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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:
weight of evidence
Study period:
11 September - 3 December, 1991
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No information on the purity of the test material. The strain Salmonella TA 102 or E.coli WP2 uvrA was not tested.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EPA OPP 84-2
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Busan 11-M1
- Substance type: No data
- Physical state: White powder
- Analytical purity: 94.3%
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: 19769
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: Room temperature

Method

Target gene:
various: reversion from histidine dependence
Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
other: Histidine, rfa and uvrB mutations
Species / strain / cell type:
S. typhimurium TA 1538
Additional strain / cell type characteristics:
other: Histidine, rfa and uvrB mutations
Metabolic activation:
with and without
Metabolic activation system:
Aroclor-induced rat liver microsomal enzymes
Test concentrations with justification for top dose:
100, 333, 1000, 3333, 5000 ug/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: No data
Controlsopen allclose all
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
9-aminoacridine
2-nitrofluorene
sodium azide
Remarks:
with metabolic activation
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
without metabolic activation
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Preincubation period: No data
- Exposure duration: 48 hours
- Expression time (cells in growth medium): No data
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data

SELECTION AGENT (mutation assays): No data

NUMBER OF REPLICATIONS: triplicate

NUMBER OF CELLS EVALUATED: No data

DETERMINATION OF CYTOTOXICITY
- Method: other: the condition of the bacterial background lawn was evaluated for evidence of test article toxicity using a dissective microscope

OTHER EXAMINATIONS:
- Determination of polyploidy:No data
- Determination of endoreplication:No data
- Other: No data

OTHER: Revertant colonies for a given tester strain and activation condition were counted either entirely by automated colony counter or entirely by hand.
Evaluation criteria:
No data
Statistics:
No data

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
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
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:
not applicable
Positive controls validity:
valid
Additional information on results:
RANGE-FINDING/SCREENING STUDIES: The maximum dose tested 5000 ug/plate did not produce precipitate or appreciable toxicity. Therefore, the maximum dose that was plated in the mutagenicity assay was 5000 ug/plate.

Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

No further data

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with and without metabolic activation

No evidence of mutagenicity was seen under the conditions of this study.
Executive summary:

In a study conducted by San and Olson(1991), the test substance, Busan 11-M1, was investigated for its ability to induce mutagenic activity when tested in anin vitroreverse mutagenicity test using four strains of the bacteria Salmonella typhimurium, specifically TA 98, TA 100, TA 1535, TA 1537 and TA 1538. The study was conducted both in the presence and absence of metabolic activation using S9 mix from Aroclor-induced rats. No evidence of mutagenicity was seen under the conditions of this study.