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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:
21/05/1991-01/06/1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well document report of a guideline study conducted to GLP.

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
/OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): OS 61349H
- Substance type: organic
- Physical state: solid
- Analytical purity: not specified
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: 100%
- Purity test date: not specified
- Lot/batch No.: not specified
- Expiration date of the lot/batch: not specified
- Stability under test conditions: stable
- Storage condition of test material: room temperature

Method

Target gene:
Histidine operon
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: Rfa mutation or ampicillin resistance
Species / strain / cell type:
S. typhimurium TA 1538
Additional strain / cell type characteristics:
other: Rfa mutation or ampicillin resistance
Species / strain / cell type:
E. coli WP2
Metabolic activation:
with and without
Metabolic activation system:
S9 microsomal fraction obtained from the liver harvested from rats 5 days following a single intraperitoneal injection of Aroclor 1254
Test concentrations with justification for top dose:
0; 15; 50; 150; 500; 1500 and 5000 microgram/plate
Vehicle / solvent:
- Vehicle used: water
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
sterile water or DMSO
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene, 9-aminoacridine, sodium azide, N-ethyl-N' -nitro-N-nitrosoguanidine, 2-nitrofluorene depending on the bacterial strain and activation parameters
Details on test system and experimental conditions:
NUMBER OF REPLICATIONS: 3

Statistics:
The mean number of revertants per plate and the standard deviation was calculated for each concentration and strain.

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:
cytotoxicity
Remarks:
slightly toxic to all strains at 5000 microgram/plate
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:
cytotoxicity
Remarks:
slightly toxic at 5000 microgram/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
E. coli WP2
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
slightly toxic at 5000 microgram/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

The test substance was slightly toxic to all Salmonella strains at the highest dose used (5000 microgram/plate) both with and without metabolic activation. For all bacterial strains tested there was no significant increase in the number of revertants at any dose of test material when compared to thecorresponding negative solvent control. The entire assay was repeated and the results seen in the first experimentwere confirmed. The positive and control solvent control forall experiments were within established historical ranges foreach bacterial strain utilized.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative

The test substance did not produce a signifIcant increase in the number of revertants, with and without metabolic activation in any test strain.