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EC number: 617-589-0 | CAS number: 84592-32-5
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
- Study period:
- 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: According to OECD 471, 472 and EEC Directive 92/69, B 13 and 14. Study conducted under GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- [(5-(4-hydroxy-2,6,6-trimethyl-3-oxo-1-cyclohexen-1-yl)-3-methyl-2,4-pentadienyl](triphenyl)phosphonium bromide
- EC Number:
- 617-589-0
- Cas Number:
- 84592-32-5
- Molecular formula:
- C33 H36 O2 P .Br
- IUPAC Name:
- [(5-(4-hydroxy-2,6,6-trimethyl-3-oxo-1-cyclohexen-1-yl)-3-methyl-2,4-pentadienyl](triphenyl)phosphonium bromide
- Details on test material:
- - Name of test substance: Asta-C15-Salz krist.
- Batch No.: 95/49-4B/Trommel 2
- CAS No.: 84592-32-5
- Date of manufacturing: Filled in November 8, 1995
- Test substance No.: 96/337
- Degree of purity: 98.0%
- Appearance, consistency: Ochre crystals
- Storage: Room temperature (protected from light, N2 conditions).
Constituent 1
Method
- Target gene:
- his, 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:
- Rat liver S-9 fraction. Induced by Aroclor.
- Test concentrations with justification for top dose:
- 20 - 5,000 ug/plate SPT.
4 - 2,500 ug/plate PIT. - Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- vehicle and sterility controls
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Information of positive control substances are given below in "Any other information materials and methods incl. tables".
- Details on test system and experimental conditions:
- Tester strains, doses, number of plates
1st Experiment
- Strains: TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA
- Doses: 0; 20; 100; 500; 2,500 and 5,000 ug/plate
- Vehicle: DMSO
- Type of test, test condition: standard plate test with and without S-9 mix; 3 test plates per dose or per control.
2nd Experiment
- Strains: TA 1535, TA 100, TA 1537, TA 98 E. coli and WP2 uvrA
- Doses: 0; 4; 20; 100; 500; and 2,500 ug/plate
- Vehicle: DMSO
- Type of test, test condition: preincubation test with and without S-9 mix
- Number of plates: 3 test plates per dose or per control - Evaluation criteria:
- Evaluation criteria:
In general, a substance to be characterized as positive in the bacterial tests has to fulfill the following requirements:
- cloubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproclucibility of the results
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A bacteriotoxic effect (reduced His or trp background growth, decrease in the number of his or trp revertants) was observed depending on the strain and test condition from about 500 ug - 2,500 ug/plate onward.
- 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, the test substance Asta-C15-Salz krist. is not mutagenic in the Ames test and in the Escherichia coli-reverse mutation assay under the experimental conditions chosen here. Thus, no classification is warranted according to Regulation (EC) No. 1272/2008.
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