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EC number: 948-260-2 | CAS number: -
- 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
- Study period:
- Nov- Dec 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997-07-21
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt Rheinland-Pfalz
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of (4Z,8E)-dodeca-4,8,11-trienal and (4E,8Z)-dodeca-4,8,11-trienal
- EC Number:
- 701-295-5
- Molecular formula:
- C12 H18 O
- IUPAC Name:
- Reaction mass of (4Z,8E)-dodeca-4,8,11-trienal and (4E,8Z)-dodeca-4,8,11-trienal
Constituent 1
- Specific details on test material used for the study:
- Test material is the main constituent of the registered substance.
Method
- Target gene:
- trp / his
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- Source of S9 : Prepared at BASF SE
- Method of preparation of S9 mix : Exposure of 5 male Wistar rats with 80 mg/kg bw phenobarbital (i.p.) and β-naphthoflavone (oral) on 3d; 24h after last administration rats were sacrificied and livers were prepared; Mixture of S9 fraction and S9 supplement prior to each experiment
- Preparation date of S9 fraction: 07 Sep 2018
- Content of protein in S9 fraction: 28.61 g/L
- Concentration or volume of S9 mix and S9 in the final culture medium : 0.5 mL S9 mix
- Sterility controls of S9 mix were performed
- Test concentrations with justification for top dose:
- Due to toxicity observed in a previous performed Non-GLP study (40M0072/18M062), the doses were adjusted in the 1st Experiment (standard plate test):
0.33; 1.0; 3.3; 10; 33 and 100 μg/plate (TA strains without S9 mix)
3.3; 10; 33; 100; 333 and 1000 μg/plate (E.coli without S9 mix)
1.0; 3.3; 10; 33; 100 and 333 μg/plate (TA strains with S9 mix)
33; 100; 333; 1000; 2500 and 5000 μg/plate (E.coli with S9 mix)
Due to toxicity observed in the standard plate test, the doses were adjusted in the preincubation test:
0; 0.33; 1.0; 3.3; 10; 33 and 100 μg/plate (TA strains with and without S9 mix)
0; 1; 3.3; 10; 33; 100 and 333 μg/plate (E. coli without S9 mix)
0; 10; 33; 100; 333; 1000 and 2500 μg/plate (E.coli with S9 mix) - Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Justification for choice of solvent/vehicle: DMSO had been demonstrated to be suitable in a bacterial reverse mutation test; historical data available
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- other: 2-aminoanthracene (2-AA); N-methyl-N'-nitro-N-nitrosoguanidine (MNNG); 4-nitro-o-phenylenediamine (NOPD)
- Remarks:
- positive control: 2-aminoanthracene was tested with S9 mix; other without S9 mix
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: 3
- Number of independent experiments : 2 experiments plus 2 control settings
METHOD OF TREATMENT/ EXPOSURE:
- Cell density at seeding (if applicable): Approximately 10^9 cells per mL
- Test substance added in soft agar (plate incorbation); preincubation
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: 20 min
- Exposure duration/duration of treatment: 48 - 72 h
- Evaluation criteria:
- The test substance was considered positive in this assay if the following criteria were met:
• A dose-related and reproducible increase in the number of revertant colonies, i.e. at least
doubling (bacteria strains with high spontaneous mutation rate, like TA 98, TA 100 and E.coli
WP2 uvrA) or tripling (bacteria strains with low spontaneous mutation rate, like TA 1535 and
TA 1537) of the spontaneous mutation rate in at least one tester strain either without S9 mix
or after adding a metabolizing system.
A test substance was generally considered non-mutagenic in this test if:
• The number of revertants for all tester strains were within the range of the historical negative
control data under all experimental conditions in at least two experiments carried out
independently of each other.
