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EC number: 206-746-5 | CAS number: 372-18-9
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- publication
- Title:
- Structural specificity of aromatic compounds with special reference to mutagenic activity in Salmonella typhimurium - A series of chloro- or fluoro-nitrobenzene derivatives
- Author:
- Shimizu Makoto, Yasui Yoshiyuki and Matsumoto Nobuo
- Year:
- 1 983
- Bibliographic source:
- Mutation research, 116, 217-238
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
- Reference substance name:
- 1,3-difluorobenzene
- EC Number:
- 206-746-5
- EC Name:
- 1,3-difluorobenzene
- Cas Number:
- 372-18-9
- Molecular formula:
- C6H4F2
- IUPAC Name:
- 1,3-difluorobenzene
- Test material form:
- liquid
- Details on test material:
- - Name of the test material: m-difluorobenzene
- Purity: 97%
- Source: Aldrich Chemical Co. Inc.
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA1537, TA1538.
- Metabolic activation:
- with and without
- Metabolic activation system:
- Metabolic activation system S9 mix was prepared from a liver microsomal fraction (S9 fraction) of male Sprague-Dawley rats induced with PCB at a dose of 500 mg/kg bw.
- Test concentrations with justification for top dose:
- 0, 0.08, 0.16, 0.32, 0.64, 1.28, 2.56, 5.12, 10.24 µl/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- Plates were inverted and incubated at 37°C in the dark for 3 days. 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.
All tests were performed in duplicate and repeated at least 3 times separately.
A contamination test was carried out through each experiment. The background bacterial lawn was routinely checked by microscopy, as high doses of the complexes proved toxic to all strains resulting in a thinning out of the bacterial lawn.
2 strains (TA98 and TA100) were checked routinely for the presence of the ampicillin resistance for the R factor.
First, the tests were carried out without metabolic activation and were terminated if the mutagenicity was positive. But if the results were negative, tests with metabolic activation were carried out additionally.
Results and discussion
Test results
- Key result
- Species / strain:
- other: Salmonella typhimurium TA 98, TA 100, TA 1535, TA1537, TA1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: 10.24 µl/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Mutagenicity results
Compound |
Dose per plate |
His+ revertants/plate |
|||||||||
TA 98 |
TA1538 |
TA1537 |
TA100 |
TA1535 |
|||||||
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
- S9 |
+ S9 |
||
DMSO (control) |
0.05 mL |
28 ± 6 (16 – 23) |
30 ± 5 (18 – 25) |
22 ± 7 (13 – 17) |
24 ± 5 (16 – 22) |
8 ± 3 (5 – 8) |
11 ± 4 (6 -10) |
181 ± 23 (148 - 166 |
175 ± 36 (152 – 170) |
32 ± 8 (18 – 26) |
30 ± 9 (18 – 27) |
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 ± 23 |
1 ,3-DFB |
0.08 µL 0.16 µL 0.32 µL 0.64 µL 1.28 µL 2.56 µL 5.12 µL 10.24 µL |
30 ± 4 34 ± 3 36 ± 4 31 ± 3 28 ± 2 26 ± 2 19 ± 3 0* |
28 ± 4 31 ± 4 35 ± 6 35 ± 6 31 ± 4 22 ± 2 23 ± 3 0* |
21 ± 2 22 ± 3 22 ± 2 23 ± 4 27 ± 7 30 ± 6 7 ± 3* 0* |
26 ± 3 28 ± 4 24 ± 3 28 ± 4 33 ± 7 26 ± 3 18 ± 2 0* |
12 ± 3 10 ± 2 8 ± 2 8 ± 1 9 ± 2 10 ± 3 4 ± 4* 0* |
10 ± 2 9 ± 2 11 ± 3 7 ± 1 12 ± 4 9 ± 2 8 ± 1 0* |
201 ± 24 188 ± 16 202 ± 18 201 ± 23 186 ± 20 177 ± 19 101 ± 38* 0* |
224 ± 22 207 ± 32 196 ± 15 188 ± 24 199 ± 17 190 ± 14 167 ± 16 0* |
28 ± 4 33 ± 6 38 ± 6 26 ± 3 39 ± 7 34 ± 4 30 ± 3 4 ± 8* |
38 ± 5 28 ± 3 32 ± 4 31 ± 4 37 ± 8 35 ± 6 28 ± 3 9 ± 6* |
Data represent the results of 3 separate experiments and give the mean values of 3 plates. The number of revertant colonies indicates mean ± standard deviation. All these revertant colonies were counted after 68-72 h incubation.
() indicates range in number of revertant colonies of control (DMSO) which was counted after 44-48 h incubation.
* indicates toxic effect.
0 indicates no revertants detectable.
ENNG: N-Ethyl-N'-nitro-N-nitrosoguanidine
2 -NF: 2 -nitrofluorene
9 -AA: 9 -aminoacridine
2 -AA: 2 -aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, 1,3-difluorobenzene did not induce gene mutations by base-pair changes or frameshifts in the genome of the strains used.
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