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The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.