Registration Dossier
Registration Dossier
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EC number: 275-654-5 | CAS number: 71598-17-9
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:
- 2016-02-26 to 2016-07-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-[2-[4-(dimethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium acetate
- EC Number:
- 275-654-5
- EC Name:
- 2-[2-[4-(dimethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium acetate
- Cas Number:
- 71598-17-9
- Molecular formula:
- C21H25N2.C2H3O2
- IUPAC Name:
- 2-{2-[4-(dimethylamino)phenyl]vinyl}-1,3,3-trimethyl-3H-indolium acetate
Constituent 1
- Specific details on test material used for the study:
- Batch identification: 5040140109
Method
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:
- Phenobarbital and ß-naphthoflavone induced rat liver S9-mix
- Test concentrations with justification for top dose:
- 1st Experiment: 0; 100; 333; 1000; 3333; 6000 and 9000 μg/plate (Standard plate test)
2nd Experiment: 0; 3.3; 10; 33; 100; 333 and 1000 μg/plate (Standard Plate test)
(TA 1535, TA 100, TA 98 and E. coli WP2 uvrA)
0; 1.0; 3.3; 10; 33; 100 and 333 μg/plate
(TA 1537)
3rd Experiment: 0; 1.0; 3.3; 10; 33; 100 and 333 μg/plate (Preincubation test)
4th Experiment: TA 98 (Preincubation test) 0; 3.3; 10; 33; 100; 333 and 1000 μg/plate - Vehicle / solvent:
- Vehicle: water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine (MNNG)
- Remarks:
- Without S9 mix: TA 1535, TA 100
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylenediamine (NOPD)
- Remarks:
- Without S9-mix (TA 98)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Without S9-mix: TA 1537
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Without S9 Mix: E. coli WP2 uvrA
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-AA)
- Remarks:
- With S9-Mix: All strains
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation, preincubation)
2 experiments: Preincubation test and Standard Plate test
DURATION
- Exposure duration: 48-72 hours at 37°C (Standard Plate test)
20 min at 37 °C (Preincubation test)
NUMBER OF REPLICATIONS: triplicates
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - 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.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- 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
- Key result
- Species / strain:
- S. typhimurium 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
- Key result
- Species / strain:
- S. typhimurium TA 1537
- 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
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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
- Key result
- Species / strain:
- E. coli WP2 uvr A
- 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
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No test substance precipitation was found with and without S9 mix.
HISTORICAL CONTROL DATA
- Positive historical control data:
TA1535, Without S9 Mix: 3795 (Mean), 1195.4 (SD)
With S9 Mix: 242 (Mean), 49.7 (SD)
TA 100, Without S9 Mix: 3094 (Mean), 933.6 (SD)
With S9 Mix: 1925 (Mean), 482.1 (SD)
TA 1537 Without S9 Mix: 958, 346.9 (SD)
With S9 Mix: 144 (Mean), 37.5 (SD)
TA 98 Without S9 Mix: 422 (Mean), 59.1 (SD)
With S9 Mix: 1573 (Mean), 402.9 (SD)
E.coli Without S9 Mix: 915 (Mean), 457.5 (SD)
With S9 Mix: 100 (Mean), 28.2 (SD)
- Negative (solvent/vehicle) historical control data:
TA1535 Without S9 Mix: 11 (Mean), 2.4 (SD)
With S9 Mix: 11 (Mean), 2.4 (SD)
TA100 Without S9 Mix: 95 (Mean), 9.0 (SD)
With S9 Mix: 99 (Mean), 10.4 (SD)
TA 1537 Without S9 Mix: 7 (Mean), 1.7 (SD)
With S9 Mix: 8 (Mean), 2.2 (SD)
TA 98 Without S9 Mix: 18 (Mean), 3.3 (SD)
With S9 Mix: 25 (Mean), 5.2 (SD)
E.coli Without S9 Mix: 22 (Mean), 3.8 (SD)
With S9 Mix: 23 (Mean), 3.7 (SD)
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- A bacteriotoxic effect (reduced his- or trp- background growth, decrease in the number of his+or trp+ revertants) was observed in the standard plate test depending on the strain and test conditions from about 100 μg/plate onward.
