6-nonyl-1,3,5-triazine-2,4-diamine

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

GLP compliance:

yes

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

6-phenyl-1,3,5-triazine-2,4-diyldiamine

EC Number:

202-095-6

EC Name:

6-phenyl-1,3,5-triazine-2,4-diyldiamine

Cas Number:

91-76-9

IUPAC Name:

6-phenyl-1,3,5-triazine-2,4-diamine

Test material form:

solid: particulate/powder

Method

Species / strain

Species / strain / cell type:

other: Human lymphocytes

Metabolic activation:

with and without

Test concentrations with justification for top dose:

78.125, 156.25, 312.5, 625, 1250 µg/mL and additionally 2500 ug/mL for the 30 hr cell harvest without metabolic activation

Vehicle / solvent:

DMSO

Details on test system and experimental conditions:

-species/cell type: Human lymphocytes
-metabolic activation system: S9mix prepared from the livers of male Sprague-Dawley rats, after
induction with Aroclor 1254.

Results and discussion

Test results

Test results 1

Key result

Species / strain:

lymphocytes: human

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Test results 2

Key result

Species / strain:

lymphocytes: human

Metabolic activation:

without

Genotoxicity:

ambiguous

Remarks:

significant increase in the frequency of cells with structural chromosome aberrations when dosed above solubility level. This may be an artifact due to the precipitation of Benzoguanamine.

Cytotoxicity / choice of top concentrations:

cytotoxicity

Any other information on results incl. tables

PRECIPITATION CONCENTRATION: A precipitate of test substance was observed  at and above a final concentration of 625 µg/ml after addition of the  test material solution to the culuture media.
TEST-SPECIFIC CONFOUNDING FACTORS: 
STATISTICAL RESULTS: Test substance did not induce chromosomal  aberrations at doses within the solibility limit of the test substance.   It produced a statistically significant but quite modest increase in the  frequency of cells with chromosomal aberrations only at dose levels  exceeding the solubility limit in the absense of a liver enzym  metabolizing sysytem. This may be an artifact due to the precipitation of Benzoguanamine.

Applicant's summary and conclusion

Conclusions:

Within the solubility range, Benzoguanamine is not clastogenic.
Under non-standard conditions (precipitation, without metabolic activation) a significant increase of incidences is observed, but it cannot be judged
as artefactual or true result.

negative with metabolic activation
negative without metabolic activation within the solubility limit
ambiguous without metabolic activation above solubility limit

Executive summary:

In a human lymphocyte chromosome aberration assay, Human Lymphocytes cells cultured in vitro were exposed to this substance in DMSO at concentrations of 78, 125, 156.25, 312.5, 625, 1250, 2500 µg/mL in the presence and absence of mammalian metabolic activation. 

 

The positive controls induced the appropriate response. There were negative and ambiguous results of induced chromosomal aberrations over background.

 

This study satisfies the requirement for Test Guideline 473 for in vitro mutagenicity (chromosome aberration test) data.