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EC number: 203-127-1 | CAS number: 103-60-6
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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:
- Not reported.
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A non-GLP study performed to sound scientific principles, with a sufficient level of reporting to assess the reliability of the submitted data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Five S. typhimurium strains were assessed for evidence of mutagenicity as a result of exposure to the test material in an Ames test. Strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100 were exposed to concentrations of the test material dissolved in DMSO ranging from 0.0001 to 10 µL/plate in both the presence and absence of metabolic activation. The mean number of revertant colonies together with the individual plate counts were recorded for evaluation. Solvent controls, positive controls, sterility and viability tests were run concurrently.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-phenoxyethyl isobutyrate
- EC Number:
- 203-127-1
- EC Name:
- 2-phenoxyethyl isobutyrate
- Cas Number:
- 103-60-6
- Molecular formula:
- C12H16O3
- IUPAC Name:
- 2-phenoxyethyl 2-methylpropanoate
- Test material form:
- other: liquid (undefined)
- Details on test material:
- - Name of test material (as cited in study report): phenoxyethyl isobutyrate (PEIB)
- Physical state: Clear liquid.
Constituent 1
Method
- Target gene:
- Histidine operon.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1538
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S-9 mix
- Test concentrations with justification for top dose:
- > Bacterial Growth Inhibition Test:
10, 1, 0.1, 0.01 and 0 µL/plate with all strains.
> Mutation Test:
10, 1, 0.1, 0.01 and 0 µL/plate with strains TA 1535, TA 1537, TA 1538 and TA 98.
> First Repeat Test:
0.1, 0.01, 0.001, 0.0001 and 0 µL/plate, with strain TA 100
0.001, 0.0001 and 0 µL/plate with strains TA 1535 TA 1537, TA 1538 and TA 98.
> Second Repeat Test:
0.05, 0.02, 0.01, 0.005 µL/plate with TA 100. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- sodium azide
- other: 4-nitro-o-phenylene diamine, 2-amino-anthracence and neutral red.
- Details on test system and experimental conditions:
- CONTROLS
Sterility and viability controls were also performed. - Evaluation criteria:
- Substantial increases in revertant colony numbers was the criteria used to determine whether or not the test material was mutagenic.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- Bacterial Growth Inhibition and Mutation Test: The test material proved to be toxic to bacteria at the two highest concentrations, 10 and 1 µL/plate, resulting in either absence or incomplete formation of a bacterial lawn. According to these findings the repeat tests were performed at lower test concentrations. See Table 1 for growth inhibition results and Table 2 for the mutation test results.
First Repeat Test: In this repeat test a slight increase in revertant colony numbers was observed with tester strain TA 100, in the absence of activation at the 0.01 µL/plate dose level only. As this increase was slight and restricted to one dose level a second repeat test was performed over a narrower dose range. No substantial increase in the revertant colony numbers were observed for any of the remaining four strains, regardless of the dose level or the presence/absence of metabolic activation. Results can be seen in Table 3. Positive and sterility control results from concurrently run tests can be seen in Table 4. Viability results are in Table 5.
Second Repeat Test: The test material failed to produce any substantial increase in revertant colony numbers with tester strain TA 100. The results of the first repeat were slight and unrepeatable and therefore not considered to be significant. Results can be seen in Table 6. Concurrently run positive and sterility control results can be seen in Table 7. Viability results are in Table 8.
