Registration Dossier
Registration Dossier
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EC number: 696-145-8 | CAS number: 944730-39-6
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The experimental phase of this study was performed between 23 October 2013 and 29 November 2013.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Meets the criteria for classification as Reliable without restriction according to Klimisch et al (1997).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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:
- tetrasodium 1,8,15,22-tetra-(3-sulfoxypropylsulfonyl)copper phthalocyanine
- EC Number:
- 696-145-8
- Cas Number:
- 944730-39-6
- Molecular formula:
- C44H36CuN8O20S8 .4Na
- IUPAC Name:
- tetrasodium 1,8,15,22-tetra-(3-sulfoxypropylsulfonyl)copper phthalocyanine
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Identification: S200059
Batch No: RD3836 Batch 1
Purity: 96.9%
Expiry Date: Not Supplied
Storage Conditions: Room temperature in the dark
Constituent 1
Method
- Target gene:
- Histidine for Salmonella
Trytophan for E.Coli
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not Applicable
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbitone/ beta-naphthoflavone induced rat liver, S9
- Test concentrations with justification for top dose:
- Experiment one: 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate.
Experiment two: 50, 150, 500, 1500 and 5000 µg/plate.
Formulated concentrations were adjusted for the water/impurity content (3.1% w/w) of the test item and therefore concentrations are quoted as active. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: sterile distilled water
- Justification for choice of solvent/vehicle: The test item was fully soluble in sterile distilled water at 50 mg/ml in solubility checks performed in house.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- (Spontaneous mutation rates of TA100)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (Sterile distilled water)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene: 1 ug/plate
- Remarks:
- With S9 mix
- Untreated negative controls:
- yes
- Remarks:
- (Spontaneous mutation rate of TA1535)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (Sterile distilled water)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene: 2 ug/plate
- Remarks:
- With S9 mix
- Untreated negative controls:
- yes
- Remarks:
- (Spontaneous mutation rate of TA1537)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (Sterile distilled water)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene: 2 ug/plate
- Remarks:
- With S9 mix
- Untreated negative controls:
- yes
- Remarks:
- (Spontaneous mutation rate of WP2uvrA)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (Sterile distilled water)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene: 10 ug/plate
- Remarks:
- With S9 mix
- Untreated negative controls:
- yes
- Remarks:
- (Spontaneous mutation rate of TA98)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (Sterile distilled water)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Benzo(a)pyrene: 5 ug/plate
- Remarks:
- With S9 mix
- Untreated negative controls:
- yes
- Remarks:
- (Spontaneous mutation rate of TA100)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (Sterile distilled water)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-ethyl-N'-nitro-N-nitrosoguanidine: 3 ug/plate
- Remarks:
- Without S9 mix
- Untreated negative controls:
- yes
- Remarks:
- (Spontaneous mutation rate of TA1535)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (Sterile distilled water)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-ethyl-N'-nitro-N-nitrosoguanidine: 5 ug/plate
- Remarks:
- Without S9 mix
- Untreated negative controls:
- yes
- Remarks:
- (Spontaneous mutation rate of TA1537)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (Sterile distilled water)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 9-aminoacridine: 80 ug/plate
- Remarks:
- Without S9 mix
- Untreated negative controls:
- yes
- Remarks:
- (Spontaneous mutation rate of WP2uvrA)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (Sterile distilled water)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-ethyl-N'-nitro-N-nitrosoguanidine: 2 ug/plate
- Remarks:
- Without S9 mix
- Untreated negative controls:
- yes
- Remarks:
- (Spontaneous mutation rate of TA98)
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (Sterile distilled water)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- other: 4-Nitroquinoline-1-oxide: 0.2 ug/plate
- Remarks:
- Without S9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar, plate incorporation for experiment 1 and preincubation for experiment 2.
DURATION
- Preincubation period: 10 hours
- Exposure duration: approximatly 48 hours
NUMBER OF REPLICATIONS: Tripicate plating.
DETERMINATION OF CYTOTOXICITY
Method: Plates were assessed for numbers of revertant colonies and examined for the effects on growth of the bacterial background lawn. - Evaluation criteria:
- Acceptance Criteria:
The reverse mutation assay may be considered valid if the following criteria are met:
All bacterial strains must have demonstrated the required characteristics as determined by their respective strain checks according to Ames et al., (1975), Maron and Ames (1983) and Mortelmans and Zeiger (2000).
