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EC number: 276-538-7 | CAS number: 72252-58-5
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- Appearance / physical state / colour
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
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- Toxicity to microorganisms
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- Toxicological Summary
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- Acute Toxicity
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- Genetic toxicity
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- Additional toxicological data

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:
- 2016 -04-19 till 2016-05-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Guideline-conform study under GLP without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tetrasodium [μ-[3-[[2-amino-5-hydroxy-6-[(2-hydroxy-5-nitro-3-sulphophenyl)azo]-7-sulpho-1-naphthyl]azo]-2-hydroxy-5-sulphobenzoato(8-)]]dichromate(4-)
- EC Number:
- 276-538-7
- EC Name:
- Tetrasodium [μ-[3-[[2-amino-5-hydroxy-6-[(2-hydroxy-5-nitro-3-sulphophenyl)azo]-7-sulpho-1-naphthyl]azo]-2-hydroxy-5-sulphobenzoato(8-)]]dichromate(4-)
- Cas Number:
- 72252-58-5
- Molecular formula:
- C23H8Cr2N6O16S3.4Na
- IUPAC Name:
- tetrasodium [μ-[3-[[2-amino-5-hydroxy-6-[(2-hydroxy-5-nitro-3-sulphophenyl)azo]-7-sulpho-1-naphthyl]azo]-2-hydroxy-5-sulphobenzoato(8-)]]dichromate(4-)
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/ß-Naphthoflavone induced rat liver S9 in experiment I and non-induced hamster liver S9 in experiment II
- Test concentrations with justification for top dose:
- 3, 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate / pre-experiment/experiment I and experiment II
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: [deionised water
- Justification for choice of solvent/vehicle: best suitable solvent
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- congo red
- other: sodium azide; 4-nitro-o-phenylene-diamine; methyl methane sulfonate, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:in agar (plate incorporation); preincubation;
DURATION
- Preincubation period: 30 min
- Exposure duration: 72 hours
NUMBER OF REPLICATIONS: 3 plates
DETERMINATION OF CYTOTOXICITY
A reduction in the number of spontaneous revertants (below the induction factor of 0.5) or a clearing of the bacterial background lawn.
- Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
Results and discussion
Test results
- Species / strain:
- other: TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- in strain TA 1535, TA 1537 and TA 98
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: none
- Water solubility: yes
- Precipitation:No precipitation occurred in the overlay agar in the test tubes at any concentration. In Experiment I the minimal agar plates were densely colored after treatment with the test items at concentrations ranging from 1000 to 5000 µg/plate. In Experiment II only after treatment with 5000 µg/plate densely colored plates were recognized.
- Other confounding effects:
COMPARISON WITH HISTORICAL CONTROL DATA: performed
ADDITIONAL INFORMATION ON CYTOTOXICITY:Toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5), were observed at the following concentrations (µg/plate):
