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EC number: 203-505-6 | CAS number: 107-58-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- 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
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The study contains experimental data of the registered substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 020
- Report date:
- 2020
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Adopted: July 21 1997, Corrected: June 26 2020
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-tert-butylacrylamide
- EC Number:
- 203-505-6
- EC Name:
- N-tert-butylacrylamide
- Cas Number:
- 107-58-4
- Molecular formula:
- C7H13NO
- IUPAC Name:
- N-tert-butylacrylamide
- Test material form:
- solid
- Details on test material:
- - Name of test material: N-tert-butylacrylamide
- Molecular formula : C7H13NO
- Molecular weight: 127.19 g/mol
- Substance type: Organic
- Physical state: Solid
Constituent 1
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Homogenate
Aroclor 1254-induced rat liver microsomal enzymes (S9 homogenate) procured commercially was used for the assay. Certificate of analysis received from the supplier was included in the report. Efficiency check of S9 was performed during the main assay. The protein concentration in the S9 fraction was 34.6 mg/ml (Annexure: 1).
S9 Mix
S9 mix cofactors solution (Cofactor ingredients: D-glucose-6-phosphate, β-NADP, magnesium chloride, potassium chloride, sodium phosphate and liver homogenate] was prepared before use. The post-mitochondrial fraction (liver homogenate) was used at the concentration of 10 % (v/v) in the S9 mix. - Test concentrations with justification for top dose:
- Concentration tested were 0.3125, 0.625, 1.25, 2.5 and 5 mg/plate. These concentrations were selected based on solubility, precipitation test and preliminary cytotoxicity test.
- Vehicle / solvent:
- Dimethyl sulfoxide (DMSO) was selected as a vehicle for the test item in this study.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- benzo(a)pyrene
- mitomycin C
- Details on test system and experimental conditions:
- The mutagenic potential of N-tert-butylacrylamide [TBAA] [CAS No. 107-58-4] was tested in two independent experiments (Trial I and Trial II) and both in the presence (10% v/v cofactor supplemented post-mitochondrial S9 fraction, prepared from rat liver) and absence of metabolic activation using Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA102.
Trial I and II: 0.3125, 0.625, 1.25, 2.5 and 5 mg/plate
Trial I was performed according to the plate incorporation method, both in the presence (10% v/v S9 mix) and absence of a metabolic activation system. The Test item together with the vehicle, negative and positive controls, was tested in triplicates. The Test item doses were selected using concentration spacing factor of 2. No increase in the number of revertant colonies or inhibition in background lawn was observed up to the highest concentration of 5 mg/plate either in the presence (10% v/v S9 mix) or absence of metabolic activation when compared to the vehicle control data.
Trial II was performed to confirm the negative results observed in Trial I.
Trial II was conducted according to the preincubation method, both in the presence (10% v/v S9 mix) and absence of a metabolic activation system. The Test item together with the vehicle, negative and positive controls, was tested in all tester strains in triplicates. There was no increase in the number of revertant colonies or inhibition of the background lawn up to the highest concentration of 5 mg/plate either in the presence (10% v/v S9 mix) or absence of metabolic activation when compared to the vehicle control data.
The numbers of revertant colonies of the vehicle, negative (spontaneous revertant colonies), and positive controls (induced revertant colonies) of all the tester strains were within the range of historical data of the laboratory. The positive controls used in the study produced significant increases in the mean number of revertant colonies under both activated and non-activated conditions in all tester strains when compared to the control data confirming the validity of the mutagenicity test.
- Evaluation criteria:
- A Test item is considered as a mutagen if a biologically relevant increase in the mean number of revertants exceeding the threshold of twice (strains TA98, TA100 and TA102) or thrice (strains TA1535 and TA1537) 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.
A dose-dependent increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent experiment.
