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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 287-719-5 | CAS number: 85567-07-3
- 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:
- 27-11-2016 to 19-12-2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Ninth Addendum to OECD Guidelines for Testing of Chemicals, Section 4, No. 471, "Bacterial Reverse Mutation Test", adopted 21st July, 1997.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- May 30, 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,2'-[[3-chloro-4-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]phenyl]imino]bisethyl bis(hydrogen sulphate), potassium sodium salt
- EC Number:
- 287-719-5
- EC Name:
- 2,2'-[[3-chloro-4-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]phenyl]imino]bisethyl bis(hydrogen sulphate), potassium sodium salt
- Cas Number:
- 85567-07-3
- Molecular formula:
- C36H42Cl2KN6NaO28S8
- IUPAC Name:
- 2,2'-[[3-chloro-4-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]phenyl]imino]bisethyl bis(hydrogen sulphate), potassium sodium salt
- Test material form:
- solid
- Details on test material:
- Batch: 1283067001
Constituent 1
Method
- Target gene:
- histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Experiment I: S9 mix from rat liver; Experiment II: S9 mix from hamster liver
- Test concentrations with justification for top dose:
- Pre-experiment (plate incorporation):
3.16, 10.0, 31.6, 100, 316, 1000, 2500 and 5000 μg/plate
The test item concentrations to be applied in the main experiments were chosen according to the results of the pre-experiment. 5000 μg/plate was selected as the maximum concentration. The concentration range covered two logarithmic decades.
Experiment I (plate incorporation test with and without rat liver S9):
31.6, 100, 316, 1000, 2500 and 5000 μg/plate
Experiment II (pre-incubation test with and without hamster liver S9):
10.0, 31.6, 100, 316, 1000, 2500 and 5000 μg/plate - Vehicle / solvent:
- - Vehicle(s): Aqua dest.
- Justification for choice of solvent/vehicle: The solvent was compatible with the survival of the bacteria and the S9 activity.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- solvent control is negative control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Aqua dest.
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- S. typhimurium: TA 100, TA 1535 without metabolic activation (dissolved in A. dest.)
- Positive control substance:
- sodium azide
- Positive controls:
- yes
- Remarks:
- S. typhimurium: TA 98, TA 1537 without metabolic activation (dissolved in DMSO)
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine (4-NOPD) 10 μg/plate for TA 98, 40 μg/plate for TA 1537
- Positive controls:
- yes
- Remarks:
- S. typhimurium: TA 102 without metabolic activation (dissolved in A. dest).
- Positive control substance:
- methylmethanesulfonate
- Positive controls:
- yes
- Remarks:
- typhimurium: TA 98, TA 100, TA 1535, TA 1537 and TA 102 with metabolic activation (Rat Liver) (dissolved in DMSO)
- Positive control substance:
- other: 2-aminoanthracene (2-AA) 2.5 μg/plate; 10 μg/plate for TA 102
- Positive controls:
- yes
- Remarks:
- S. typhimurium: TA 1535, TA 1537, TA 102 with metabolic activation (Hamster Liver) (dissolved in DMSO)
- Positive control substance:
- other: 2-aminoanthracene (2-AA)
- Positive controls:
- yes
- Remarks:
- S. typhimurium: TA 98, TA 100 with metabolic activation (Hamster Liver) (dissolved in A. Dest.)
- Positive control substance:
- congo red
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Experiment I: in agar (plate incorporation)
Experiment II: preincubation with hamster liver S9
DURATION
Experiment I: in agar (plate incorporation)
- Preincubation period: No
- Exposure duration: at least 48 h in the dark at 37 °C
- Expression time (cells in growth medium): Not applicable
- Selection time (if incubation with a selection agent): at least 48 h in the dark at 37 °C
- Fixation time (start of exposure up to fixation or harvest of cells): Not applicable
Experiment II: preincubation with hamster liver S9
- Preincubation period: 30 min at 30 °C
- Exposure duration: 30 min at 30°C and at least 48 h in the dark at 37 °C
- Expression time (cells in growth medium): Not applicable
- Selection time (if incubation with a selection agent): at least 48 h in the dark at 37 °C
- Fixation time (start of exposure up to fixation or harvest of cells): Not applicable
SELECTION AGENT (mutation assays): histidine (overlay agar)
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: other: clearing or rather diminution of the background lawn or a reduction in the number of revertants down to a mutation factor of approximately ≤ 0.5 in relation to the solvent control - Evaluation criteria:
- The Mutation Factor is calculated by dividing the mean value of the revertant counts by the mean values of the solvent control (the exact and not the rounded values are used for calculation).
