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EC number: 700-408-5 | CAS number: 103429-90-9
Toxicological information
Genetic toxicity: in vitro
Currently viewing:
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:
- 1992-01-09 to 1992-02-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to official test guidelines (Japanese Ministry of Labour), and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Guidelines of the Ministry of Labour (Notification No. 77, 1988)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- The study report cites GLP according to Ministry of Labour guidelines, and includes a statement of Quality Assurance.
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-Methoxy-3-methylbutyl acetate
- EC Number:
- 700-408-5
- Cas Number:
- 103429-90-9
- Molecular formula:
- C8H16O3
- IUPAC Name:
- 3-Methoxy-3-methylbutyl acetate
- Details on test material:
- - Name of test material (as cited in study report): Solfit-AC
- State: Colorless transparent liquid
- Analytical purity: 99.49%
- Impurities (identity and concentrations): Water, 0.010 % by weight
- Lot/batch No.: 033224
Constituent 1
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:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix (prepared in-house from SD rat livers after treatment at PB and BF ip)
- Test concentrations with justification for top dose:
- 0 (Solvent control), 313, 625, 1250, 2500, 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: Material is soluble in DMSO, and soluble at 6.8% in water.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide (AF-2)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene (2-AA)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 Minutes
- Exposure duration: 48 Hours
SELECTION AGENT (mutation assays):
NUMBER OF REPLICATIONS: 2
DETERMINATION OF CYTOTOXICITY
- Method: Not reported - Evaluation criteria:
- The increase in the number of revertant colonies reletive to the negative control was determined for each concentration level. A two-fold increase was considered to show positive evidence of mutagenicity.
- Statistics:
- None
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:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not applicable
- 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:
- not specified
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- The test material did not induce more than twice increase in the revertant colony count compared with the count of the negative control in any of the tester strains, either with or without metabolic activation.
- Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
| Test Results: main Study Test Material Name: Solfit-AC | |||||||
| With or Without S9-Mix | Test substance concentration (µg/plate) | Number of revertants (mean number of colonies perplate) | |||||
| Base-pair substitution type | Frameshift type | ||||||
| TA100 | TA1535 | WP2uvrA- | TA98 | TA1537 | |||
| - | 0 (Solvent control) | 140 146 (143) | 26 34 (30) | 34 41 (38) | 20 30 (25) | 4 8 (6) | |
| 313 | 135 132 (134) | 24 25 (25) | 38 38 (38) | 29 22 (26) | 10 3 (7) | ||
| 625 | 122 116 (119) | 19 21 (20) | 45 32 (39) | 37 18 (28) | 10 2 (6) | ||
| 1250 | 132 144 (138) | 18 32 (25) | 49 32 (41) | 21 34 (28) | 10 7 (9) | ||
| 2500 | 141 145 (143) | 21 24 (23) | 37 29 (33) | 30 33 (32) | 9 9 (9) | ||
| 5000 | 154 143 (149) | 28 29 (29) | 36 25 (31) | 33 24 (29) | 4 8 (6) | ||
| + | 0 (Solvent control) | 145 149 (147) | 30 32 (31) | 33 38 (36) | 34 42 (38) | 12 11 (12) | |
| 313 | 153 160 (157) | 20 30 (25) | 38 58 (48) | 43 34 (39) | 9 7 (8) | ||
| 625 | 153 113 (133) | 27 23 (25) | 46 37 (42) | 36 44 (40) | 7 9 (8) | ||
| 1250 | 143 157 (150) | 25 20 (23) | 50 46 (48) | 42 41 (42) | 14 10 (12) | ||
| 2500 | 168 164 (166) | 20 22 (21) | 41 35 (38) | 45 54 (50) | 10 12 (11) | ||
| 5000 | 177 165 (171) | 19 21 (20) | 49 40 (45) | 58 59 (59) | 6 10 (8) | ||
| Positive controls | S-9 Mix - | Name | AF-2 | NaN3 | ENNG | AF-2 | 9-AA |
| Concentration (µg/plate) | 0.01 | 0.5 | 2 | 0.1 | 80 | ||
| No. colonies per plate | 403 390 (397) | 221 240 (231) | 466 400 (433) | 367 310 (339) | 74 70 (72) | ||
| S-9 Mix + | Name | BP | 2-AA | 2-AA | BP | BP | |
| Concentration (µg/plate) | 5 | 2 | 10 | 5 | 5 | ||
| No. colonies per plate | 470 600 (535) | 177 146 (162) | 425 462 (444) | 244 259 (252) | 106 116 (111) | ||
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative With and without metabolic activation
The test material did not induce more than twice increase in the revertant colony count compared with the count of the negative control in any of the tester strains, either with or without metabolic activation.
Therefore, it was not considered that the test material is mutagenic.
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