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Reaction mass of Sodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-,Sodium bis[1-[(2-hydroxy-5-nitrophenyl)azo]naphthalen-2-olato(2-)]cobaltate(1-)and Sodium bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]cobaltate(1-)
EC number: 916-867-1 | 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:
- 20 March 2017 - 23 March 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)
- Version / remarks:
- 21 Jul 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- Aug 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of Sodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-,Sodium bis[1-[(2-hydroxy-5-nitrophenyl)azo]naphthalen-2-olato(2-)]cobaltate(1-)and Sodium bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]cobaltate(1-)
- EC Number:
- 916-867-1
- Cas Number:
- 12270-00-7
- Molecular formula:
- C32H18CoN6O8Na - C32H20CoN8O8Na - C32H22CoN10O8Na
- IUPAC Name:
- Reaction mass of Sodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-,Sodium bis[1-[(2-hydroxy-5-nitrophenyl)azo]naphthalen-2-olato(2-)]cobaltate(1-)and Sodium bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]cobaltate(1-)
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 16/137
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor.
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:
- S9 mix from phenobarbital (i.p.) and β-naphthoflavone (p.o) induced rat liver
- Test concentrations with justification for top dose:
- 0; 33; 100; 333; 1000; 3125 and 6250 μg/plate (Standard plate test)
Due to the purity of the test substance 6.25 mg/plate was used as top dose. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Due to insolubility of the test substance in water, DMSO was used as vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-AA)
- Remarks:
- With S9 mix, 2.5 μg/plate, dissolved in DMSO (TA 1535, TA 100, TA 1537, TA 98); 60 μg/plate, dissolved in DMSO E.coli WP2uvrA
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine
- Remarks:
- Without S9 mix, 5 μg/plate, dissolved in DMSO (TA 1535, TA 100)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylenediamine (NOPD)
- Remarks:
- Without S9 mix, 10 μg/plate, dissolved in DMSO (TA 98)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Without S9 mix, 100 μg/plate, dissolved in DMSO (TA 1537)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Without S9 mix, 5 μg/plate, dissolved in DMSO (E. coli WP2 uvrA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 – 72 hours
NUMBER OF REPLICATIONS: 3 test plates per dose or per control
DETERMINATION OF CYTOTOXICITY
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)
was recorded for all test groups both with and without S9 mix in the experiment and indicated in the tables. Single values with a factor ≤ 0.6 were not detected as toxicity in low dose groups. - 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 expriments 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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
- Remarks:
