Registration Dossier

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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study without detailed documentation. Tn.publication is sufficiently detailed to allow a scientific evaluation of the results

Data source

Reference
Reference Type:
publication
Title:
Salmonella Mutagenicity Tests: V. Results from the Testing of 311 Chemicals
Author:
Zeiger E, Anderson B, Haworth S, Lawlor T & Mortelmans K
Year:
1992
Bibliographic source:
Environmental and Molecular Mutagenesis, Volume 19, Supplement 21:2-141

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
S. typhimurium strain TA102 or E. coli strain WP2 uvrA were not used & 2-aminoanthracene was the only positive control compound used to test the efficacy of the S9 fraction.
GLP compliance:
no
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): Isopropanol
- Analytical purity: Vendor's purity = 99% and analytical purity = > 99%

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not applicable
Species / strain / cell type:
S. typhimurium TA 97
Additional strain / cell type characteristics:
not applicable
Metabolic activation:
with and without
Metabolic activation system:
Aroclor 1254-induced rat and hamster liver microsomes (10% and 30% for strains TA 98, TA 100 and TA 1535 and 30% for strain TA 1537)
Test concentrations with justification for top dose:
100, 333, 1000, 3333, or 10000 µg/plate
Vehicle / solvent:
Vehicle(s)/solvent(s) used: Distilled water
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: 1342 See Table 1
Details on test system and experimental conditions:
METHOD OF APPLICATION: preincubation

DURATION
- Preincubation period: 20 minutes at 37 ºC
- Exposure duration: 48 hours at 37 ºC

NUMBER OF REPLICATIONS: At least five doses of each chemical were tested in triplicate, and repeat experiments were performed at least one week following the initial trial.
Evaluation criteria:
Revertant colonies were counted
Statistics:
None performed (revertant colonies were counted)

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
Remarks:
no cytotoxicity when tested at levels ≤ 10,000 µg/plate which is higher than the limit concentration of 5,000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 97
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
no cytotoxicity when tested at levels ≤ 10,000 µg/plate which is higher than the limit concentration of 5,000 µg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
not applicable
Positive controls validity:
other: Revertant colony count did not double in the presence of 30% hamster liver microsomes. An adequate positive control response was observed for all other tested conditions.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

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

negative with/without activation