All tester strain cultures should exhibit a characteristic number of spontaneous revertants per plate in the vehicle and untreated controls.
All tester strain cultures should be in the range of 0.9 to 9 x 10^9 bacteria per mL.
All of the positive control chemicals used in the study should induce marked increases in the frequency of revertant colonies, both with or without metabolic activation.
There should be a minimum of four non-toxic test item dose levels.
There should be no evidence of excessive contamination.
Evaluation Criteria
There are several criteria for determining a positive result. Any, one, or all of the following can be used to determine the overall result of the study:
1. A dose-related increase in mutant frequency over the dose range tested (De Serres and Shelby, 1979).
2. A reproducible increase at one or more concentrations.
3. Biological relevance against in-house historical control ranges.
4. Statistical analysis of data as determined by UKEMS (Mahon et al., 1989).
5. Fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out of historical range response (Cariello and Piegorsch, 1996)).
A test item will be considered non-mutagenic (negative) in the test system if the above criteria are not met.
Although most experiments will give clear positive or negative results, in some instances the data generated will prohibit making a definite judgment about test item activity. Results of this type will be reported as equivocal. - Statistics:
- None.
Results and discussion
Test resultsopen allclose all
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- (Test up to a maximum recommended dose of 5000 ug/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- 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
- Remarks:
- (Test up to a maximum recommended dose of 5000 ug/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- There was no visible reduction in the growth of the bacterial background lawn at any dose level, either in the presence or absence of metabolic activation, in the first mutation test (plate incorporation method) and consequently the same maximum dose level was used in the second mutation test.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Test Results: Experiment 1 – Without Metabolic Activation
Test Period |
From: 14 November 2013 |
To: 17 November 2013 |
||||||||||
S9-Mix (-) |
Dose Level Per Plate |
Number of revertants (mean) +/- SD |
||||||||||
Base-pair substitution strains |
Frameshift strains |
|||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||||||||
Solvent Control (Water) |
134 123 132 |
(130) 5.9# |
28 21 23 |
(24) 3.6 |
31 25 35 |
(30) 5.0 |
19 25 16 |
(20) 4.6 |
15 12 8 |
(12) 3.5 |
||
1.5 µg |
119 112 116 |
(116) 3.5 |
23 23 19 |
(22) 2.3 |
28 33 36 |
(32) 4.0 |
15 15 25 |
(18) 5.8 |
9 9 15 |
(11) 3.5 |
||
5 µg |
134 139 98 |
(124) 22.4 |
21 21 24 |
(22) 1.7 |
25 20 32 |
(26) 6.0 |
21 23 15 |
(20) 4.2 |
9 15 9 |
(11) 3.5 |
||
15 µg |
131 95 92 |
(106) 21.7 |
21 21 15 |
(19) 3.5 |
31 21 32 |
(28) 6.1 |
24 23 23 |
(23) 0.6 |
11 15 11 |
(12) 2.3 |
||
50 µg |
78 92 95 |
(88) 9.1 |
27 23 15 |
(22) 6.1 |
25 25 24 |
(25) 0.6 |
21 17 23 |
(20) 3.1 |
11 11 15 |
(12) 2.3 |
||
150 µg |
92 95 79 |
(89) 8.5 |
13 21 25 |
(20) 6.1 |
15 35 23 |
(24) 10.1 |
17 20 20 |
(19) 1.7 |
5 9 9 |
