Perhydropyrimidin-2-one

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 guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

only four tester strains

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Perhydropyrimidin-2-one

EC Number:

217-443-2

EC Name:

Perhydropyrimidin-2-one

Cas Number:

1852-17-1

Molecular formula:

C4H8N2O

IUPAC Name:

tetrahydro-2(1H)-pyrimidinone

Details on test material:

- Name of test substance: Propylene urea
- CAS No.: 1852-17-1
- Date of manufacture: May 9, 1989
- Degree of purity: 93.8%
- Appearance, consistency: Colorless crystals
- Storage: Room temperature

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

Aroclor-induced rat liver S-9 mix

Test concentrations with justification for top dose:

20 - 5000 µg/plate

Vehicle / solvent:

- Vehicle/solvent used: DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Remarks:

w/ S-9 mix: 2.5 µg 2-AA for all strains; w/o S-9 mix: 5 µg MNNG for strains TA 100 and TA 1535, 10 µg NOPD for strain TA 98, 100 µg AAC for strain TA 1537

Details on test system and experimental conditions:

METHOD OF APPLICATION: standard plate test and preincubation test

NUMBER OF REPLICATIONS: two independent experiments, 3 plates per dose or per control

DETERMINATION OF CYTOTOXICITY
- Method: titer determination, his- background grwoth, decrease in number of his+ revertants

Evaluation criteria:

In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results

Results and discussion

Test results

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

Remarks:

only in the preincubation test at 5000 µg/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No test substance precipitation was found.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

According to the results of this study, the test substance Propylene urea was not mutagenic in the Ames test under the experimental conditions chosen here.