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Registration Dossier
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EC number: 200-849-9 | CAS number: 75-21-8
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicity of Ethylene Oxide Determined on Experimental Animals
- Author:
- Hollingsworth, R.L. et al.
- Year:
- 1 956
- Bibliographic source:
- A.M.A. Arch. Ind. Health, Vol 13, 217-227 (1956)
Materials and methods
- Principles of method if other than guideline:
- Subacute oral study in rats
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Ethylene oxide
- EC Number:
- 200-849-9
- EC Name:
- Ethylene oxide
- Cas Number:
- 75-21-8
- Molecular formula:
- C2H4O
- IUPAC Name:
- oxirane
- Test material form:
- liquid
- Details on test material:
- Purity minimum 99.7%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- 21 and 30 days
- Frequency of treatment:
- 5 d/wk (15 and 22 dosages)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
15 x 100 mg/kg, 22 x 30 mg/kg and 10 x 3 mg/kg
Basis:
- Control animals:
- yes
- Details on study design:
- Post-exposure period: no data
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 30 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- female
Target system / organ toxicity
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 100 mg/kg bw/day (nominal)
- System:
- gastrointestinal tract
- Organ:
- liver
- stomach
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Any other information on results incl. tables
The 21-day exposure of 100 mg/kg showed a clear weight reduction, irritation of the stomach and slight liver damage.
The 30-day exposure of 30 mg/kg and 3 mg/kg showed no visible damage regarding growth, hematology, organ weights as well as macroscopic and histological changes.
Applicant's summary and conclusion
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