In the preincubation assay bacteriotoxicity (reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants) was observed depending on the strain and test conditions from about 100 μg/plate onward.
Any other information on results incl. tables
Standard Plate test |
Experiment: |
1st-SPT |
|||||
Without metabolic activation |
|||||||
Strain |
Test group |
Dose |
Mean revertants |
Standard |
Factor |
Individual revertant colony counts |
|
TA 1535 |
Water |
- |
7.3 |
0.6 |
- |
7, 8, 7 |
|
Test item |
100 |
19.7 |
1.5 |
2.7 |
18, 20, 21 |
||
333 |
16.3 |
4.2 |
2.2 |
13, 21, 15 |
|||
1000 |
6.7 |
3.8 |
0.9 |
11B, 4B, 5B |
|||
3333 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B, |
|||
6000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B, |
|||
9000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B, |
|||
MNNG |
5.0 |
6169.0 |
382.8 |
841.2 |
5923, 5974, 6610 |
||
TA100 |
Water |
- |
96.3 |
8.5 |
- |
105, 96, 88 |
|
Test item |
100 |
139.7 |
8.4 |
1.4 |
130, 144, 145 |
||
333 |
146.3 |
21.9 |
1.5 |
129, 139, 171 |
|||
1000 |
14.3 |
11.5 |
0.1 |
3 B, 14 B, 26 B |
|||
3333 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B, |
|||
6000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B, |
|||
9000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B, |
|||
MNNG |
5.0 |
5300.0 |
268.2 |
55.0 |
5556, 5323, 5021 |
||
TA 1537 |
Water |
- |
6.7 |
1.2 |
- |
8, 6, 6 |
|
Test item |
100 |
5.7 |
0.6 |
0.9 |
6, 5, 6 |
||
333 |
2.3 |
3.2 |
0.4 |
6 B, 0 B, 1B |
|||
1000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B, |
|||
3333 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B, |
|||
6000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B, |
|||
9000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B, |
|||
AAC |
5.0 |
405.7 |
7.5 |
60.9 |
398, 406, 413 |
||
TA 98 |
Water |
- |
22.0 |
5.2 |
- |
25, 25, 16 |
|
Test item |
100 |
29.7 |
1.5 |
1.3 |
30, 28, 31 |
||
333 |
18.3 |
5.0 |
0.8 |
19, 23, 13 |
|||
1000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B, |
|||
3333 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B, |
|||
6000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B, |
|||
9000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B, |
|||
NOPD |
5.0 |
711.7 |
23.2 |
32.3 |
738, 694, 703 |
||
E.coli |
Water |
- |
21.7 |
1.2 |
- |
21, 21, 23 |
|
