Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 916-868-7 | 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:
- 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of Amines, C12-14-tert-alkyl, bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(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:
- 916-868-7
- Molecular formula:
- C32H22CoN10O8.C10-14H21-29NH2 and C32H22CoN10O8.Na
- IUPAC Name:
- Reaction mass of Amines, C12-14-tert-alkyl, bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(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
- Batch No. of test material: 002-151203
- Expiration date of the batch: 2020-04-16
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
OTHER SPECIFICS: Solid / orange
Method
- Target gene:
- his / trp
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Remarks:
- uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital and β-naphthoflavone induced rat liver S9 mix
- Test concentrations with justification for top dose:
- 1st Experiment
Doses: 0, 33, 100, 333, 1000, 2500, and 5000 μg/plate
2nd Experiment
Doses: 0, 3.3, 10, 33, 100, 333, and 1000 μg/plate
In agreement with the recommendations of current guidelines 5 mg/plate or 5 μL/plate were generally selected as maximum test dose at least in the 1st Experiment. However, this maximum dose was tested even in the case of relatively insoluble test compounds to detect possible mutagenic impurities. Furthermore, doses > 5 mg/plate or > 5 μL/plate might also be tested in repeat experiments for further clarification/substantiation. - Vehicle / solvent:
- - Solvent used: DMSO
- Justification for choice of solvent/vehicle: Due to the 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:
- 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: 2.5 μg/plate, TA 1535, TA 100, TA 1537, TA 98; 60 μg/plate, Escherichia coli WP2 uvrA
- 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: 5 μg/plate, 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: 10 μg/plate, 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: 100 μg/plate, 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: 5 μg/plate, E. coli WP2 uvrA
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 - 72 hours at 37 °C
NUMBER OF REPLICATIONS: in triplicate
NUMBER OF CELLS EVALUATED: all revertants / colonies counted
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 all experiments and indicated in the tables. Single values with a factor ≤ 0.6 were not detected as toxicity in low dose groups. - Evaluation criteria:
- Acceptance criteria
Generally, the experiment was considered valid if the following criteria were met:
- The number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain.
- The sterility controls revealed no indication of bacterial contamination.
- The positive control substances both with and without S9 mix induced a distinct increase in the number of revertant colonies within the range of the historical positive control data or above.
- Fresh bacterial culture containing approximately 10E9 cells per mL were used.
Assessment 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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:
- positive
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A weak bacteriotoxic effect (decrease in number of his+ revertants) was observed only using the tester strain TA 1537 without S9 mix at 5000 μg/plate in the 1st Experiment
- 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:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
No bacteriotoxic effect (reduced his- or trp- background growth, decrease in the number of his+ or trp+ revertants) was observed in the standard plate test up to the highest required concentration.
Any other information on results incl. tables
MUTAGENICITY
According to the results of the present study the test substance led to an evident and dose dependent increase in the number of his+ revertants with the tester strains TA 100, TA 1537, and TA 98, all with and without S9 mix. The increase of revertants was reproducible in two experiments carried out independently of each other. Based on the recent assessment criteria the test substance has to be considered positive.
Tests without S9 mix (see Table 1):
- TA 1535: No relevant increase in the number of his+ revertants.
-TA 100: 1st Exp.: Increase in the number of his+ revertants at concentrations of 100, 333, 1000, 2500, and 5000 μg/plate (factors 3.2, 6.9, 12.5, 13.5, and 8.4, respectively).
2nd Exp.: Increase in the number of his+ revertants at concentrations of 100, 333, and 1000 μg/plate (factors 3.0, 7.0, and 15.5, respectively).
-TA 1537: 1st Exp.: Increase in the number of his+ revertants at concentrations of 100, 333, 1000, 2500, and 5000 μg/plate (factors 3.2, 8.1, 13.4,
13.9, and 3.1, respectively). 2nd Exp.: Increase in the number of his+ revertants at concentrations of 100, 333, and 1000 μg/plate (factors 5.3, 11.1, and 26.0, respectively).
