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EC number: 235-437-8 | CAS number: 12227-62-2 This substance is identified in the Colour Index by Colour Index Constitution Number, C.I. 16185:1.
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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data is from peer reviewed publication
Data source
Reference
- Reference Type:
- publication
- Title:
- Mutagenicity testing of certified food colours & related azo,xanthene & triphenylmethane dyes with salmonella/microsome
- Author:
- Brown,J.P.,Roehm,G.W & Brown,R .J
- Year:
- 1 978
- Bibliographic source:
- Mutation research; 56,249-271,1978
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- Gene mutation toxicity study was performed to determine the mutagenic nature of Brilliant Blue FCF
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Trisodium 3-hydroxy-4-(4'-sulphonatonaphthylazo)naphthalene-2,7-disulphonate
- EC Number:
- 213-022-2
- EC Name:
- Trisodium 3-hydroxy-4-(4'-sulphonatonaphthylazo)naphthalene-2,7-disulphonate
- Cas Number:
- 915-67-3
- Molecular formula:
- C20H14N2O10S3.3Na
- IUPAC Name:
- trisodium (4E)-3-oxo-4-[2-(4-sulfonatonaphthalen-1-yl)hydrazin-1-ylidene]-3,4-dihydronaphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name of test material (as cited in study report): Amaranth dye
Molecular formula : C20H11N2Na3O10S3
Molecular weight : 604.47g/mol
Smiles notation : c1ccc2c(c1)c(ccc2S(=O)(=O)[O])N=Nc3c4ccc(cc4cc(c3O)S(=O)(=O)[O-])S(=O)(=O)[O-].[Na+].[Na+].[Na+]
InChl : 1S/C20H14N2O10S3.3Na/c23-20-18(35(30,31)32)10-11-9-12(33(24,25)26)5-6-13(11)19(20)22-21-16-7-8-17(34(27,28)29)15-4-2-1-3-14(15)16;;;/h1-10,23H,(H,24,25,26)(H,27,28,29)(H,30,31,32);;;/q;3*+1/p-3
Substance type: Organic
Physical state: Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material : Amaranth dye
- Molecular formula: C20H11N2Na3O10S3
- Molecular weight: 604.47 g/mol
- Smiles notation: c1ccc2c(c1)c(ccc2S(=O)(=O)[O])N=Nc3c4ccc(cc4cc(c3O)S(=O)(=O)[O-])S(=O)(=O)[O-].[Na+].[Na+].[Na+]
- InChl: 1S/C20H14N2O10S3.3Na/c23-20-18(35(30,31)32)10-11-9-12(33(24,25)26)5-6-13(11)19(20)22-21-16-7-8-17(34(27,28)29)15-4-2-1-3-14(15)16;;;/h1-10,23H,(H,24,25,26)(H,27,28,29)(H,30,31,32);;;/q;3*+1/p-3
- Substance type: Organic
- Physical state: Solid
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA1535, TA100, TA1537, TA1538, TA98
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- The mammalian liver homogenate fraction "S-9" was prepared from female Sprague Dawley rats
- Test concentrations with justification for top dose:
- 0, 50, 100, 250 or 1000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Glass distilled water or DMSO
- Justification for choice of solvent/vehicle: The test chemical was dissolved in Glass distilled water or DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- Sodium dithionite and historical
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Glass distilled water or DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- ethylmethanesulphonate
- methylmethanesulfonate
- other: Nitroquinoline-N-oxide (TA1538/TA98, -S9), Anthragallol (TA1538/TA98, -S9) and 2-Anthramine (TA98, +S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation assay
- Cell density at seeding (if applicable): No data
DURATION
- Preincubation period: No data
- Exposure duration: 3 days
- Expression time (cells in growth medium): 3 days
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data
NUMBER OF REPLICATIONS: No data
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: No data
NUMBER OF CELLS EVALUATED: No data
NUMBER OF METAPHASE SPREADS ANALYSED PER DOSE (if in vitro cytogenicity study in mammalian cells): No data
CRITERIA FOR MICRONUCLEUS IDENTIFICATION: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data
- Any supplementary information relevant to cytotoxicity: No data
OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Methods, such as kinetochore antibody binding, to characterize whether micronuclei contain whole or fragmented chromosomes (if applicable): No data
- OTHER: No data - Rationale for test conditions:
- No data
- Evaluation criteria:
- The observed number of revertants should exceed twice the background value for that given assay and exceed the 99.9% confidence limit based on our historical controls.