A dose-dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if it is reproduced in an independent experiment. - Statistics:
- The colonies were counted manually. The mean number of revertant colonies and the standard deviation within the plates for each concentration were compared to the spontaneous reversion rates of the control. Microsoft Office Excel-based calculations were used for descriptive statistical analysis.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: No Mutagenic pottential
Any other information on results incl. tables
Table1 Mean Revertant Colony Count – Preliminary Cytotoxicity Assay
Test Item Concentration (mg/plate) |
TA 98 |
TA 100 |
||||||
- S9 |
+ S9 |
- S9 |
+ S9 |
|||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
NC |
20.33 |
3.21 |
22.33 |
2.89 |
103.33 |
9.50 |
103.67 |
7.02 |
VC |
20.33 |
2.52 |
21.00 |
1.73 |
100.67 |
4.73 |
102.00 |
8.00 |
T1 0.0390625 |
20.67 |
2.52 |
21.67 |
1.15 |
93.00 |
3.46 |
96.00 |
6.24 |
T2 0.078125 |
19.00 |
1.73 |
22.00 |
1.73 |
104.33 |
8.08 |
107.67 |
8.50 |
T3 0.15625 |
21.33 |
1.53 |
22.00 |
2.65 |
95.33 |
7.09 |
96.00 |
6.24 |
T4 0.3125 |
21.00 |
1.73 |
21.00 |
3.61 |
96.33 |
6.51 |
108.33 |
5.69 |
T5 0.625 |
20.33 |
2.52 |
21.67 |
2.31 |
96.00 |
6.24 |
100.33 |
8.50 |
T6 1.25 |
21.00 |
3.46 |
20.33 |
2.52 |
93.67 |
5.03 |
98.00 |
8.00 |
T7 2.5 |
19.33 |
1.15 |
21.67 |
1.15 |
109.67 |
6.66 |
91.33 |
2.52 |
T8 5.0 |
20.67 |
2.08 |
20.33 |
2.31 |
96.00 |
6.24 |
95.00 |
1.73 |
PC |
401.33 |
18.01 |
389.00 |
26.06 |
703.00 |
10.54 |
703.33 |
15.53 |
Key:NC = Negative control,VC = Vehicle control, PC = Positive Control, -S9 = Absence of metabolic activation, +S9 = Presence of metabolic activation, SD = Standard Deviation, NI = No Inhibition.
Note: Since there was no reduction in the revertant count and noinhibition of thebackground lawn observedat 5 mg/plate, Trial I (plate incorporation method) was performed with 5 mg/plate as thehighest concentration.
Positive Controls:
2-Nitrofluorene |
: |
TA98 (absence of metabolic activation) |
Sodium azide |
: |
TA100 (absence of metabolic activation) |
Benzo[a]pyrene |
: |
TA98 and TA100 (presence of metabolic activation) |
Mean Revertant Colony Count -Trial I
Plate Incorporation Method [Absence of metabolic activation (-S9)] |
|
||||||
Test Item Concentration (mg/plate) |
TA 1535 |
TA 1537 |
TA 102 |
||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
||
NC |
14.00 |
1.73 |
6.67 |
1.15 |
235.67 |
7.77 |
|
VC |
12.67 |
1.53 |
7.33 |
0.58 |
238.00 |
5.00 |
|
T1(0.3125) |
11.33 |
1.53 |
5.33 |
1.15 |
228.00 |
22.61 |
|
T2(0.625) |
12.33 |
2.31 |
5.00 |
0.00 |
227.00 |
9.85 |
|
T3(1.25) |
12.33 |
3.21 |
5.00 |
1.73 |
219.33 |
3.51 |
|
T4(2.5) |
15.00 |
1.73 |
5.67 |
1.15 |
219.33 |
13.32 |
|
T5(5.0) |
13.33 |
2.52 |
5.33 |
1.15 |
215.33 |
10.21 |
|
PC |
390.00 |
18.33 |
226.67 |
9.45 |
1562.67 |
42.67 |
|
Plate Incorporation Method [Presence of metabolic activation (+S9 10 % v/v S9 Mix)] |
||||||
Test Item Concentration (mg/plate) |
TA 1535 |
TA 1537 |
TA 102 |
|||
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
NC |
13.67 |
1.15 |
7.33 |
1.15 |
229.33 |
10.02 |
VC |
14.67 |
1.15 |
7.00 |
1.00 |
214.00 |
14.00 |
T1(0.3125) |
15.67 |
2.52 |
7.33 |
2.31 |
216.67 |
11.02 |
T2(0.625) |
13.67 |
0.58 |
9.33 |
1.53 |
222.33 |
17.04 |
T3(1.25) |
14.00 |
1.00 |
8.67 |
2.31 |
224.33 |
9.07 |
T4(2.5) |
13.00 |
2.00 |
6.33 |
1.53 |
225.33 |
7.77 |
T5(5.0) |
14.67 |
1.15 |
6.33 |
0.58 |
233.33 |
6.03 |
PC |
385.33 |
27.47 |
230.67 |
12.01 |
1499.67 |
20.60 |
Key:NC = Negative control, VC = Vehicle control, PC = Positive Control, -S9 = Absence of metabolic activation, +S9 = Presence of metabolic activation, SD = Standard Deviation.