- A weak bacteriotoxic effect was observed only with S9 mix at a concentration of 6250 μg/plate.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Test substance precipitation was found from about 1000 μg/plate onward with and without S9 mix.
HISTORICAL CONTROL DATA: Please refer to tables 3 and 4
TOXICITY
A weak bacteriotoxic effect (slight decrease in the number of trp+ revertants) was observed only using the tester strain E. coli with S9 mix at a concentration of 6250 μg/plate.
Any other information on results incl. tables
Table 1: Results without metabolic acitivation ( Standard Plate Test)
Strain |
Test group |
Dose |
Mean |
Standard |
Factor |
Individual revertant colony |
|
|
(µg/plate) |
revertants |
deviation |
|
counts |
|
||||||
TA1535 |
DMSO |
- |
7.7 |
0.6 |
- |
7, 8, 8 |
|
Test item |
33 |
9.7 |
5.5 |
1.3 |
7, 6, 16 |
|
|
100 |
11.7 |
5.0 |
1.5 |
17, 11, 7 |
|
|
333 |
13.7 |
4.2 |
1.8 |
9, 15, 17 |
|
|
1000 |
12.0 |
4.4 |
1.6 |
9 P, 17 P, 10 P |
|
|
3125 |
13.7 |
5.0 |
1.8 |
19 P, 13 P, 9 P |
|
|
6250 |
18.7 |
3.1 |
2.4 |
22 P, 16 P, 18 P |
|
MNNG |
5.0 |
7183.0 |
372.7 |
936.9 |
6753, 7384, 7412 |
|
||||||
TA100 |
DMSO |
- |
116.7 |
10.3 |
- |
128, 114, 108 |
|
Test item |
33 |
154.7 |
7.8 |
1.3 |
146, 157, 161 |
|
|
100 |
226.3 |
6.0 |
1.9 |
227, 232, 220 |
|
|
333 |
363.7 |
22.2 |
3.1 |
340, 384, 367 |
|
|
1000 |
458.0 |
53.0 |
3.9 |
432 P, 423 P, 519 P |
|
|
3125 |
627.7 |
22.4 |
5.4 |
623 P, 608 P, 652 P |
|
|
6250 |
546.7 |
59.9 |
4.7 |
596 P, 480 P, 564 P |
|
MNNG |
5.0 |
6016.3 |
1079.8 |
51.6 |
6884, 6358, 4807 |
|
||||||
TA1537 |
DMSO |
- |
13.0 |
3.5 |
- |
17, 11,11 |
|
Test item |
33 |
26.0 |
4.4 |
2.0 |
29, 28, 21 |
|
|
100 |
37.7 |
5.5 |
2.9 |
38, 32, 43 |
|
|
333 |
67.0 |
10.4 |
5.2 |
60, 62, 79 |
|
|
1000 |
89.7 |
7.8 |
6.9 |
92 P, 81 P, 96 P |
|
|
3125 |
87.7 |
4.0 |
6.7 |
92 P, 87 P, 84 P |
|
|
6250 |
96.3 |
5.0 |
7.4 |
91 P, 97 P, 101 P |
|
AAC |
100 |
700.7 |
24.1 |
53.9 |
678, 698, 726 |
|
||||||
TA 98 |
DMSO |
- |
26.0 |
6.9 |
- |
34, 22, 22 |
|
Test item |
33 |
310.0 |
32.1 |
11.9 |
338, 275, 317 |
|
|
100 |
587.3 |
68.3 |
22.6 |
575, 661, 526 |
|
|
333 |
961.7 |
59.7 |
37.0 |
893, 1001, 991 |
|
|
1000 |
871.7 |
70.1 |
33.5 |
823 P, 840 P, 952 P |
|
|
3125 |
919.3 |
64.0 |
35.4 |
948 P, 846 P, 964 P |
|
|
6250 |
1355.3 |
60.3 |
52.1 |
1286 P, 1384 P, 1396 P |
|
NOPD |
10 |
600.0 |
27.8 |
23.1 |
614, 568, 618 |
|
||||||
E. COM |
DMSO |
- |
21.7 |
2.3 |
- |
23, 19, 23 |
|
Test item |
33 |
24.3 |
0.6 |
1.1 |
25, 24, 24 |
|
|
100 |
22.7 |
5.8 |
1.0 |
26, 26, 16 |
|
|
333 |
26.0 |
5.0 |
1.2 |
21, 31,26 |
|
|
1000 |
17.0 |
1.0 |
0.8 |
18 P, 16 P, 17 P |
|
|
3125 |
14.3 |
2.1 |
0.7 |
12 P, 16 P, 15 P |
|
|
6250 |
15.0 |
1.7 |
0.7 |
14 P, 14 P, 17 P |
|
4-NOO |
5 |
1102.7 |
93.4 |
50.9 |
1081, 1205, 1022 |
P=Precipitation
Table 2: Results with metabolic acitivation ( Standard Plate Test)
Strain |
Test group |
Dose |
Mean |
Standard |
Factor |
Individual revertant colony |
|
|
(µg/plate) |
revertants |
deviation |
|
counts |
|
||||||
TA 1535 |
DMSO |
- |
9.0 |
2.6 |
- |
8, 7,12 |
|
Test item |
33 |
9.3 |
4.6 |
1.0 |
12, 12, 4 |
|
|
100 |
14.7 |
5.0 |
1.6 |
