N-[2-[(2,6-dicyano-p-tolyl)azo]-5-(diethylamino)phenyl]methanesulphonamide

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

23 Nov 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

No Prival modification

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N-[2-[(2,6-dicyano-p-tolyl)azo]-5-(diethylamino)phenyl]methanesulphonamide

EC Number:

269-887-1

EC Name:

N-[2-[(2,6-dicyano-p-tolyl)azo]-5-(diethylamino)phenyl]methanesulphonamide

Cas Number:

68385-96-6

Molecular formula:

C20H22N6O2S

IUPAC Name:

N-[2-[(2,6-dicyano-p-tolyl)azo]-5-(diethylamino)phenyl]methanesulphonamide

Test material form:

solid: particulate/powder

Method

Target gene:

uvrB

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Metabolic activation:

with and without

Metabolic activation system:

S9 mix rat

Test concentrations with justification for top dose:

Concentration range in the main test (with and without metabolic activation): 0, 8, 40, 200, 1000, 5000 µg/plate

Vehicle / solvent:

Solvent: DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

other: Nitrofurantoin; 4-nitro-1,2-phenylendiamine; 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: plate incorporation

DURATION
- Exposure duration: 48 h at 37°C

SELECTION AGENT (mutation assays): histidine solution

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Results and discussion

Test results

Species / strain:

other: TA 1535, TA 100, TA 1537, TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

starting from >1000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

The positive controls sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine and 2-aminoanthracene increased mutant counts to well over those of the negative controls, and thus demonstrated the system's sensitivity and the activity of the S9 mix.

Any other information on results incl. tables

Substance precipiation occurring from >=8 µg/plate

Applicant's summary and conclusion

Conclusions:

Although statistical evaluation noted a weak positive effect in Salmonalla typhimurium TA 98 in the presence of S9-mix, no 2-fold increases of revert mutations was found in any strain tested.
The substance was found to be cytotoxic in all strains tested >1000 µg/plate.