Test item |
100 |
22.3 |
5.0 |
1.0 |
23, 27, 17 |
||
333 |
14.3 |
2.5 |
0.7 |
17, 12, 14 |
|||
1000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B, |
|||
3333 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B, |
|||
6000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B, |
|||
9000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B, |
|||
4-NQO |
5.0 |
1231.0 |
47.9 |
56.8 |
1275, 1180, 1238 |
||
Standard Plate test |
Experiment: |
1st-SPT |
|||||
With metabolic activation |
|||||||
Strain |
Test group |
Dose |
Mean revertants |
Standard |
Factor |
Individual revertant colony counts |
|
TA 1535 |
Water |
- |
11.3 |
2.1 |
- |
9, 13, 12 |
|
Test item |
100 |
12.7 |
1.2 |
1.1 |
14, 12, 12, |
||
333 |
10.7 |
2.1 |
0.9 |
10, 13, 9 |
|||
1000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B |
|||
3333 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B |
|||
6000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B |
|||
9000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B |
|||
2-AA |
2.5 |
252.0 |
40.3 |
22.2 |
246, 295, 215 |
||
TA100 |
Water |
- |
123.7 |
5. 7 |
- |
122, 119, 130 |
|
Test item |
100 |
156.3 |
5.7 |
1.3 |
152, 160, 157 |
||
333 |
103.0 |
4.0 |
0.8 |
105, 107, 97 |
|||
1000 |
0.0 |
5.3 |
0.0 |
0B, 0B, 0B |
|||
3333 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B |
|||
6000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B |
|||
9000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B |
|||
2-AA |
2.5 |
2467.0 |
155.9 |
19.9 |
100, 148, 108 |
||
TA 1537 |
Water |
- |
8.7 |
1.5 |
- |
7, 9, 10 |
|
Test item |
100 |
8.0 |
3.6 |
0.9 |
11, 9, 4 |
||
333 |
1.0 |
1.0 |
0.1 |
2B, 1B, 0B |
|||
1000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B |
|||
3333 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B |
|||
6000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B |
|||
9000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B |
|||
2-AA |
2.5 |
118.7 |
25.7 |
13.7 |
100, 148, 108 |
||
TA 98 |
Water |
- |
20.0 |
1.0 |
- |
20, 21, 19 |
|
Test item |
100 |
27.8 |
7.5 |
1.4 |
23, 23, 36 |
||
333 |
25.0 |
5.2 |
1.3 |
22, 31, 22 |
|||
1000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B |
|||
3333 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B |
|||
6000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B |
