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EC number: 419-720-5 | CAS number: 182061-89-8
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1 August 1995 to 18 August 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, performed to valid guidelines and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
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
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- -
- EC Number:
- 419-720-5
- EC Name:
- -
- Cas Number:
- 182061-89-8
- Molecular formula:
- C25H26N9O12S3 . 3 Na
- IUPAC Name:
- trisodium 6-amino-5-{2-[4-({4-[bis(2-hydroxyethyl)amino]-6-[(2-sulfonatoethyl)amino]-1,3,5-triazin-2-yl}amino)-2-sulfonatophenyl]diazen-1-yl}-4-hydroxynaphthalene-2-sulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): M-377
- Physical state: solid
- Appearance: garnet powder
- Storage condition of test material: room temperature and protected from light
Constituent 1
Method
- Target gene:
- Histidine synthesis
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: rfa (all strains), uvr B (all strains), pKM 101 (TA98, TA 100)
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- other: rfa, pKM 101, pAQ1
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- Preliminary test:
0, 10, 100, 500, 1000, 2500, 5000 μg/plate (stains; TA 98, TA 100 and TA 102, with and without metabolic activation)
First Mutagenicity test:
0, 125, 250, 500, 1000, 2000 μg/plate (strains; TA 1535, TA 1537, TA 100 and TA 102, with and without metabolic activation)
0, 114.5, 229, 458, 916, 1832 μg/plate (strain; TA 98, with and without metabolic activation)
Second Mutagenicity test:
0, 125, 250, 500, 1000, 2000 μg/plate (stains; TA 1535, TA 1537, TA 98, TA 100 and TA 102; with and without metabolic activation) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: distilled water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- congo red
- mitomycin C
- other: 2-anthramine
- Details on test system and experimental conditions:
- STUDY DESIGN: A preliminary test, followed by two independent mutagenicity tests.
METHOD OF APPLICATION: preincubation
The day before treatment, cultures were inoculated from frozen permanents. A crystal was sampled under sterile conditions and put into approximately 6 mL of nutrient broth. The nutrient broth was then placed under agitation in an incubator at 37 °C for about 14 hours.
0.05 to 0.1 mL of the test material solution, 0.5 mL phosphate buffer pH 7.4 (without S9 mix) or 0.5 mL of S9 mix (with S9 mix) and 0.1 mL of the strain were incubated for 30 minutes at 30 °C prior to adding the overlay agar and pouring onto the surface of a minimal agar plate (the agar containing 0.5 % rather than 2 % glucose).
DURATION
- Exposure duration: Plates were incubated inverted at 37 °C for 48 to 72 hours.
NUMBER OF REPLICATIONS: Test concentrations were performed in triplicate
EVALUATION PROCEDURE: Following the total incubation period, revertants were scored with an automatic counter.
OTHER: The sterility of the test solution was checked during the preliminary test. The sterility of the S9 mix was checked during each of the mutagenicity tests at the beginning and end of the experiment. - Evaluation criteria:
- The study was considered valid if the following were met:
- The number of revertants of the controls was within the range of historical control data
- The number of revertants of the positive controls was higher than that of the controls and within the range of historical data
Biological relevance of the results was considered first. In addition, the following criteria were used as an aid in the determination of a positive result:
- a dose-related increase in the number of revertants and/or
- a reproducible increase in the number of revertants (doubling in at least one strain when compared to that of the controls) for at least one of the doses.
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:
- cytotoxicity
- Remarks:
- (> 2000 µg/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- (> 2000 µg/plate)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- - Preliminary Toxicity Study
The test material was freely soluble in the vehicle at 50 mg/mL in active material. Consequently, with a maximum dose volume of 100 μL/plate, the doses were 10, 100, 500, 1000, 2500 and 5000 μg/plate expressed in active material.
No precipitation, but slight to strong yellow colouration was observed in the Petri plate when scoring the revertants from 500 to 5000 μg/plate, renders scoring impossible at 2500 and 5000 μg/plate.
No toxicity was noted towards the strains with or without S9 mix.
The sterility of the test material was found to be satisfactory.
- Mutagenicity Study
The number of revertants of the vehicle and positive controls was as specified in the acceptance criteria and were within the range of historical data for the test lab.
The top dose was selected as concentrations higher would interfere with scoring the plates. Slight toxicity was noted towards some of the strains as shown by a decrease in the number of revertants.
The test material did not induce any significant increase in the number of revertants, with or without S9 mix, in any of the tester strains used in the study.
In both mutagenicity tests colouration of the agar was noted from a test concentrations of 144.5 µg/plate increasing in intensity up to the top dose of 2000 µg/plate.
No precipitation was recorded.
No signs of toxicity were recorded.
