1,1'-(p-tolylimino)dipropan-2-ol

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

Study period:

21.04.1998-26.05.1998

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP and guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

testing lab.

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1,1'-(p-tolylimino)dipropan-2-ol

EC Number:

254-075-1

EC Name:

1,1'-(p-tolylimino)dipropan-2-ol

Cas Number:

38668-48-3

Molecular formula:

C13H21NO2

IUPAC Name:

1,1'-(p-tolylimino)dipropan-2-ol

Method

Target gene:

S. typhimurium and E. coli

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

microsomal enzyme system (S-9 mix) from Aroclor 1254 induced Sprague Dawley rat liver

Test concentrations with justification for top dose:

20 µg - 5000 µg/plate (standard plate test and preincubation test)

Vehicle / solvent:

DMSO

Controls

Controls 1

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

yes

Positive controls:

yes

Positive control substance:

other: 2-amninoanthracene

Remarks:

with S-9 mix, in TA 1535, TA 100, TA 1537, TA 98, Escherichia coli WP2 uvrA

Controls 2

Positive controls:

yes

Positive control substance:

other: aniline and o-toluidine

Remarks:

with S-9 mix and norharman, in TA 98

Controls 3

Positive controls:

yes

Positive control substance:

other: N-methyl-N'-nitro-N-nitrosoguanidine

Remarks:

without S-9 mix, in TA 1535, TA 100

Controls 4

Positive controls:

yes

Positive control substance:

other: 4-nitro-o-phenylendiamine

Remarks:

without S-9 mix, TA 98

Controls 5

Positive controls:

yes

Positive control substance:

other: 9-amninoacridine

Remarks:

without S-9 mix, TA 1537

Controls 6

Positive controls:

yes

Positive control substance:

other: 4-Nitroquinoline-N-Oxide

Remarks:

without S-9 mix, E. coli WP uvrA

Details on test system and experimental conditions:

METHOD OF APPLICATION: standard plate and preincubation method

DURATION
- Preincubation period: 20 minutes
- Expression time (cells in growth medium): 48-72 h

NUMBER OF PLATES: 3 per dose or control

DETERMINATION OF CYTOTOXICITY
- Method:
Examination of background lawn and comperison of spontaneous revertants with control
The titer of viable bacteria was >= 10E9/mL

Evaluation criteria:

The test chemical is considered positive in this assay if the following criteria are met:
- A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S-9 mix or after adding a metabolizing system.
A test substance is generally considered nonmutagenic in this test if:
- The number of revertants for all tester strains were within the historical negative control range under all experimental conditions in two experiments carried out independently of each other.

Results and discussion

Test results

Test results 1

Species / strain:

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

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not valid

Positive controls validity:

valid

Test results 2

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not valid

Positive controls validity:

valid

Additional information on results:

An increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test either without S-9 mix or after the addition of a metabolizing system.
The number of revertant colonies in the negative controls was within the normal range of the historical control data for each tester strain
The sterility controls revealed no indication of bacterial contamination
The positive control articles both with and without S-9 mix induced a significant increase in the number of revertant colonies within the range of the historical control data.
Cytotoxicity:
S.thyphimurium TA 1535, TA 1537, TA 98 and TA 100
standard plate test: slight decrease his+ revertants in the about 5000 µg/plate (TA 1535, TA 100, TA 1537) and 2500 µg/plate onward (TA 98). The preincubation assay: bacteriotoxicity from about 2500 µg/plate (Salmonella strains).
E.coli and WP2 uvr A
Preincubaton assay: bacteriotoxicity at 5000 µg/plate
Precipitation: was not found

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.