|||
9000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B |
|||
2-AA |
2.5 |
1649.3 |
275 |
82.5 |
1644, 1927, 1377 |
||
E.coli |
Water |
- |
30.3 |
10.3 |
- |
39, 19, 33 |
|
Test item |
100 |
28.0 |
7.0 |
0.9 |
36, 25, 23 |
||
333 |
15.3 |
5.7 |
0.5 |
17, 20, 9 |
|||
1000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B |
|||
3333 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B |
|||
6000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B |
|||
9000 |
0.0 |
0.0 |
0.0 |
0B, 0B, 0B |
|||
2-AA |
2.5 |
1649.3 |
24.9 |
5.5 |
152, 156, 197 |
||
Standard Plate test |
Experiment: |
2nd-SPT |
|||||
Without metabolic activation |
|||||||
Strain |
Test group |
Dose |
Mean revertants |
Standard |
Factor |
Individual revertant colony counts |
|
TA 1535 |
Water |
- |
9.7 |
2.1 |
- |
9, 8, 12 |
|
Test item |
3.3 |
8.3 |
2.5 |
0.9 |
8, 6, 11 |
||
10 |
9.0 |
3.6 |
0.9 |
6, 13, 8 |
|||
33 |
9.0 |
3.5 |
0.9 |
11, 5, 11 |
|||
100 |
12.3 |
4.2 |
1.3 |
9, 17, 11 |
|||
333 |
10.3 |
7.8 |
1.1 |
8, 4, 19 |
|||
1000 |
0.0 |
0.0 |
0.0 |
0b, 0b, 0b |
|||
MNNG |
5.0 |
5689.3 |
491.6 |
588.6 |
5865, 6069, 5134 |
||
TA100 |
Water |
- |
107.7 |
12.9 |
- |
93, 117, 113 |
|
Test item |
3.3 |
88.3 |
8.5 |
0.8 |
98, 85, 82 |
||
10 |
87.0 |
9.5 |
0.8 |
97, 86, 78 |
|||
33 |
98.0 |
15.5 |
0.9 |
113, 99, 82 |
|||
100 |
123.0 |
19.3 |
1.1 |
145, 109, 115 |
|||
333 |
114.0 |
6.2 |
1.1 |
112, 109, 121 |
|||
1000 |
0.0 |
0.0 |
0.0 |
0b, 0b, 0b |
|||
MNNG |
5.0 |
4774.7 |
442.0 |
44.3 |
5279, 4455, 4590 |
||
TA 1537 |
Water |
- |
5.3 |
1.5 |
- |
4, 7, 5 |
|
Test item |
1.0 |
5.7 |
2.5 |
1.1 |
3, 6, 8 |
||
3.3 |
6.7 |
1.2 |
1.3 |
8, 6, 6 |
|||
10 |
7.3 |
1.5 |
1.4 |
6, 9, 7 |
|||
33 |
5.3 |
3.1 |
1.0 |
8, 2, 6 |
|||
100 |
3.3 |
1.2 |
0.6 |
4, 4, 2 |
|||
333 |
0.0 |
0.0 |
0.0 |
0b, 0b, 0b |
|||
AAC |
100 |
1417.0 |
169.1 |
265.7 |
1310, 1329, 1612 |
||
TA 98 |
Water |
- |
18.3 |
1.2 |
- |
19, 19, 17 |
|
Test item |
3.3 |
18.7 |
3.2 |
1.0 |
20, 15, 21 |
||
10 |
16.0 |
3.0 |
0.9 |
13, 19, 16 |
|||
33 |
17.3 |
5.7 |
0.9 |
22, 11, 19 |
|||
100 |
43.3 |
2.3 |
2.4 |
42, 42, 46 |
|||
333 |
16.0 |
1.0 |
0.9 |
15 B, 16 B, 17 B |
|||
1000 |
0.0 |
0.0 |
0.0 |
0b, 0b, 0b |
|||
NOPD |
10 |
1118.7 |
120.7 |
61.0 |
1235, 1127, 994 |
||
E.coli |
Water |
- |
22.0 |
1.0 |
- |
21, 23, 22 |
|
Test item |
3.3 |
25.3 |
7.2 |
1.2 |
