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EC number: 201-247-9 | CAS number: 80-07-9
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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
- Study period:
- year completed 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to OECD guideline with GLP, acceptable with restrictions (only 4 strains were used)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: NTP standard protocol according to Zeiger et al 1992
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- not applicable
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Bis(4-chlorophenyl) sulphone
- EC Number:
- 201-247-9
- EC Name:
- Bis(4-chlorophenyl) sulphone
- Cas Number:
- 80-07-9
- Molecular formula:
- C12H8Cl2O2S
- IUPAC Name:
- 1-chloro-4-(4-chlorobenzenesulfonyl)benzene
- Details on test material:
- - Name of test material (as cited in study report): p,p'-Dichlorodiphenyl Sulfone
- Physical state: white powder
- Analytical purity: > 99%
- Lot/batch No.: AX01 (TCI America, Portland), P02300 (Lancaster Synthesis Inc., Windham) aliquot delivered via Radian Corporation (Austin, TX)
Constituent 1
Method
- Target gene:
- Salmonella typhimurium: histidine operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 1535
- Species / strain / cell type:
- S. typhimurium TA 97
- Species / strain / cell type:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced male Sprague-Dawley rat and Syrian hamster liver
- Test concentrations with justification for top dose:
- 0, 10, 33, 100, 333, and 1000 µg/plate
- Vehicle / solvent:
- - Vehicle/solvent used: no data
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylenediamine
- Remarks:
- strain TA98 in the absence of metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- strains TA100 and TA1535 in the absence of metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- strain TA97 in the absence of metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with all strains with metabolic activation
- Details on test system and experimental conditions:
- Testing was performed as reported by Zeiger et al. (1992). DCDPS was incubated with the Salmonella typhimurium tester strains TA97, TA98, TA100, and TA1535 either in buffer or S9 mix (metabolic activation enzymes and cofactors from Aroclor 1254-induced male Sprague-Dawley rat or Syrian hamster liver) for 20 minutes at 37° C.
Top agar supplemented with L-histidine and d-biotin was added, and the contents of the tubes were mixed and poured onto the surfaces of minimal glucose agar plates. Histidine-independent mutant colonies arising on these plates were counted following incubation for 2 days at 37° C.
Each trial consisted of triplicate plates of concurrent positive and negative controls and five doses of DCDPS. The high dose was limited by solubility. All trials without S9 were repeated. Trials initially performed with 10% S9 were repeated with 30% S9.
Zeiger et al (1992). Salmonella mutagenicity tests: V. Results from the testing of 311 chemicals. PMID: 1541260, Environ Mol Mutagen 19(Suppl 21):2-141 - Evaluation criteria:
- A positive response is defined as a reproducible, dose-related increase in histidine-independent (revertant) colonies in any one strain/activation combination.
An equivocal response is defined as an increase in revertants that is not dose related, is not reproducible, or is not of sufficient magnitude to support a determination of mutagenicity.
A negative response is obtained when no increase in revertant colonies is observed following chemical treatment.
Results and discussion
Test results
- Species / strain:
- other: TA100, TA 535, TA97, TA98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: the test substance precipitated at 100 µg/plate and above - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table from NIH (2001, NTP TR 501, p. 197)
Mutagenicity of DCDPS in Salmonella typhimuriuma
Strain Dose [µg/plate] |
Revertants/Plateb |
|||||
-S9 |
+hamster S9 |
+rat S9 |
||||
Trial 1 |
Trial 2 |
10% |
30% |
10% |
30% |
|
TA100 0 |
127 ± 15.1 |
110 ± 7.1 |
123 ± 8.0 |
161 ± 11.9 |
135 ± 7.2 |
159 ± 2.3 |
10 |
121 ± 2.1 |
116 ± 8.2 |
134 ± 8.8 |
156 ± 9.4 |
118 ± 11.9 |
152 ± 2.1 |