Any other information on results incl. tables
Table 1: Bacterial Growth Inhibition Test
Strain | Conc. of Test Material (µL/well) | Zone of Inhibition on his- medium well (mm) |
TA 1535 | 10 | 18 |
1 | 10 | |
0.1 | 10 | |
0.01 | 10 | |
0 | 10 | |
TA 1537 | 10 | 20 |
1 | 10 | |
0.1 | 10 | |
0.01 | 10 | |
0 | 10 | |
TA 1538 | 10 | 19 |
1 | 10 | |
0.1 | 10 | |
0.01 | 10 | |
0 | 10 | |
TA 98 | 10 | 17 |
1 | 10 | |
0.1 | 10 | |
0.01 | 10 | |
0 | 10 | |
TA 100 | 10 | 20 |
1 | 10 | |
0.1 | 10 | |
0.01 | 10 | |
0 | 10 |
Table 2: Mutation Test
Strain | Conc. of Test Material (µL/plate) | Metabolic Activation | Mean Revertant Colony Counts |
TA 1535 | 10 | N | NL |
1 | N | NL | |
0.1 | N | 13 | |
0.01 | N | 16 | |
0 | N | 16 | |
10 | Y | IL | |
1 | Y | 15 | |
0.1 | Y | 16 | |
0.01 | Y | 14 | |
0 | Y | 15 | |
TA 1537 | 10 | N | NL |
1 | N | NL | |
0.1 | N | 6 | |
0.01 | N | 7 | |
0 | N | 7 | |
10 | Y | IL | |
1 | Y | 7 | |
0.1 | Y | 7 | |
0.01 | Y | 6 | |
0 | Y | 7 | |
TA 1538 | 10 | N | NL |
1 | N | NL | |
0.1 | N | 16 | |
0.01 | N | 18 | |
0 | N | 15 | |
10 | Y | IL | |
1 | Y | IL | |
0.1 | Y | 16 | |
0.01 | Y | 16 | |
0 | Y | 15 | |
TA 98 | 10 | N | NL |
1 | N | NL | |
0.1 | N | 34 | |
0.01 | N | 35 | |
0 | N | 34 | |
10 | Y | IL | |
1 | Y | IL | |
0.1 | Y | 31 | |
0.01 | Y | 40 | |
0 | Y | 36 |
N = absence
Y = presence
NL = no bacterial lawn
IL = incomplete bacterial lawn
Table 3: Revertant Colony Counts Obtained per Plate, First Repeat Test
Strain | Conc. Test Material (µL/plate) | Metabolic Activation | Mean Revertant Colony Counts | Individual Revertant Colony Counts |
TA 1535 | 0.001 | N | 17 | 17, 15, 18 |
0.0001 | N | 18 | 19, 17, 17 | |
0 | N | 16 | 18, 14, 15 | |
0.001 | Y | 10 | 11, 19, 9 | |
0.0001 | Y | 9 | 9, 8, 11 | |
0 | Y | 12 | 10, 11, 15 | |
TA 1537 | 0.001 | N | 9 | 5, C, 13 |
0.0001 | N | 8 | 9, 6, 9 | |
0 | N | 8 | 10, 8, 6 | |
0.001 | Y | 10 | 8, 11, 12 | |
0.0001 | Y | 7 | 8, 7, 6 | |
0 | Y | 10 | 12, 8, 10 | |
TA 1538 | 0.001 | N | 14 | 17, 14, 12 |
0.0001 | N | 10 | 13, 8, 10 | |
0 | N | 15 | 17, 18, 11 | |
0.001 | Y | 14 | 15, 13, 13 | |
0.0001 | Y | 12 | 12, 12, 13 | |
0 | Y | 13 | 16, 10, 13 | |
TA 98 | 0.001 | N | 39 | 31, 47, C |
0.0001 | N | 39 | 40, 38, C | |
0 | N | 39 | 40, C, 37 | |
0.001 | Y | 32 | 29, 35, 33 | |
0.0001 | Y | 30 | 27, 32, 30 | |
0 | Y | 31 | 30, 32, 31 | |
TA 100 | 0.1 | N | IL | IL |
0.01 | N | 111 | 109, 97, 127 | |
0.001 | N | 76 | 83, 80, 64 | |
0.0001 | N | 85 | 97, 84, 74 | |
0 | N | 86 | 86, 93, 80 | |
0.1 | Y | 60 | 59, 64, 58 | |
0.01 | Y | 62 | 59, 57, 71 | |
0.001 | Y | 61 | 56, 67, 61 | |
0.0001 | Y | 55 | C, 57, 53 | |
0 | Y | 68 | 64, 69, 70 |
N = absence
Y = presence
C = contaminated
IL = incomplete bacterial lawn
Table 4: Mutability and Sterility Tests (Positive Controls)
Strain | Compound | Conc Compound (µL/plate) | Metabolic Activation | Mean Revertant Colony Counts | Individual Revertant Colony Counts |
TA 1535 | sodium azide | 5 | N | 926 | 1016, 865, 897 |
TA 1537 | 4-nitro-o-phenylene diamine | 500 | N | 136 | 158, 128, 122 |
TA 1538 | N | 1158 | 1132, 1044, 1298 | ||
TA 98 | N | 1600 | 1546, 1621, 1632 | ||
TA 100 | sodium azide | 5 | N | 644 | 785, 558, 589 |
TA 1535 | 2-amino-anthracene | 2 | Y | 178 | 178, C, C |
TA 1537 | neutral red | 10 | Y | 65 | 65, C, C |
TA 1538 | 2-acetyl-amnofluorene | 20 | Y | 183 | C, C, 183 |
TA 98 | 2-amino-anthracene | 2 | Y | C | C, C, C |
TA 100 | 2-amino-anthracene | 2 | Y | C | C, C, C |
─ | S-9 mix | 500 µL | 0 | 0 | |
─ | test material | 0.1 µL | N | 0 | 0 |
N = absence
Y = presence
C = contaminated
Table 5: Viability Test
Dilution** | Strain | ||||
TA 1535 | TA 1537 | TA 1538 | TA 98 | TA 100 | |
10E-1 D | 24 | 8 | 9 | 18 | 82 |
10E-6 R | * | * | * | * | * |
