Registration Dossier
Registration Dossier
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EC number: 215-410-7 | CAS number: 1325-87-7
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:
- 14 Jun - 14 Jul 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Economy, Trade and Industry, Japanese Ministry of Health, Labour and Welfare and Japanese Ministry of Agriculture, Forestry and Fisheries
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, molybdatetungstatephosphate
- EC Number:
- 215-410-7
- EC Name:
- Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, molybdatetungstatephosphate
- Cas Number:
- 1325-87-7
- Molecular formula:
- (C33H40N3)z.O3.P2O5.(WO3)x.(MoO3)y 12 ≤ x+y ≤ 24 (x≥1; y≥1) z = 6-10
- IUPAC Name:
- tetrakis(4-{[4-(diethylamino)phenyl][4-(ethylamino)naphthalen-1-yl]methylidene}-N,N-diethylcyclohexa-2,5-dien-1-iminium) (phosphonatoperoxy)tungstenoylolate molybdenumoylolate
- Test material form:
- solid: nanoform
- Details on test material:
- Shape
Shape Category: spheroidal
Shape: spherical
Pure Shape: Yes
Typical Composition: ≤100%
range: >0; ≤100%
Particle size distribution & range
Shape Category: spheroidal
Percentile D10, typical value: 35nm
Percentile D10, range: ≥10; ≤50nm
Percentile D50, typical value: 50nm
Percentile D50, range: ≥35; ≤100nm
Percentile D90, typical value: 85nm
Percentile D90, range: ≥50; ≤150nm
Fraction in size range 1-100nm: ≥50; ≤100%
Crystallinity
structure: Amorphous
Pure structure: Yes
Specific Surface Area
Typical specific surface area: ca. 50m2/g
Range: ≥10; ≤200m2/g
skeletal density ca. 1.8 g/cm3
Surface Functionalisation/treatment
surface treatment applied: no
Constituent 1
- Specific details on test material used for the study:
- - Identification: Lumière Blue PTM 0154N
- Physical state/Appearance: Blue powder
- Batch: 981108
- Purity: Preparation containing ≥90% UVCB (treated as 100%)
- Expiry Date: 28 April 2022
- Storage Conditions: Room temperature in the dark
The vehicle control used was as follows:
Identity: Dimethyl sulphoxide
Batch number (purity): 1690734 (>99%), Expiry: 03/2022 (Experiment 1) 1710280 (>99%), Expiry: 05/2022 (Experiment 2)
Identity: N-ethyl-N'-nitro-N-nitrosoguanidine (ENNG)
Expiry date: 18 September 2017
Solvent: DMSO
Concentration: 2 μg/plate for WP2uvrA 3 μg/plate for TA100 5 μg/plate for TA1535
Identity: 9-Aminoacridine (9AA)
Purity: 99.9%
Expiry date: 01 October 2017
Solvent: DMSO
Concentration: 80 μg/plate for TA1537
Identity: 4-Nitroquinoline-1-oxide (4NQO)
Purity: 100%
Expiry date: 08 October 2017
Solvent: DMSO
Concentration: 0.2 μg/plate for TA98
Identity: 2-Aminoanthracene (2AA)
Purity: 97.5%
Expiry date: 08 October 2017