33 |
130 ± 3.8 |
90 ± 5.3 |
130 ± 8.3 |
143 ± 1.5 |
128 ± 10.2 |
171 ± 4.4 |
100c |
104 ± 8.3 |
124 ± 0.6 |
155 ± 2.8 |
148 ± 7.4 |
121 ± 10.2 |
139 ± 4.1 |
333c |
131 ± 0.9 |
105 ± 5.5 |
131 ± 7.3 |
158 ± 9.3 |
109 ± 7.2 |
164 ± 7.3 |
1,000c |
137 ± 3.0 |
128 ± 14.4 |
131 ± 4.7 |
149 ± 5.4 |
119 ± 5.9 |
165 ± 9.5 |
Trial summary |
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
Positive controld |
561 ± 9.5 |
573 ± 13.5 |
479 ± 10.0 |
471 ± 15.7 |
1,525 ± 64.2 |
491 ± 20.5 |
TA1535 0 |
8 ± 1.7 |
10 ± 0.6 |
11 ± 2.4 |
10 ± 1.5 |
8e |
12 ± 1.7 |
10 |
8 ± 0.9 |
9 ± 1.2 |
12 ± 2.3 |
13 ± 0.9 |
9 ± 1.2 |
12 ± 1.7 |
33 |
9 ± 0.7 |
9 ± 0.9 |
9 ± 0.6 |
11 ± 0.3 |
8 ± 1.2 |
12 ± 1.2 |
100c |
7 ± 0.7 |
12 ± 2.4 |
10 ± 1.8 |
11 ± 2.6 |
7 ± 1.5 |
13 ± 2.0 |
333c |
9 ± 1.0 |
9 ± 1.2 |
7 ± 0.9 |
9 ± 2.2 |
9 ± 1.5 |
12 ± 1.3 |
1,000c |
11 ± 0.7 |
9 ± 1.7 |
7 ± 1.0 |
13 ± 2.3 |
6 ± 2.0 |
11 ± 2.4 |
Trial summary |
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
Positive control |
159 ± 15.4 |
371 ± 22.0 |
50 ± 8.6 |
66 ± 4.9 |
158 ± 6.2 |
140 ± 9.1 |
TA97 0 |
134 ± 5.3 |
151 ± 4.2 |
164 ± 5.8 |
138 ± 4.3 |
159 ± 4.7 |
188 ± 3.2 |
10 |
127 ± 0.9 |
161 ± 8.0 |
157 ± 3.8 |
145 ± 6.4 |
133 ± 4.0 |
187 ± 5.5 |
33 |
140 ± 5.2 |
158 ± 7.5 |
128 ± 5.9 |
149 ± 5.1 |
160 ± 5.4 |
193 ± 12.9 |
100c |
125 ± 7.5 |
142 ± 7.3 |
161 ± 3.2 |
160 ± 8.1 |
166 ± 9.5 |
189 ± 5.6 |
333c |
139 ± 16.8 |
141 ± 9.2 |
154 ± 6.9 |
158 ± 7.4 |
149 ± 19.0 |
180 ± 3.1 |
1,000c |
127 ± 8.1 |
125 ± 2.9 |
151 ± 8.4 |
171 ± 2.4 |
108 ± 5.9 |
185 ± 4.9 |
Trial summary |
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
Positive control |
353 ± 9.8 |
347 ± 9.6 |
992 ± 8.1 |
661 ± 5.2 |
1,719 ± 31.5 |
561 ± 39.8 |
TA98 0 |
16 ± 1.5 |
15 ± 2.6 |
15 ± 1.3 |
25 ± 5.2 |
19 ± 0.9 |
24 ± 1.2 |
10 |
10 ± 0.9 |
15 ± 2.7 |
20 ± 0.9 |
27 ± 3.9 |
18 ± 1.5 |
24 ± 2.7 |
33 |
13 ± 2.0 |
11 ± 3.1 |
20 ± 2.2 |
31 ± 1.0 |
21 ± 2.0 |
27 ± 0.9 |
100c |
13 ± 3.7 |
15 ± 1.9 |
18 ± 0.7 |
22 ± 4.4 |
18 ± 1.2 |
25 ± 1.2 |
333c |
11 ± 1.5 |
16 ± 1.9 |
21 ± 2.8 |
18 ± 1.9 |
19 ± 0.3 |
26 ± 1.9 |
1,000c |
17 ± 1.8 |
11 ± 0.6 |
17 ± 2.6 |
31 ± 5.4 |
23± 1.7 |
33 ± 2.3 |
Trial summary |
Negative |
Negative |
Negative |
Negative |
Negative |
Negative |
Positive control |
286 ± 17.5 |
278 ± 3.8 |
419 ± 33.2 |
465 ± 20.7 |
458 ± 23.7 |
239 ± 8.1 |
a Study was performed at Microbiological Associates. The detailed protocol is presented by Zeiger et al. (1992). 0 µg/plate was the solvent control.
b Revertants are presented as mean ± standard error from three plates.
c Precipitate on all plates
d The positive controls in the absence of metabolic activation were sodium azide (TA100 and TA1535), 9-aminoacridine (TA97), and 4-nitro-o-phenylenediamine (TA98). The positive control for metabolic activation with all strains was 2-aminoanthracene.
e Results available from a single plate only
No significant dose related increase in the number of revertants were observed in all 4 strains. Under the condition of this assay, the compound was concluded to be not mutagenic with and without metabolic activation system.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the all test conditions DCDPS gave an unequivocal negative response. DCDPS (10 to 1,000 µg/plate) was not mutagenic in S. typhimurium strain TA97, TA98, TA100, or TA1535, with or without induced rat or hamster liver S9 metabolic activation enzymes. - Executive summary:
DCDPS was tested for mutagenicity in Salmonella typhimurium strains TA97, TA98. TA100, and TA1535 according to the method published by Zeiger et al 1992 (NIH 2001). The protocol is comparable to the OECD TGD 471 standards.
The applied doses were 0, 10, 33, 100, 333, and 1000 µg/plate. Each concentration was tested in triplicates. Concurrent vehicle and positive controls were included.The tests were conducted using a preincubation protocol in the absence of exogenous metabolic activation, and in the presence of liver S-9 from Aroclor-induced male Sprague-Dawley rats and Syrian hamsters. DCDPS was not cytotoxic. It precipitated at concentrations of 100 µg/plate and higher. DCDPS gave an non-mutagenic response under all conditions.
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