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EC number: 211-536-1 | CAS number: 659-70-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Boiling point
- Density
- Particle size distribution (Granulometry)
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- Oxidation reduction potential
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
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- Additional toxicological data
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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:
- 19-08-2015 to 23-09-2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 3-methylbutyl isovalerate
- EC Number:
- 211-536-1
- EC Name:
- 3-methylbutyl isovalerate
- Cas Number:
- 659-70-1
- Molecular formula:
- C10H20O2
- IUPAC Name:
- 3-methylbutyl 3-methylbutanoate
Constituent 1
Method
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:
- S9
- Test concentrations with justification for top dose:
- 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate (experiments 1 and 2); top dose chosen following the pre-experiment (experiment 1)
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The solvent was chosen because of its solubility properties and its relative nontoxicity to the bacteria.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- Medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, 2-AA
- Remarks:
- TA 1535, TA 1537, TA 98, TA 100, WP2 uvrA with metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- Medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535, TA 100 without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- Medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine, 4-NOPD
- Remarks:
- TA 1537, TA 98 without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- Medium
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2 uvrA without metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 min
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: spontaneous reversion rates - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Experiment 1
Without metabolic activation
|
Dose/plate |
TA 1535 |
TA 1537 |
TA98 |
TA100 |
WP2uvrA |
DMSO |
|
12±2 |
11±3 |
31±2 |
176±10 |
36±5 |
Untreated |
|
9±1 |
10±6 |
31±8 |
181±6 |
51±4 |
Isoamyl isovalerate µg |
3 |
11±4 |
11±3 |
30±5 |
175±11 |
38±5 |
10 |
14±1 |
10±1 |
30±3 |
175±17 |
40±2 |
|
33 |
14±2 |
9±3 |
34±3 |
181±5 |
43±5 |
|
100 |
14±3 |
11±3 |
30±8 |
121±14 |
46±4 |
|
333 |
10±3 |
11±2 |
23±5 |
80±11 |
40±3 |
|
1000 |
11±1 |
11±2 |
28±4 |
66±8 |
37±1 |
|
2500
|
10±2 |
13±3 |
27±2 |
65±6 |
42±1 |
|
5000 |
9±2 |
9±4 |
22±3 |
71±4 |
45±7 |
|
NaN3 |
10 µg |
1146±15 |
|
|
1978±228 |
|
4-NOPD |
10 µg |
|
|
362±4 |
|
|
4-NOPD |
50 µg |
|
98±8 |
|
|
|
MMS |
2 µl |
|
|
|
|
890±65 |
With metabolic activation
|
Dose/plate |
TA 1535 |
TA 1537 |
TA98 |
TA100 |
WP2uvrA |
DMSO |
|
13±1 |
9±1 |
41±12 |
125±16 |
49±8 |
Untreated |
|
11±3 |
16±3 |
36±8 |
164±12 |
50±4 |
Isoamyl isovalerate µg |
3 |
13±1 |
9±1 |
44±13 |
134±4 |
48±9 |
10 |
12±2 |
9±2 |
32±8 |
111±7 |
53±5 |
|
33 |
14±2 |
11±4 |
32±2 |
128±10 |
48±4 |
|
100 |
12±3 |
14±2 |
36±3 |
139±21 |
61±4 |
|
333 |
11±3 |
12±2 |
39±2 |
138±12 |
57±9 |
|
1000 |
13±3 |
12±3 |
36±6 |
132±18 |
45±4 |
|
2500
|
10±3 |
11±4 |
36±2 |
116±20 |
64±3 |
|
5000 |
8±0 |
14±1 |
38±8 |
84±31 |
45±5 |
|
2_AA |
2.5 µg |
413±7 |
178±12 |
4167±483 |
3660±204 |
|
2_AA |
10 µg |
|
|
|
|
333±31 |
Experiment 2
Without metabolic activation
|
Dose/plate |
TA 1535 |
TA 1537 |
TA98 |
TA100 |
WP2uvrA |
DMSO |
|
12±2 |
11±3 |
31±2 |
176±10 |
36±5 |
Untreated |
|
9±1 |
10±6 |
31±8 |
181±6 |
51±4 |
Isoamyl isovalerate µg |
3 |
11±4 |
11±3 |
30±5 |
175±11 |
38±6 |
10 |
14±1 |
10±1 |
30±3 |
175±17 |
40±2 |
|
33 |
14±2 |
9±3 |
24±3 |
181±5 |
43±5 |
|
100 |
14±3 |
11±3 |
30±8 |
121±14 |
46±4 |
|
333 |
10±3 |
11±2 |
23±5 |
80±11 |
40±3 |
|
1000 |
11±1 |
11±2 |
28±4 |
66±8 |
37±1 |
|
2500
|
10±2 |
13±3 |
27±2 |
65±6 |
42±1 |
|
5000 |
9±2 |
9±4 |
22±3 |
71±4 |
45±17 |
|
NaN3 |
10 µg |
1146±15 |
|
|
1978±228 |
|
4-NOPD |
10 µg |
|
|
362±4 |
|
|
4-NOPD |
50 µg |
|
98±8 |
|
|
|
MMS |
2 µl |
|
|
|
|
890±65 |
With metabolic activation
|
Dose/plate |
TA 1535 |
TA 1537 |
TA98 |
TA100 |
WP2uvrA |
DMSO |
|
11±4 |
10±4 |
35±10 |
130±13 |
42±8 |
Untreated |
|
10±2 |
12±6 |
31±9 |
168±7 |
52±8 |
Isoamyl isovalerate µg |
3 |
10±3 |
11±6 |
38±10 |
106±7 |
50±1 |
10 |
9±2 |
11±3 |
26±10 |
138±8 |
40±6 |
|
33 |
11±3 |
12±4 |
31±9 |
126±11 |
50±9 |
|
100 |
10±4 |
10±3 |
34±4 |
109±16 |
43±5 |
|
333 |
10±2 |
11±1 |
38±5 |
110±22 |
47±12 |
|
1000 |
10±3 |
10±2 |
28±8 |
60±11 |
41±12 |
|
2500
|
10±3 |
12±4 |
27±2 |
47±4 |
48±1 |
|
5000 |
5±1* |
11±2 |
30±10* |
42±8* |
42±6* |
|
2_AA |
2.5 µg |
372±30 |
190±16 |
4072±483 |
2999±225 |
|
2_AA |
10 µg |
|
|
|
|
367±19 |
NaN3 2-AA 4-NOPD MMS |
sodium azide 2-aminoanthracene 4-nitro-o-phenylene-diamine methyl methane sulfonate |
*Reduced background count
Applicant's summary and conclusion
- Conclusions:
- In a bacterial reverse mutation assay using S. typhimurium TA 1535, TA 1537, TA 98 and TA 100, and E. coli WP2 uvr A with and without S9 metabolic activation the test substance was not mutagenic.
- Executive summary:
This study was performed to investigate the potential of the test substance to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100, and the Escherichia coli strain WP2 uvrA. The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the controls, was tested in triplicate. The test item was tested at the following concentrations in both experiments: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate. No precipitation of the test item occurred up to the highest investigated dose.
The plates incubated with the test item showed reduced background growth in nearly all strains used. Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in strains TA1537, TA 98 and, TA 100. No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with the test substance at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance. Appropriate reference mutagens were used as positive controls and showed a distinct increase of induced revertant colonies.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used. Therefore, the test substance is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay.
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