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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
weight of evidence
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:
Genotoxic effects of ethylene oxide and propylene oxide: a comparative study.
Author:
Agurell, E., Cederberg, H., Ehrenberg, L., Lindal-Kiessling, K. Rannug, U., Törnqvist, M.
Year:
1991
Bibliographic source:
Mutation Research 250, 229 - 237

Materials and methods

Principles of method if other than guideline:
according to Maron, D.M. and Ames, B.N.: Mut. Res. 113, 173-215
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

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

Method

Target gene:
S. typhimurium strains
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535
Species / strain / cell type:
S. typhimurium TA 100
Metabolic activation:
without
Metabolic activation system:
no data
Test concentrations with justification for top dose:
0 - 12 mMh

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 100
Metabolic activation:
without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
not specified
Untreated negative controls validity:
not specified
Positive controls validity:
not specified
Additional information on results:
EO gave a dose-dependent increase in the number of revertants on both tester strains.

Applicant's summary and conclusion

Conclusions:
In conclusions, under the conditions chosen the test substance induced mutations in the salmonella typhimurium strains TA 100 and TA 1535 and thus, is considered to be mutagenic.

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