Positive Controls:
2-Nitrofluorene |
: |
TA98 (absence of metabolic activation) |
Sodium azide |
: |
TA100 and TA1535 (absence of metabolic activation) |
9-Aminoacridine |
: |
TA1537 (absence of metabolic activation) |
Mitomycin-C |
: |
TA102(absence of metabolic activation) |
Benzo[a]pyrene |
: |
TA98, TA100, TA1535, TA1537 and TA102 (presence of metabolic activation) |
Table3 Mean Revertant
Colony Count -Trial II
Preincubation Method [Absence of metabolic activation] |
||||||||||
Test Item Concentration (mg/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
|||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
NC |
21.67 |
2.89 |
98.33 |
8.39 |
14.00 |
1.73 |
9.00 |
1.00 |
231.67 |
5.69 |
VC |
21.67 |
2.65 |
100.67 |
8.50 |
12.67 |
1.53 |
6.33 |
0.70 |
225.33 |
5.69 |
T1(0.3125) |
19.67 |
1.00 |
105.67 |
6.81 |
14.33 |
0.58 |
9.00 |
1.42 |
215.67 |
4.63 |
T2(0.625) |
20.67 |
3.79 |
98.00 |
4.58 |
11.67 |
1.15 |
7.67 |
1.21 |
234.33 |
5.28 |
T3(1.25) |
19.67 |
1.00 |
104.67 |
7.64 |
13.00 |
2.65 |
5.33 |
0.84 |
207.00 |
7.57 |
T4(2.5) |
22.00 |
2.00 |
102.67 |
10.02 |
12.00 |
1.73 |
6.67 |
1.05 |
217.67 |
13.01 |
T5(5.0) |
22.00 |
2.65 |
92.33 |
4.16 |
12.00 |
1.73 |
7.33 |
1.16 |
215.00 |
14.00 |
PC |
263.00 |
9.54 |
810.00 |
27.18 |
383.67 |
8.74 |
220.00 |
34.74 |
1726.00 |
6.11 |
Preincubation Method [Presence of metabolic activation (+S9 10% v/v S9 Mix)] |
||||||||||
Test Item Concentration (mg/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
|||||
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
Mean |
SD |
|
NC |
22.33 |
2.89 |
102.00 |
5.57 |
15.33 |
0.58 |
7.33 |
1.00 |
216.67 |
17.62 |
VC |
21.00 |
2.65 |
103.67 |
11.37 |
13.67 |
0.58 |
6.67 |
0.91 |
224.00 |
13.00 |
T1(0.3125) |
20.00 |
1.00 |
107.33 |
9.07 |
12.67 |
0.58 |
7.67 |
1.15 |
235.33 |
6.66 |
T2(0.625) |
21.33 |
3.79 |
107.00 |
7.94 |
12.00 |
1.73 |
9.00 |
1.35 |
219.00 |
8.00 |
T3(1.25) |
20.00 |
1.00 |
98.67 |
8.02 |
12.00 |
1.73 |
7.33 |
1.10 |
237.00 |
9.54 |
T4(2.5) |
21.00 |
2.00 |
101.33 |
11.15 |
13.00 |
2.00 |
7.33 |
1.10 |
216.67 |
11.68 |
T5(5.0) |
21.00 |
2.65 |
104.33 |
7.57 |
11.67 |
1.15 |
7.00 |
1.05 |
207.00 |
4.00 |
PC |
368.00 |
9.54 |
822.33 |
31.97 |
375.00 |
11.53 |
212.67 |
31.90 |
1699.00 |
44.98 |
Key:NC = Negative control, VC = Vehicle control, PC = Positive Control, -S9 = Absence of metabolic activation, +S9 = Presence of metabolic activation, SD = Standard Deviation.
