6-hydroxy-1H-pyrimidin-4-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:

weight of evidence

Study period:

1996 or before

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Published under the US National Toxicology Program, according to the quality rules of the NTP interagency program ("best science available"). Experimental details well documented, but no explicit reference to GLP. Only four S. typhimurium strains, but no E. coli tested.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1996

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.5265 (The Salmonella typhimurium Bacterial Reverse Mutation Test)

Version / remarks:

No explicit reference to this guideline

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

6-hydroxy-1-H-pyrimidin-4-one

IUPAC Name:

6-hydroxy-1-H-pyrimidin-4-one

Constituent 2

Reference substance name:

6-Hydroxy-4(1H)-pyrimidinone

IUPAC Name:

6-Hydroxy-4(1H)-pyrimidinone

Constituent 3

Reference substance name:

6-hydroxy-1H-pyrimidin-4-one

EC Number:

214-772-3

EC Name:

6-hydroxy-1H-pyrimidin-4-one

Cas Number:

1193-24-4

Molecular formula:

C4H4N2O2

IUPAC Name:

6-hydroxypyrimidin-4(3H)-one

Method

Target gene:

hisG46, hisD3052, hisC3076 (from choice of strains)

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 100

Species / strain 3

Species / strain / cell type:

S. typhimurium TA 97

Species / strain 4

Species / strain / cell type:

S. typhimurium TA 98

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254-induced male Sprague-Dawley rat liver S9, 10% and 30%; Aroclor 1254-induced male Syrian hamster liver S9, 10% and 30%

Test concentrations with justification for top dose:

100, 333, 1000, 3333, 10000 microgram/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: water

Controls

Controls 1

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

water

True negative controls:

no

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

without metabolic activation

Migrated to IUCLID6: for TA 98; sodium azide (TA100 + TA1535); 9-aminoacridine (TA97)

Controls 2

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

water

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene (all strains)

Remarks:

with metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 minutes at 37°
- Exposure duration: 2 days

NUMBER OF REPLICATIONS:
- not stated; sufficient to calculate mean and standard error of mean

NUMBER OF CELLS EVALUATED:
- no data

Evaluation criteria:

Significant increase of mutant colonies over spontaneous control rate
Pattern and strength of mutant response
Verification of response in repeat test

Statistics:

Mean and standard error of mean (SEM)

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Remarks:

no toxicity up to 10000 microgram/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Remarks:

no toxicity up to 10000 microgram/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 3

Species / strain:

S. typhimurium TA 97

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Remarks:

no toxicity up to 10000 microgram/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 4

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Remarks:

no toxicity up to 10000 microgram/plate

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The results are sufficiently detailed and unambiguous as to be reliable for risk assessment, classification and labeling.