30, 29, 17 |
||
10 |
23.7 |
6.7 |
1.1 |
18, 22, 31 |
|||
33 |
24.3 |
7.2 |
1.1 |
16, 28, 29 |
|||
100 |
16.0 |
1.0 |
0.7 |
17, 16, 15 |
|||
333 |
11.3 |
4.7 |
0.5 |
15 B, 13 B, 6 B |
|||
1000 |
0.0 |
0.0 |
0.0 |
0b, 0b, 0b |
|||
4-NQO |
5 |
1279.7 |
92.6 |
58.2 |
1309, 1176, 1354 |
||
Standard Plate test |
Experiment: |
2nd-SPT |
|||||
With metabolic activation |
|||||||
Strain |
Test group |
Dose |
Mean revertants |
Standard |
Factor |
Individual revertant colony counts |
|
TA 1535 |
Water |
- |
7.7 |
2.1 |
- |
7, 6, 10 |
|
Test item |
3.3 |
9.0 |
2.0 |
1.2 |
11, 9, 7 |
||
10 |
6.3 |
3.2 |
0.8 |
4, 5, 10 |
|||
33 |
6.3 |
1.2 |
0.8 |
7, 5, 7 |
|||
100 |
7.7 |
2.1 |
1.0 |
10, 6, 7 |
|||
333 |
5.7 |
2.1 |
0.7 |
4, 8, 5 |
|||
1000 |
0.0 |
0.0 |
0.0 |
0b, 0b, 0b |
|||
2-AA |
2.5 |
195.3 |
20.2 |
25.5 |
172´, 207, 207 |
||
TA100 |
Water |
- |
105.7 |
13.8 |
- |
4, 6, 10 |
|
Test item |
3.3 |
99.3 |
4.9 |
0.9 |
12, 4, 11 |
||
10 |
98.7 |
6.7 |
0.9 |
3, 8, 8 |
|||
33 |
119.0 |
10.5 |
1.1 |
11, 6, 13 |
|||
100 |
139.0 |
14.7 |
1.3 |
4, 3, 8 |
|||
333 |
96.3 |
3.1 |
0.9 |
7, 4, 6 |
|||
1000 |
0.0 |
0.0 |
0.0 |
0b, 0b, 0b |
|||
2-AA |
2.5 |
1649.7 |
492.1 |
15.6 |
188, 160, 164 |
||
TA 1537 |
Water |
- |
6.7 |
3.1 |
- |
4, 6, 10 |
|
Test item |
1.0 |
9.0 |
4.4 |
1.4 |
12, 4, 11 |
||
3.3 |
6.3 |
2.9 |
1.0 |
3, 8, 8 |
|||
10 |
10.0 |
3.6 |
1.5 |
11, 6, 13 |
|||
33 |
5.0 |
2.6 |
0.8 |
4, 3, 8 |
|||
100 |
5.7 |
1.5 |
0.9 |
7, 4, 6 |
|||
333 |
0.0 |
0.0 |
0.0 |
0b, 0b, 0b |
|||
2-AA |
2.5 |
170.7 |
15.1 |
25.6 |
188, 160, 164 |
||
TA 98 |
Water |
- |
27.0 |
1.0 |
- |
26, 27, 28 |
|
Test item |
3.3 |
34.3 |
4.6 |
1.3 |
37, 37, 29 |
||
10 |
27.3 |
1.5 |
1.0 |
29, 27, 26 |
|||
33 |
30.3 |
4.6 |
1.1 |
25, 33, 33 |
|||
100 |
30.0 |
8.5 |
1.1 |
21, 31, 38 |
|||
333 |
26.0 |
7.5 |
1.0 |
34, 19, 25 |
|||
1000 |
0.0 |
0.0 |
0.0 |
0b, 0b, 0b |
|||
2-AA |
2.5 |
1654.3 |
110.6 |
61.3 |
1636, 1554, 1773 |
||
E.coli |
Water |
- |
30.0 |
2.6 |
- |
28, 33, 29 |
|
Test item |
3.3 |
25.7 |
3.2 |
0.9 |
22, 27, 28 |
||
10 |
28.0 |
2.6 |
0.9 |
27, 26, 31 |
|||
33 |
37.7 |
5.1 |
1.3 |
32, 42, 39 |
|||
100 |
21.0 |
6.0 |
0.7 |
21, 27, 15 |
|||
333 |
16.0 |
3.6 |
0.5 |
15, 20, 13 |
|||
1000 |
0.0 |
0.0 |
0.0 |
0b, 0b, 0b |
|||
2-AA |
60 |
109.7 |
4.2 |
3.7 |
111, 105, 113 |
||
Standard Plate test |
Experiment: |
4th-SPT |
|||||