Positive Controls:
2-Nitrofluorene |
: |
TA98 (absence of metabolic activation) |
Sodium azide |
: |
TA100 and TA1535 (absence of metabolic activation) |
9-Aminoacridine |
: |
TA1537 (absence of metabolic activation) |
Mitomycin-C |
: |
TA102(absence of metabolic activation) |
Benzo[a]pyrene |
: |
TA98, TA100, TA1535, TA1537 and TA102 (presence of metabolic activation) |
Fold Increase
Trial I - Plate Incorporation Method |
||||||||||
Test Item Concentration (mg/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
NC |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
VC |
1.00 |
1.02 |
0.90 |
1.10 |
1.01 |
1.00 |
1.02 |
0.90 |
1.10 |
1.01 |
T1(0.3125) |
1.03 |
0.93 |
0.89 |
0.73 |
0.96 |
1.03 |
0.93 |
0.89 |
0.73 |
0.96 |
T2(0.625) |
1.00 |
0.93 |
0.97 |
0.68 |
0.95 |
1.00 |
0.93 |
0.97 |
0.68 |
0.95 |
T3(1.25) |
1.03 |
0.91 |
0.97 |
0.68 |
0.92 |
1.03 |
0.91 |
0.97 |
0.68 |
0.92 |
T4(2.5) |
0.95 |
1.06 |
1.18 |
0.77 |
0.92 |
0.95 |
1.06 |
1.18 |
0.77 |
0.92 |
T5(5.0) |
1.02 |
0.93 |
1.05 |
0.73 |
0.90 |
1.02 |
0.93 |
1.05 |
0.73 |
0.90 |
PC |
19.74 |
6.80 |
30.79 |
30.91 |
6.57 |
19.74 |
6.80 |
30.79 |
30.91 |
6.57 |
Trial II – Preincubation Method |
||||||||||
Test Item Concentration (mg/plate) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
TA 102 |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
NC |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
1.00 |
VC |
0.94 |
0.98 |
1.07 |
0.95 |
0.93 |
0.94 |
0.98 |
1.07 |
0.95 |
0.93 |
T1(0.3125) |
1.00 |
1.06 |
1.07 |
1.05 |
1.01 |
1.00 |
1.06 |
1.07 |
1.05 |
1.01 |
T2(0.625) |
1.03 |
0.98 |
0.93 |
1.33 |
1.04 |
1.03 |
0.98 |
0.93 |
1.33 |
1.04 |
T3(1.25) |
0.97 |
0.96 |
0.95 |
1.24 |
1.05 |
0.97 |
0.96 |
0.95 |
1.24 |
1.05 |
T4(2.5) |
1.03 |
0.90 |
0.89 |
0.90 |
1.05 |
1.03 |
0.90 |
0.89 |
0.90 |
1.05 |
T5(5.0) |
0.97 |
0.93 |
1.00 |
0.90 |
1.09 |
0.97 |
0.93 |
1.00 |
0.90 |
1.09 |
PC |
18.52 |
6.90 |
26.27 |
32.95 |
7.01 |
18.52 |
6.90 |
26.27 |
32.95 |
7.01 |
Key:NC = Negative control,VC = Vehicle control, PC = Positive Control, -S9 = Absence of metabolic activation, +S9 = Presence of metabolic activation.
S9 Efficiency Check- Summary
Summary of S9 efficiency check |
||||
|
TA100 |
TA1535 |
||
Mean |
SD |
Mean |
SD |
|
VC Distilled water (-S9) |
100.67 |
4.73 |
12.67 |
1.53 |
VC Distilled water (+S9) |
102.00 |
8.00 |
14.67 |
1.15 |
PC Benzo[a]pyrene (-S9)
|
103.67 |
7.02 |
12.67 |
1.53 |
PC Benzo[a]pyrene (+S9)
|
703.33 |
15.53 |
385.33 |
27.47 |
Key:VC = Vehicle control, PC = Positive control, -S9 = Absence of metabolic activation, +S9 = Presence of metabolic activation, SD = Standard Deviation.
