Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
1956
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

Constituent 1
Chemical structure
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%

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