Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: A Klimisch scoring of 3 has to be assigned to the study as it omitted one Salmonella tester strain mentioned in the OECD Guideline.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
only 4 strains used
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA 97, 98, 100, 102
Metabolic activation:
with and without
Metabolic activation system:
S9
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide

Results and discussion

Test results
Species / strain:
S. typhimurium, other: TA 97, 98, 100, 102
Metabolic activation:
with and without
Genotoxicity:
negative
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

-

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Substance is not mutagenic
Executive summary:

The test substance was tested for mutagenicity using the preincubation version of the Salmonella/mammalian microsome test. The four tester strains TA97, TA98, TA100 and TA102 were employed. The metabolic activation system was prepared from the livers of phenobarbital/p-naphthoflavone treated rats. Since the test compound was rather volatile care was taken to ensure a good exposure of the bacteria by a prolonged preincubation period in tightly closed glass tubes. The highest dose levels (3.16 and 10 mg/plate) caused toxic effects. There was no increase of the number of revertant colonies after treatment with Propenylmethylether while the positive control compounds gave the expected results, verifying the sensitivity of the strains and the activity of the metabolic system. Thus it can be concluded that Propenylmethylether is not mutagenic in the Ames test under the described test conditions.