Strain Experiment I Experiment II
without S9 mix with S9 mix without S9 mix with S9 mix
TA 1535 / / / 5000
TA 1537 / 5000 5000 /
TA 98 / 5000 / /
TA 100 / / / /
WP2 uvrA / / / / - Remarks on result:
- other: other: reverse mutation assay
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Summary Tabellen
Table1 Summary of Experiment I
Study Name: 1763502 |
Study Code: Envigo 1763502 |
Experiment: 1763502 VV Plate |
Date Plated: 19.04.2016 |
Assay Conditions: |
Date Counted: 26.04.2016 |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
|
|
|
|
|
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|
|
|
|
|
|
|
Without Activation |
Deion. water |
|
11 ± 4 |
9 ± 2 |
29 ± 4 |
186 ± 16 |
54 ± 6 |
Untreated |
|
12 ± 3 |
9 ± 4 |
32 ± 6 |
157 ± 14 |
52 ± 11 |
|
Sanodal- |
3 µg |
9 ± 1 |
10 ± 3 |
34 ± 4 |
172 ± 4 |
49 ± 11 |
|
Schwarz 2LW |
10 µg |
15 ± 5 |
7 ± 2 |
26 ± 5 |
172 ± 17 |
51 ± 7 |
|
|
33 µg |
11 ± 1 |
9 ± 1 |
27 ± 6 |
157 ± 6 |
41 ± 4 |
|
|
100 µg |
13 ± 6 |
11 ± 5 |
28 ± 6 |
166 ± 28 |
61 ± 6 |
|
|
333 µg |
12 ± 3 |
6 ± 1 |
29 ± 3 |
168 ± 12 |
48 ± 5 |
|
|
1000 µg |
10 ± 2D M |
8 ± 4D M |
26 ± 7D M |
149 ± 4D M |
43 ± 6D M |
|
|
2500 µg |
10 ± 3D M |
8 ± 3D M |
19 ± 5D M |
146 ± 7D M |
36 ± 4D M |
|
|
5000 µg |
8 ± 2D M |
7 ± 1D M |
15 ± 1D M |
135 ± 5D M |
36 ± 3D M |
|
NaN3 |
10 µg |
1382 ± 52 |
|
|
2415 ± 69 |
|
|
4-NOPD |
10 µg |
|
|
403 ± 23 |
|
|
|
4-NOPD |
50 µg |
|
75 ± 7 |
|
|
|
|
MMS |
2.0 µL |
|
|
|
|
1075 ± 78 |
|
|
|
|
|
|
|
|
|
With Activation |
Deion. water |
|
10 ± 2 |
9 ± 3 |
40 ± 6 |
170 ± 20 |
63 ± 5 |
Untreated |
|
13 ± 4 |
10 ± 5 |
45 ± 7 |
165 ± 20 |
61 ± 14 |
|
Sanodal- |
3 µg |
10 ± 1 |
11 ± 4 |
44 ± 6 |
167 ± 8 |
62 ± 8 |
|
Schwarz 2LW |
10 µg |
12 ± 5 |
9 ± 3 |
48 ± 6 |
172 ± 18 |
53 ± 10 |
|
|
33 µg |
8 ± 2 |
11 ± 2 |
37 ± 5 |
172 ± 16 |
52 ± 4 |
|
|
100 µg |
10 ± 0 |
8 ± 3 |
40 ± 10 |
173 ± 21 |
69 ± 11 |
|
|
333 µg |
9 ± 5 |
11 ± 4 |
34 ± 2 |
174 ± 25 |
54 ± 13 |
|
|
1000 µg |
10 ± 1D M |
8 ± 2D M |
27 ± 4D M |
135 ± 6D M |
42 ± 1D M |
|
|
2500 µg |
7 ± 3D M |
5 ± 2D M |
23 ± 6D M |
115 ± 8D M |
40 ± 2D M |
|
|
5000 µg |
5 ± 2D M |
3 ± 1D M |
17 ± 2D M |
106 ± 7D M |
30 ± 4D M |
|
|
2-AA |
2.5 µg |
415 ± 21 |
219 ± 43 |
6586 ± 361 |
4872 ± 201 |
|
|
2-AA |
10.0 µg |
|
|
|
|
414 ± 15 |
|
|
|
|
|
|
|
|
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
NaN3 2-AA 4-NOPD MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine methyl methane sulfonate |
D M |
Densely coloured plate Manual count |
Table2 Summary of Experiment II
Study Name: 1763502 |
Study Code: Envigo 1763502 |
Experiment: 1763502 HV2 Pre |
Date Plated: 12.05.2016 |
Assay Conditions: |
Date Counted: 18.05.2016 |
Metabolic Activation |
Test Group |
Dose Level (per plate) |
Revertant Colony Counts (Mean ±SD) |
||||
|
|
|
|
|
|
|
|
|
|
|
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvrA |
|
|
|
|
|
|
|
|
Without Activation |
Deion. water |
|
10 ± 1 |
13 ± 3 |
29 ± 2 |
146 ± 22 |
51 ± 9 |
Untreated |
|
12 ± 7 |
12 ± 2 |
32 ± 8 |
169 ± 11 |
52 ± 7 |
|
Sanodal- |
3 µg |
11 ± 1 |
11 ± 1 |
26 ± 9 |
161 ± 8 |
41 ± 1 |
|
Schwarz 2LW |
10 µg |
12 ± 6 |
10 ± 2 |
25 ± 6 |
167 ± 13 |
42 ± 2 |
|
|
33 µg |
13 ± 3 |
12 ± 6 |
28 ± 2 |
148 ± 22 |
50 ± 5 |
|
|
100 µg |
13 ± 3 |
11 ± 3 |
27 ± 12 |
154 ± 8 |
37 ± 3 |
|
|
333 µg |
14 ± 4P |
