after oral admistration of 400 mg/kg bw/d from day 6 through 15 of gestation. The dose selection was based on a maternal tolerance study. It did not induce any maternal or developmental toxic effect under the reported conditions. The NOAEL derived from this study is greater than 400 mg/kg bw/d. (David et al, 1983)

Conclusion

Based on the available data and its reliabilty there is no evidence that acetaldehyde has developmental effects after oral exposure at maternally non-toxic levels. The corresponding NOAEL for developmetal effects after repeated oral exposure is accordingly greater than 400 mg/kg bw/d .

No data is available on developmental effects after inhaltive exposure.

Literature:

David G., Serota, Ph.D. (Hazelton laboratories, USA by order of thr Celanese Corporation), Teratology screen in Rats 1983, Report # 299-534, owner: Celanese Corporation

Justification for classification or non-classification

see above