Registration Dossier
Registration Dossier
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EC number: 200-661-7 | CAS number: 67-63-0
Genetic toxicity: in vitro
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:
- 1 992
- Bibliographic source:
- Environmental and Molecular Mutagenesis, Volume 19, Supplement 21:2-141
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- 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 substance name:
- Propan-2-ol
- EC Number:
- 200-661-7
- EC Name:
- Propan-2-ol
- Cas Number:
- 67-63-0
- Molecular formula:
- C3H8O
- IUPAC Name:
- propan-2-ol
- Details on test material:
- - Name of test material (as cited in study report): Isopropanol
- Analytical purity: Vendor's purity = 99% and analytical purity = > 99%
Constituent 1
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
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