4-[(2-chloro-4-nitrophenyl)azo]-N-ethyl-N-[2-[1-(2-methylpropoxy)ethoxy]ethyl]aniline

Genetic toxicity: in vitro

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:

Gene mutation toxicity study of the test chemical

Author:

Cheung et al

Year:

1994

Bibliographic source:

Carcinogenesis vol.15 no.6 pp.1257-1263, 1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Refer below principle

Principles of method if other than guideline:

Ames assay was performed to determine the mutagenic nature of the test chemical

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

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:

4-(Diethylamino)azobenzene

Details on test material:

- Name of test material: 4-diethylaminoazobenzene
- IUPAC name: 4-(Diethylamino)azobenzene
- Molecular formula: C16H19N3
- Molecular weight: 253.347 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data
- Impurities (identity and concentrations): No data

Method

Target gene:

Histidine

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA98 and TA100

Details on mammalian cell type (if applicable):

Not applicable

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

No data

Metabolic activation:

with and without

Metabolic activation system:

10% (v/v) microsomal fractions (25% w/v) from Aroclor 1254-treated animals and supplemented with glucose 6-phosphate dehydrogenase (1 unit/plate).

Test concentrations with justification for top dose:

0-100 µg/plate

Vehicle / solvent:

No data

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

True negative controls:

not specified

Positive controls:

not specified

Positive control substance:

not specified

Details on test system and experimental conditions:

Details on test system and conditions
METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 1 hr in shaking water bath at 37˚C
- Exposure duration: No data
- Expression time (cells in growth medium): No data
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data

SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data

NUMBER OF REPLICATIONS: Triplicate

NUMBER OF CELLS EVALUATED: No data

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

OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Other: No data

OTHER: No data

Rationale for test conditions:

No data

Evaluation criteria:

The plates were observed for an increase in the number of revertants/plate

Statistics:

Statistical analysis was carried out using Student's t-test.

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA98 and TA100

Metabolic activation:

with and without

Genotoxicity:

negative

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: No mutagenic potential

Applicant's summary and conclusion

Conclusions:

The given test chemical did not induce gene mutation in Salmonella typhimurium strains TA98 and TA100 in the presence and absence of metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.

Executive summary:

Ames assay was performed to determine the mutagenic nature of the given test chemical. The study was performed using Salmonella typhimurium strains TA98 and TA100 in the presence and absence of metabolic activation system. The study was performed as per the princubation assay. The test chemical was preincubated with the bacterial strains for 1 hr and studied at dose levels of 0-100µg/plate. The test chemical did not induce gene mutation in Salmonella typhimurium strains TA98 and TA100 in the presence and absence of metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.