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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:
03 September 1999 - 21 September 1999
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Test method not reported but correct tester strains have been used. Not a GLP study (no QA audit). Purity and lot number given. Positive and negative controls have been tested. Report contains detailed description of equipment, procedures and calculations. Experimental work of good scientific quality. Study design meets all the requirements of current OECD Guideline 471.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Principles of method if other than guideline:
This test was conducted at the testing facilities meeting the requirements provided in Article 4 of the “Order that stipulates items relating to the tests on new chemical substances and investigation into harmfulness of designated chemical substances” (Environmental Planning & Research No. 233, Sanitation No.38, November 18, 1988).
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): 1,3-Dimethyl-2-imidazolidinone (DMI)
- Physical state: Transparent, colorless and mobile liquid
- Analytical purity: 99.9%
- Lot/batch No.: 990517
- Stability under test conditions: stable

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
S9Mix
Test concentrations with justification for top dose:
Dose setting test (with and without S9Mix): 5, 20, 78, 313, 1250, 5000 μg/plate
Main test: 313, 625, 1250, 2500, 5000 μg/plate
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
sodium azide
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
9-aminoacridine
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
benzo(a)pyrene
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: 10 hours
- Exposure duration: 48 hours


NUMBER OF REPLICATIONS: 2

Results and discussion

Test resultsopen allclose all
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:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Any other information on results incl. tables

A dose setting test was conducted to set dose levels for the main test and the counting of the number of reverted colonies was carried out as well as an observation as to whether there were antibacterial activity and sedimentation.

The dose level in the dose setting test was set to 6 levels at a common ratio of 4, with 500μg/plate being set as the highest dose level. As a result, regardless of whether or not metabolic activation was carried out, the test substance did not show any antibacterial activity against any of the bacterial strains or an increase of more than two times as large as the number of reverted colonies compared with the negative (solvent) control. Moreover, the test substance did not show any sedimentation at any of the dose levels.

Based on the results described above, a total of 5 dose levels at a common ratio of 2 was set for all bacterial strains, with the highest dose level being 5000μg/plate, regardless of whether or not metabolic activation was carried out.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

Regardless of whether or not metabolic activation was carried out, the test substance did not show any antibacterial activity against any of the
bacterial strains or any sedimentation occurring at any of the dose levels.

On the basis of the results as described above, it was judged under the conditions of the test that the test substance was negative.