Acetamide, N-[5-[bis(2-methoxyethyl)amino]-2-[2-(2,6-dicyano-4-nitrophenyl)diazenyl]phenyl]-

Genetic toxicity: in vivo

Administrative data

Endpoint:

in vivo mammalian cell study: DNA damage and/or repair

Remarks:

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21-01-2002 - 20-05-2002

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 486 (Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo)

Version / remarks:

21st July 1997

GLP compliance:

yes

Type of assay:

unscheduled DNA synthesis

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

437-930-5

EC Name:

-

Cas Number:

51553-03-8

Molecular formula:

Hill formula: C22H23N7O5 CAS formula: C22H23N7O5

IUPAC Name:

N-{5-[bis(2-methoxyethyl)amino]-2-[2-(2,6-dicyano-4-nitrophenyl)diazen-1-yl]phenyl}acetamide

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

26 male rats

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

1% (w/v) carboxymethylcellulose, suspension

Details on exposure:

PREPARATION OF DOSING SOLUTIONS:
The test substance was suspended in 1 % (w/v) carboxymethylcellulose. The suspensions were treated with ultrasonic waves to obtain a homogeneous suspension.

Duration of treatment / exposure:

2 - 4 h or 12 - 16 h

Frequency of treatment:

single dosing

Post exposure period:

2 - 4 h or 14 - 18 h

Doses / concentrations

Doses / concentrations 1

Dose / conc.:

2 000 mg/kg bw/day (actual dose received)

Doses / concentrations 2

Dose / conc.:

1 500 mg/kg bw/day (actual dose received)

Doses / concentrations 3

Dose / conc.:

1 000 mg/kg bw/day (actual dose received)

No. of animals per sex per dose:

Male: 2000 mg/kg; No. of animals: 3; Sampling time: 2 - 4 hours
Male: 1500 mg/kg; No. of animals: 3; Sampling time: 2 - 4 hours
Male: 1000 mg/kg; No. of animals: 3; Sampling time: 2 - 4 hours
Male: 2000 mg/kg; No. of animals: 3; Sampling time: 12 - 16 hours
Male: 1500 mg/kg; No. of animals: 3; Sampling time: 12 - 16 hours
Male: 1000 mg/kg; No. of animals: 3; Sampling time: 12 - 16 hours

Control animals:

yes

Positive control(s):

2-acetylaminofluorene (12 - 16 h treatment time):
- Route of administration: oral
- Doses / concentrations: 50 mg/kg bw, administered in corn oil
N-dimethylnitrosamine (2 - 4 h treatment time):
- Route of administration: oral
- Doses / concentrations: 10 mg/kg bw, administered in water

Examinations

Tissues and cell types examined:

liver; hepatocytes (living parenchymic liver cells)

Results and discussion

Test results

Sex:

male

Genotoxicity:

negative

Toxicity:

no effects

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

Observations:
The net nuclear grain count in the solvent-treated control cultures were within the historical control data range and the positive control cultures showed responses within the expected range. The viability of liver cells was at least 51%.

Applicant's summary and conclusion

Conclusions:

BDF 054-1 is not genotoxic in the DNA-repair assay using hepatocytes obtained from male rat liver following in vivo exposure for 2 - 4 or 12 - 16 hours to the test substance up to concentrations of 2000 mg/kg bw.