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Diss Factsheets

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP, OECD-guideline 471 and EEC Directive 92/69, B14 and B13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Reference substance name:
609-333-1
EC Number:
609-333-1
Cas Number:
37143-54-7
Molecular formula:
C4 H11 N O
IUPAC Name:
609-333-1
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): 2-Amino-1-methoxypropan
- Physical state: colourless liquid
- Purity test date: 99.7%
- Lot/batch No.: 080995003
- Storage condition of test material: room temperature

Method

Target gene:
his or trp
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:
male S.D. rats liver S9, induced by Aroclor 1254
Test concentrations with justification for top dose:
20, 100, 500, 2500 and 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: details are listed in "Any other information on materials and methods incl. tables"
Details on test system and experimental conditions:
Test conducted according to the Ames procedure (standard plate test and preincubation test, with and without S9-Mix).

Number of plates: 3 test plates per dose or per control.

Vehicle: DMSO

The study comprised 2 independent experiments.

1st Experiment:
Strains: TA 1535, TA 100, TA 1537, TA 98, E. coli WP2 uvrA.
Doses: 0; 20; 100; 500; 2500 and 5000 ug/plate.
Vehicle: DMSO.
Type of test and test conditions: standard plate test with and without S9-Mix.
Number of plates: 3 test plates per dose or per control.

2nd Experiment:
Strains: TA 1535, TA 100, TA 1537, TA 98, E. coli WP2 uvrA.
Doses: 0; 20; 100; 500; 2500 and 5000 ug/plate.
Vehicle: DMSO.
Type of test and test condition: preincubation test with and without S9 mix.
Number of plates: 3 test plates per dose or per control.
Evaluation criteria:
The assessment for the test was based on the number of histidine or tryptophan revertant colonies per plate. In general, a substance to be characterized as positive in the Ames test has to meet the following points:
i) doubling of the spontaneous mutation rate (control);
ii) dose-response relationship; iii) reproducibility of the results.

Results and discussion

Test resultsopen allclose all
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: A weakly bacteriotoxic effect (slight decrease in the number of revertants, reduction in the titer) was observed in the standard plate test only using TA 98 from about 2500 ug/plate onward.
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
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
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
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:
According to the results of the present study, 2-amino-1-methoxypropan is not mutagenic in the Ames test and in the Escherichia coli - reverse mutation assay under the chosen experimental conditions.