Bis[[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthyl]methylene]cyclohexa-2,5-dien-1-ylidene]diethylammonium] dicopper(1+) hexa(cyano-C)ferrate(4-)

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro DNA damage and/or repair study

Remarks:

Type of genotoxicity: DNA damage and/or repair

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 publication

Data source

Reference

Reference Type:

publication

Title:

The genotoxicity of a variety of aniline derivatives in a DNA repair test with primary cultured rat hepatocytes

Author:

Naoki Yoshimi, Shigeyuki Sugie, Hitoshi Iwata, Kenji Niwa, Hideki Mori, Chise Hashida and Hidesuke Shimizu

Year:

1988

Bibliographic source:

Mutation Research, 206 (1988) 183-191

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Refer below principle

Principles of method if other than guideline:

Hepatocyte/DNA repair test was performed to determine the mutagenic nature of N,N-Diethylaniline

GLP compliance:

not specified

Type of assay:

DNA damage and repair assay, unscheduled DNA synthesis in mammalian cells in vitro

Test material

Test material information

Constituent 1

Reference substance name:

N,N-diethylaniline

EC Number:

202-088-8

EC Name:

N,N-diethylaniline

Cas Number:

91-66-7

Molecular formula:

C10H15N

IUPAC Name:

N,N-diethylaniline

Details on test material:

- Name of test material (as cited in study report): N,N-Diethylaniline
- Molecular formula (if other than submission substance): C10H15N
- Molecular weight (if other than submission substance): 149.236 g/mol
- Substance type: organic
- Physical state: solid
- Purity: > 99%
- Impurities (identity and concentrations): no data available

Specific details on test material used for the study:

- Name of test material: N,N-Diethylaniline
- Molecular formula: C10H15N
- Molecular weight: 149.236 g/mol
- Substance type: organic
- Physical state: solid
- Purity: > 99%
- Impurities: < 1%

Method

Target gene:

No data available

Species / strain

Species / strain / cell type:

hepatocytes: ACI Rat hepatocytes

Details on mammalian cell type (if applicable):

No data available

Additional strain / cell type characteristics:

not specified

Cytokinesis block (if used):

No data

Metabolic activation:

not specified

Metabolic activation system:

No data available

Test concentrations with justification for top dose:

10-3, 10-4, 10-5, 10-6 M

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: N-2-fluorenylacetamide

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium

DURATION
- Preincubation period: No data available
- Exposure duration: 20 hrs
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent):
- 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: No data available

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: The test was performed in accordance with the method of Williams et al. Hepatocytes were isolated from the livers of male ACI rats weighing 200-250 g. The isolated hepatocytes were allowed to attach for 2 h on plastic coverslips in primary culture using Williams' Medium E. The cultures were then washed and exposed to the test chemical and [Me- 3H]thymidine (10 µCi/ml; 49 Ci/mmole) for 20 h. It was logarithmically diluted before addition to the cultures. At the end of incubation, the cultures were washed, and the coverslips were mounted on glass slides. The slides were dipped in Sakura NR-M2 photographic emulsion and exposed for 14 days. Autoradiographic grains were counted on a television screen (Olympus, type S) with a microscopic attachment.
The data were expressed as the average net counts/nucleus for 3 coverslips + the standard deviation (50 cells/coverslip). Two experiments were performed for the test compound for the assays with rat hepatocytes.

Rationale for test conditions:

No data

Evaluation criteria:

The test chemical was considered positive when the mean net nuclear grain count was more than 5 grains above background and statistically greater than that of controls (unpaired t-test; P < 0.01).

Statistics:

Mean ± standard deviation

Results and discussion

Test results

Species / strain:

hepatocytes: ACI Rat hepatocytes

Metabolic activation:

not specified

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:

No data available

Remarks on result:

other: No mutagenic effect were observed

Applicant's summary and conclusion

Conclusions:

N,N-Diethylaniline(91-66-7) failed to induce mutation in ACI rat hepatocytes and hence is negative in the rat hepatocyte/ DNA repair test.

Executive summary:

The hepatocyte/DNA repair test which measures unscheduled DNA synthesis (UDS) is known to be sensitive to various classes of DNA-reactive carcinogens and is regarded as a reliable short-term test for the detection of chemical carcinogens. In this study, the genotoxicity of N,N-Diethylaniline was examined by a DNA repair test with rat hepatocytes.

 

The test was performed basically in accordance with the method of Williams et al. The test material was dissolved in DMSO and used at dose level of 10^-3, 10^-4, 10^-5, 10^-6 M and the positive control used was N-2-fluorenylacetamide.

 

N,N-Diethylaniline failed to induce mutation in ACI rat hepatocytes and hence is negative in the rat hepatocyte/ DNA repair test.