Toxicity detected by a
• decrease in the number of revertants (factor ≤ 0.6)
• clearing or diminution of the background lawn (= reduced his- or trp- background growth)
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at and above 3.3 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True 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:
- cytotoxicity
- Remarks:
- at and above 100 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True 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:
- cytotoxicity
- Remarks:
- at and above 1.0 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True 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:
- cytotoxicity
- Remarks:
- at and above 3.3 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at and above 333 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation and time of the determination: No test substance precipitation was observed with and without S9 mix
STUDY RESULTS
Concurrent vehicle negative and positive control data :
-The number of revertant colonies in the negative controls was within the range of the
historical negative control data for each tested strain
- The positive control substances both with and without S9 mix induced a distinct increase in
the number of revertant colonies compatible with the range of the historical positive control
data or above
-The sterility controls revealed no indication of bacterial contamination
Ames test:
- Signs of toxicity : Bacteriotoxic effects were observed (dependend on bacterial strain and test condition) in the standard plate test and preincubation test
Any other information on results incl. tables
TOXICITY
Tab.1: Decreased revertant numbers were observed at following concentrations (μg/plate)
Experiment |
S9 |
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
E.coli |
1st-STP |
Without |
100 |
100 |
10 - 100 |
100 |
1000 |
With |
333 |
333 |
100 - 333 |
100 - 333 |
2500 - 5000 |
|
2nd-PIT |
Without |
10 - 100 |
100 |
1.0, 3.3, 33, 100 |
3.3, 33 - 100 |
333 |
With |
3.3, 10, 100 |
100 |
0.33 - 100 |
100 |
1000 - 2500 |
STP- standard plate test: PIT- preincubation test
Tab. 2: Reduced background growth was observed at following concentrations (μg/plate)
Experiment |
S9 |
TA 1535 |
TA 100 |
TA 1537 |
TA 98 |
E.coli |
1st-STP |
Without |
100 |
100 |
100 |
100 |
333 - 1000 |
With |
333 |
333 |
333 |
333 |
2500 - 5000 |
|
2nd-PIT |
Without |
100 |
100 |
100 |
100 |
333 |
With |
100 |
100 |
100 |
100 |
1000 - 2500 |
STP- standard plate test: PIT- preincubation test
STANDARD PLATE TEST
Tab. 3: Standard plate test with metabolic activation
Strain |
Test group |
Dose (µg/plate) |
Mean revertants per plate |
Standard deviation |
Factor |
Individual revertant colony counts |
TA 1535 |
DMSO |