Solvent: DMSO
Concentration: 1 μg/plate for TA100 2 μg/plate for TA1535 and TA1537 10 μg/plate for WP2uvrA
Identity: Benzo(a)pyrene (BP)
Purity: 96%
Expiry date: 12 October 2017
Solvent: DMSO
Concentration: 5 μg/plate for TA98
Method
- Target gene:
- histidine synthesis
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 fraction
- Test concentrations with justification for top dose:
- 0.5, 1.5, 5, 15, 50, 150, 500, 1500 μg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO;
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- other: 2-Aminoanthracene (2AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation)
- Exposure duration: 48h
NUMBER OF REPLICATIONS: 3 - Evaluation criteria:
- The test material may be considered positive in this test system if it induces a reproducible, dose-related
and statistically significant increase in the revertant count in at least one strain of bacteria. - Statistics:
- Dunnetts Regression Analysis (* = p < 0.05)
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:
- not determined
- 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:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- 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:
- 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:
- not determined
- 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:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Spontaneous Mutation Rates (Concurrent Negative Controls)
Experiment 1 (Plate Incorporation)
Number of revertants (mean number of colonies per plate) |
|||||||||
Base-pair substitution type |
Frameshift type |
||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||||
91 |
11 |
35 |
24 |
11 |
|||||
114 |
(98) |
9 |
(9) |
35 |
(36) |
18 |
(20) |
14 |
(13) |
90 |
8 |
39 |
18 |
14 |
|||||
Experiment 2 (Pre-Incubation)
Number of revertants (mean number of colonies per plate) |
|||||||||
Base-pair substitution type |
Frameshift type |
||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||||
96 |
28 |
21 |
16 |
9 |
|||||
77 |
(88) |
14 |
(22) |
24 |
(24) |
23 |
(17) |
12 |
(12) |
90 |
25 |
26 |
11 |
14 |
|||||
Test Results: Experiment 1 – Without Metabolic Activation (Plate Incorporation)
Test Period |
From: 27 June 2017 |
To: 30 June 2017 |
||||||||||||||||||||||||||
S9-Mix (-) |
Dose Level Per Plate |
Number of revertants (mean) +/- SD |
||||||||||||||||||||||||||
Base-pair substitution strains |
Frameshift strains |
|||||||||||||||||||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|
|||||||||||||||||||||||
Solvent Control (DMSO) |
107 81 108 |
(99) 15.3# |
10 9 11 |
(10) 1.0 |
34 31 32 |
(32) 1.5 |
19 21 25 |
(22) 3.1 |
18 18 19 |
(18) 0.6 |
|