- Statistics:
- No data
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA1535, TA100, TA1537, TA1538, TA98
- Metabolic activation:
- not specified
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No data
- Remarks on result:
- other: No mutagenic potential
Any other information on results incl. tables
Table: Summary of Historical and Test Control Values for the Salmonella/Microsome System
Control |
S9 |
No. of revertants/plate |
||||
TA1535 |
TA100 |
TA1537 |
TA1538 |
TA98 |
||
Negative control |
|
|
|
|
|
|
Historical |
- |
31±22 (203) |
94±25 (205) |
8±5 (222) |
12±5 (222) |
36±21 (207) |
|
+ |
20±21 (183) |
87±24 (193) |
12±5 (208) |
35±16 (207) |
28±15 (233) |
100µg dithionite |
- |
30±5 (10) |
79±15 (5) |
8±4 (5) |
15±3 (5) |
34±7 (5) |
|
+ |
12±3 (10) |
79±12 (5) |
10±2 (5) |
31±5 (5) |
25±5 (4) |
1mg dithionite |
- |
15±6 (10) |
65±7 (5) |
4±0.4 (5) |
11±3 (5) |
12±4 (5) |
|
+ |
11±3 (10) |
58±10 (5) |
15±12 (5) |
18±5 (5) |
19±3 (5) |
Positive control |
|
|
|
|
|
|
EMS |
- |
> 10000 (30) |
|
|
|
|
MMS |
- |
|
1340 (30) |
|
|
|
9-AA |
- |
|
|
921 (26) |
|
|
NQO |
- |
|
|
|
90 (19) |
177 (19) |
Anthragallol |
- |
|
|
|
126 (8) |
221 (7) |
2-Anthramine |
+ |
|
|
|
|
2846 (30) |
Table: Mutagenicity result
Test compound |
µg |
Chemical reduction (dithionite) |
S9 |
No. of revertants/plate |
||||
TA1535 |
TA100 |
TA1537 |
TA1538 |
TA98 |
||||
Controls |
- |
- |
- |
31±22 (203) |
94±25 (205) |
8±5 (222) |
12±5 (222) |
36±21 (207) |
|
|
|
+ |
20±21 (183) |
87±24 (193) |
12±5 (208) |
35±16 (207) |
28±15 (233) |
FD and C Red no 2 |
50 |
- |
- |
72 |
78 |
3 |
11 |
28 |
|
|
+ |
23 |
97 |
13 |
26 |
27 |
|
250 |
- |
- |
68 |
94 |
13 |
6 |
31 |
|
|
|
+ |
29 |
70 |
20 |
23 |
34 |
|
1000 |
- |
- |
75 |
89 |
9 |
12 |
39 |
|
|
|
+ |
19 |
74 |
7 |
20 |
13 |
|
100 |
+ |
- |
78 |
79 |
16 |
11 |
13 |
|
|
|
+ |
15 |
58 |
16 |
31 |
27 |
|
1000 |
+ |
- |
9 |
51 |
4 |
14 |
8 |
|
|
|
- |
15 |
68 |
4 |
8 |
13 |
|
Applicant's summary and conclusion
- Conclusions:
- Amaranth did not induce gene mutation in Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538, TA98 n the presence and absence of S9 metabolic activation system and hence it is considered to be non-mutagenic.
- Executive summary:
Gene mutation toxicity study was performed to determine the mutagenic nature of Amaranth. The study was performed as per the qualitative plate test using Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538, TA98 in the presence and absence of S9 metabolic activation system. The test chemical was dissolved in glass distilled water or DMSO and used at dose levels of 0, 50, 100, 250 or 1000 µg/plate. Concurrent solvent, negative, historical and positive control chemicals were also included in the study. Amaranth did not induce gene mutation in Salmonella typhimurium strains TA1535, TA100, TA1537, TA1538, TA98 in the presence and absence of S9 metabolic activation system and hence it is considered to be non-mutagenic.
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