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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: Comparable to guideline study with acceptable deviations

Data source

Reference
Reference Type:
publication
Title:
Structural specificity of aromatic compounds with special reference to mutagenic activity in Samonella thyphimurium- a series of chloro- or fluoro-nitrobenzene derivatives
Author:
Shimizu M, Yasui Y, and Matsumoto N
Year:
1983
Bibliographic source:
Mutat. Res. 116, 217-238

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
Rats were injected with PCB instead of Aroclor 1254. The S. thyphimurium strains, TA98, TA1538, TA1537, TA100 and TA 1535 were used instead of TA1535, TA1537 (or TA97a or TA97), TA98, and TA100 , and E.coli WP2 strains or S. typhimurium TA102.
Principles of method if other than guideline:
The mutagenicity of chlorobenzene compounds in Salmonella typhimurium (strains TA98, TA1538, TA1537, TA100 and TA1535) was examined.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: no data
- Name of test material (as cited in study report): m-dichlorobenzene
- Analytical purity: 98%

Method

Target gene:
his
Species / strain
Species / strain / cell type:
other: TA 98, TA 100, TA 1535, TA 1537, TA 1538
Metabolic activation:
with and without
Metabolic activation system:
S9 mix
Test concentrations with justification for top dose:
0.02, 0.04, 0.08, 0.16, 0.32, 0.64, 1.28, 2.56 µL
Vehicle / solvent:
- Vehicle used: DMSO
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: N-Ethyl-N´-nitro-N-nitrosoguanidine (ENNG), 2-nitrofluorene (2-NF), 9-aminoacridine (9-AA) and 2-aminoanthracene (2-AA)
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation
NUMBER OF REPLICATIONS: all test were performed in duplicate and repeated at least 3 times

Evaluation criteria:
Colonies of his+ revertants were counted after incubation, and chemicals inducing more than twice the number of revertant colonies on the control plate were considered as mutagenic.
Statistics:
Not performed

Results and discussion

Test results
Species / strain:
other: TA 98, TA 100, TA 1535, TA 1537, TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: TA 98, TA 100, TA 1535, TA 1537, TA 1538

Any other information on results incl. tables

Mutagenicity of 1,3-dichlorobenzene in S.typhimurium TA 98, TA 1538, TA 1537, TA100, and TA 1535

 

 

Dose per plate µL

His+ revertants/plate

 

TA98

TA 1538

TA 1537

TA 100

TA 1535

 

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

-S9

+S9

0.02

30 ± 3

29 ± 4

24 ± 4

24 ± 5

8 ± 2

6 ± 2

180 ± 22

228 ± 22

36 ± 5

32 ± 4

0.04

28 ± 3

33 ± 7

22 ± 3

18 ± 3

13 ± 3

9 ± 2

172 ± 16

196 ± 17

31 ± 4

38 ± 6

0.08

30 ± 5

24 ± 3

21 ± 3

22 ± 3

10 ± 2

9 ± 2

135 ± 25

190 ± 15

32 ± 5

30 ± 3

0.16

21 ± 3

29 ± 5

17 ± 2

30 ± 6

8 ± 2

8 ± 2

142 ±18

186 ±18

29 ± 4

24 ± 3

0.32

23 ± 4

22 ± 3

25 ± 5

20 ± 2

9 ± 2

11 ± 4

154 ± 13

177 ±16

22 ± 3

28 ±4

0.64

17 ± 2

25 ± 4

21 ± 4

31 ± 5

10 ± 3

9 ± 2

156 ±18

181 ± 17

28 ± 5

24 ± 3

1.28

15 ± 3 *

20 ± 3

0*

2± 8*

3 ± 3*

5 ± 3*

155 ± 9

164 ±14

6 ± 8*

17 ± 3

2.56

0*

0*

0*

0*

0*

0*

0*

42 ±22*

0*

0*

 

 

 

 

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative
Executive summary:

The mutagenicity of 1,3-dichlorobenzene was examined in Salmonella typhimurium (strains TA98, TA, 1538, TA 1537, TA 100, and TA 1535). The test was carried out with and without liver microsomal activation.

1,3-dichlorobenzene showed no mutagenic activity and toxicity at higher doses.