4,4'-methylenebis(2,6-xylidine)

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:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards, well documented and acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Principles of method if other than guideline:

According to: Ames BN, McCann J, Yamasaki E (1975): Methods for detecting carcinogens and mutagens with the Salmonella/ mammalian-microsome mutagenicity test, Mutat Res 31: 47-364, with minor modifications

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-methylenebis(2,6-xylidine)

EC Number:

223-786-9

EC Name:

4,4'-methylenebis(2,6-xylidine)

Cas Number:

4073-98-7

Molecular formula:

C17H22N2

IUPAC Name:

4-[(4-amino-3,5-dimethylphenyl)methyl]-2,6-dimethylaniline

Details on test material:

- Name of test material: Toluidinbase/ 3,3',5,5'-tetramethyl-4,4´-diaminodiphenylmethane

Method

Species / strain

Species / strain 1

Species / strain / cell type:

other: Salmonella typhimurium TA 98, TA 100, TA 1537

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

Liver S-9 mix from male rats treated with Aroclor 1254

Test concentrations with justification for top dose:

3.15 - 3000 µg/plate

Vehicle / solvent:

DMSO

Controls

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

other: see details on test system

Details on test system and experimental conditions:

Standard platetest: The test compound dissolved in DMSO, bacterial suspension and top agar were mixed in the absence and presence of Aroclor 1254, phenobarbital or ß-naphthoflavone induced male rat liver S9-mix and poured into a minimal agar containing petri dish. After incubation for 2-3 days in the dark, his+ revertants were counted.
Test concentration without metabolic activation: 0, 31.5, 100, 315, 1000, 3000 µg/plate
Test concentration with metabolic activation: 0, 3.15, 10, 31.5, 100, 315, 1000, 3000 µg/plate
Every single experiment contained positive controls for checking the activity of the metabolizing system and the mutability of the bacteria as well as negative controls.

Positive controls:
Without metabolic activation: N-methyl-N'-nitro-N-nitrosoguanidine and benzo(a)pyrene-4,5-oxide for all strains
With metabolic activation: 3-methylcholanthrene, benzo(a)pyrene and 2-aminoanthracene for all strains

Evaluation criteria:

Positive results
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the result

Results and discussion

Test results

Test results 1

Species / strain:

other: S. typhimurium TA 100, TA 1537, TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.