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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented standard NTP study

Data source

Reference
Reference Type:
publication
Title:
Comparative mutagenicity of aliphatic epoxides in Salmonella
Author:
Canter, D.A., Zeiger, E., Haworth, S., Lawlor, T., Mortelmans, K., and Speck, W.
Year:
1986
Bibliographic source:
Mutation Res. Vol. 172 (1986) 105-138

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
four strains only, but data for all strains are positive
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
Automatically generated during migration to IUCLID 6, no data available
IUPAC Name:
Automatically generated during migration to IUCLID 6, no data available
Details on test material:
CAS: 122-60-1

Method

Target gene:
HIs operon
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA100, TA1535, TA97, TA98
Metabolic activation:
with and without
Metabolic activation system:
Hamster and Rat S9
Test concentrations with justification for top dose:
0, 10, 33, 100, 333, 1000
Controls
Untreated negative controls:
yes
Positive control substance:
other: TA98, 2-nitrofluorene or alternatively, TA98 and TA1538, 4-nitro-o-phenylenediamine TA100 and TA1535, sodium azide TA97 and TA1537, 9-aminoacridine, 2-aminoanthracene
Details on test system and experimental conditions:
In the standard protocol (preincubation) for conducting the Ames assay, a test tube containing a suspension of one strain of Salmonella typhimurium (or E. coli) plus S9 mix or plain buffer without S9, is incubated for 20 minutes at 37º C with the test chemical. Control cultures, with all the same ingredients except the test chemical, are also incubated. In addition, positive control cultures are prepared; these contain the particular bacterial tester strain under investigation, the various culture ingredients, and a known potent mutagen*. After 20 minutes, agar is added to the cultures and the contents of the tubes are thoroughly mixed and poured onto the surface of Petri dishes containing standard bacterial culture medium. The plates are incubated, and bacterial colonies that do not require an excess of supplemental histidine appear and grow. These colonies are comprised of bacteria that have undergone reverse mutation to restore function of the histidine-manufacturing gene. The number of colonies is usually counted after 2 days.
Evaluation criteria:
Several doses (usually at least 5) of each test chemical and multiple strains of bacteria are used in each experiment. In addition, cultures are set up with and without added liver S9 enzymes at varying concentrations. Therefore, a variety of culture conditions are employed to maximize the opportunity to detect a mutagenic chemical. In analyzing the data, the pattern and the strength of the mutant response are taken into account in determining the mutagenicity of a chemical. All observed responses are verified in repeat tests. If no increase in mutant colonies is seen after testing several strains under several different culture conditions, the test chemical is considered to be nonmutagenic in the Ames test.

Results and discussion

Test results
Species / strain:
S. typhimurium, other: all strains
Metabolic activation:
with and without
Genotoxicity:
positive
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
positive

The test substance is positive in vitro.