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Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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.