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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Constituent 1
Chemical structure
Reference substance name:
1-vinyl-2-pyrrolidone
EC Number:
201-800-4
EC Name:
1-vinyl-2-pyrrolidone
Cas Number:
88-12-0
Molecular formula:
C6H9NO
IUPAC Name:
1-ethenylpyrrolidin-2-one
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