Individual Revertant Colony Count-Trial I
Trial I- Plate Incorporation Method- Absence of Metabolic Activation |
||||
Test ItemConcentration (mg/plate) |
R |
TA1535 |
TA1537 |
TA102 |
NC |
1 |
13 |
6 |
238 |
2 |
16 |
8 |
242 |
|
3 |
13 |
6 |
227 |
|
VC |
1 |
11 |
7 |
233 |
2 |
13 |
7 |
243 |
|
3 |
14 |
8 |
238 |
|
T1 (0.3125) |
1 |
13 |
6 |
203 |
2 |
11 |
6 |
247 |
|
3 |
10 |
4 |
234 |
|
T2 (0.625) |
1 |
11 |
5 |
219 |
2 |
11 |
5 |
238 |
|
3 |
15 |
5 |
224 |
|
T3 (1.25) |
1 |
11 |
4 |
216 |
2 |
10 |
7 |
223 |
|
3 |
16 |
4 |
219 |
|
T4 (2.5) |
1 |
14 |
5 |
208 |
2 |
14 |
5 |
216 |
|
3 |
17 |
7 |
234 |
|
T5 (5) |
1 |
11 |
6 |
211 |
2 |
13 |
4 |
208 |
|
3 |
16 |
6 |
227 |
|
PC |
1 |
410 |
216 |
1518 |
2 |
386 |
234 |
1603 |
|
3 |
374 |
230 |
1567 |
Key:NC = Negative control, VC = Vehicle control, PC = Positive Control, R = Replicate, TI-T5 = Test Item concentration from lower to higher concentration.
Positive Controls:
2-Nitrofluorene |
: |
TA98 (absence of metabolic activation) |
Sodium azide |
: |
TA100 and TA1535 (absence of metabolic activation) |
9-Aminoacridine |
: |
TA1537 (absence of metabolic activation) |
Mitomycin-C |
: |
TA102(absence of metabolic activation) |
Benzo[a]pyrene |
: |
TA98, TA100, TA1535, TA1537 and TA102 (presence of metabolic activation) |
Individual Revertant Colony
Count-Trial II
Trial II- Preincubation Method- Presence of Metabolic Activation |
||||||
Test Item Concentration (mg/plate) |
R |
TA98 |
TA100 |
TA1535 |
TA1537 |
TA102 |
NC |
1 |
18 |
94 |
16 |
8 |
238 |
2 |
23 |
108 |
13 |
10 |
227 |
|
3 |
24 |
93 |
13 |
9 |
230 |
|
VC |
1 |
20 |
91 |
11 |
6 |
227 |
2 |
21 |
107 |
13 |
6 |
219 |
|
3 |
24 |
104 |
14 |
7 |
230 |
|
T1 (0.3125) |
1 |
18 |
111 |
14 |
9 |
221 |
2 |
18 |
108 |
15 |
10 |
219 |
|
3 |
23 |
98 |
14 |
8 |
207 |
|
T2 (0.625) |
1 |
21 |
103 |
11 |
8 |
233 |
2 |
22 |
97 |
11 |
8 |
229 |
|
3 |
19 |
94 |
13 |
7 |
241 |
|
T3 (1.25) |
1 |
17 |
103 |
10 |
6 |
197 |
2 |
23 |
113 |
14 |
4 |
208 |
|
3 |
24 |
98 |
15 |
6 |
216 |
|
T4 (2.5) |
1 |
21 |
93 |
11 |
6 |
207 |
2 |
21 |
113 |
11 |
8 |
219 |
|
3 |
17 |
102 |
14 |
6 |
227 |
|
T5 (5.0) |
1 |
24 |
91 |
13 |
7 |
216 |
2 |
25 |
89 |
13 |
7 |
209 |
|
3 |
20 |
97 |
10 |
8 |
220 |
|
PC |
1 |
378 |
780 |
386 |
219 |
1673 |
2 |
391 |
833 |
374 |
234 |
1811 |
|
3 |
364 |
817 |
391 |
207 |
1694 |
Key:NC = Negative control, VC = Vehicle control, PC = Positive Control, R = Replicate, TI-T5 = Test Item concentration from lower to higher concentration.
