2-(2-oxoimidazolidin-1-yl)ethyl methacrylate

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:

2002-07-25 to 2002-08-23

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Version / remarks:

updated and adopted July 2 1, 1997. Including E. coli tester strain (former OECD guideline 472)

Deviations:

no

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

2-(2-oxoimidazolidin-1-yl)ethyl methacrylate

EC Number:

289-214-5

EC Name:

2-(2-oxoimidazolidin-1-yl)ethyl methacrylate

Cas Number:

86261-90-7

Molecular formula:

C9H14N2O3

IUPAC Name:

2-(2-oxoimidazolidin-1-yl)ethyl methacrylate

Test material form:

other: liquid

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix from Aroclor 1254 induced rat livers

Test concentrations with justification for top dose:

33.3, 100, 333, 1000, 3330, 5000 µg/plate

Vehicle / solvent:

water

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: with S9: benzo[a]pyrene (TA98), 2-aminoanthracene (all other strains); without S9 mix: 2-nitrofluorene (TA98), sodium azide (TA100, TA1535), ICR- 191 (TA1537), 4-nitroquinoline-N-oxide (E. coli)

Details on test system and experimental conditions:

METHOD OF APPLICATION: plate incorporation (SPT)
- Application: When S9 was not required, 100 μL of tester strain and 50 μL of test or control article were added to 2.5 mL of molten selective top agar (maintained at 45 ± 2°C). When S9 was required, 500 μL of S9 mix, 100 μL of tester strain and 50 μL of test or control article dose were added to 2.0 mL of molten selective top agar. After the required components had been added, the mixture was vortexed and overlaid onto the surface of 25 mL of minimal bottom agar contained in a 15 x 100 mm petri dish.
- Exposure duration: After the overlay solidified, the plates were inverted and incubated for 52 ± 4 hours at 37 ± 2°C.
NUMBER OF REPLICATIONS: 3
NUMBER OF INDEPENDENT TESTS: 2
DETERMINATION OF CYTOTOXICITY
- Method: background lawn

Evaluation criteria:

For strains TA98, TA100 and E. coli, the test article had to produce at least a 2-fold increase in the number of revertants per plate to be considered a positive response. For strains TA1535 and TA1537, the increase had to be 3-fold. This increase in the mean number of revertants per plate had to be accompanied by a dose response to increasing concentrations of the test article.

Statistics:

Statistical methods beyond the calculation of the mean and standard deviation are not considered necessary for the interpretation of this study.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

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

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation occurred.
- Other confounding effects: In the independent confirmatory experiment, increases in revertant frequencies to approximately 2.0-2.7-fold control values, were observed in tester strain WP2uvrA at doses of 33.3 to 333 μg/plate without S9. However, these increases did not appear to be dose-dependent, and all observed values were within acceptable negative control ranges. The slight increase observed in this strain are considered to be a statistical aberration due to random fluctuation of the spontaneous revertant frequency.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.