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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: Meets generally accepted scientific standards, well documented and acceptable for assessment.

Data source

Referenceopen allclose all

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 Type:
secondary source
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:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: 99%
- Supplier: Tokyo Kasei Kogyo Co. Ltd.

Method

Species / strain
Species / strain / cell type:
S. typhimurium, other: TA 98, TA 1538, TA 1537, TA 100 and TA 1535
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
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
Positive controls:
yes
Positive control substance:
other: Without S9: N-Ethyl-N'-nitro-N-nitrosoguanidine (ENNG), 2-nitrofluorene (2-NF) and 9-aminoacridine (9-AA). With S9: 2-aminoanthracene (2-AA).
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

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:
Interpretation of results (migrated information):
negative

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