- |
12.7 |
6.0 |
- |
19, 7, 12 |
|
Test item |
1.0 |
8.3 |
2.9 |
0.7 |
5, 10, 10 |
|
|
3.3 |
14.0 |
8.7 |
1.1 |
19, 19, 4 |
|
|
10 |
11.0 |
1.7 |
0.9 |
9, 12, 12 |
|
|
33 |
10.0 |
1.0 |
0.8 |
10, 9, 11 |
|
|
100 |
8.3 |
0.6 |
0.7 |
9, 8, 8 |
|
|
333 |
2.0 |
1.7 |
0.2 |
1 B, 4 B, 1 B |
|
2-AA |
2.5 |
148.0 |
1.0 |
11.7 |
148, 147, 149 |
|
|
|
|
|
|
|
TA 100 |
DMSO |
- |
104.7 |
5.5 |
- |
99, 105, 110 |
|
Test item |
1.0 |
106.0 |
18.2 |
1.0 |
94, 97, 127 |
|
|
3.3 |
114.7 |
13.9 |
1.1 |
130, 103, 111 |
|
|
10 |
106.7 |
17.0 |
1.0 |
108, 123, 89 |
|
|
33 |
101.7 |
6.7 |
1.0 |
96, 109, 100 |
|
|
100 |
106.7 |
11.6 |
1.0 |
101, 120, 99 |
|
|
333 |
0.0 |
0.0 |
0.0 |
0 B, 0 B, 0 B |
|
2-AA |
2.5 |
1483.0 |
582.0 |
14.2 |
811, 1811, 1827 |
|
|
|
|
|
|
|
TA 1537 |
DMSO |
- |
5.7 |
0.6 |
- |
6, 5, 6 |
|
Test item |
1.0 |
8.3 |
2.1 |
1.5 |
6, 10, 9 |
|
|
3.3 |
7.0 |
4.6 |
1.2 |
6, 12, 3 |
|
|
10 |
6.3 |
2.5 |
1.1 |
6, 9, 4 |
|
|
33 |
4.3 |
1.5 |
0.8 |
4, 3, 6 |
|
|
100 |
3.3 |
2.5 |
0.6 |
3, 6, 1 |
|
|
333 |
0.0 |
0.0 |
0.0 |
0 B, 0 B, 0 B |
|
2-AA |
2.5 |
158.0 |
37.2 |
27.9 |
180, 115, 179 |
|
|
|
|
|
|
|
TA 98 |
DMSO Test item |
- |
19.3 |
8.6 |
- |
27, 10, 21 |
|
1.0 |
22.0 |
1.0 |
1.1 |
22, 21, 23 |
|
|
|
3.3 |
17.3 |
3.5 |
0.9 |
17, 21, 14 |
|
|
10 |
15.0 |
6.6 |
0.8 |
9, 22, 14 |
|
|
33 |
14.0 |
1.0 |
0.7 |
15, 13, 14 |
|
|
100 |
7.3 |
4.5 |
0.4 |
12, 7, 3 |
|
|
333 |
1.7 |
1.2 |
0.1 |
3 B, 1 B, 1 B |
|
2-AA |
2.5 |
1178.3 |
174.0 |
60.9 |
1335, 1209, 991 |
|
|
|
|
|
|
|
E. coli |
DMSO Test item |
- |
19.7 |
3.8 |
- |
17, 24, 18 |
|
33 |
20.7 |
3.1 |
1.1 |
18, 20, 24 |
|
|
|
100 |
21.7 |
8.1 |
1.1 |
17, 31, 17 |
|
|
333 |
22.7 |
5.5 |
1.2 |
28, 23, 17 |
|
|
1000 |
14.3 |
10.5 |
0.7 |
25, 4, 14 |
|
|
2500 |
7.7 |
3.1 |
0.4 |
7 B, 11 B, 5 B |
|
|
5000 |
0.0 |
0.0 |
0.0 |
0 B, 0 B, 0 B |
|
2-AA |
60 |
212.0 |
35.2 |
10.8 |
172, 238, 226 |
Tab. 4: Standard plate test without metabolic activation
Strain |
Test group |
Dose (µg/plate) |
Mean revertants per plate |
Standard deviation |
Factor |
Individual revertant colony counts |
TA 1535 |
DMSO |
- |
11.0 |
1.7 |
- |
12, 12, 9 |
|
Test item |
0.33 |
9.3 |
2.1 |
0.8 |
10, 11, 7 |
|
|
1.0 |
12.7 |
2.3 |
1.2 |
14, 10, 14 |
|
|
3.3 |
9.3 |
3.5 |
0.8 |
9, 13, 6 |
|
|
10 |
8.7 |
2.5 |
0.8 |
6, 11, 9 |
|
|
33 |
14.3 |
0.6 |
1.3 |
14, 14, 15 |
|
|
100 |
2.0 |
0.0 |
0.2 |
2 B, 2 B, 2 B |
|
MNNG |
5.0 |
6079.0 |
61.0 |
552.6 |
6029, 6061, 6147 |
|
|
|
|
|
|
|
TA 100 |
DMSO |
- |
126.0 |
18.5 |
- |
147, 119, 112 |
|
Test item |
0.33 |
123.3 |
15.9 |
1.0 |
141, 119, 110 |
|
|
1.0 |
126.3 |
4.0 |
1.0 |
124, 124, 131 |
|
|
3.3 |
118.3 |
26.3 |
0.9 |
88, 132, 135 |
|
|
10 |
99.7 |
4.7 |
0.8 |
105, 96, 98 |
|
|
33 |
101.7 |
8.5 |
0.8 |
92, 108, 105 |
|
|
100 |
37.3 |
22.2 |
