1-vinylhexahydro-2H-azepin-2-one

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:

2 Feb 1989-20 Feb 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with GLP, acceptable with restriction (analytical purity of the test substance not reported).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: Guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities including MITI, MHW, MOL and MAFF.

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes

Remarks:

(Safepharm Laboratories Limited, UK)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1-vinylhexahydro-2H-azepin-2-one

EC Number:

218-787-6

EC Name:

1-vinylhexahydro-2H-azepin-2-one

Cas Number:

2235-00-9

Molecular formula:

C8H13NO

IUPAC Name:

1-vinylazepan-2-one

Details on test material:

- Name of test material: N-vinylcaprolactam

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 induced rat liver S-9 mix

Test concentrations with justification for top dose:

Experiment 1: 8, 40, 200, 1000 and 5000 µg/plate;
Experiment 2: 312.5, 625, 1250, 2500 and 5000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-Aminoanthracene for all strains

Remarks:

with S9

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

without S9

Migrated to IUCLID6: 50 µg/plate for TA1537

Controls 3

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: N-Methyl-N-nitro-N-nitrosoguanidine, 2 µg/plate for TA1535 and TA100

Remarks:

without S9

Controls 4

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 4-Nitro-O-phenylenediamine, 10 µg/plate for TA98

Remarks:

without S9

Controls 5

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

Remarks:

without S9

Migrated to IUCLID6: 3.3 µg/plate for WP2uvrA

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation)


DURATION
- Exposure duration: 48 h at 37°C

NUMBER OF INDEPENDENT EXPERIMENTS: 2

NUMBER OF REPLICATIONS: 3

DETERMINATION OF CYTOTOXICITY
Plates were scored for revertant colonies and examined for a thinning of the background lawn

Evaluation criteria:

For a substance to be considered positive in this test system, it should have induced a dose-related and statistically significant increase in mutation rate (of at least twice the spontaneous reversion rate) in one or more strains of bacteria in the presence and/or absence of the S-9 microsomal enzymes in both experiments. To be considered negative the number of induced revertants compared to spontaneous revertants should be less than two fold at each dose level employed, the intervals of which should be between 2 and 5 fold and extend to the limits imposed by toxicity or solubility or up to the maximum recommended dose of 5000 µg/plate. In this case, the limiting factor was the maximum recommended dose.

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

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

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

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

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

	TA 98		TA 100		TA 1535		TA 1537		WP2uvrA
Dose (µg/ml)	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9
0	18	31	75	94	11	15	4	11	24	25
8	16	22	70	92	10	11	7	9	19	22
40	20	18	84	92	15	12	6	9	28	26
200	14	27	73	95	15	12	5	10	25	26
1000	19	24	65	85	12	11	5	8	22	25
5000	14	17	68	91	9	13	4	8	26	35
Positive control	643	503	774	814	304	77	288	74	589	198

	TA 98		TA 100		TA 1535		TA 1537		WP2uvrA
Dose (µg/ml)	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9
0	13	23	75	97	13	12	5	9	21	22
312.5	17	25	67	99	13	12	4	6	20	21
625	17	22	74	93	9	14	6	4	24	25
1250	13	36	73	96	12	9	7	5	26	29
2500	16	29	98	81	12	14	4	7	21	28
5000	15	25	89	89	12	14	6	3	24	35
Positive control	751	551	519	970	45	65	316	41	670	123