4-(vinyloxy)butan-1-ol

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Comparable to guideline with acceptable restrictions (only 4 strains tested).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

only 4 strains tested

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

4-(vinyloxy)butan-1-ol

EC Number:

241-793-5

EC Name:

4-(vinyloxy)butan-1-ol

Cas Number:

17832-28-9

Molecular formula:

C6H12O2

IUPAC Name:

4-(ethenyloxy)butan-1-ol

Details on test material:

- Name of test material (as cited in study report): Vinylhydroxybutylether
- Physical state: colorless liquid
- Analytical purity: >99%
- Lot/batch No.: Vers. 2/91
- Expiration date of the lot/batch: not reported
- Storage condition of test material: 4-6°C

Method

Target gene:

Salmonella typhimurium: (his-)

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 induced rat liver S-9 mix

Test concentrations with justification for top dose:

20, 100, 500, 2500 and 5000 µg/plate

Vehicle / solvent:

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

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: with metabolic activation: 2-aminoanthracene; without metabolic activation: N-methyl-N'-nitro-N-nitrosoguanidine for TA100 and TA1535, 4-nitro-o-phenylendiamine for TA98, 9-aminoacridine chloride monohydrate for TA 1537

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (plate incorporation); preincubation


DURATION
- Preincubation period: 20 min at 37°C
- Exposure duration: 48-72 hr at 37°C


NUMBER OF REPLICATIONS: 3

Evaluation criteria:

- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results

Statistics:

Mean and standard deviation calculated in result tables. No further data.

Results and discussion

Test results

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

Vehicle controls validity:

valid

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

Mean Revertants/ plate in Standard plate test

Dose (µg/ml)	TA 98		TA 100		TA 1535		TA 1537
	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9
0	28	41	115	116	18	23	8	13
20	31	42	101	128	16	18	10	12
100	38	38	108	129	15	14	8	9
500	32	52	118	114	17	15	8	10
2500	29	41	121	125	17	18	11	13
5000	40	30	114	125	16	13	11	11
Positive control	787	982	1315	1160	1500	329	458	140

Mean Revertants/ plate in Pre incubation test

	TA 98		TA 100		TA 1535		TA 1537
Dose (µg/ml)	-S9	+S9	-S9	+S9	-S9	+S9	-S9	+S9
0	28	41	117	132	16	12	12	12
20	29	39	118	121	12	13	9	14
100	27	39	122	114	12	11	9	11
500	22	46	112	72	11	13	8	15
2500	25	49	108	92	13	13	9	13
5000	26	39	126	110	19	20	6	16
Positive control	899	1583	2010	4963	2077	249	536	152

Applicant's summary and conclusion

Executive summary:

This study was conducted comparable to the OECD Guideline 471 and is reliable with acceptable restrictions (missing TA102/ E. coli strain, standard plate test only, no GLP). The test substance was tested in the standard plate test and pre-incubation test with and without metabolic activation (MA) in S. typhimurium TA98, TA100, TA1535 and TA1537 at dose levels of 20 -5000 µg/plate. No increase in the number of revertants was detected in any strain with and without MA. No bacteriotoxic effect was observed. Vehicle controls and positive controls were valid.

Conclusion: According to the results of the present study, the test substance is not mutagenic in the Salmonella typhimurium reverse mutation assay under the experimental conditions chosen here.