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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

in vitro gene mutation study in bacteria
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given, comparable to standards

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
no guideline followed
Principles of method if other than guideline:
Study performance before implementation of the corresponding international (OECD or EC) guidelines. However, study performance according to Ames et al. complies to a large extent to the later implemented international guidelines.
GLP compliance:
study performance before implementation of GLP
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
EC Number:
EC Name:
Cas Number:
Molecular formula:
Details on test material:
- Name of test material (as cited in study report): acrolein
no further data given


Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538
Metabolic activation:
with and without
Metabolic activation system:
Energy Resources Co, Inc, a 9000 XG supernatant fraction from adult male rat liver induced with Aroclor 1254
Test concentrations with justification for top dose:
0.001, 0.01, 0.1, and 1 ug/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: not given
Controlsopen allclose all
Negative solvent / vehicle controls:
True negative controls:
Positive controls:
Positive control substance:
Migrated to IUCLID6: and Sodium azide and quinacrine mustard without metabolic activation
Positive control substance:
other: 2 -Aminoanthracene with metabolic activation
Details on test system and experimental conditions:
Initial screening test on toxicity.

Approximately 10exp8 cells from a overnight culture of each indicator strain were added to separate test tubes containing the test chemical and 2.0 ml of molten agar supplemented with biotin and a trace of histidine.
For nonactivation tests, contents of the appropriate tubes were poured over the surface of selective agar plates.
In activation tests, just prior to pouring, an aliquot of reaction mixture (0.5 ml) containing the 9000 XG liver homogenate) was added to each of the activation overlay tubes.
The plates were incubated for 48 hours at 37°C and then scored for the number of colonies growing on each plate. Solvent controls and positive (using both directly active positive chemicals and those that require metabolic activation) were run with each assay.

NUMBER OF REPLICATIONS: Each dose was run in triplicate

The number of colonies on each plate were counted and recorded directly on a printed form. The results are presented as revertants per plate for each indicator strain employed in the assay. The positive and the solvent controls are provided as reference points.
Positive and negative control assays are conducted with each experiment and consist of direct-acting mutagens for nonactivation assays and mutagens that require metabolic biotransformation in activation assays. Negative controles consist of the test compound solvent in the overlay agar together with the other essential components. The negative control plate for each strain gives a reference point to which the test data are compared. The positive control assay is conducted to demonstrate that the test systems are functional with known mutagens.
Evaluation criteria:
To be considered positive (mutagenic), test results must satisfy two criteria; one for magnitude of response and one for dose dependency. For all five tester strains, the dose dependency criterion is satisfied if a dose-response effect is evident over three dose levels separated by at least one-half log units.
Since strains TA-1535, TA-1537 and TA-1538 exhibit relatively low spontaneous reversion frequencies (4-12), the minimum magnitude of response within the dose-dependent range must be at least twice the response of the solvent control.
Since strains TA-98 and TA-100 exhibit relatively high spontaneous reversion frequencies (23-65), a test compound is judged positive if the maximum level of response within the dose-dependent range must is at least twice the response of the solvent control.

Results and discussion

Test results
Metabolic activation:
with and without
Cytotoxicity / choice of top concentrations:
in initial screening test at >/= 10 µg/plate without metabolic activation
Vehicle controls validity:
Positive controls validity:
not valid
Additional information on results:
Nonactivation test results: The test compound, Acrolein, did not show a sigificant increase in number of revertant colonies per plate over negative control plates. In initial screening tests, toxicity was observed at and above 10 µg/plate.

Activation test results: In the presence of the S-9 metabolic activation system, the test compound, Acrolein, did not show a significant increase in number of revertant colonies per plate over negative control plates. Since tester strain TA-1537 failed to respond to the positive control, a second run was made. In this retry, the tester strain did respond to the positive control and the test compound produced no increase in the number of revertants compared to the negative control.
Remarks on result:
other: other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA 1537, TA 1538
Migrated from field 'Test system'.

Applicant's summary and conclusion

Interpretation of results (migrated information):
Executive summary:

In a reverse gene mutation assay in bacteria, performed before implementation of corresponding international (OECD or EC) guidelines, however complying s to a large extent to the later implemented international guidelines, strains TA 98, 100, 1535, 1537and 1538 of S. typhimurium were exposed to acrolein (no data on a.i.) dissolved in DMSO at concentrations of 0.001, 0.01, 0.1, and 1 µg/plate in the presence and absence of mammalian metabolic activation. Test was performed as plate incorporation test.


In initial screening tests without metabolic activation, toxicity was observed at and above 10 µg/plate. The positive controls induced the appropriate responses in the corresponding strains.   There was no evidence of induced mutant colonies over background.


This study is classified as acceptable.