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Registration Dossier
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EC number: 807-365-2 | CAS number: 127961-54-0
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 29, 1998 - Aug. 21, 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sucrose tetrastearate triacetate
- IUPAC Name:
- Sucrose tetrastearate triacetate
Constituent 1
Method
- Target gene:
- His and trp 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, gal, chl, bio, uvrB
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- 3, 10, 33, 100, 333 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: daunomycine, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hrs
NUMBER OF REPLICATIONS: 3 - Evaluation criteria:
- Negative control data within historical range. Positive control within historical range. Dosage range should include clearly toxic concentration, or exhibit limited solubility, or extend to 5 mg/plate.
Negative response:Total number of revertants in tester strain not greater than two times solvent control value. Negative response reproducible in at least one independently repeated experiment.
Postiive response: Induces at least 2-fold dose related increase in number of revertants compared to solvent control. Response is reproducible in at least one independently repeated experiment.
Results and discussion
Test resultsopen allclose all
- Key result
- 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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: precipitation of the test substance was observed at the 333 μg/plate concentration
RANGE-FINDING/SCREENING STUDIES: A range-finding test was performed at 3, 10, 33, 100, 333, 1000, 3330, and 5000 μg/plate. The test substance precipitated at concentrations of 333 μg/plate or higher.
HISTORICAL CONTROL DATA: Negative and positive controls were within historical norms.
- Positive historical control data: Positive controls were within historical norms
- Negative (solvent/vehicle) historical control data: Negative controls were within historical norms
Any other information on results incl. tables
Experiment 1 - without S9 -mix - mean revertants
| Dose (ug/plate) | TA1535 | TA1537 | TA98 | TA100 | E. coli |
| positive control | 268 +/- 14 | 311 +/- 54 | 761 +/- 117 | 731 +/- 76 | 1408 +/- 33 |
| solvent control | 13 +/- 3 | 20 +/- 2 | 24 +/- 7 | 86 +/- 2 | 9 +/- 1 |
| 3 | 10 +/- 3 | 22 +/- 2 | 29 +/- 7 | 86 +/- 8 | 7 +/- 1 |
| 10 | 12 +/- 4 | 17 +/- 7 | 22 +/- 4 | 79 +/- 81 (2) | 7 +/- 2 |
| 33 | 13 +/- 1 | 17 +/- 6 | 21 +/- 4 | 108 +/- 11 | 10 +/- 2 |
| 100 | 12 +/- 6 | 18 +/- 0 | 25 +/- 4 | 85 +/- 13 | 10 +/- 3 |
| 333 | 12 +/- 0 | 19 +/- 1 | 21 +/- 3 | 87 +/- 12 | 10 +/- 1 |
| 1000 | 86 +/- 14 | 10 +/- 2 | |||
| 3330 | 73 +/- 5 | 7 +/- 1 | |||
| 5000 | 70 +/- 5 | 8 +/- 3 |
Experiment 1 - with S9-mix - mean revertants
| Dose (ug/plate) | TA1535 | TA1537 | TA98 | TA100 | E. coli |
| positive control | 272 +/- 20 | 717 +/- 50 | 1189 +/- 99 | 990 +/- 147 | 154 +/- 14 |
| negative control | 9 +/- 3 | 20 +/- 4 | 23 +/- 2 | 84 +/- 8 | 4 +/- 0 |
| 3 | 9 +/- 4 | 20 +/- 3 | 26 +/- 1 | 100 +/- 10 | 8 +/- 4 |
| 10 | 8 +/- 0 | 16 +/- 2 | 27 +/- 2 | 93 +/- 11 | 9 +/- 2 |
| 33 | 9 +/- 3 | 19 +/- 4 | 22 +/- 6 | 107 +/- 15 | 8 +/- 3 |
| 100 | 10 +/- 4 | 17 +/- 1 | 26 +/- 7 | 93 +/- 92 (2) | 9 +/- 3 |
| 333 | 9 +/- 3 | 21 +/- 4 | 21 +/- 4 | 83 +/- 113 (2) | 8 +/- 3 |
| 1000 | 95 +/- 114 (2) | 7 +/- 1 | |||
| 3330 | 81 +/- 3 | 7 +/- 3 | |||
| 5000 | 79 +/- 10 | 6 +/- 3 |
Experiment 2 - without S9-mix - mean revertants
| Dose (ug/plate) | TA1535 | TA1537 | TA98 | TA100 | E. coli |
| positive control | 236 +/- 9 | 337 +/- 59 | 552 +/- 183 | 895 +/- 46 | 632 +/- 60 |
| negative control | 9 +/- 1 | 5 +/- 2 | 13 +/- 1 | 85 +/- 10 | 12 +/- 1 |
| 3 | 11 +/- 4 | 6 +/- 2 | 14 +/- 1 | 74 +/- 8 | 11 +/- 2 |
| 10 | 13 +/- 4 | 5 +/- 2 | 14 +/- 0 | 77 +/- 10 | 8 +/- 3 |
| 33 | 11 +/- 2 | 5 +/- 1 | 18 +/- 4 | 81 +/- 7 | 12 +/- 2 |
| 100 | 14 +/- 2 | 7 +/- 3 | 14 +/- 3 | 79 +/- 9 | 8 +/- 1 |
| 333 | 12 +/- 1 | 4 +/- 1 | 12 +/- 0 | 72 +/- 2 | 7 +/- 3 |
Experiment 2 - without S9-mix - mean revertants
| Dose (ug/plate) | TA1535 | TA1537 | TA98 | TA100 | E. coli |
| positive control | 236 +/- 9 | 337 +/- 59 | 552 +/- 183 | 895 +/- 46 | 632 +/- 60 |
| negative control | 9 +/- 1 | 5 +/- 2 | 13 +/- 1 | 85 +/- 10 | 12 +/- 1 |
| 3 | 11 +/- 4 | 6 +/- 2 | 14 +/- 1 | 74 +/- 8 | 11 +/- 2 |
| 10 | 13 +/- 4 | 5 +/- 2 | 14 +/- 0 | 77 +/- 10 | 8 +/- 3 |
| 33 | 11 +/- 2 | 5 +/- 1 | 18 +/- 4 | 81 +/- 7 | 12 +/- 2 |
| 100 | 14 +/- 2 | 7 +/- 3 | 14 +/- 3 | 79 +/- 9 | 8 +/- 1 |
| 333 | 12 +/- 1 | 4 +/- 1 | 12 +/- 0 | 72 +/- 2 | 7 +/- 3 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative. The test substance is not mutagenic both in the presence and absence of metabolic activation.
- Executive summary:
A mutagenicity study was performed on the test substance using S. typhimurium, and E. coli both in the presence and absence of metabolic activation. Concentrations of 3, 10, 33, 100, and 333 ug/plate were tested in triplicate. Precipitation was obersved at the 333 ug/plate concentration. A negative response was observed in all replicates at all concentrations, and no evidence of cytotoxicity was observed. Results for negative and positive controls were within historical norms. The test substance is not mutagenic.
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