N-vinylformamide

Genetic toxicity: in vitro

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:

January 3 - February 21, 1992

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline study with acceptable restrictions (E. coli strain is missing)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

E. coli strain is missing

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N-vinylformamide

EC Number:

236-102-9

EC Name:

N-vinylformamide

Cas Number:

13162-05-5

Molecular formula:

C3H5NO

IUPAC Name:

N-vinylformamide

Details on test material:

- Purity: 99%
- Physical state: clear, colorless liquid
- Storage Conditions: -20+/-5°C; protected from exposure to light
- Expiration date: 1992-06-30

Method

Species / strain

Species / strain / cell type:

other: S. typhimurium TA98, TA100, TA1535, TA1537, TA1538

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced rat liver S-9

Test concentrations with justification for top dose:

0.3, 1.0, 3.3, 10, 33, 100, 33, 1000, 3333, 5000 µg/plate

Vehicle / solvent:

- Vehicle/solvent used: water (CAS# 7732-18-5)

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Remarks:

With S9: 1 µg/plate 2-aminoanthracene (all strains); without S9: 1 µg/plate 2-nitrofluorene (TA98, TA1538), 1 µg/plate sodium azide (TA100, TA1535), 75 µg/plate 9-aminoacridine (TA1537)

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)
NUMBER OF REPLICATIONS: 3 plates
NUMBER OF EXPERIMENTS: 3 individual experiments were conducted (dose range-finding study, mutagenicity study, and confirmatory study)
DETERMINATION OF CYTOTOXICITY: condition of the bacterial background lawn

Evaluation criteria:

To be evaluated positive, there must be an increase of revertants by factor >= 2 (TA 98, TA 100) or factor >= 3 (TA 1535, TA 1537, TA 1538) at the peak of the dose response.

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA98, TA100, TA1535, TA1537, TA1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Positive controls validity:

valid

Any other information on results incl. tables

Frequency of mutants (confirmatory assay):

	TA98		TA100		TA1535		TA1537		TA1538
	- S-9	+ S-9	- S-9	+ S-9	- S-9	+ S-9	- S-9	+ S-9	- S-9	+ S-9
Vehicle control	13 (16)	28 (27)	134 (153)	208 (187)	12 (13)	14 (17)	6 (5)	9 (9)	8 (6)	12 (12)
Treatments	12-19 (16-18)	26-33 (28-33)	124-144 (141-158)	180-212 (171-196)	10-13 (9-14)	11-14 (11-15)	5-8 (5-6)	6-9 (6-12)	5-8 (6-9)	11-14 (10-13)
Positive control	169 (191)	717 (1513)	596 (699)	754 (1779)	377 (431)	76 (99)	434 (474)	96 (79)	388 (364)	1082 (831)
Result	negative	negative	negative	negative	negative	negative	negative	negative	negative	negative

 

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative in all strains with and without metabolic activation

Under the conditions of this study, the test substance has no mutagenic potential in Salmonella typhimurium strains TA98, TA100, TA1535. TA1537 and TA1538 tested with and without metabolic activation at dose levels up to 5000 μg/plate.

Executive summary:

The study is comparable to OECD Guideline 471 with acceptable restrictions (E. coli strain is missing), and GLP standards were fulfilled.

Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA1538 were tested in the plate incorporation assay with and without metabolic activation at dose levels of 0.3, 1.0, 3.3, 10, 33, 100, 33, 1000, 3333, 5000 µg/plate in 3 independent experiments. Water was used as the vehicle (CAS# 7732-18-5). No increase in the number of revertants was found in comparison to the concurrent vehicle control at any concentration in any strain. Neither precipitate nor appreciable toxicity was observed (but tested up to the recommended limit dose level of 5000 µg/plate). The vehicle control and the positive control values were valid.

Conclusion: Under the conditions of this study, the test substance has no mutagenic potential in Salmonella typhimurium strains TA98, TA100, TA1535. TA1537 and TA1538 tested with and without metabolic activation at dose levels up to 5000 μg/plate.