4-(phenylazo)benzene-1,3-diamine acetate

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:

supporting 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 journal

Data source

Reference

Reference Type:

publication

Title:

Lack of release from hepatocytes in vitro or excretion in vivo of mutagenic chrysoidine metabolites

Author:

Punam Sandhu and James K. Chipman

Year:

1991

Bibliographic source:

Toxicology Letters, 58 (1991) 43-50

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Refer below principle

Principles of method if other than guideline:

The Salmonella/S9 mutagenicity assay was performed to evaluate the mutagenic nature of the test compound chrysoidine R

GLP compliance:

not specified

Type of assay:

bacterial gene mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

4-(phenylazo)benzene-1,3-diamine

EC Number:

207-803-7

EC Name:

4-(phenylazo)benzene-1,3-diamine

Cas Number:

495-54-5

Molecular formula:

C12H12N4

IUPAC Name:

4-(phenyldiazenyl)benzene-1,3-diamine

Constituent 2

Reference substance name:

Chrysoidine free base

IUPAC Name:

Chrysoidine free base

Details on test material:

- Name of test material (as cited in study report): Chrysoidine R
- Molecular formula (if other than submission substance): C12-H12-N4
- Molecular weight (if other than submission substance): 212.255 g/mol
- Substance type: Organic
- Physical state: No data available
Purity: No data available
- Impurities (identity and concentrations): No data available

Specific details on test material used for the study:

- Name of test material: Chrysoidine R
- Molecular formula: C12H12N4
- Molecular weight: 212.255 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 / cell type:

S. typhimurium TA 100

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not applicable

Cytokinesis block (if used):

No data

Metabolic activation:

with

Metabolic activation system:

S9 fractions were prepared from the livers of control and B-naphthoflavone (βNF)-induced rats.

Test concentrations with justification for top dose:

5-80 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test compound was dissolved in dimethyl sulphoxide (DMSO)

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

not specified

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 mins
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- 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: Duplicate

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:

Increase in number of his +revertant colonies per plate was noted.

Statistics:

Mean ± SEM

Results and discussion

Test results

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

No data

Remarks on result:

other: Mutagenic potential

Applicant's summary and conclusion

Conclusions:

The test compound Chrysoidine R was found to increase the number of revertant colonies per plate and hence is mutagenic in vitro.

Executive summary:

The Salmonella/S9 mutagenicity assay was performed to evaluate the mutagenic nature of the test compound chrysoidine R with or without the addition of β-glucuronidase (βG). Chrysoidine R was dissolved in dimethyl sulphoxide (DMSO) and added (20 µL) at a concentration of 5-80 µg/plate. The test compound was found to increase the number of revertant colonies per plate and hence is mutagenic in vitro.