-TA 98: 1st Exp.: Increase in the number of his+ revertants at concentrations of 100, 333, 1000, 2500, and 5000 μg/plate (factors 2.9, 5.6, 11.0, 13.0, and 20.7, respectively). 2nd Exp.: Increase in the number of his+ revertants at concentrations of 100, 333, and 1000 μg/plate (factors 2.3, 6.9, and 16.1, respectively).
-E. coli WP2 uvrA: No relevant increase in the number of trp+ revertants.
Tests with S9 mix (see Table 2):
- TA 1535: 1st Exp.: Slight increase in the number of his+ revertants at a concentration of 2500 μg/plate (factor 2.5) 2nd Exp.: No relevant increase in the number of his+ revertants.
- TA 100: 1st Exp.: Increase in the number of his+ revertants at concentrations of 100, 333, 1000, 2500, and 5000 μg/plate (factors 2.8, 4.9, 11.4, 10.7, and 10.3, respectively). 2nd Exp.: Increase in the number of his+ revertants at concentrations of 100, 333, and 1000 μg/plate (factors 2.5, 4.5, and 11.7, respectively).
- TA 1537: 1st Exp.: Increase in the number of his+ revertants at concentrations of 333, 1000, 2500, and 5000 μg/plate (factors 5.6, 13.3, 12.2, and 4.5, respectively). 2nd Exp.: Increase in the number of his+ revertants at concentrations of 333 and 1000 μg/plate (factors 4.7 and 15.7, respectively).
- TA 98: 1st Exp.: Increase in the number of his+ revertants at concentrations of 333, 1000, 2500, and 5000 μg/plate (factors 2.3, 5.7, 15.5, and 16.3, respectively). 2nd Exp.: Increase in the number of his+ revertants at concentrations of 333 and 1000 μg/plate (factors 2.8 and 7.9, respectively).
- E. coli WP2 uvrA: No relevant increase in the number of trp+ revertants.
Table 1: SPT – without metabolic activation
Strain |
Test group |
Dose (µg/plate) |
Mean revertants per plate |
Standard deviation |
Factor |
TA 1535 |
DMSO |
- |
15.7 |
3.8 |
- |
|
Test item |
33 |
18.7 |
5.7 |
1.2 |
|
|
100 |
14.3 |
3.2 |
0.9 |
|
|
333 |
13.0 |
4.0 |
0.8 |
|
|
1000 |
16.0 |
3.0 |
P 1.0 |
|
|
2500 |
20.3 |
2.1 |
P 1.3 |
|
|
5000 |
16.7 |
2.1 |
P 1.1 |
|
MNNG |
5.0 |
4606.0 |
133.4 |
294.0 |
TA 100 |
DMSO |
- |
106.3 |
4.0 |
- |
|
Test item |
33 |
174.7 |
10.7 |
1.6 |
|
|
100 |
337.0 |
15.1 |
3.2 |
|
|
333 |
734.0 |
40.7 |
6.9 |
|
|
1000 |
1329.7 |
57.6 |
P 12.5 |
|
|
2500 |
1430.7 |
282.9 |
P 13.5 |
|
|
5000 |
889.3 |
86.9 |
P 8.4 |
|
MNNG |
5.0 |
4396.3 |
126.1 |
41.3 |
TA1537 |
DMSO |
- |
10.0 |
4.6 |
- |
|
Test item |
33 |
18.3 |
2.3 |
1.8 |
|
|
100 |
32.3 |
11.7 |
3.2 |
|
|
333 |
81.0 |
3.5 |
8.1 |
|
|
1000 |
133.7 |
10.5 |
P 13.4 |
|
|
2500 |
138.7 |