|||||||||||||||||
1.5 μg |
92 111 103 |
(102) 9.5 |
11 11 11 |
(11) 0.0 |
35 40 40 |
(38) 2.9 |
20 15 20 |
(18) 2.9 |
10 19 20 |
(16) 5.5 |
|
|||||||||||||||||
5 μg |
94 92 91 |
(92) 1.5 |
9 8 10 |
(9) 1.0 |
45 34 30 |
(36) 7.8 |
21 22 24 |
(22) 1.5 |
19 24 20 |
(21) 2.6 |
|
|||||||||||||||||
15 μg |
104 122 114 |
(113) 9.0 |
11 10 10 |
(10) 0.6 |
35 36 33 |
(35) 1.5 |
23 24 23 |
(23) 0.6 |
10 18 13 |
(14) 4.0 |
|
|||||||||||||||||
50 μg |
118 98 103 |
(106) 10.4 |
11 11 10 |
(11) 0.6 |
32 41 39 |
(37) 4.7 |
24 28 19 |
(24) 4.5 |
19 17 18 |
(18) 1.0 |
|
|||||||||||||||||
150 μg |
108 105 102 |
(105) 3.0 |
10 12 7 |
(10) 2.5 |
42 35 34 |
(37) 4.4 |
25 13 23 |
(20) 6.4 |
19 19 22 |
(20) 1.7 |
|
|||||||||||||||||
500 μg |
113 104 113 |
(110) 5.2 |
10 12 9 |
(10) 1.5 |
30 32 32 |
(31) 1.2 |
22 25 28 |
(25) 3.0 |
20 17 23 |
(20) 3.0 |
|
|||||||||||||||||
1500 μg |
32 PSI 30 PSI 21 PSI |
(28) 5.9 |
0 PVI 0 PVI 0 PVI |
(0) 0.0 |
24 PSI 22 PSI 18 PSI |
(21) 3.1 |
17 PSI 15 PSI 11 PSI |
(14) 3.1 |
14 PSI 12 PSI 10 PSI |
(12) 2.0 |
|
|||||||||||||||||
5000 μg |
0 PTI 0 PTI 0 PTI |
(0) 0.0 |
0 PTI 0 PTI 0 PTI |
(0) 0.0 |
8 PSI 7 PSI 9 PSI |
(8) 1.0 |
0 PTI 0 PTI 0 PTI |
(0) 0.0 |
0 PTI 0 PTI 0 PTI |
(0) 0.0 |
|
|||||||||||||||||
Positive controls S9-Mix (-) |
Name Dose Level No. of Revertants |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
|
|||||||||||||||||||||
3 μg |
5 μg |
2 μg |
0.2 μg |
80 μg |
|
|||||||||||||||||||||||
797 742 887 |
(809) 73.2 |
419 511 605 |
(512) 93.0 |
210 192 228 |
(210) 18.0 |
182 235 220 |
(212) 27.3 |
345 306 376 |
(342) 35.1 |
|
||||||||||||||||||
Test Results: Experiment 1 – With Metabolic Activation (Plate Incorporation)
Test Period |
From: 27 June 2017 |
To: 30 June 2017 |
|||||||||||||||||||||||||
S9-Mix (+) |
Dose Level Per Plate |
Number of revertants (mean) +/- SD |
|||||||||||||||||||||||||
Base-pair substitution strains |
Frameshift strains |
||||||||||||||||||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||||||||||||||||||||||
Solvent Control (DMSO) |
90 93 100 |
(94) 5.1# |
11 11 10 |
(11) 0.6 |
33 34 34 |
(34) 0.6 |
31 18 24 |
(24) 6.5 |
12 10 14 |
(12) 2.0 |
|||||||||||||||||
1.5 μg |
112 95 106 |
(104) 8.6 |
9 8 12 |
(10) 2.1 |
42 41 13 |
(32) 16.5 |
25 26 21 |
(24) 2.6 |
13 13 13 |
(13) 0.0 |
|||||||||||||||||
5 μg |
106 101 97 |
(101) 4.5 |
14 15 14 |
(14) 0.6 |
33 34 34 |
(34) 0.6 |
26 21 21 |
(23) 2.9 |
18 9 10 |
(12) 4.9 |
|||||||||||||||||
15 μg |
102 107 107 |
(105) 2.9 |
12 8 11 |
(10) 2.1 |
40 39 41 |
(40) 1.0 |
21 24 17 |
(21) 3.5 |
14 10 13 |
(12) 2.1 |
|||||||||||||||||
50 μg |
106 92 97 |
(98) 7.1 |
12 8 6 |
(9) 3.1 |
38 34 33 |
(35) 2.6 |
18 21 19 |
(19) 1.5 |