A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA 98, TA 100 and TA 102 the number of reversions is at least twice as high
- if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher than the reversion rate of the solvent control.
According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
A test item producing neither a dose related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups is considered to be non-mutagenic in this system. - Statistics:
- According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Remarks:
- Experiment I and II
- 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
- Remarks:
- Experiment I and II
- 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 102
- Remarks:
- Eperiment I and II
- 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 1535
- Remarks:
- Experiment I and II
- 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 1537
- Remarks:
- Experiment II
- 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 1537
- Remarks:
- Experiment I
- Metabolic activation:
- with
- 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 1537
- Remarks:
- Experiment I
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at concentrations of 2500 μg/plate and higher
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: No precipitation of the test item was observed in any tester strain used in experiment I and II (with and without metabolic activation).
RANGE-FINDING STUDY:
Substance |
Dose (μg/plate) |
TA 98 Mutation Factor [toxicity]* |
TA 100 Mutation Factor [toxicity]* |
||
without S9 |
with S9 |
without S9 |
with S9 |
||
Solvent Control (A. dest) |
|
1.0 |
1.0 |
1.0 |
1.0 |
4-NOPD |
10.0 |
16.6 |
- |
- |
- |
NaN3 |
10.0 |
- |
- |
5.7 |
- |
2-AA |
2.50 |
- |
83.4 |
- |
12.8 |
Test Item
|
3.16 |
1.2 |
1.2 |
1.0 |
1.0 |
10.0 |
1.2 |
1.0 |
1.0 |
1.0 |
|
31.6 |
1.0 |
0.9 |
1.1 |
1.0 |
|
100 |
1.1 |
1.0 |
1.1 |
1.0 |
|
316 |
1.3 |
0.8 |
1.2 |
1.0 |
|
1000 |
1.7 |
1.2 |
1.0 |
0.9 |
|
2500 |
0.9 |
0.9 |
1.0 |
1.1 |
|
5000 |
1.1 |
0.9 |
1.2 |
1.1 |
* [toxicity parameter]: B = Background lawn reduced; N = No background lawn
MAIN STUDY:
Experiment I (rat liver S9):
Mean revertant colonies per plate
TA 98 | TA 100 | TA 1535 | TA 1537 | TA 102 | |||||||
Treatment | Dose/plate (µg) | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
Aq. Dest | 20 | 29 | 129 | 136 | 20 | 13 | 13 | 11 | 422 | 490 | |
Test item | 10 | 20 | 25 | 148 | 133 | 22 | 16 | 13 | 9 | 388 | 432 |
100 | 23 | 28 | 139 | 139 | 22 | 12 | 10 | 12 | 396 | 473 | |
316 | 26 | 25 | 151 | 142 | 19 | 13 | 11 | 14 | 367 | 432 | |
1000 | 34 | 34 | 135 | 121 | 21 | 13 | 10 | 12 | 371 | 408 | |
2500 | 19 | 25 | 136 | 154 | 14 | 11 | 6 | 7 | 296 | 335 | |
5000 | 23 | 26 | 158 | 155 | 16 | 12 | 6 | 7 | 321 | 296 | |
4-NOPD | 10 | 337 | - | 733 | - | 1112 | - | 70 | - | 2274 | - |
2-AA | 2.5 | - | 2445 | - | 1743 | - | 203 | - | 396 | - | 1024 |
Mutation factor
TA98 | TA100 | TA 1535 | TA 1537 | TA 102 | |||||||
Treatment | Dose/plate | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
Aq. Dest | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
Test item | 31.6 µg | 1 | 0.9 | 1.1 | 1 | 1.1 | 1.2 | 1 | 0.9 | 0.9 | 0.9 |
100 µg | 1.1 | 1 | 1.1 | 1 | 1.1 | 0.9 | 0.8 | 1.2 | 0.9 | 1 | |
316 µg | 1.3 | 0.8 | 1.2 | 1 | 0.9 | 1 | 0.8 | 1.3 | 0.9 | 0.9 | |
1000 µg | 1.7 | 1.2 | 1 | 0.9 | 1 | 1 | 0.8 | 1.1 | 0.9 | 0.8 | |
2500 µg | 0.9 | 0.9 | 1 | 1.1 | 0.7 | 0.9 | 0.5 | 0.7 | 0.7 | 0.7 | |
5000 µg | 1.1 | 0.9 | 1.2 | 1.1 | 0.8 | 0.9 | 0.5 | 0.7 | 0.8 | 0.6 | |
4-NOPD | 10 µg | 16.6 | - | 5.7 | - | 54.7 | - | 5.3 | - | 5.4 | - |