20.1 |
P 13.9 |
|
|
5000 |
30.7 |
7.1 |
P 3.1 |
|
AAC |
100 |
922.3 |
88.3 |
92.2 |
TA 98 |
DMSO |
- |
24.7 |
5.8 |
- |
|
Test item |
33 |
36.7 |
4.9 |
1.5 |
|
|
100 |
71.7 |
6.1 |
2.9 |
|
|
333 |
137.0 |
20.3 |
5.6 |
|
|
1000 |
270.7 |
26.8 |
P 11.0 |
|
|
2500 |
320.0 |
122.0 |
P 13.0 |
|
|
5000 |
510.3 |
48.7 |
P 20.7 |
|
NOPD |
10 |
980.0 |
21.5 |
39.7 |
E. coli |
DMSO |
- |
27.0 |
9.5 |
- |
|
Test item |
33 |
30.7 |
4.5 |
1.1 |
|
|
100 |
30.0 |
2.6 |
1.1 |
|
|
333 |
26.7 |
7.0 |
1.0 |
|
|
1000 |
21.7 |
3.5 |
P 0.8 |
|
|
2500 |
25.0 |
3.0 |
P 0.9 |
|
|
5000 |
18.7 |
2.9 |
P 0.7 |
|
4-NQO |
5.0 |
1082.3 |
6.1 |
40.1 |
P Precipitation
Table 2: SPT – with metabolic activation
Strain |
Test group |
Dose (µg/plate) |
Mean revertants per plate |
Standard deviation |
Factor |
TA 1535 |
DMSO |
- |
11.0 |
1.7 |
- |
|
Test item |
33 |
20.3 |
2.1 |
1.8 |
|
|
100 |
8.3 |
2.1 |
0.8 |
|
|
333 |
17.3 |
2.1 |
1.6 |
|
|
1000 |
24.0 |
6.9 |
P 2.2 |
|
|
2500 |
27.3 |
6.1 |
P 2.5 |
|
|
5000 |
21.7 |
1.5 |
P 2.0 |
|
2-AA |
2.5 |
311.0 |
33.0 |
28.3 |
TA 100 |
DMSO |
- |
110.0 |
6.2 |
- |
|
Test item |
33 |
179.0 |
27.6 |
1.6 |
|
|
100 |
303.7 |
22.2 |
2.8 |
|
|
333 |
538.3 |
34.3 |
4.9 |
|
|
1000 |
1252.3 |
86.9 |
P 11.4 |
|
|
2500 |
1173.3 |
153.1 |
P 10.7 |
|
|
5000 |
1133.3 |
84.0 |
P 10.3 |
|
2-AA |
2.5 |
2296.7 |
272.2 |
20.9 |
TA1537 |
DMSO |
- |
12.0 |
3.0 |
- |
|
Test item |
33 |
21.0 |
4.0 |
1.8 |
|
|
100 |
22.0 |
7.0 |
1.8 |
|
|
333 |
66.7 |
9.1 |
5.6 |
|
|
1000 |
159.0 |
6.2 |
P 13.3 |
|
|
2500 |
146.0 |
16.4 |
P 12.2 |
|
|
5000 |
53.7 |
11.2 |
P 4.5 |
|
2-AA |
2.5 |
217.7 |
21.7 |
18.1 |
TA 98 |
DMSO |
- |
28.0 |
2.0 |
- |
|
Test item |
33 |
31.0 |
5.6 |
1.1 |
|
|
100 |
42.0 |
8.7 |
1.5 |
|
|
333 |
63.7 |
11.7 |
2.3 |
|
|
1000 |
159.3 |
16.0 |
P 5.7 |
|
|
2500 |
435.0 |
36.9 |
P 15.5 |
|
|
5000 |
457.3 |
32.1 |
P 16.3 |
|
2-AA |
2.5 |
1729.3 |
409.1 |
61.8 |
E. coli |
DMSO |
- |
24.0 |
6.2 |
- |
|
Test item |
33 |
35.7 |
12.1 |
1.5 |
|
|
100 |
39.0 |
7.9 |
1.6 |
|
|
333 |
38.0 |
2.0 |
1.6 |
|
|
1000 |
25.0 |
3.5 |
P 1.0 |
|
|
2500 |
18.7 |
1.2 |
P 0.8 |
|
|
5000 |
15.3 |
4.9 |
P 0.6 |
|
2-AA |
60 |
204.0 |
2.6 |
8.5 |
P Precipitation
Applicant's summary and conclusion
- Conclusions:
- Thus, under the experimental conditions chosen here, it is concluded that the test item is a potent mutagenic test substance in the bacterial reverse mutation test in the absence and the presence of metabolic activation.
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.