Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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)

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:
1987
Bibliographic source:
Mutation Research, 189 (1987) 223-261

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as per mentioned below
Principles of method if other than guideline:
Evaluate mutagenicity of C.I. Acid blue 74 by the standard plate-incorporation assay (Ames et al. 1975).
GLP compliance:
no
Type of assay:
bacterial gene mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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-S2.2NaC16-H8-N2-Na2-O8-S2C16-H8-N2-O8-S2.2Na- Molecular weight (if other than submission substance): 466.3572 g/mol- Substance type: Organic- Physical state: SolidPurity: 85%

Method

Target gene:
Standard Plate-incorporation
Species / strain
Species / strain:
other: TA1535, TA1537, TA1538, TA98 and TA100
Details on mammalian cell lines (if applicable):
Not applicable
Additional strain characteristics:
not specified
Metabolic activation:
with and without
Test concentrations with justification for top dose:
3333, 1000, 6666 and 10000 µg/plate
Vehicle:
Vehicle- Vehicle(s)/solvent(s) used: Yes- Justification for choice of solvent/vehicle: No data available
Controls
Negative controls:
not specified
Solvent controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: sodium azide for strains TA1535 & TA100:(1.0/1µg/plate), 9-aminoacridine for TA1537 (50.0/µg/plate), and 2-nitrofluorene for TA1538 &TA98 (1.0, 2.0 or 5.0 /µg/plate) 2-aminoanthracene (2.5/µg/plate for TA1535 and TA1537, 1.0/µg/plate for TA1538 and TA98
Details on test system and conditions:
Details on test system and conditionsMETHOD 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 availableSELECTION AGENT (mutation assays): No data availableSPINDLE INHIBITOR (cytogenetic assays): No data availableSTAIN (for cytogenetic assays): No data availableNUMBER OF REPLICATIONS: No data availableNUMBER OF CELLS EVALUATED: No data availableDETERMINATION OF CYTOTOXICITY- Method: No data availableOTHER EXAMINATIONS:- Determination of polyploidy: No data available- Determination of endoreplication: No data available- Other: 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:
No data available

Results and discussion

Test results
Species / strain:
other: TA1535, TA1537, TA1538, TA98 and TA100
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
yes
Negative controls valid:
not specified
Positive controls valid:
yes
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: Aroclor 1254-induced male Fischer 344 rats and Syrian golden hamsters
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:
Interpretation of results (migrated information):negative Negative (with and without)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:

Plate-incorporation was carried out according to the method of Prival and Mitchell, 1982; Prival et al., 1984, to observe genetic effect of C.I. Acid blue 74 in S.typhimurium strainTA1535, TA1537, TA1538, TA98 and TA100. All strain were tested at dose 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 is 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 substanceC.I. Acid blue 74is considered to be not mutagenic inSalmonella typhimurium strain TA1535, TA1537, TA1538, TA98 and TA100 with and without metabolic activation.