Fluorobenzene

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

AMES

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Structural specificity of aromatic compounds with special reference to mutagenic activity in Salmonella typhimurium - a series of chloro- or fluoronitrobenzene derivatives

Author:

Shimizu, M., et al.

Year:

1983

Bibliographic source:

Mutat. Res., 116, 217-238

Reference 2

Reference Type:

publication

Title:

Toxicological Evaluations Vol. 13

Author:

BG Chemie

Year:

1998

Bibliographic source:

Springer-Verlag Berlin Heidelberg, ISBN 3-540-62658-1

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Fluorobenzene

EC Number:

207-321-7

EC Name:

Fluorobenzene

Cas Number:

462-06-6

Molecular formula:

C6H5F

IUPAC Name:

fluorobenzene

Details on test material:

- Purity: 99%
- Supplier: Tokyo Kasei Kogyo Co. Ltd.

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:

S. typhimurium, other: TA 1538

Metabolic activation:

with and without

Metabolic activation system:

S9-mix from PCB-induced rat liver

Test concentrations with justification for top dose:

0.08, 0.16, 0.32, 0.64, 1.28, 2.56, 5.12 or 10.24 µI/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

N-ethyl-N-nitro-N-nitrosoguanidine

other: 2-aminoantharcene

Details on test system and experimental conditions:

The test was performed in duplicate and repeated at least 3 times separately. Plates were inverted and incubated at 37°C in the dark for 3 days. Colonies of his+ revertants were counted after incubation.

Evaluation criteria:

Chemicals inducing more than twice the number of revertant colonies on the control plate were considered as mutagenic.

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA 98, TA 1538, TA 1537, TA 100 and TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

≥ 5.12 µl/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

True negative controls validity:

not specified

Positive controls validity:

valid

Any other information on results incl. tables

Number of revertant colonies in Ames test with fluorobenzene in S. typhimurium TA 98, TA 1538, TA 1537, TA 100 and TA 1535:

Compound	Dose/plate	His^+revertants/plate
		TA 98		TA 1538		TA 1537		TA 100		TA 1535
		- S9	+ S9	- S9	+ S9	- S9	+ S9	- S9	+ S9	- S9	+ S9
DMSO	0.05 ml	28±6	30±5	22±7	24±5	8±3	11±4	181±23	175±36	32±8	30±9
ENNG	2 µg	-	-	-	-	-	-	1994±377	-	-	-
	10 µg	-	-	-	-	-	-	-	-	2489±287	-
2-NF	2 µg	1798±258	-	-	-	-	-	-	-	-	-
	5 µg	-	-	1659±228	-	-	-	-	-	-	-
9-AA	100 µg	-	-	-	-	1288±198	-	-	-	-	-
2-AA	5 µg	-	1249±202	-	753±62	-	132±36	-	1549±269	-	174±21
Fluorobenzene	0.08 µl	28±3	29±4	28±4	32±6	10±3	9±2	184±19	196±21	33±3	31±3
	0.16 µl	31±4	33±8	24±3	22±4	10±2	10±3	165±12	188±16	30±3	51±7
	0.32 µl	33±5	28±4	21±3	27±5	12±4	8±1	157±22	195±19	40±5	41±8
	0.64 µl	30±3	26±3	23±4	27±4	10±3	8±2	180±16	204±28	38±4	31±4
	1.28 µl	28±3	33±5	27±5	20±3	11±3	9±2	160±19	172±15	31±3	32±3
	2.56 µl	26±3	21±3	18±2	24±4	9±2	7±1	204±18	185±17	33±4	30±3
	5.12 µl	15±4*	26±4	8±4*	18±2	2±4*	8±2	172±14	191±24	34±5	36±6
	10.24 µl	0*	0*	0*	0*	0*	0*	0*	0*	0*	0*

Data represent the results of 3 separate experiments and give the mean values of 3 plates. The number of revertant colonies indicates mean±SD. All these revertant colonies were counted after 68-72 h incubation. * indicates toxic effects.

Applicant's summary and conclusion

Conclusions:

Fluorobenzene was not mutagenic in any of the strains tested either with or without metabolic activation.