4-(hydroxymethyl)-4-methyl-1-phenylpyrazolidin-3-one

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 February 1985 to 03 May 1985

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

26 May 1983

Deviations:

yes

Remarks:

no strain to induce cross-linking was included

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

4-(hydroxymethyl)-4-methyl-1-phenylpyrazolidin-3-one

EC Number:

235-920-3

EC Name:

4-(hydroxymethyl)-4-methyl-1-phenylpyrazolidin-3-one

Cas Number:

13047-13-7

Molecular formula:

C11H14N2O2

IUPAC Name:

4-(hydroxymethyl)-4-methyl-1-phenylpyrazolidin-3-one

Test material form:

solid

Method

Target gene:

Histidine

Species / strain

Species / strain 1

Species / strain / cell type:

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

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

Aroclor 1254 induced rat S9

Test concentrations with justification for top dose:

2 exp at 10, 33, 100, 333 and 500 ug/plate based on viability as tested in a pre-test with TA100 (decreased viability at 1000 ug/plate and above, no effects up to 333 ug/plate)

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: no data

Controls

Controls 1

Negative solvent / vehicle controls:

yes

Remarks:

0.1 mL ethanol

Positive controls:

yes

Positive control substance:

9-aminoacridine

sodium azide

methylmethanesulfonate

other: 4-nitro-o-phenylene-diamine

Controls 2

Negative solvent / vehicle controls:

not specified

Remarks:

0.1 mL ethanol

Positive control substance:

other: 2-aminoanthracene

Details on test system and experimental conditions:

METHOD OF APPLICATION: plate incorporation
- Cell density at seeding: 10E8/mL

DURATION
- Preincubation period: NA
- Exposure duration: 48 h at 37°C

NUMBER OF REPLICATIONS: 3/concentration

DETERMINATION OF CYTOTOXICITY
- Method: relative total growth

Evaluation criteria:

not included in the report

Statistics:

NA

Results and discussion

Test results

Test results 1

Key result

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

in the repeat test reduction of bacterial background lawn at 500 ug/plate

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 2

Key result

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

in the repeat test reduction of bacterial background lawn at 500 ug/plate

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 3

Key result

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

in the repeat test reduction of bacterial background lawn at 500 ug/plate

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 4

Key result

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

in the repeat test reduction of bacterial background lawn at 500 ug/plate

Vehicle controls validity:

valid

Positive controls validity:

valid

Test results 5

Key result

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

in the repeat test reduction of bacterial background lawn at 500 ug/plate

Vehicle controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

The substance did not induce mutagenic effects in the Ames test

Executive summary:

The substance was tested in the Ames test (plate incorporation) in two independent assays at 10,33, 100, 333 and 500 ug/plate in ethanol in Salmonella typhimurium TA98, TA100, TA1535, TA1537 and TA1538 with and without metabolic activation. In none of the strains any increases in the number of revertants was observed. The sbstance is concluded to be not mutagenic in bacteria.