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Toxicological information

Genetic toxicity: in vitro

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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

Constituent 1
Chemical structure
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'.

Applicant's summary and conclusion

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