N-isopropyl-N'-phenyl-p-phenylenediamine

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:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP study, comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Principles of method if other than guideline:

Ames assay according to Ames et al. (1975) Methods for detecting carcinogens and mutagens with Salmonella Mammalian-microsome test, Mutat. Res. 31, 347-364

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N-isopropyl-N'-phenyl-p-phenylenediamine

EC Number:

202-969-7

EC Name:

N-isopropyl-N'-phenyl-p-phenylenediamine

Cas Number:

101-72-4

Molecular formula:

C15H18N2

IUPAC Name:

N1-phenyl-N4-(propan-2-yl)benzene-1,4-diamine

Details on test material:

Santoflex IP, purity: 92 to 99%

Method

Target gene:

Ames assay

Species / strain

Species / strain / cell type:

S. typhimurium, other: TA98, TA100, TA 1535, TA 1537

Metabolic activation:

with and without

Metabolic activation system:

S9 mix, S9 from Aroclor 1254-induced male Spreague-Dawley rat livers

Test concentrations with justification for top dose:

0, 0.2, 4, 20, 60, 200 µg/plate

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

other: -S9: 4-nitroquinoline-N-oxide, NaNO2, 9-aminoacridine, +S9: 2-acetylaminofluorene, benzo(a)pyrene, 2-aminoanthracene

Results and discussion

Test results

Species / strain:

S. typhimurium, other: TA98, TA100, TA 1535, TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'. Remarks: TA98, TA100, TA 1535, TA 1537

Any other information on results incl. tables

Pretest:

A toxicity screen was conducted using test strain TA100 with and without S-9 Mix. In the toxicity screen the test sample was toxic at levels of 200 µg/plate and above. Plate incorporation tests were conducted with maximum levels of 200 µg/plate in the presence and absence of S-9 Mix. These maximum levels tested were toxic in the plate incorporation tests.

Results of the statistical analyses of plate in-corporation assay results indicated that the test sample was not mutagenic. None of the strain/microsome combinations had three treatment levels with revertants/plate significantly elevated over control values (p<0.0l) or a

significant positive dose response (p<0.0l).

The authors concluded that the test sample, Santoflex IP, was not mutagenic towards any of the Salmonella typhimurium test strains used (TA98, TA100, TA1535 or TA1537) in presence or absence of a rat liver homogenate mammalian metabolic activation system (S-9mix).

Applicant's summary and conclusion

Conclusions:

negative