Without metabolic activation |
|||||||
Strain |
Test group |
Dose |
Mean revertants |
Standard |
Factor |
Individual revertant colony counts |
|
TA 98 |
Water |
- |
22.7 |
3.1 |
- |
20, 22, 26 |
|
Test item |
3.3 |
19.0 |
1.0 |
0.8 |
18, 20, 19 |
||
10 |
16.3 |
4.2 |
0.7 |
15, 21, 13 |
|||
33 |
21.3 |
7.1 |
0.9 |
29, 20, 15 |
|||
100 |
25.7 |
6.8 |
1.1 |
18, 28, 31 |
|||
333 |
22.0 |
7.8 |
1.0 |
31, 17, 18 |
|||
1000 |
4.7 |
3.5 |
0.2 |
8b, 1b, 5b |
|||
NOPD |
10 |
940.0 |
89.6 |
41.5 |
1035, 857, 928 |
||
Preincubation test |
Experiment: |
3rd-PIT |
|||||
Without metabolic activation |
|||||||
Strain |
Test group |
Dose |
Mean revertants |
Standard |
Factor |
Individual revertant colony counts |
|
TA 1535 |
Water |
- |
8.3 |
3.1 |
- |
11, 5, 9 |
|
Test item |
1 |
9.3 |
2.9 |
1.1 |
11, 6, 11 |
||
3.3 |
9.3 |
1.5 |
1.1 |
8, 11, 9 |
|||
10 |
8.0 |
1.0 |
1.0 |
8, 7, 9 |
|||
33 |
14.3 |
1.5 |
1.7 |
14, 16, 13 |
|||
100 |
10.7 |
5.5 |
1.3 |
11, 5, 16 |
|||
333 |
6.7 |
3.1 |
0.8 |
6b, 10b, 4b |
|||
MNNG |
5.0 |
4131.0 |
382.4 |
495.7 |
4559, 1011, 3823 |
||
TA100 |
Water |
- |
98.0 |
5.0 |
- |
103, 98, 93 |
|
Test item |
1 |
91.7 |
10.6 |
0.9 |
90, 82, 103 |
||
3.3 |
91.3 |
9.3 |
0.9 |
81, 99, 94 |
|||
10 |
100.0 |
21.1 |
1.0 |
102, 120, 78 |
|||
33 |
98.0 |
5.6 |
1.0 |
103, 92, 99 |
|||
100 |
108.3 |
3.1 |
1.1 |
109, 111, 105 |
|||
333 |
71.3 |
3.8 |
0.7 |
73b, 67b, 74b |
|||
MNNG |
5.0 |
3850.7 |
46.8 |
39.3 |
3872, 3883, 3797 |
||
TA 1537 |
Water |
- |
9.7 |
3.2 |
- |
11, 12, 6 |
|
Test item |
1 |
8.3 |
3.8 |
0.9 |
11, 10, 4 |
||
3.3 |
7.7 |
3.2 |
0.8 |
10, 4, 9 |
|||
10 |
8.3 |
2.1 |
0.9 |
10, 9, 6 |
|||
33 |
9.7 |
4.0 |
1.0 |
5, 12, 12 |
|||
100 |
11.0 |
2.0 |
1.1 |
13, 9, 11 |
|||
333 |
0.0 |
0.0 |
0.0 |
0b, 0b, 0b |
|||
AAC |
5.0 |
1227.7 |
53.5 |
127.0 |
1173, 1280, 1230 |
||
TA 98 |
Water |
- |
22.0 |
1.0 |
- |
21, 23, 22 |
|
Test item |
1 |
15.3 |
3.5 |
0.7 |
12, 19, 15 |
||
3.3 |
24.7 |
4.7 |
1.1 |
30, 23, 21 |
|||
10 |
19.3 |
5.9 |
0.9 |
15, 17, 26 |
|||
33 |
23.3 |
3.5 |
1.1 |
23, 27, 20 |
|||
100 |
26.0 |
9.0 |
1.2 |
35, 17, 26 |
|||
333 |
11.0 |
3.6 |
0.5 |
15b, 8b, 10 b |
|||
NOPD |
10 |
965.0 |
9.5 |
43.9 |
975, 964, ,956 |
||
E.coli |
Water |
- |
33.3 |
1.2 |
- |
32, 34, 34 |
|
Test item |
1 |
44.7 |
7.5 |
1.3 |
49, 49, 36 |
||
3.3 |
41.0 |
7.2 |
1.2 |
39, 49, 35 |
|||