(8) 2.3 |
||
500 µg |
115 112 90 |
(106) 13.7 |
16 24 16 |
(19) 4.6 |
23 17 24 |
(21) 3.8 |
16 24 21 |
(20) 4.0 |
12 12 9 |
(11) 1.7 |
||
1500 µg |
88 I 91 I 101 I |
(93) 6.8 |
21 I 24 I 19 I |
(21) 2.5 |
28 I 31 I 21 I |
(27) 5.1 |
17 I 20 I 22 I |
(20) 2.5 |
9 I 10 I 11 I |
(10) 1.0 |
||
5000 µg |
92 I 89 I 91 I |
(91) 1.5 |
28 I 21 I 20 I |
(23) 4.4 |
25 I 30 I 28 I |
(28) 2.5 |
13 I 19 I 20 I |
(17) 3.8 |
13 I 10 I 12 I |
(12) 1.5 |
||
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 |
||||||||
432 460 469 |
(454) 19.3 |
203 235 218 |
(219) 16.0 |
473 641 334 |
(483) 153.7 |
115 107 120 |
(114) 6.6 |
1136 1141 1152 |
(1143) 8.2 |
|||
Test Results: Experiment 1 – With Metabolic Activation
Test Period |
From: 14 November 2013 |
To: 17 November 2013 |
||||||||||
S9-Mix (+) |
Dose Level Per Plate |
Number of revertants (mean) +/- SD |
||||||||||
Base-pair substitution strains |
Frameshift strains |
|||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||||||||
Solvent Control (Water) |
134 112 127 |
(124) 11.2# |
16 17 12 |
(15) 2.6 |
41 36 39 |
(39) 2.5 |
31 27 27 |
(28) 2.3 |
17 16 15 |
(16) 1.0 |
||
1.5 µg |
131 134 132 |
(132) 1.5 |
13 17 19 |
(16) 3.1 |
39 31 41 |
(37) 5.3 |
28 25 25 |
(26) 1.7 |
16 13 19 |
(16) 3.0 |
||
5 µg |
88 103 91 |
(94) 7.9 |
16 17 16 |
(16) 0.6 |
44 29 36 |
(36) 7.5 |
31 27 32 |
(30) 2.6 |
11 16 12 |
(13) 2.6 |
||
15 µg |
107 116 95 |
(106) 10.5 |
12 12 17 |
(14) 2.9 |
31 32 35 |
(33) 2.1 |
19 21 23 |
(21) 2.0 |
13 19 11 |
(14) 4.2 |
||
50 µg |
131 106 114 |
(117) 12.8 |
12 16 17 |
(15) 2.6 |
31 31 31 |
(31) 0.0 |
29 16 33 |
(26) 8.9 |
16 16 15 |
(16) 0.6 |
||
150 µg |
100 92 94 |
(95) 4.2 |
13 17 17 |
(16) 2.3 |
39 37 21 |
(32) 9.9 |
23 25 28 |
(25) 2.5 |
11 19 19 |
(16) 4.6 |
||
500 µg |
95 112 108 |
(105) 8.9 |
12 13 17 |
(14) 2.6 |
31 28 28 |
(29) 1.7 |
23 29 27 |
(26) 3.1 |
12 9 12 |
(11) 1.7 |
||
1500 µg |
91 I 94 I 88 I |
(91) 3.0 |
13 I 16 I 13 I |
(14) 1.7 |
32 I 35 I 28 I |
(32) 3.5 |
21 I 24 I 25 I |
(23) 2.1 |
10 I 11 I 16 I |
(12) 3.2 |
||
5000 µg |
101 I 98 I 97 I |
(99) 2.1 |
14 I 13 I 15 I |
(14) 1.0 |
37 I 32 I 35 I |
(35) 2.5 |
28 I 21 I 22 I |
(24) 3.8 |
15 I 14 I 12 I |
(14) 1.5 |
||
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 |
||||||||
1131 954 984 |
(1023) 94.7 |
253 255 246 |
(251) 4.7 |
303 323 306 |
(311) 10.8 |
233 207 226 |
(222) 13.5 |
257 225 238 |
(240) 16.1 |
|||
Test Results: Experiment 2 – Without Metabolic Activation
Test Period |
From: 25 November 2013 |
To: 28 November 2013 |
||||||||||
S9-Mix (-) |
Dose Level Per Plate |
Number of revertants (mean) +/- SD |
||||||||||
Base-pair substitution strains |
Frameshift strains |
|||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||||||||
Solvent Control (Water) |
79 68 94 |
(80) 13.1# |
13 19 13 |
(15) 3.5 |
25 28 16 |
(23) 6.2 |
23 17 21 |
(20) 3.1 |
7 12 8 |
(9) 2.6 |
||
50 µg |
65 108 100 |
(91) 22.9 |
13 21 16 |
(17) 4.0 |
29 25 23 |
(26) 3.1 |
16 17 15 |
(16) 1.0 |
4 19 5 |
(9) 8.4 |
||
150 µg |
91 75 69 |
(78) 11.4 |
16 15 16 |
(16) 0.6 |
24 28 27 |
(26) 2.1 |
20 16 15 |
(17) 2.6 |
16 11 9 |
(12) 3.6 |
||
500 µg |
76 80 76 |
(77) 2.3 |
15 8 15 |
(13) 4.0 |
24 16 29 |
(23) 6.6 |
17 23 15 |
(18) 4.2 |
12 7 8 |
(9) 2.6 |
||
1500 µg |
82 I 96 I 87 I |
(88) 7.1 |
20 I 23 I 16 I |
(20) 3.5 |
13 I 29 I 20 I |