10 9 8 |
(9) 1.0 |
|||||||||||||||||
150 μg |
107 103 94 |
(101) 6.7 |
11 12 12 |
(12) 0.6 |
34 36 44 |
(38) 5.3 |
19 24 18 |
(20) 3.2 |
10 12 6 |
(9) 3.1 |
|||||||||||||||||
500 μg |
100 105 106 |
(104) 3.2 |
10 13 9 |
(11) 2.1 |
43 38 34 |
(38) 4.5 |
12 8 12 |
(11) 2.3 |
12 18 12 |
(14) 3.5 |
|||||||||||||||||
1500 μg |
28 PSI 35 PSI 25 PSI |
(29) 5.1 |
6 PSI 4 PSI 4 PSI |
(5) 1.2 |
22 PSI 30 PSI 21 PSI |
(24) 4.9 |
4 PSI 7 PSI 11 PSI |
(7) 3.5 |
9 PSI 6 PSI 8 PSI |
(8) 1.5 |
|||||||||||||||||
5000 μg |
0 PTI 0 PTI 0 PTI |
(0) 0.0 |
0 PTI 0 PTI 0 PTI |
(0) 0.0 |
8 PSI 6 PSI 9 PSI |
(8) 1.5 |
0 PTI 0 PTI 0 PTI |
(0) 0.0 |
0 PTI 0 PTI 0 PTI |
(0) 0.0 |
|||||||||||||||||
Positive controls S9-Mix (+) |
Name Dose Level No. of Revertants |
2AA |
2AA |
2AA |
BP |
2AA |
|||||||||||||||||||||
1 μg |
2 μg |
10 μg |
5 μg |
2 μg |
|||||||||||||||||||||||
1770 2076 1950 |
(1932) 153.8 |
298 332 339 |
(323) 21.9 |
483 389 400 |
(424) 51.4 |
193 189 220 |
(201) 16.9 |
468 519 532 |
(506) 33.8 |
||||||||||||||||||
Test Results: Experiment 2 – Without Metabolic Activation (Pre-Incubation)
Test Period |
From: 11 July 2017 |
To: 14 July 2017 |
|||||||||||||||||||||||||
S9-Mix (-) |
Dose Level Per Plate |
Number of revertants (mean) +/- SD |
|||||||||||||||||||||||||
Base-pair substitution strains |
Frameshift strains |
||||||||||||||||||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||||||||||||||||||||||
Solvent Control (DMSO) |
88 117 108 |
(104) 14.8# |
12 21 17 |
(17) 4.5 |
21 31 27 |
(26) 5.0 |
19 20 15 |
(18) 2.6 |
15 10 9 |
(11) 3.2 |
|||||||||||||||||
0.5 μg |
109 80 110 |
(100) 17.0 |
19 13 14 |
(15) 3.2 |
30 20 25 |
(25) 5.0 |
14 17 28 |
(20) 7.4 |
16 16 13 |
(15) 1.7 |
|||||||||||||||||
1.5 μg |
63 116 129 |
(103) 35.0 |
18 16 11 |
(15) 3.6 |
24 30 42 |
(32) 9.2 |
14 17 22 |
(18) 4.0 |
11 13 11 |
(12) 1.2 |
|||||||||||||||||
5 μg |
94 123 103 |
(107) 14.8 |
19 17 16 |
(17) 1.5 |
26 32 43 |
(34) 8.6 |
12 19 9 |
(13) 5.1 |
12 19 14 |
(15) 3.6 |
|||||||||||||||||
15 μg |
114 108 86 |
(103) 14.7 |
20 18 10 |
(16) 5.3 |
30 30 27 |
(29) 1.7 |
12 6 16 |
(11) 5.0 |
14 15 15 |
(15) 0.6 |
|||||||||||||||||
50 μg |
83 76 71 |
(77) 6.0 |
10 17 13 |
(13) 3.5 |
30 31 24 |
(28) 3.8 |
17 17 21 |
(18) 2.3 |
15 7 13 |
(12) 4.2 |
|||||||||||||||||
150 μg |
62 61 64 |
(62) 1.5 |
24 S 14 S 17 S |
(18) 5.1 |
16 30 29 |
(25) 7.8 |
13 12 14 |
(13) 1.0 |
6 S 12 S 16 S |
(11) 5.0 |
|||||||||||||||||
500 μg |
36 S 27 S 24 S |
(29) 6.2 |
0 V 0 V 0 V |
(0) 0.0 |
14 13 18 |
(15) 2.6 |
7 S 11 S 7 S |
(8) 2.3 |
0 V 0 V 0 V |
(0) 0.0 |
|||||||||||||||||
1500 μg |
0 PVI 0 PVI 0 PVI |
(0) 0.0 |
0 PTI 0 PTI 0 PTI |
(0) 0.0 |
15 PSI 13 PSI 15 PSI |
(14) 1.2 |
