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Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
Data is from publication .

Data source

Reference
Reference Type:
publication
Title:
In Vitro Mutagenicity Assays of Chemical Carcinogens and Related Compounds with Salmonella typhimurium
Author:
Vincent F. Simmon
Year:
1979
Bibliographic source:
J Natl Cancer Inst (1979) 62 (4): 893-899

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: As mention below
Principles of method if other than guideline:
To evaluate the mutagenic potential of 4-(Diethylamino)azobenzene in Salmonella typhimurium strain TA1535, TA1537 and TA1538 by Salmonella-microsome assay.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
N,N-diethyl-p-(phenylazo)aniline
EC Number:
219-616-8
EC Name:
N,N-diethyl-p-(phenylazo)aniline
Cas Number:
2481-94-9
Molecular formula:
C16H19N3
IUPAC Name:
N,N-diethyl-p-(phenylazo)aniline
Test material form:
solid
Details on test material:
- Name of test material: 4-(Diethylamino)azobenzene; N,N-diethyl-p-(phenylazo)aniline
- Molecular formula: C16H19N3
- Molecular weight: 253.347 g/mol
- Smiles notation: c1(N(CC)CC)ccc(\N=N\c2ccccc2)cc1
- InChl: 1S/C16H19N3/c1-3-19(4-2)16-12-10-15(11-13-16)18-17-14-8-6-5-7-9-14/h5-13H,3-4H2,1-2H3/b18-17+
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
- Name of test material: 4-(Diethylamino)azobenzene
- Molecular formula: C16H19N3
- Molecular weight: 253.347 g/mol
- Smiles notation: c1(N(CC)CC)ccc(\N=N\c2ccccc2)cc1
- InChl: 1S/C16H19N3/c1-3-19(4-2)16-12-10-15(11-13-16)18-17-14-8-6-5-7-9-14/h5-13H,3-4H2,1-2H3/b18-17+
- Substance type: Organic
- Physical state: Solid

Method

Target gene:
Histidine
Species / strain
Species / strain / cell type:
S. typhimurium, other: strain TA1535, TA1537 and TA1538
Details on mammalian cell type (if applicable):
Not applicable.
Additional strain / cell type characteristics:
other: uvrB-deficient (to reduce the repair ofchemically induced lesions in the DNA) and are rfa (to prevent the synthesis of a normal lipopolysaccheride.
Cytokinesis block (if used):
not specified
Metabolic activation:
with and without
Metabolic activation system:
S9 mix, Adult male Sprague-Dawley rats (200- 250 g) pretreated with Aroclor 1254 (500 mg/kg) were used to obtain liver for the metabolic activation system
Test concentrations with justification for top dose:
0-1000µg/plate (4.44µ/mol)
Vehicle / solvent:
Yes ,but not specified .
Controls
Untreated negative controls:
not specified
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: detailed data not available.
Details on test system and experimental conditions:
Details on test system and conditions
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 24 hour


Other: The strains were checked periodically for relevant genetic markers and for rfa by crystal violet sensitivity.
Rationale for test conditions:
No data available.
Evaluation criteria:
The numbers of histidine-independent revertants for each S. typhimurium strain were taken from the linear portion of dose-response curves after the background was subtracted. The range of spontaneous revertants was 25-55 for TA1535 and 7-25 for TA1537. A positive response was defined as a reproducible, dose-related increase in the
Statistics:
Not specified.

Results and discussion

Test results
Key result
Species / strain:
S. typhimurium, other: strain TA1535, TA1537 and TA1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
Additional information on results:
Not specified.
Remarks on result:
other: No mutagenic effect were observed.

Applicant's summary and conclusion

Conclusions:
4-(Diethylamino) azobenzene was evaluated for its mutagenic potential in Salmonella typhimurium strain TA1535, TA1537 and TA1538 by AMES assay.The test result was considered to be negative in the presece and absence of S9.
Executive summary:

Genetic toxicity in vitro for 4-(Diethylamino) azobenzene was assessed for its possible mutagenic potential .For this purpose Salmonella-microsome assay was performed on Salmonella typhimurium strainTA1535, TA1537 and TA1538,using test substance concentration of 0-1000µg/plate (4.44µmol/plate).The test substance was exposed to the Salmonella typhimurium strainTA1535, TA1537 and TA1538 in the presence and absence of metabolic activation system.S9 mix, Adult male Sprague-Dawley rats (200- 250 g) pre-treated with Aroclor 1254 (500 mg/kg) were used to obtain liver for the metabolic activation system. The strains were checked periodically for relevant genetic markers and for rfa by crystal violet sensitivity.Each experiment included solvent controls as well as known direct-acting mutagens and a mutagen that required metabolic activation. No mutagenic effects were observed during the study. Therefore4-(Diethylamino) azobenzene was considered to be non mutagenic in Salmonella typhimurium strainTA1535, TA1537 and TA1538 by AMES assay. Hence it cannot be classified as gene mutant in vitro.

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