(21) 8.0 |
21 I 17 I 17 I |
(18) 2.3 |
8 I 12 I 5 I |
(8) 3.5 |
||
5000 µg |
62 I 65 I 76 I |
(68) 7.4 |
8 I 11 I 14 I |
(11) 3.0 |
21 I 20 I 21 I |
(21) 0.6 |
12 I 20 I 13 I |
(15) 4.4 |
9 I 6 I 4 I |
(6) 2.5 |
||
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 |
||||||||
792 637 744 |
(724) 79.3 |
436 255 898 |
(530) 331.6 |
372 368 426 |
(389) 32.4 |
187 135 191 |
(171) 31.2 |
230 502 382 |
(371) 136.3 |
|||
Test Results: Experiment 2 – With Metabolic Activation
Test Period |
From: 25 November 2013 |
To: 28 November 2013 |
||||||||||
S9-Mix (+) |
Dose Level Per Plate |
Number of revertants (mean) +/- SD |
||||||||||
Base-pair substitution strains |
Frameshift strains |
|||||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
||||||||
Solvent Control (Water) |
92 91 71 |
(85) 11.8# |
12 12 8 |
(11) 2.3 |
27 35 36 |
(33) 4.9 |
23 16 17 |
(19) 3.8 |
8 12 8 |
(9) 2.3 |
||
50 µg |
116 92 82 |
(97) 17.5 |
11 17 11 |
(13) 3.5 |
28 43 28 |
(33) 8.7 |
19 21 15 |
(18) 3.1 |
8 9 13 |
(10) 2.6 |
||
150 µg |
92 92 86 |
(90) 3.5 |
11 8 11 |
(10) 1.7 |
31 35 28 |
(31) 3.5 |
21 20 24 |
(22) 2.1 |
9 7 3 |
(6) 3.1 |
||
500 µg |
63 108 83 |
(85) 22.5 |
8 19 12 |
(13) 5.6 |
17 35 20 |
(24) 9.6 |
19 29 23 |
(24) 5.0 |
15 8 9 |
(11) 3.8 |
||
1500 µg |
75 I 87 I 84 I |
(82) 6.2 |
9 I 19 I 8 I |
(12) 6.1 |
29 I 19 I 29 I |
(26) 5.8 |
8 I 13 I 19 I |
(13) 5.5 |
5 I 13 I 17 I |
(12) 6.1 |
||
5000 µg |
62 I 62 I 60 I |
(61) 1.2 |
8 I 10 I 12 I |
(10) 2.0 |
18 I 36 I 26 I |
(27) 9.0 |
14 I 26 I 17 I |
(19) 6.2 |
11 I 7 I 4 I |
(7) 3.5 |
||
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 |
||||||||
922 839 818 |
(860) 55.0 |
131 82 92 |
(102) 25.9 |
219 190 239 |
(216) 24.6 |
100 114 128 |
(114) 14.0 |
172 134 160 |
(155) 19.4 |
|||
BP: Benzo(a)pyrene
2AA: 2 -Aminoanthracene
I: Intense test item induced coloration
#: Standard deviation
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item was considered to be non-mutagenic under the conditions of the test. - Executive summary:
Introduction
The test item was tested using a protocol designed to be compatible with OECD Guidelines for Testing of Chemicals No. 471 (1997) "Bacterial Reverse Mutation Test" and Method B13/14 of Commission Regulation (EC) number 440/2008 of 30 May 2008.
Methods
Salmonella typhimurium strainsTA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA were treated with the test item using both the Ames plate incorporation and pre-incubation methods at up to eight dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolizing system (10% liver S9 in standard co-factors). The dose range for the plate incorporation experiment was 1.5 to 5000 µg/plate and for the pre-incubation experiment 50 to 5000 µg/plate.
….
Results
…….
The vehicle (sterile distilled water) control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated.
The test item caused no visible reduction in the growth of the bacterial background lawn at any dose level. No test item precipitate was observed on the plates at any of the doses tested in either the presence or absence of S9-mix.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation or exposure method.
Conclusion
The test item was considered to be non-mutagenic under the conditions of this test.
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