0.3 |
63 B, 25 B, 24 B |
|
MNNG |
5.0 |
6004.7 |
222.7 |
47.7 |
5832, 6256, 5926 |
|
|
|
|
|
|
|
TA 1537 |
DMSO |
- |
10.3 |
3.1 |
- |
7, 11, 13 |
|
Test item |
0.33 |
8.0 |
2.0 |
0.8 |
6, 8, 10 |
|
|
1.0 |
7.3 |
3.1 |
0.7 |
10, 8, 4 |
|
|
3.3 |
7.0 |
3.0 |
0.7 |
4, 10, 7 |
|
|
10 |
4.7 |
2.9 |
0.5 |
3, 8, 3 |
|
|
33 |
5.0 |
3.6 |
0.5 |
6, 1, 8 |
|
|
100 |
2.7 |
1.2 |
0.3 |
4 B, 2 B, 2 B |
|
AAC |
100 |
999.7 |
295.1 |
96.7 |
1090, 670, 1239 |
|
|
|
|
|
|
|
TA 98 |
DMSO Test item |
- |
17.0 |
1.7 |
- |
19, 16, 16 |
|
0.33 |
18.7 |
7.4 |
1.1 |
16, 27, 13 |
|
|
|
1.0 |
12.7 |
4.2 |
0.7 |
8, 16, 14 |
|
|
3.3 |
15.3 |
4.7 |
0.9 |
10, 17, 19 |
|
|
10 |
13.7 |
1.5 |
0.8 |
12, 14, 15 |
|
|
33 |
13.0 |
1.7 |
0.8 |
14, 14, 11 |
|
|
100 |
4.3 |
2.9 |
0.3 |
1 B, 6 B, 6 B |
|
NOPD |
10 |
855.0 |
56.3 |
50.3 |
916, 805, 844 |
|
|
|
|
|
|
|
E. coli |
DMSO Test item |
- |
21.0 |
3.6 |
- |
24, 17, 22 |
|
3.3 |
18.0 |
5.6 |
0.9 |
23, 19, 12 |
|
|
|
10 |
26.0 |
4.6 |
1.2 |
22, 31, 25 |
|
|
33 |
25.0 |
5.6 |
1.2 |
19, 26, 30 |
|
|
100 |
16.7 |
7.2 |
0.8 |
25, 13, 12 |
|
|
333 |
14.7 |
7.4 |
0.7 |
23 B, 12 B, 9 B |
|
|
1000 |
0.0 |
0.0 |
0.0 |
0 B, 0 B, 0 B |
|
4-NQO |
5 |
1528.3 |
45.9 |
72.8 |
1568, 1539, 1478 |
PREINCUBATION TEST
Tab. 5: Preincubation test without metabolic activation
Strain |
Test group |
Dose (µg/plate) |
Mean revertants per plate |
Standard deviation |
Factor |
Individual revertant colony counts |
|
|
|
|
|
|
|
TA 1535 |
DMSO |
- |
15.3 |
4.9 |
- |
21, 12, 13 |
|
Test item |
0.33 |
16.3 |
5.5 |
1.1 |
19, 10, 20 |
|
|
1.0 |
11.0 |
3.6 |
0.7 |
8, 15, 10 |
|
|
3.3 |
14.3 |
4.2 |
0.9 |
19, 11, 13 |
|
|
10 |
9.3 |
2.1 |
0.6 |
11, 10, 7 |
|
|
33 |
7.7 |
2.3 |
0.5 |
9, 9, 5 |
|
|
100 |
1.0 |
0.0 |
0.1 |
1 B, 1 B, 1 B |
|
MNNG |
5.0 |
6535.0 |
309.9 |
426.2 |
6886, 6299, 6420 |
|
|
|
|
|
|
|
TA 100 |
DMSO |
- |
105.3 |
12.9 |
- |
96, 100, 120 |
|
Test item |
0.33 |
111.0 |
6.0 |
1.1 |
105, 117, 111 |
|
|
1.0 |
112.7 |
14.0 |
1.1 |
117, 124, 97 |
|
|
3.3 |
112.7 |
27.5 |
1.1 |
86, 141, 111 |
|
|
10 |
100.3 |
14.6 |
1.0 |
90, 94, 117 |
|
|
33 |
99.0 |
4.4 |
0.9 |
94, 102, 101 |
|
|
100 |
0.0 |
0.0 |
0.0 |
0 B, 0 B, 0 B |
|
MNNG |
5.0 |
5002.7 |
223.6 |
47.5 |
4745, 5118, 5145 |
|
|
|
|
|
|
|
TA 1537 |
DMSO |
- |
9.3 |
6.1 |
- |
16, 4, 8 |
|
Test item |
0.33 |
13.7 |
4.0 |
1.5 |
16, 16, 9 |
|
|
1.0 |
5.0 |
2.6 |
0.5 |
8, 4, 3 |
|
|
3.3 |
5.3 |
2.9 |
0.6 |
7, 7, 2 |
|
|
10 |
7.3 |
2.1 |
0.8 |
9, 8, 5 |
|
|
33 |
5.3 |
0.6 |
0.6 |
6, 5, 5 |
|
|
100 |
1.7 |
1.2 |
0.2 |
3 B, 1 B, 1 B |
|
AAC |
100 |
953.3 |
234.4 |
102.1 |
1224, 819, 817 |
|
|
|
|
|
|
|
TA 98 |
DMSO |
- |
24.0 |
0.0 |
- |
24, 24, 24 |
|
Test item |
0.33 |
16.7 |
4.0 |
0.7 |
19, 19, 12 |
|
|
1.0 |
15.7 |
4.9 |
0.7 |
19, 10, 18 |
|
|
3.3 |
14.7 |
4.9 |
