Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 214-901-3 | CAS number: 1208-67-9
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
- 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:
- Mutagenic activity of 27 dyes and related chemicals in the Salmonella/microsome and mouse lymphoma TK +/- assays
- Author:
- T.P. Cameron, T.J. Hughes, P.E. Kirby, V.A. Fung and V.C. Dunkel
- Year:
- 1 987
- Bibliographic source:
- Mutation Research, 189 (1987) 223-261
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- Gene mutation toxicity study was performed to evaluate mutagenicity of C.I. Acid blue 74 by the standard plate-incorporation assay
- GLP compliance:
- no
- Type of assay:
- bacterial gene mutation assay
Test material
- Reference substance name:
- Disodium 5,5'-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate
- EC Number:
- 212-728-8
- EC Name:
- Disodium 5,5'-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate
- Cas Number:
- 860-22-0
- Molecular formula:
- C16H10N2O8S2.2Na
- IUPAC Name:
- disodium 3,3'-dioxo-1,1',3,3'-tetrahydro-2,2'-biindole-5,5'-disulfonate
- Reference substance name:
- Indigo tin disulfonate sodium
- IUPAC Name:
- Indigo tin disulfonate sodium
- Details on test material:
- Details on test material
- Name of test material (as cited in study report): C.I. Acid blue 74
- Molecular formula (if other than submission substance):
C16-H10-N2-O8-S2.2Na
C16-H8-N2-Na2-O8-S2
C16-H8-N2-O8-S2.2Na
- Molecular weight (if other than submission substance): 466.3572 g/mol
- Substance type: Organic
- Physical state: Solid
Purity: 85%
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- - Name of test material: C.I. Acid blue 74
- Molecular formula: C16-H10-N2-O8-S2.2Na
C16-H8-N2-Na2-O8-S2
C16-H8-N2-O8-S2.2Na
- Molecular weight: 466.3572 g/mol
- Substance type: Organic
- Physical state: Solid
- Purity: 85%
- Impurity: < 10% H2O, < 7% NaCl, Na2SO4
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA1535, TA1537, TA1538, TA98 and TA100
- 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:
- S9 mix from Aroclor 1254-induced male Fischer 344 rats and Syrian golden hamsters
- Test concentrations with justification for top dose:
- 0, 3333, 1000, 6666 and 10000 µg/plate
- Vehicle / solvent:
- Vehicle
- Vehicle(s)/solvent(s) used: Yes
- Justification for choice of solvent/vehicle: No data available
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- sodium azide
- other: 2-aminoanthracene (All strains, +S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: No data available
- Exposure duration: No data available
- Expression time (cells in growth medium): No data available
- Selection time (if incubation with a selection agent): No data available
- Fixation time (start of exposure): No data available
- Fixation time (start of exposure up to fixation or harvest of cells): No data available
SELECTION AGENT (mutation assays): No data available
SPINDLE INHIBITOR (cytogenetic assays): No data available
STAIN (for cytogenetic assays): No data available
NUMBER OF REPLICATIONS: No data available
NUMBER OF CELLS EVALUATED: No data available
DETERMINATION OF CYTOTOXICITY
- Method: No data available
OTHER EXAMINATIONS:
- Determination of polyploidy: No data available
- Determination of endoreplication: No data available
- Other: No data available - Rationale for test conditions:
- No data available
- Evaluation criteria:
- Dose-related increase in the number of revertants above spontaneous solvent controls, with a 2-fold increase for strains TA1535, TA1538, TA98 and TA100, and a 3-fold increase for TA1537.
- Statistics:
- Mean and standard deviation.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA1535, TA1537, TA1538, TA98 and TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- No data available
Any other information on results incl. tables
MUTAGENICITY OF MISCELLANEOUS DYE IN THE S. typhimurium ASSAY:
Revertants per plate:
µg/plate |
TA1535 |
TA1537 |
||||
(-)S9 |
(R)S9 |
(H)S9 |
(-)S9 |
(R)S9 |
(H)S9 |
|
Solvent control |
23±3 |
9±5 |
15±5 |
9±2 |
10±3 |
9±4 |
Positive control |
814±42 |
156±17 |
171±14 |
269±28 |
294±14 |
157±11 |
333 |
23±2 |
13±4 |
11±3 |
7±1 |
7±4 |
Toxic |
1000 |
17±3 |
10±4 |
13±5 |
4±1 |
8±4 |
6±3 |
3333 |
21±2 |
11±2 |
9±3 |
3±2 |
7±3 |
3±1 |
6666 |
19±7 |
12±0 |
14±3 |
5±1 |
5±2 |
6±1 |
10000 |
19±3 |
22±4 |
10±4 |
3±1 |
Toxic |
4±2 |
µg/plate |
TA1538
|
TA98 |
TA100
|
||||||
(-)S9 |
(R)S9 |
(H)S9 |
(-)S9 |
(R)S9 |
(H)S9 |
(-)S9 |
(R)S9 |
(H)S9 |
|
Solvent control |
20±6 |
19±6 |
22±7 |
20±4 |
33±7 |
30±6 |
161±26 |
160±17 |
183±4 |
Positive control |
677±27 |
750±33 |
449±23 |
269±12 |
1725±66 |
775±60 |
1104±36 |
2818±14 |
1469±35 |
333 |
10±2 |
17±3 |
27±7 |
18±2 |
23±6 |
32±4 |
160±7 |
147±20 |
171±17 |
1000 |
6±5 |
15±5 |
19±6 |
17±1 |
22±6 |
28±3 |
158±10 |
161±7 |
187±2 |
3333 |
5±3 |
13±3 |
13±3 |
13±6 |
16±7 |
22±3 |
158±16 |
169±11 |
205±48 |
6666 |
7±3 |
9±2 |
18±2 |
13±3 |
20±5 |
15±4 |
193±28 |
182±15 |
246±46 |
10000 |
7±1 |
7±5 |
13±3 |
23±11 |
17±2 |
15±7 |
167±31 |
198±17 |
201±11 |
Applicant's summary and conclusion
- Conclusions:
- The substance C.I. Acid blue 74 is considered to be not mutagenic in Salmonella typhimurium strain TA1535, TA1537, TA1538, TA98 and TA100 with and without metabolic activation.
- Executive summary:
Gene mutation toxicity study was performed to evaluate mutagenicity of C.I. Acid blue 74 by the standard plate-incorporation assay.The study was performed using S.typhimurium strain TA1535, TA1537, TA1538, TA98 and TA100. All strain were tested at dose levels of 0, 3333, 1000, 6666 and 10000 µg/plate both with and without metabolic activation (Aroclor 1254-induced male Fischer). Positive control and solvent control as used. There was no dose-related increase in the number of revertants above spontaneous solvent controls, with a 2-fold increase for strains TA1535, TA1538, TA98 and TA100, and a 3-fold increase for TA1537. Hence, the substance C.I. Acid blue 74 is considered to be not mutagenic in Salmonella typhimurium strain TA1535, TA1537, TA1538, TA98 and TA100 with and without metabolic activation.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