Positive Controls:
2-Nitrofluorene |
: |
TA98 (absence of metabolic activation) |
Sodium azide |
: |
TA100 and TA1535 (absence of metabolic activation) |
9-Aminoacridine |
: |
TA1537 (absence of metabolic activation) |
Mitomycin-C |
: |
TA102(absence of metabolic activation) |
Benzo[a]pyrene |
: |
TA98, TA100, TA1535, TA1537 and TA102 (presence of metabolic activation) |
Applicant's summary and conclusion
- Conclusions:
- The registered substance, N-tert-butylacrylamide (CAS No. 107-58-4) is non-mutagenic (negative) as it does not induce (point) gene mutations by base-pair changes or frameshift in the histidine operon of Salmonella typhimurium tester strains (TA1537, TA1535, TA98, TA100 or TA102 neither in the present nor in the absence of S9 metabolic activation system.
- Executive summary:
Ames test of-tert-butylacrylamide [TBAA] [CAS No.107-58-4] was conducted according to the plate incorporation and preincubation methods. This study was performed as per the OECD guideline No. 471 (Adopted: July 21 1997, Corrected: June 26 2020). Based on the solubility test, dimethyl sulfoxide (DMSO) was selected as a vehicle for the test item in the study. The mutagenic potential of N-tert-butylacrylamide [TBAA] [CAS No. 107-58-4] was tested in two independent experiments (Trial I and Trial II) and both in the presence (10% v/v cofactor supplemented post-mitochondrial S9 fraction, prepared from rat liver) and absence of metabolic activation using Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 and TA102. The Test item was tested along with solvent-vehicle control (DMSO), negative (distilled water), and concurrent positive control substances in triplicates. A preliminary cytotoxicity assay was performed using the strains TA98 and TA100 with the following concentrations along with the vehicle, negative and positive controls both in the presence (10% v/v S9 mix) and absence of metabolic activation in triplicates: 0.0390625, 0.078125, 0.15625, 0.3125, 0.625, 1.25, 2.5 and 5 mg/plate. In the tester strains, TA98 and TA100, no reduction in the revertant count and no inhibition in background lawn were observed at any of the concentrations, either in the presence (10% v/v S9 mix) or the absence of metabolic activation, when compared to the vehicle control data. Based on the preliminary cytotoxicity test results, the main study was performed with the following concentrations: Trial I and II: 0.3125, 0.625, 1.25, 2.5, and 5 mg/plate
Trial I was performed according to the plate incorporation method, both in the presence (10% v/v S9 mix) and absence of a metabolic activation system. The Test item and the vehicle, negative and positive controls, were tested in triplicates. The Test item doses were selected using a concentration spacing factor of 2. No increase in the number of revertant colonies or inhibition in the background lawn was observed up to the highest concentration of 5mg/plate either in the presence (10% v/v S9 mix) or absence of metabolic activation when compared to the vehicle control data.
Trial II was performed to confirm the negative results observed in Trial I. Trial II was conducted according to the preincubation method, both in the presence (10% v/v S9 mix) and absence of a metabolic activation system. The Test item and the vehicle, negative and positive controls, were tested in all tester strains in triplicates. There was no increase in the number of revertant colonies or inhibition of the background lawn up to the highest concentration of 5 mg/plate either in the presence (10% v/v S9 mix) or absence of metabolic activation when compared to the vehicle control data. The numbers of revertant colonies of the vehicle, negative (spontaneous revertant colonies), and positive controls (induced revertant colonies) of all the tester strains were within the range of historical data of the laboratory. The positive controls used in the study produced significant increases in the mean number of revertant colonies under both activated and non-activated conditions in all tester strains when compared to the control data confirming the validity of the mutagenicity test.
Based on the results of this study, it is concluded that N-tert-butylacrylamide [TBAA] [CAS No. 107-58-4] is non-mutagenic as it does not induce (point) gene mutations in the histidine operon by base-pair changes or frameshifts, in the presence and the absence of metabolic activation system, in the tester strains of Salmonella typhimurium (TA1537, TA1535, TA98, TA100, and TA102).
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