0.6 |
18, 9, 17 |
|
|
10 |
22.7 |
3.8 |
0.9 |
27, 21, 20 |
|
|
33 |
12.3 |
1.2 |
0.5 |
11, 13, 13 |
|
|
100 |
0.0 |
0.0 |
0.0 |
0 B, 0 B, 0 B |
|
NOPD |
10 |
958.3 |
17.1 |
39.9 |
947, 950, 978 |
|
|
|
|
|
|
|
E. coli |
DMSO |
- |
21.3 |
6.5 |
- |
28, 15, 21 |
|
Test item |
1.0 |
26.0 |
3.6 |
1.2 |
25, 23, 30 |
|
|
3.3 |
26.7 |
7.4 |
1.3 |
24, 35, 21 |
|
|
10 |
27.3 |
4.0 |
1.3 |
23, 28, 31 |
|
|
33 |
18.7 |
2.9 |
0.9 |
17, 17, 22 |
|
|
100 |
26.0 |
12.2 |
1.2 |
32, 34, 12 |
|
|
333 |
9.3 |
6.8 |
0.4 |
17 B, 4 B, 7 B |
|
4-NQO |
5 |
655.3 |
0.6 |
30.7 |
655, 655, 656 |
Tab.6: Preincubation test with metabolic activation
Strain |
Test group |
Dose (µg/plate) |
Mean revertants per plate |
Standard deviation |
Factor |
Individual revertant colony counts |
|
|
|
|
|
|
|
TA 1535 |
DMSO |
- |
15.3 |
4.9 |
- |
21, 12, 13 |
|
Test item |
0.33 |
16.3 |
5.5 |
1.1 |
19, 10, 20 |
|
|
1.0 |
11.0 |
3.6 |
0.7 |
8, 15, 10 |
|
|
3.3 |
14.3 |
4.2 |
0.9 |
19, 11, 13 |
|
|
10 |
9.3 |
2.1 |
0.6 |
11, 10, 7 |
|
|
33 |
7.7 |
2.3 |
0.5 |
9, 9, 5 |
|
|
100 |
1.0 |
0.0 |
0.1 |
1 B, 1 B, 1 B |
|
2-AA |
5.0 |
6535.0 |
309.9 |
426.2 |
6886, 6299, 6420 |
|
|
|
|
|
|
|
TA 100 |
DMSO |
- |
105.3 |
12.9 |
- |
96, 100, 120 |
|
Test item |
0.33 |
111.0 |
6.0 |
1.1 |
105, 117, 111 |
|
|
1.0 |
112.7 |
14.0 |
1.1 |
117, 124, 97 |
|
|
3.3 |
112.7 |
27.5 |
1.1 |
86, 141, 111 |
|
|
10 |
100.3 |
14.6 |
1.0 |
90, 94, 117 |
|
|
33 |
99.0 |
4.4 |
0.9 |
94, 102, 101 |
|
|
100 |
0.0 |
0.0 |
0.0 |
0 B, 0 B, 0 B |
|
2-AA |
5.0 |
5002.7 |
223.6 |
47.5 |
4745, 5118, 5145 |
|
|
|
|
|
|
|
TA 1537 |
DMSO |
- |
9.3 |
6.1 |
- |
16, 4, 8 |
|
Test item |
0.33 |
13.7 |
4.0 |
1.5 |
16, 16, 9 |
|
|
1.0 |
5.0 |
2.6 |
0.5 |
8, 4, 3 |
|
|
3.3 |
5.3 |
2.9 |
0.6 |
7, 7, 2 |
|
|
10 |
7.3 |
2.1 |
0.8 |
9, 8, 5 |
|
|
33 |
5.3 |
0.6 |
0.6 |
6, 5, 5 |
|
|
100 |
1.7 |
1.2 |
0.2 |
3 B, 1 B, 1 B |
|
2-AA |
100 |
953.3 |
234.4 |
102.1 |
1224, 819, 817 |
|
|
|
|
|
|
|
TA 98 |
DMSO |
- |
24.0 |
0.0 |
- |
24, 24, 24 |
|
Test item |
0.33 |
16.7 |
4.0 |
0.7 |
19, 19, 12 |
|
|
1.0 |
15.7 |
4.9 |
0.7 |
19, 10, 18 |
|
|
3.3 |
14.7 |
4.9 |
0.6 |
18, 9, 17 |
|
|
10 |
22.7 |
3.8 |
0.9 |
27, 21, 20 |
|
|
33 |
12.3 |
1.2 |
0.5 |
11, 13, 13 |
|
|
100 |
0.0 |
0.0 |
0.0 |
0 B, 0 B, 0 B |
|
2-AA |
10 |
958.3 |
17.1 |
39.9 |
947, 950, 978 |
|
|
|
|
|
|
|
E. coli |
DMSO |
- |
21.3 |
6.5 |
- |
28, 15, 21 |
|
Test item |
1.0 |
26.0 |
3.6 |
1.2 |
25, 23, 30 |
|
|
3.3 |
26.7 |
7.4 |
1.3 |
24, 35, 21 |
|
|
10 |
27.3 |
4.0 |
1.3 |
23, 28, 31 |
|
|
33 |
18.7 |
2.9 |
0.9 |
17, 17, 22 |
|
|
100 |
26.0 |
12.2 |
1.2 |
32, 34, 12 |
|
|
333 |
9.3 |
6.8 |
0.4 |
17 B, 4 B, 7 B |
|
2-AA |
5 |
655.3 |
0.6 |
30.7 |
655, 655, 656 |
HISTORICAL CONTROL DATA
Tab. 7: Historical negative control
Strain |
S9 Mix |