2-AA | 2.5 µg | - | 83.4 | - | 12.8 | - | 15.3 | - | 37.1 | - | 2.1 |
Experiment II (hamster liver S9):
Mean revertant colonies per plate
TA 98 | TA 100 | TA 1535 | TA 1537 | TA 102 | |||||||
Treatment | Dose/plate (µg) | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
Aq. Dest | 17 | 36 | 89 | 97 | 21 | 15 | 7 | 19 | 270 | 444 | |
Test item | 10 | 15 | 38 | 88 | 82 | 25 | 11 | 9 | 20 | 328 | 388 |
31.6 | 16 | 35 | 109 | 95 | 27 | 11 | 9 | 18 | 290 | 430 | |
100 | 17 | 43 | 106 | 95 | 22 | 16 | 7 | 18 | 229 | 382 | |
316 | 16 | 39 | 110 | 106 | 25 | 14 | 9 | 17 | 235 | 365 | |
1000 | 18 | 42 | 104 | 108 | 22 | 16 | 6 | 18 | 255 | 400 | |
2500 | 17 | 27 | 125 | 107 | 19 | 13 | 6 | 13 | 241 | 441 | |
5000 | 14 | 25 | 137 | 131 | 18 | 16 | 5 | 11 | 281 | 260 | |
Congo Red | 700 | - | 242 | - | 301 | 1104 | - | 120 | - | 1227 | - |
NaN3 | 10 | 425 | - | 748 | - | - | 230 | - | 294 | - | 1513 |
Mutation factor
TA 98 | TA 100 | TA 1535 | TA 1537 | TA 102 | |||||||
Treatment | Dose/plate (µg) | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
Aq. Dest | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 | |
Test item | 10 | 0.9 | 1.1 | 1 | 0.8 | 1.2 | 0.8 | 1.2 | 1.1 | 1.2 | 0.9 |
31.6 | 0.9 | 1 | 1.2 | 1 | 1.3 | 0.7 | 1.2 | 0.9 | 1.1 | 1 | |
100 | 1 | 1.2 | 1.2 | 1 | 1 | 1 | 1 | 0.9 | 0.8 | 0.9 | |
316 | 0.9 | 1.1 | 1.2 | 1.1 | 1.2 | 0.9 | 1.3 | 0.9 | 0.9 | 0.8 | |
1000 | 1 | 1.2 | 1.2 | 1.1 | 1 | 1 | 0.8 | 0.9 | 0.9 | 0.9 | |
2500 | 1 | 0.8 | 1.4 | 1.1 | 0.9 | 0.8 | 0.8 | 0.7 | 0.9 | 1 | |
5000 | 0.8 | 0.7 | 1.5 | 1.4 | 0.9 | 1.1 | 0.8 | 0.6 | 1 | 0.6 | |
Congo Red | 700 | - | 6.8 | - | 3.1 | 53.4 | - | 17.1 | - | 4.5 | - |
NaN3 | 10 | 24.5 | - | 8.4 | - | - | 15.4 | - | 15.5 | - | 3.4 |
Applicant's summary and conclusion
- Conclusions:
- The test item did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore, the test item is considered to be non-mutagenic in this bacterial reverse mutation assay.
- Executive summary:
The test item was assessed for its ability to induce gene mutations in a study performed according to OECD 471, a bacterial reverse mutation test. The plate incorporation test with rat liver S9 (experiment I) and the pre-incubation test with hamster liver S9 (experiment II), were performed with the Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and TA 102.
In two independent experiments several concentrations of the test item were used: 31.6, 100, 316, 1000, 2500 and 5000 μg/plate in experiment I and 10.0, 31.6, 100, 316, 1000, 2500 and 5000 μg/plate in experiment II. The concentrations, including the controls, were tested in triplicate.
No precipitation of the test item was observed in any tester strain used in experiment I and II (with and without metabolic activation). No toxic effects of the test item were noted in any of the five tester strains used up to the highest dose group evaluated (with and without metabolic activation) in experiment I and II, with one exception: In experiment I toxic effects of the test item were noted in tester strain TA 1537 at concentrations of 2500 μg/plate and higher (without metabolic activation). No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with the test item at any concentration level, neither in the presence nor absence of metabolic activation in experiment I and II.
All criteria of validity were met.
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore, the test item is considered to be non-mutagenic in this bacterial reverse mutation assay.
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.