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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the standard U.S. National Toxicology Program study protocol with GLP compliance.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
No E. coli tester strains included.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
2,3-epoxypropyl o-tolyl ether
EC Number:
218-645-3
EC Name:
2,3-epoxypropyl o-tolyl ether
Cas Number:
2210-79-9
Molecular formula:
C10H12O2
IUPAC Name:
oxirane
Constituent 2
Reference substance name:
Oxirane, 2-[(2-methylphenoxy)methyl]-
IUPAC Name:
Oxirane, 2-[(2-methylphenoxy)methyl]-
Details on test material:
As per IUCLID Sections 1.1. 1.2. and 4.1.

Method

Target gene:
Histidine synthesis gene.
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 97
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced male, Sprague-Dawley rats and Syrian hamsters liver S9 fraction.
Test concentrations with justification for top dose:
0, 3.3, 10, 33, 100 and 333 ug/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: See testing Haworth et al., 1983, Environ. Mutagen., 5. Suppl. 1, 3—142.
Details on test system and experimental conditions:
The test substance was tested in Salmonella strains TA98, TA100, TA1535, and TA1537 and/or TA97 without metabolic activation and with liver S9 preparations from Aroclor 1254-induced male, Sprague-Dawley rats and Syrian hamsters, in a liquid preincubation protocol. Tester strains grown up over night in nutrient broth cultures were to 5 doses, using triplicate plates. Tests were repeated at least once; a chemical was not designated positive or negative unless the results were reproducible. Following the preincubation treatment at approximately 37 C minimal soft agar was added to the treatment test tubes and the contents of the tubes poured over minimal agar plates. The plates were incubated 48-72 hr at 37 C before scoring for histdine positive revertants. For additional methodological details see Haworth et al., 1983, Environ. Mutagen., 5. Suppl. 1, 3—142.
Evaluation criteria:
The test substance was not designated positive or negative unless the results were reproducible. A positive response was defined as a reproducible, dose-related increase in his + revertants over the solvent control level. The tester strains must have demonstrated their relevant genetic characterstics and responded to the positive controls.
Statistics:
None.

Results and discussion

Test resultsopen allclose all
Species / strain:
S. typhimurium TA 1535
Metabolic activation:
without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 100
Metabolic activation:
without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Additional information on results:
Treatment with the test substance, 2,3-epoxypropyl o-tolyl ether, induced a reproducible, dose-related increase in the frequency of histidine positive revertants in both tester strains TA1535 and TA100 without metabolic activation preparation. The increase in revertant frequency reached 6.2-fold the concurent spontaneous background frequency in tester strain TA100 at the high dose level of 100 ug/plate. A 14.4-fold increase of the His+ revertant frequency was observed in tester strain TA 1535 at the high dose level 333 ug/plate.
Remarks on result:
other: strain/cell type: TA1535
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive only without S9 metabolic activation preparation.

The test substance induced a reproducible, dose-related increase in the His+ revertant frequency in Salmonella tester strains TA1535 and TA100 without rodent liver S9 metabolic activation. Therefore, the test substance is a direct-acting gene-mutagen in Salmonella under the conditions of the study.
Executive summary:

The test substance, 2,3-epoxypropyl o-tolyl ether was evaluated for its potential to induce gene-mutation in bacteria by the U.S. National Toxicology using the preincubation O.E.C.D. test guideline no. 471 method. The test substance induced a reproducible, dose-related increase in the His+ revertant frequency in Salmonella tester strains TA1535 and TA100 without rodent liver S9 metabolic activation. Therefore, the test substance is a direct-acting gene-mutagen in Salmonella under the conditions of the study.