Registration Dossier
Registration Dossier
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EC number: 213-497-6 | CAS number: 959-26-2
Toxicity to reproduction: other studies
Administrative data
- Endpoint:
- toxicity to reproduction: other studies
- Remarks:
- aetiology of ethylene glycol developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Ethylene Glycol Developmental Toxicity: Unraveling the Roles of Glycolic Acid and Metabolic Acidosis.
- Author:
- Carney, E.W. et al.
- Year:
- 1 999
- Bibliographic source:
- Toxicology Sciences 50, 117 - 126
Materials and methods
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ethane-1,2-diol
- EC Number:
- 203-473-3
- EC Name:
- Ethane-1,2-diol
- Cas Number:
- 107-21-1
- Molecular formula:
- C2H6O2
- IUPAC Name:
- ethylene glycol
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- g.d. 6 - 15
- Frequency of treatment:
- daily
- Duration of test:
- g.d. 21
Doses / concentrations
- Dose / conc.:
- 2 500 mg/kg bw/day
- No. of animals per sex per dose:
- 25
Results and discussion
Any other information on results incl. tables
EG and GA decreased fetal body weights and caused a similar spectrum of developmental effects, including numerous axial skeleton malformations. These results indicate that glycolate, in the absence of metabolic acidosis, can cause the most sensitive of EG's developmental effects, whereas metabolic acidosis appears to interact with glycolate at very high doses to markedly enhanced teratogenesis. These results support previous studies, which indicated that glycolate is the proximate developmental toxicant for EG, and that GA toxicokinetic parameters can be used to define a quantitative, physiologically based threshold for EG-induced developmental effects.
Applicant's summary and conclusion
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Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
