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EC number: 220-189-5 | CAS number: 2657-00-3
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07 Aug - 17 Aug 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- 1993
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sodium 6-diazo-5,6-dihydro-5-oxonaphthalene-1-sulphonate
- EC Number:
- 220-189-5
- EC Name:
- Sodium 6-diazo-5,6-dihydro-5-oxonaphthalene-1-sulphonate
- Cas Number:
- 2657-00-3
- Molecular formula:
- C10H6N2O4S.Na
- IUPAC Name:
- sodium 6-diazo-5,6-dihydro-5-oxonaphthalene-1-sulphonate
- Test material form:
- solid
Constituent 1
Method
- Target gene:
- his operon, trp operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver S9 induced by ß-Naphthoflavone/phenobarbital
- Test concentrations with justification for top dose:
- 1st series: 5, 15.8, 50, 158, 500, 1580, 5000 µg/plate (with and without S9 mix)
2nd series: 50, 158, 500, 1580, 5000 µg/plate (with and without S9 mix) - Vehicle / solvent:
- - Solvent used: Ultra pure water, final concentration 100 µL per plate
- Justification for choice of solvent: solubitlity properties of the test item, non toxicity to bacteria
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- sodium azide
- other: 2-aminoanthracene 2-10 µg/plate, daunomycin 1 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 2-3 days
NUMBER OF REPLICATIONS: 3 replicates for test item concentrations and positive controls, 6 replicates for solvent controls
DETERMINATION OF CYTOTOXICITY
- Method: counting numbers of revertants
OTHER:
-S9 concentration: 1st series 10%, 2nd series 20% - Evaluation criteria:
- A test material was to be defined as positive or mutagenic in this assay if
- the assay is considered valid AND
- a biologically relevant increase in the mean number of revertants above a threshold of 2-fold (TA98, TA100, WP2 uvrA) or 3-fold (TA1535, TA1537) as compared to the concurrent negative controls is observed.
- an increase exceeding the threshold at only one concentration is considered as biologically meaningful if reproduced in a 2nd independent experiment.
- a concentration-dependent increase is considered biologically meaningful if the threshold is exceeded at more than one concentration
A test material is considered negative or non-mutagenic in this assay if
- the assay is considered valid AND
- non of the above criteria are met - Statistics:
- Not performed as not mandatory for this test system.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- weak toxicity at the highest concentration tested
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- at
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- Following treatment with the test item, no precipitation on the agar plates occurred. Weak toxicity to the bacteria was observed in the 2nd series in the presence of S9-mix in TA1537 at the highest concentration tested.
Under the experimental conditions described, there were no relevant increases in revertant numbers observed after exposure to the test item un the absence and presence of S9-mix.
According to the criteria for negative and positive results as predetermined in the study plan, the test item was not mutagenic under the described experimental conditions.
Any other information on results incl. tables
Table 1: Summary of Experiment 1