14, 10, 20 |
|
|
333 |
12.3 |
6.7 |
1.4 |
18, 14, 5 |
|
|
1000 |
10.0 |
1.7 |
1.1 |
9P, 9P, 12P |
|
|
3125 |
14.3 |
2.5 |
1.6 |
17P, 14P, 12P |
|
|
6250 |
10.7 |
5.7 |
1.2 |
17P, 9P, 6P |
|
2-AA |
2.5 |
245.7 |
30.7 |
27.3 |
280, 221, 236 |
|
||||||
TA 100 |
DMSO |
- |
123.3 |
13.8 |
- |
118, 113, 139 |
|
Test item |
33 |
183.0 |
18.5 |
1.5 |
176, 169, 204 |
|
|
100 |
296.0 |
19.0 |
2.4 |
315, 277, 296 |
|
|
333 |
485.3 |
47.2 |
3.9 |
535, 480, 441 |
|
|
1000 |
431.7 |
29.8 |
3.5 |
412 P, 466 P,417P |
|
|
3125 |
418.7 |
57.5 |
3.4 |
376 P, 484 P, 396 P |
|
|
6250 |
328.7 |
6.1 |
2.7 |
334 P, 322 P, 330 P |
|
2-AA |
2.5 |
2669.3 |
551.1 |
21.6 |
2932, 3040, 2036 |
|
||||||
TA 1537 |
DMSO |
- |
7.0 |
1.0 |
- |
8, 7, 6 |
|
Test item |
33 |
12.0 |
1.7 |
1.7 |
14,11,11 |
|
|
100 |
40.7 |
3.8 |
5.8 |
39, 45, 38 |
|
|
333 |
84.7 |
9.6 |
12.1 |
76, 95, 83 |
|
|
1000 |
53.7 |
18.9 |
7.7 |
39 P, 75 P, 47 P |
|
|
3125 |
58.7 |
19.6 |
8.4 |
77 P, 61 P, 38 P |
|
|
6250 |
62.7 |
10.7 |
9.0 |
65 P, 72 P, 51 P |
|
2-AA |
2.5 |
170.3 |
5.5 |
24.3 |
165, 170, 176 |
|
||||||
TA 98 |
DMSO |
_ |
27.3 |
6.7 |
- |
35, 23, 24 |
|
Test item |
33 |
251.3 |
15.1 |
9.2 |
258, 234, 262 |
|
|
100 |
593.7 |
88.2 |
21.7 |
492, 639, 650 |
|
|
333 |
1334.7 |
33.2 |
48.8 |
1330. 1370. 1304 |
|
|
1000 |
846.0 |
9.2 |
31.0 |
836 P, 854 P, 848 P |
|
|
3125 |
845.3 |
12.9 |
30.9 |
836 P, 840 P, 860 P |
|
|
6250 |
754.7 |
8.3 |
27.6 |
752 P, 764 P, 748 P |
|
2-AA |
2.5 |
1878.7 |
125.5 |
68.7 |
1944. 1734. 1958 |
|
||||||
E. coli |
DMSO |
- |
18.7 |
1.5 |
- |
20, 17, 19 |
|
Test item |
33 |
21.3 |
3.5 |
1.1 |
18, 21,25 |
|
|
100 |
31.0 |
7.9 |
1.7 |
25, 40, 28 |
|
|
333 |
26.7 |
3.1 |
1.4 |
24, 26, 30 |
|
|
1000 |
16.7 |
4.7 |
0.9 |
22 P, 13 P, 15 P |
|
|
3125 |
14.3 |
4.5 |
0.8 |
14 P, 10 P, 19 P |
|
|
6250 |
8.0 |
2.6 |
0.4 |
9P, 10 P, 5P |
|
2-AA |
60 |
96.3 |
4.2 |
5.2 |
95, 101. 93 |
P=Precipitation
Table 3: Historical Positive controls (based on Sorcerer Counter / Ames Study Mananger System (Feb 2016 - Feb 2017)
Strain |
S9 Mix |
Positive |
No. of |
No. of |
Min |
Max |
Mean |
SD |
|
||||||||
TA 1535 |
Without |
MNNG |
312 |
110 |
1541 |
6171 |
3967 |
1253.9 |
|
||||||||
TA 100 |
Without |
MNNG |
315 |
110 111 |
1126 |
5557 |
3298 |
1109.6 |
|
||||||||
TA 1537 |
Without |
AAC |
309 |
110 |
253 |
2190 |
1044 |
404.3 |
|
||||||||
TA98 |
Without |
NOPD |
309 |
110 |
324 |
1746 |
863 |
206.8 |
Table 4: Historical Negative controls (based on Sorcerer Counter / Ames Study Mananger System (Feb 2016 - Feb 2017)
Strain |
S9 Mix |
Vehicle |
No. of |
No. of |
Min |
Max |
Mean |
SD |
||||||||||||||||||
|
||||||||||||||||||||||||||
TA 1535 |
Without |
All All |
414 |
152 |
7 |
16 |
10 |
2.0 |
||||||||||||||||||
|
||||||||||||||||||||||||||
TA 100 |
Without |
All |
426 |
152 153 |
71 |
132 |
100 |
11.4 |
||||||||||||||||||
|
||||||||||||||||||||||||||
TA 1537 |
Without |
All |
411 |
152 |
5 |
13 |
8 |
1.7 |
||||||||||||||||||
|
||||||||||||||||||||||||||
TA98 |
Without |
All |
420 |
152 |
14 |
34 |
21 |
3.3 |
||||||||||||||||||
|
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.