11 PSI 7 PSI 9 PSI |
(9) 2.0 |
0 PTI 0 PTI 0 PTI |
(0) 0.0 |
|||||||||||||||||
Positive controls S9-Mix (-) |
Name Dose Level No. of Revertants |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
|||||||||||||||||||||
3 μg |
5 μg |
2 μg |
0.2 μg |
80 μg |
|||||||||||||||||||||||
690 753 862 |
(768) 87.0 |
2001 2252 2346 |
(2200) 178.4 |
483 503 553 |
(513) 36.1 |
295 332 330 |
(319) 20.8 |
178 166 176 |
(173) 6.4 |
||||||||||||||||||
Test Results: Experiment 2 – With Metabolic Activation (Pre-Incubation)
Test Period |
From: 11 July 2017 |
To: 14 July 2017 |
|||||||||||||||||||||||||
S9-Mix (+) |
Dose Level Per Plate |
Number of revertants (mean) +/- SD |
|||||||||||||||||||||||||
Base-pair substitution strains |
Frameshift strains |
||||||||||||||||||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||||||||||||||||||||||
Solvent Control (DMSO) |
101 91 105 |
(99) 7.2# |
27 21 25 |
(24) 3.1 |
41 30 33 |
(35) 5.7 |
31 18 22 |
(24) 6.7 |
20 15 15 |
(17) 2.9 |
|||||||||||||||||
0.5 μg |
64 76 63 |
(68) 7.2 |
21 21 19 |
(20) 1.2 |
37 36 33 |
(35) 2.1 |
16 26 21 |
(21) 5.0 |
6 15 13 |
(11) 4.7 |
|||||||||||||||||
1.5 μg |
67 72 74 |
(71) 3.6 |
19 18 21 |
(19) 1.5 |
32 41 37 |
(37) 4.5 |
28 19 26 |
(24) 4.7 |
19 20 21 |
(20) 1.0 |
|||||||||||||||||
5 μg |
81 73 78 |
(77) 4.0 |
18 15 17 |
(17) 1.5 |
36 36 23 |
(32) 7.5 |
23 24 20 |
(22) 2.1 |
9 8 13 |
(10) 2.6 |
|||||||||||||||||
15 μg |
69 65 73 |
(69) 4.0 |
17 24 25 |
(22) 4.4 |
36 44 31 |
(37) 6.6 |
15 22 24 |
(20) 4.7 |
9 14 16 |
(13) 3.6 |
|||||||||||||||||
50 μg |
72 71 65 |
(69) 3.8 |
21 16 12 |
(16) 4.5 |
39 27 27 |
(31) 6.9 |
27 23 24 |
(25) 2.1 |
15 11 12 |
(13) 2.1 |
|||||||||||||||||
150 μg |
65 54 51 |
(57) 7.4 |
14 25 18 |
(19) 5.6 |
31 28 15 |
(25) 8.5 |
16 28 19 |
(21) 6.2 |
15 22 23 |
(20) 4.4 |
|||||||||||||||||
500 μg |
41 48 49 |
(46) 4.4 |
21 S 24 S 23 S |
(23) 1.5 |
42 39 29 |
(37) 6.8 |
29 17 22 |
(23) 6.0 |
9 14 18 |
(14) 4.5 |
|||||||||||||||||
1500 μg |
17 PSI 19 PSI 17 PSI |
(18) 1.2 |
0 PVI 0 PVI 0 PVI |
(0) 0.0 |
17 PSI 19 PSI 17 PSI |
(18) 1.2 |
15 PSI 8 PSI 12 PSI |
(12) 3.5 |
3 PSI 3 PSI 2 PSI |
(3) 0.6 |
|||||||||||||||||
Positive controls S9-Mix (+) |
Name Dose Level No. of Revertants |
2AA |
2AA |
2AA |
BP |
2AA |
|||||||||||||||||||||
1 μg |
2 μg |
10 μg |
5 μg |
2 μg |
|||||||||||||||||||||||
671 645 650 |
(655) 13.8 |
271 252 283 |
(269) 15.6 |
110 118 111 |
(113) 4.4 |
141 125 131 |
(132) 8.1 |
388 307 393 |
(363) 48.3 |
||||||||||||||||||
Applicant's summary and conclusion
- Conclusions:
- The test item was considered to be non-mutagenic under the conditions of this test.
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.