Metabolic Activation |
Test material |
Concentr. (µg/plate) |
Revertant Colony Counts (Mean ± SD) |
||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvrA |
|||
Without Activation |
H20 |
|
37 +/- 9 |
127 +/- 7 |
23 +/- 5 |
6 +/- 3 |
39 +/- 5 |
Test item |
5 |
39 +/- 6 |
134 +/- 9 |
22 +/- 2 |
7 +/- 3 |
32 +/- 8 |
|
15.8 |
39 +/- 4 |
121 +/- 14 |
24 +/- 2 |
10 +/- 3 |
30 +/- 10 |
||
50 |
41 +/- 4 |
134 +/- 15 |
22 +/- 7 |
8 +/- 2 |
36 +/- 3 |
||
158 |
42 +/- 10 |
147 +/- 4 |
26 +/- 6 |
4 +/- 3 |
34 +/- 3 |
||
500 |
33 +/- 4 |
126 +/- 22 |
25 +/- 3 |
9 +/- 2 |
40 +/- 13 |
||
1580 |
36 +/- 10 |
131 +/- 10 |
19 +/- 5 |
7 +/- 6 |
38 +/- 5 |
||
5000 |
33 +/- 9 |
146 +/- 12 |
15 +/- 4 |
4 +/- 3 |
41 +/- 6 |
||
DAUN |
1 |
269 +/- 18 |
|
|
|
|
|
NaN3 |
2 |
|
1647 +/- 56 |
875 +/- 31 |
|
|
|
9-AA |
50 |
|
|
|
949 +/- 306 |
|
|
NQO |
2 |
|
|
|
|
1727 +/- 145 |
|
With Activation |
H20 |
|
47 +/- 8 |
130 +/- 12 |
17 +/- 5 |
10 +/- 4 |
42 +/- 6 |
Test item |
5 |
37 +/- 5 |
129 +/- 17 |
16 +/- 2 |
7 +/- 1 |
47 +/- 3 |
|
15.8 |
35 +/- 9 |
146 +/- 4 |
21 +/- 6 |
11 +/- 4 |
37 +/- 1 |
||
50 |
41 +/- 4 |
128 +/- 10 |
20 +/- 3 |
12 +/- 8 |
42 +/- 7 |
||
158 |
42 +/- 9 |
126 +/- 13 |
24 +/- 11 |
13 +/- 3 |
44 +/- 9 |
||
500 |
37 +/- 3 |
131 +/- 8 |
19 +/- 8 |
10 +/- 6 |
37 +/- 8 |
||
1580 |
44 +/- 13 |
144 +/- 14 |
13 +/- 4 |
7 +/- 2 |
42 +/- 5 |
||
5000 |
49 +/- 25 |
146 +/- 24 |
17 +/- 6 |
8 +/- 1 |
48 +/- 6 |
||
2-AA |
2 |
878 +/- 61 |
1693 +/- 125 |
|
|
||
2-AA |
5 |
|
|
176 +/- 10 |
348 +/- 80 |
|
|
2-AA |
10 |
|
|
|
|
420 +/- 40 |
|
Table 1: Summary of Experiment 2
Metabolic Activation |
Test material |
Concentr. (µg/plate) |
Revertant Colony Counts (Mean ± SD) |
||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvrA |
|||
Without Activation |
H20 |
|
27 +/- 8 |
130 +/- 12 |
23 +/- 2 |
10 +/- 5 |
31 +/- 7 |
Test item |
5 |
-- |
-- |
-- |
-- |
-- |
|
15.8 |
-- |
-- |
-- |
-- |
-- |
||
50 |
31 +/- 7 |
119 +/- 16 |
22 +/- 7 |
7 +/- 4 |
34 +/- 5 |
||
158 |
37 +/- 5 |
122 +/- 10 |
22 +/- 2 |
9 +/- 2 |
39 +/- 7 |
||
500 |
27 +/- 7 |
127 +/- 3 |
18 +/- 4 |
8 +/- 4 |
32 +/- 10 |
||
1580 |
31 +/- 2 |
134 +/- 4 |
19 +/- 4 |
7 +/- 5 |
30 +/- 11 |
||
5000 |
23 +/- 4 |
146 +/- 23 |
18 +/- 3 |
9 +/- 1 |
31 +/- 12 |
||
DAUN |
1 |
169 +/- 32 |
|
|
|
|
|
NaN3 |
2 |
|
1660 +/- 54 |
842 +/- 19 |
|
|
|
9-AA |
50 |
|
|
|
850 +/- 333 |
|
|
NQO |
2 |
|
|
|
|
1423 +/- 100 |
|
With Activation |
H20 |
|
45 +/- 4 |
129 +/- 17 |
20 +/- 5 |
12 +/- 3 |
42 +/- 8 |
Test item |
5 |
-- |
-- |
-- |
-- |
-- |
|
15.8 |
-- |
-- |
-- |
-- |
-- |
||
50 |
34 +/- 6 |
128 +/- 8 |
13 +/- 7 |
5 +/- 3 |
44 +/- 11 |
||
158 |
37 +/- 5 |
122 +/- 9 |
14 +/- 4 |
10 +/- 4 |
39 +/- 2 |
||
500 |
33 +/- 4 |
121 +/- 4 |
15 +/- 5 |
9 +/- 3 |
43 +/- 4 |
||
1580 |
39 +/- 10 |
116 +/- 3 |
13 +/- 1 |
7 +/- 2 |
37 +/- 1 |
||
5000 |
37 +/- 7 |
112 +/- 12 |
14 +/- 5 |
6 +/- 3 |
35 +/- 9 |
||
2-AA |
2 |
269 +/- 28 |
485 +/- 25 |
|
|
||
2-AA |
5 |
|
|
111 +/- 31 |
72 +/- 1 |
|
|
2-AA |
10 |
|
|
|
|
173 +/- 10 |
|
Key to Positive Controls
NaN3 Sodium azide
2-AA 2-Aminoanthracene
9-AA 9-Aminoacridine
DAUN Daunomycin
NQO 4-Nitroquinoline-N-oxide
Applicant's summary and conclusion
- Conclusions:
- The test item is considered not mutagenic under the test conditions described.
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