10 |
46.0 |
2.0 |
1.4 |
48, 44, 46 |
|||
33 |
43.0 |
12.1 |
1.3 |
45, 54, 30 |
|||
100 |
33.0 |
13.0 |
1.0 |
25, 48, 26 |
|||
333 |
10.7 |
4.7 |
0.3 |
7b, 9b, 16 b |
|||
4-NQO |
5.0 |
651.0 |
14.4 |
19.5 |
667, 647, 639 |
||
Preincubation test |
Experiment: |
3rd-PIT |
|||||
With metabolic activation |
|||||||
Strain |
Test group |
Dose |
Mean revertants |
Standard |
Factor |
Individual revertant colony counts |
|
TA 1535 |
Water |
- |
12.3 |
3.8 |
- |
14, 15, 8 |
|
Test item |
1 |
11.3 |
1.2 |
0.9 |
10, 12, 12 |
||
3.3 |
12.0 |
7.2 |
1.0 |
6, 20, 10 |
|||
10 |
11.7 |
2.1 |
0.9 |
11, 14, 10 |
|||
33 |
10.3 |
1.5 |
0.8 |
9, 10, 12 |
|||
100 |
13.7 |
2.1 |
1.1 |
16, 12, 13 |
|||
333 |
13.0 |
3.6 |
1.1 |
10b, 12b, 17b |
|||
2-AA |
2.5 |
107.7 |
11.9 |
8.7 |
94, 113, 116 |
||
TA100 |
Water |
- |
93.7 |
13.8 |
- |
104, 99, 78 |
|
Test item |
1 |
105.7 |
10.5 |
1.1 |
106, 116, 95 |
||
3.3 |
111.3 |
16.2 |
1.2 |
101, 130, 103 |
|||
10 |
100.3 |
11.4 |
1.1 |
113, 91, 97 |
|||
33 |
117.7 |
11.6 |
1.3 |
116, 107, 130 |
|||
100 |
161.3 |
7.5 |
1.7 |
161, 169, 154 |
|||
333 |
117.7 |
5.7 |
1.3 |
124b, 116 b 113 b |
|||
2-AA |
2.5 |
1173.0 |
15.7 |
12.5 |
1155, 1184, 1180 |
||
TA 1537 |
Water |
- |
16.0 |
2.6 |
- |
14, 19, 15 |
|
Test item |
1 |
13.7 |
3.1 |
0.9 |
13, 17, 11 |
||
3.3 |
9.7 |
3.2 |
0.6 |
6, 11, 12 |
|||
10 |
8.3 |
3.5 |
0.5 |
12, 5, 8 |
|||
33 |
11.0 |
1.0 |
0.7 |
10, 11, 12 |
|||
100 |
9.3 |
0.6 |
0.6 |
9, 9, 10 |
|||
333 |
0.0 |
0.0 |
0.0 |
0b, 0b, 0b |
|||
2-AA |
2.5 |
79.3 |
17.7 |
5.0 |
59, 88, 91 |
||
TA 98 |
Water |
- |
31.3 |
8.6 |
- |
22, 39, 33 |
|
Test item |
1 |
30.7 |
3.1 |
1.0 |
28, 30, 34 |
||
3.3 |
30.3 |
4.5 |
1.0 |
26, 30, 35 |
|||
10 |
34.3 |
5.8 |
1.1 |
31, 31, 41 |
|||
33 |
31.3 |
5.9 |
1.0 |
29, 27, 38 |
|||
100 |
41.3 |
0.6 |
1.3 |
41, 41, 42 |
|||
333 |
23.3 |
1.5 |
0.7 |
25b, 22b, 223b |
|||
2-AA |
2.5 |
903.3 |
181.0 |
28.8 |
1103, 857, 750 |
||
E.coli |
Water |
- |
30.0 |
2.6 |
- |
28, 33, 29 |
|
Test item |
1 |
29.7 |
3.8 |
1.0 |
34, 27, 28 |
||
3.3 |
23.0 |
8.2 |
0.8 |
16, 32, 21 |
|||
10 |
26.0 |
2.6 |
0.9 |
27, 23, 28 |
|||
33 |
25.0 |
11.3 |
0.8 |
31, 12, 32 |
|||
100 |
25.0 |
2.0 |
0.8 |
23, 27, 25 |
|||
333 |
21.3 |
4.0 |
0.7 |
17 b, 25 b, 22 b |
|||
2-AA |
60 |
93.3 |
16.2 |
3.1 |
84, 112, 84 |
||
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
