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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study report which meets basic scientific principles

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
Pursuant to the method of Ames B.N. et al., Mutat. Res., 31, 347-364, (1975)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Vinylpyrrolidon
- Physical state: solid
- Storage condition of test material: stored at 4°C in the dark

Method

Target gene:
his-
Species / strain
Species / strain / cell type:
other: Salmonella typhimurium TA98, TA100, TA1537
Metabolic activation:
with and without
Metabolic activation system:
S9 Mix from the livers of aroclor 1254 treated Sprague Dawley rats
Test concentrations with justification for top dose:
3.15, 10, 31.5, 100, 315, 1000, 3000 ug/plate
Vehicle / solvent:
DMSO
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: with metabolic activation: 3-methylcholanthren, benzo(a)pyrene, 2-aminoanthracen (for each strain); without metabolic activation: N-methyl-N'-nitro-N-nitrosoguanidine, benzo(a)pyrene 4,5-oxide (for each strain)
Details on test system and experimental conditions:
Standard plate test:
Test compound, 0.5 ml S9 mix (in tests with metabolic activation) or 0.5 ml 150 mM KCl (in tests without metabolic activation) 0.1 ml of the bacterial suspension and 2 ml top agar (45°C) were mixed in a test tube and poured onto a petridish with minimal agar (Vogel-Bonner). Where indicated the epoxide hydratase inhibitor and glutathione depletor 1,1,1-trichloropropene 2,3-oxide was added (0.3 µl per plate) in 19 µl DMSO. Corresponding plates without TCPO received 10 µl DMSO. In each experiment 2 test plates per dose or per control were used. After incubation for 3 days in the dark, the bacterial colonies ( his+ revertants) were counted.

Positive control:
with metabolic activation: 90 μg/plate 3-methylcholanthren, 10 µg/plate benzo(a)pyrene, 10 µg/plate 2-aminoanthracen (for each strain);
without metabolic activation: 10 μg/plate N-methyl-N'-nitro-N-nitrosoguanidine and 1 µg/plate benzo(a)pyrene 4,5-oxide (for each strain); all substances were dissolved in DMSO.

The titer was determined and sterility control was performed.

Results and discussion

Test results
Species / strain:
other: Salmonella typhimurium TA98, TA100, TA1537
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
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'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with and without activation