The sterility of the S9 mix was found to be satisfactory. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: First Mutagenicity Test
Strain |
Dose |
Without S9 |
With S9 |
||
Mean revertants/ plate |
Ratio |
Mean revertants/ plate |
Ratio |
||
TA 1535 |
0 |
19 |
- | 17 |
- |
125 |
14 |
0.8 |
13 |
0.8 |
|
250 |
15 |
0.8 |
17 |
1.0 |
|
500 |
16 |
0.8 |
17 |
1.0 |
|
1000 |
15 |
0.8 |
13 |
0.8 |
|
2000 |
15 |
0.8 |
13 |
0.8 |
|
NaN3 / 2AM |
502 |
26.9 |
229 |
13.8 |
|
TA 1537 |
0 |
9 |
- | 15 |
- |
125 |
7 |
0.7 |
6 |
0.4 |
|
250 |
6 |
0.6 |
8 |
0.5 |
|
500 |
5 |
0.5 |
8 |
0.6 |
|
1000 |
4 |
0.5 |
6 |
0.4 |
|
2000 |
4 |
0.5 |
8 |
0.5 |
|
9AA / 2AM |
300 |
32.2 |
246 |
16.4 |
|
TA 98 |
0 |
19 |
- | 25 |
- |
114.5 |
14 |
0.7 |
11 |
0.4 |
|
229 |
11 |
0.6 |
7 |
0.3 |
|
458 |
12 |
0.6 |
9 |
0.4 |
|
916 |
12 |
0.6 |
12 |
0.5 |
|
1832 |
14 |
0.7 |
6 |
0.2 |
|
2NF / CR |
142 |
7.3 |
270 |
10.6 |
|
TA 100 |
0 |
95 |
99 |
||
125 |
86 |
0.9 |
78 |
0.8 |
|
250 |
94 |
1.0 |
99 |
1.0 |
|
500 |
93 |
1.0 |
87 |
0.9 |
|
1000 |
87 |
0.9 |
76 |
0.8 |
|
2000 |
82 |
0.9 |
75 |
0.8 |
|
NaN3 / 2AM |
541 |
5.7 |
1552 |
15.7 |
|
TA 102 |
0 |
259 |
- | 305 |
- |
125 |
181 |
0.7 |
284 |
0.9 |
|
250 |
256 |
1.0 |
285 |
0.9 |
|
500 |
173 |
0.7 |
250 |
0.8 |
|
1000 |
268 |
1.0 |
222 |
0.7 |
|
2000 |
186 |
0.7 |
217 |
0.7 |
|
MMC / 2AM |
2528 |
9.7 |
2204 |
7.2 |
Table 2: Second Mutagenicity Test
Strain |
Dose |
Without S9 |
With S9 |
||
Mean revertants/ plate |
Ratio |
Mean revertants/ plate |
Ratio |
||
TA 1535 |
0 |
15 |
- |
19 |
- |
125 |
11 |
0.8 |
14 |
0.7 |
|
250 |
8 |
0.6 |
16 |
0.9 |
|
500 |
14 |
0.9 |
18 |
0.9 |
|
1000 |
11 |
0.8 |
13 |
0.7 |
|
2000 |
12 |
0.8 |
13 |
0.7 |
|
NaN3 / 2AM |
970 |
64.7 |
964 |
50.8 |
|
TA 1537 |
0 |
9 |
- |
12 |
- |
125 |
6 |
0.7 |
9 |
0.7 |
|
250 |
7 |
0.8 |
10 |
0.9 |
|
500 |
7 |
0.8 |
7 |
0.6 |
|
1000 |
9 |
1.1 |
5 |
0.4 |
|
2000 |
5 |
0.5 |
4 |
0.3 |
|
9AA / 2AM |
1879 |
216.8 |
94 |
8.1 |
|
TA 98 |
0 |
23 |
- |
29 |
- |
125 |
18 |
0.8 |
18 |
0.6 |
|
250 |
14 |
0.6 |
16 |
0.5 |
|
500 |
15 |
0.7 |
18 |
0.6 |
|
1000 |
12 |
0.5 |
25 |
0.9 |
|
2000 |
10 |
0.5 |
8 |
0.3 |
|
2NF / CR |
157 |
6.9 |
157 |
5.4 |
|
TA 100 |
0 |
75 |
- |
117 |
- |
125 |
66 |
0.9 |
87 |
0.7 |
|
250 |
63 |
0.8 |
71 |
0.6 |
|
500 |
70 |
0.9 |
62 |
0.5 |
|
1000 |
61 |
0.8 |
89 |
0.8 |
|
2000 |
51 |
0.7 |
76 |
0.7 |
|
NaN3 / 2AM |
740 |
9.8 |
949 |
8.1 |
|
TA 102 |
0 |
269 |
- |
391 |
- |
125 |
243 |
0.9 |
433 |
1.1 |
|
250 |
275 |
1.0 |
293 |
0.7 |
|
500 |
288 |
1.1 |
141 |
0.4 |
|
1000 |
283 |
1.0 |
183 |
0.5 |
|
2000 |
220 |
0.8 |
111 |
0.3 |
|
MMC / 2AM |
1641 |
6.1 |
879 |
2.2 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
Under the specific conditions of this assay, the test material gave a negative (i.e. non-mutagenic), response in Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA 102 both in the presence and absence of metabolic activation. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes. - Executive summary:
The potential of the test material to cause gene mutation in bacterial strains was determined in accordance with standardised guidelines OECD 471 and EU Method B.14. Five strains of Salmonella typhimurium (TA1535, TA1537, TA98, TA100 and TA102) were treated in the presence and absence of a metabolic activation system (S9 mix). In two separate assays, the test material did not induce any significant, reproducible increases in the observed number of revertant colonies in any of the tester strains used in the presence or absence of metabolic activation.
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