10E-7 R | 245 | 205 | 217 | 228 | 205 |
10E-8 R | 22 | 26 | 15 | 24 | 16 |
D = plated onto histidine deficient agar
R = plated onto histidine rich agar
* = too many colonies for accurate counting
** = 3 mL of each dilution per plate
Table 6: Revertant Colony Counts Obtained per Plate using strain TA 100, Second Repeat Test
Strain | Conc. of Test Material (µL/plate) | Metabolic Activation | Mean Revertant Colony Counts | Individual Revertant Colony Counts |
TA 100 | 0.05 | N | 58 | 47, 76, 50 |
0.02 | N | 66 | 61, 72, 64 | |
0.01 | N | 60 | 57, 55, 69 | |
0.005 | N | 61 | 65, 56, 63 | |
0 | N | 61 | 56, 68, 58 |
N = absence
Y = presence
Table 7: Mutability and Sterility Tests with Strain TA 100
Strain | Compound | Conc. of Compound (µL/plate) | Metabolic Activation | Mean Revertant Colony Counts | Individual Revertant Colony Counts |
TA 100 | sodium azide | 5 | N | 1673 | 1661, 1657, 1700 |
─ | S-9 mix | 500 µL | 0 | 0 | |
─ | test material | 50 µg/plate | 0 | 0 |
N = absence
Table 8: Viability Test
Dilution** | Strain TA 100 |
10E-1 D | 88 |
10E-6 R | * |
10E-7 R | 156 |
10E-8 R | 26 |
D = plated onto histidine deficient agar
R = plated onto histidine rich agar
* = too many colonies for accurate counting
** = 3 mL of each dilution per plate
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
Under the conditions of the study the test material gave a negative (i.e. non-mutagenic) response in Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100 in the presence and absence of metabolic activation. - Executive summary:
The potential for the test material to cause gene mutation in S. typhimurium TA 1535, TA 1537, TA 1538, TA 98 and TA 100 was determined in an Ames test conducted in the presence and absence of metabolic activation. Strains were exposed to the test material at concentrations ranging from 0.0001 to 10 µL/plate dissolved in DMSO. The mean number of revertant colonies together with the individual plate counts were recorded for evaluation. Solvent controls, positive controls, sterility and viability tests were run concurrently.
During the bacterial growth inhibition and mutation tests (0, 0.01, 0.1, 0.1, 1.0 and 10.0 µL/plate), the test material proved to be toxic to bacteria at the two highest concentrations, 10 and 1 µL/well, resulting in either absence or incomplete formation of a bacterial lawn. According to these findings repeat tests were performed at lower test concentrations. The first repeat test was conducted at concentrations of 0, 0.0001, 0.001, 0.01 and 0.1 µL/plate for TA 100, for all other strains at concentrations of 0, 0.0001 and 0.001 µL/plate. A slight increase in revertant colony numbers was observed with tester strain TA 100, in the absence of metabolic activation at the 0.01 µL/plate dose level only. As this increase was slight and restricted to one dose level a second repeat test was performed over a narrower dose range. No substantial increase in the revertant colony numbers was observed for any of the remaining four strains, regardless of the dose level or the presence/absence of metabolic activation. The second repeat test was performed to verify the TA 100 results at concentrations of 0, 0.005, 0.1, 0.02 and 0.05 µL/plate. The test material failed to produce any substantial increase in revertant colony numbers. As the results of the first repeat were slight and unrepeatable the result was not considered to be significant. Concurrently run viability test and positive, vehicle and sterility control confirm the viability of the test system.
Under the conditions of the test, the test material was determined to be non-mutagenic giving a negative result.
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