4-amino-2-methylpyrimidine-5-methylamine

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:

04/09/2002 - 14/02/2003

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: according to guidline under GLP

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Principles of method if other than guideline:

not relevant

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

4-amino-2-methylpyrimidine-5-methylamine

EC Number:

202-384-7

EC Name:

4-amino-2-methylpyrimidine-5-methylamine

Cas Number:

95-02-3

Molecular formula:

C6H10N4

IUPAC Name:

5-(aminomethyl)-2-methylpyrimidin-4-amine

Details on test material:

- Name of test material (as cited in study report): Grewe-diamine

Method

Target gene:

TA97a: hisD6610, TA 98: hisD3052; TA 100 and TA 1535 hisG46, TA102: hisG428

Species / strain

Species / strain / cell type:

other: TA97a, TA 98; TA 100, TA 1535, TA102

Details on mammalian cell type (if applicable):

not applicable

Additional strain / cell type characteristics:

other: TA97a, TA98 and TA100: uvrB; TA100 & 102: pKM 101 (TA97a, TA98, TA100 and TA 102 are rfa)

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

5, 1.5, 0.5, 0.15, 0.005 mg/ plate

Controls

Untreated negative controls:

yes

Remarks:

pure solvent

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

benzo(a)pyrene

Remarks:

Migrated to IUCLID6: Aminoanthracene, NaN3

Results and discussion

Test results

Species / strain:

other: TA97a, TA 98; TA 100, TA 1535, TA102

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no 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'.

Any other information on results incl. tables

no additional remarks

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Grewe-diamin can be considered as not mutagenic and not cytotoxic in the Ames test under the described experimental conditions.

Executive summary:

Grewe-diamin was evaluated for mutagenic activity in the Ames test. A standard plate incorporation and a preincubation modification assay in absence and in presence of an exogenous metabolic activation system (S9) were performed. Five Salmonella typhimurium

tester strains (TA1535, TA97a, TA98, TA100, and TA102) were employed. The activity of the S9 -mix and the responsiveness of the tester strains were verified by including appropriate controls into each experiment. The substance was dissolved in water. Five different concentrations up to 5 mg/plate were chosen for the main experiment.

No significant increase in the number of revertant colonies was apparent in all five tester strains (TA1535, TA97a, TA98, TA100, and TA102) using both methods, after treatment with Grewe-diamin.

Based on these data Grewe-diamin can be considered as not mutagenic and not cytotoxic in the Ames test under the described experimental conditions.