Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
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 of Anthraquinone and Azo Dyes in Ames' Salmonella Typhimurium Test
Author:
S. Venturini and M. Tamaro
Year:
1979
Bibliographic source:
Mutation Research, 68 (1979) 307-312

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
Bacterial gene mutation test was performed to evaluate the mutagenic response for the test chemical Red H3B (C.I. reactive red 3)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: Red H3B (C.I. reactive red 3)
- IUPAC name: trisodium 5-{[4-chloro-6-(phenylamino)-1,3,5-triazin-2-yl]amino}-4-hydroxy-3-[(E)-2-(2-sulfonatophenyl)diazen-1-yl]naphthalene-2,7-disulfonate
- Molecular formula: C25H18ClN7O10S3.3Na
- Molecular weight: 774.054 g/mol
- Substance type: Organic
Specific details on test material used for the study:
- Name of test material: Red H3B (C.I. reactive red 3)
- IUPAC name: trisodium 5-{[4-chloro-6-(phenylamino)-1,3,5-triazin-2-yl]amino}-4-hydroxy-3-[(E)-2-(2-sulfonatophenyl)diazen-1-yl]naphthalene-2,7-disulfonate
- Molecular formula: C25H18ClN7O10S3.3Na
- Molecular weight: 774.054 g/mol
- Substance type: Organic
- Physical state: No data available
- Purity No data available
- Impurities (identity and concentrations): No data available

Method

Target gene:
Histidine
Species / strain
Species / strain:
other: TA1535, TA100, TA1538 and TA98
Details on mammalian cell lines (if applicable):
Not applicable
Additional strain characteristics:
not specified
Cytokinesis block (if used):
No data
Metabolic activation:
with and without
Metabolic activation system:
S9 mix was prepared from liver homogenate of rats treated with Aroclor 1254 plus adequate cofactors
Test concentrations with justification for top dose:
100, 500 or 1000 µg/plate
Vehicle:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test chemical was soluble in DMSO
Controls
Negative controls:
not specified
Solvent controls:
not specified
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
ethylmethanesulphonate
methylmethanesulfonate
other: Hycanthone (TA1538 and TA98)
Details on test system and conditions:
METHOD OF APPLICATION: soft-agar overlay method

DURATION
- Preincubation period: No data
- Exposure duration: No data
- Expression time (cells in growth medium): No data
- Selection time (if incubation with a selection agent): 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: 4 experiments were performed

NUMBER OF CELLS EVALUATED: No data available

DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data available

OTHER EXAMINATIONS:
- Determination of polyploidy: No data available

- Determination of endoreplication: No data available

- Other: No data available

OTHER: No data available
Rationale for test conditions:
No data
Evaluation criteria:
The plates were observed for number of revertants/plate
Statistics:
No data

Results and discussion

Test results
Species / strain:
other: TA1535, TA100, TA1538, and TA98
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity:
not specified
Vehicle controls valid:
not specified
Negative controls valid:
not specified
Positive controls valid:
yes
Remarks on result:
other: No mutagenic potential
Additional information on results:
No data

Any other information on results incl. tables

Table: Mutagenic activity of Xylene light yellow 2G (C.I. acid yellow 17)

Dose (µg/plate)

Number of His + revertants/plate

TA1535

TA100

TA1538

TA98

-

+

-

+

-

+

-

+

1000

12

19

13

18

5

6

4

8

500

9

10

7

9

2

2

2

4

100

0

10

2

8

0

1

2

3

Applicant's summary and conclusion

Conclusions:
Red H3B (C.I. reactive red 3) did not induce reversion of mutation when applied to Salmonella typhimurium strains TA1535, TA100, TA1538, and TA98 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.
Executive summary:

Bacterial gene mutation test was performed to evaluate the mutagenic response for the test chemical Red H3B (C.I. reactive red 3). The test was performed using Salmonella typhimurium strainsTA1535, TA100, TA1538, and TA98 in the presence and absence of S9 metabolic activation system. The test compound was dissolved in DMSO and used at dose levels of 100, 500 or 1000µg/plate. Concurrent positive control chemicals were also included in the study. Xylene light yellow 2G (C.I. acid yellow 17)did not induce reversion of mutation when applied to Salmonella typhimurium strainsTA1535, TA100, TA1538, and TA98 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.