10 ± 1P |
32 ± 9P |
167 ± 7P |
32 ± 8P |
|
|
1000 µg |
7 ± 3P M |
8 ± 2P M |
16 ± 2P M |
159 ± 6P M |
29 ± 4M P |
|
|
2500 µg |
7 ± 2P M |
8 ± 2P M |
14 ± 2P M |
157 ± 14P M |
28 ± 7M P |
|
|
5000 µg |
7 ± 2P D M |
4 ± 1P D M |
15 ± 3P D M |
143 ± 6P D M |
28 ± 9M P D |
|
NaN3 |
10 µg |
1140 ± 35 |
|
|
1849 ± 49 |
|
|
4-NOPD |
10 µg |
|
|
447 ± 25 |
|
|
|
4-NOPD |
50 µg |
|
72 ± 12 |
|
|
|
|
MMS |
2 µL |
|
|
|
|
879 ± 65 |
|
|
|
|
|
|
|
|
|
With Activation |
Deion. water |
|
18 ± 4 |
25 ± 3 |
50 ± 2 |
140 ± 32 |
46 ± 4 |
Untreated |
|
18 ± 4 |
23 ± 9 |
57 ± 10 |
123 ± 19 |
50 ± 11 |
|
Sanodal- |
3 µg |
22 ± 0 |
29 ± 2 |
57 ± 3 |
147 ± 14 |
51 ± 3 |
|
Schwarz 2LW |
10 µg |
20 ± 4 |
30 ± 6 |
55 ± 13 |
150 ± 11 |
48 ± 3 |
|
|
33 µg |
22 ± 6 |
31 ± 10 |
55 ± 6 |
177 ± 13 |
42 ± 4 |
|
|
100 µg |
13 ± 1 |
30 ± 6 |
49 ± 8 |
167 ± 32 |
45 ± 11 |
|
|
333 µg |
16 ± 5P |
29 ± 4P |
51 ± 4P |
143 ± 7P |
49 ± 4P |
|
|
1000 µg |
13 ± 3P M |
30 ± 8P M |
36 ± 3P M |
139 ± 12P M |
31 ± 5P M |
|
|
|
2500 µg |
11 ± 3P M |
21 ± 3P M |
29 ± 4P M |
132 ± 11P M |
33 ± 8P M |
|
|
5000 µg |
8 ± 2P D M |
18 ± 3P D M |
23 ± 3P D M |
123 ± 2P D M |
26 ± 9P D M |
|
2-AA |
2.5 µg |
|
|
|
963 ± 99 |
|
|
2-AA |
2.5 µg |
329 ± 27 |
115 ± 14 |
|
|
|
|
2-AA |
10 µg |
|
|
|
|
1043 ± 60 |
|
Congo red |
500 µg |
|
|
328 ± 10 |
|
|
|
|
|
|
|
|
|
|
Key to Positive Controls |
Key to Plate Postfix Codes |
||
|
|
||
NaN3 2-AA 4-NOPD Congo red MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine Congo red methyl methane sulfonate |
P M D |
Precipitate Manual count Densely coloured plate |
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
- Executive summary:
This study was performed to investigate the potential of the test item to induce gene mutations according to the plate incorporation test (experiment I) with and without rat S9 mix and the pre-incubation test (experiment II) with and without hamster S9 mix using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration and the controls were tested in triplicate. The test item was tested at the following concentrations in both experiments:
3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
No precipitation occurred in the overlay agar in the test tubes at any concentration. In Experiment I the minimal agar plates were densely colored after treatment with the test items at concentrations ranging from 1000 to 5000 µg/plate. In Experiment II only after treatment with 5000 µg/plate densely colored plates were recognized.
Furthermore in Experiment II precipitation of the test item in the overlay agar on the incubated agar plates was observed from 333 to 5000 µg/plate.The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without S9 mix in all strains used.
Toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5), were observed at the following concentrations (µg/plate):
Strain
Experiment I
Experiment II
without S9 mix
with S9 mix
without S9 mix
with S9 mix
TA 1535
/
/
/
5000
TA 1537
/
5000
5000
/
TA 98
/
5000
/
/
TA 100
/
/
/
/
WP2 uvrA
/
/
/
/
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Sanodal-Schwarz 2LW at any concentration level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls. They showed a distinct increase in induced revertant colonies.
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