Vehicle |
No. of Plates |
No. of Values |
Min |
Max |
Mean |
SD |
TA 1535 |
without |
(All) |
315 |
112 |
7 |
19 |
11 |
2.3 |
with |
(All) |
318 |
112 |
6 |
21 |
11 |
2.6 |
|
|
|
|
|
|
|
|
|
|
TA 100 |
without |
(All) |
318 |
113 |
78 |
140 |
106 |
12.1 |
with |
(All) |
327 |
113 |
72 |
135 |
107 |
11.2 |
|
|
|
|
|
|
|
|
|
|
TA 1537 |
without |
(All) |
309 |
112 |
4 |
12 |
8 |
1.7 |
with |
(All) |
309 |
112 |
5 |
13 |
9 |
1.6 |
|
|
|
|
|
|
|
|
|
|
TA 98 |
without |
(All) |
318 |
113 |
12 |
27 |
18 |
2.9 |
with |
(All) |
312 |
113 |
18 |
45 |
25 |
4.0 |
|
|
|
|
|
|
|
|
|
|
E. coli |
without |
(All) |
306 |
113 |
19 |
38 |
26 |
4.2 |
with |
(All) |
306 |
113 |
18 |
40 |
26 |
4.1 |
Tab. 8: Historical poositive control
Strain
|
S9 Mix |
Positive control |
No. of Plates |
No. of Values |
Min |
Max |
Mean |
SD |
TA 1535 |
Without |
MNNG |
252 |
88 |
2345 |
7317 |
4484 |
1042.2 |
|
With |
2-AA |
252 |
88 |
50 |
334 |
193 |
53.3 |
|
|
|
|
|
|
|
|
|
TA 100 |
Without |
MNNG |
252 |
88 |
814 |
5801 |
3443 |
1004.7 |
|
With |
2-AA |
258 |
88 |
413 |
2943 |
1563 |
492.8 |
|
|
|
|
|
|
|
|
|
TA 1537 |
Without |
AAC |
246 |
88 |
282 |
1497 |
809 |
237.1 |
|
With |
2-AA |
252 |
88 |
41 |
254 |
108 |
36.8 |
|
|
|
|
|
|
|
|
|
TA 98 |
Without |
NOPD |
252 |
88 |
484 |
1239 |
986 |
141.1 |
|
With |
2-AA |
249 |
88 |
161 |
2347 |
1098 |
379.9 |
|
|
|
|
|
|
|
|
|
E. coli |
Without |
4-NQO |
246 |
88 |
176 |
1931 |
750 |
395.9 |
|
With |
2-AA |
246 |
88 |
66 |
259 |
115 |
45.7 |
Applicant's summary and conclusion
- Conclusions:
- Under the experimental conditions of this study, the test substance is not
mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the
absence and the presence of metabolic activation. - Executive summary:
The test substance was tested for its mutagenic potential based on the ability
to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella
typhimurium and Escherichia coli, in a reverse mutation assay.
Strains: TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA
Dose range: 0.33 μg - 5000 μg/plate (SPT); 0.33 μg - 2500 μg/plate (PIT)
Test conditions: Standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (liver S9 mix from induced rats).
Solubility: No precipitation of the test substance was observed with and without S9 mix.
Toxicity: A bacteriotoxic effect was observed depending on the strain and test conditions at and above 0.33 μg/plate
Mutagenicity: A relevant increase in the number of his+ or trp+ revertants (factor ≥ 2: TA 100, TA 98 and E.coli
WP2 uvrA or factor ≥ 3: TA 1535 and TA 1537) was not observed in the standard plate test or in the preincubation test without S9 mix or after the addition of a metabolizing system (BASF SE, 2019)
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