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EC number: 267-636-0 | CAS number: 67905-17-3
- 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:
- 27-10-2004 - 19-11-2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Data is from study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Qualifier:
- according to guideline
- Guideline:
- other: EC Directive 2000/32/EC, L 136, Annex 4D, B.13/B.14
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Substance Control Law (JSCL) Test Guideline III. 1 Gene Mutation Test With Bacteria
- Principles of method if other than guideline:
- Salmonella/microsome mutagenicity test (Ames test) (plate incorporation) was performed to assess the mutagenic nature of the test chemical.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-[4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]phenyl]acetamide
- EC Number:
- 267-636-0
- EC Name:
- N-[4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]phenyl]acetamide
- Cas Number:
- 67905-17-3
- Molecular formula:
- C22H16N2O4
- IUPAC Name:
- N-[4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]phenyl]acetamide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material : Polysynthrene Blue R
- Molecular formula): C22H16N2O4
- Molecular weight : 372.37 g/mol
- Smiles notation : O=C(Nc1ccc(Nc2c3c(c(O)cc2)C(=O)c2c(cccc2)C3=O)cc1)C
- InChl: 1S/C22H16N2O4/c1-12(25)23-13-6-8-14(9-7-13)24-17-10-11-18(26)20-19(17)21(27)15-4-2-3-5-16(15)22(20)28/h2-11,24,26H,1H3,(H,23,25)
- Substance type: Organic
- Physical state: Blue Powder
- Content: 83.5% by HPLC
14.3% organic by-productes by HPLC
2.1% Water by Karl-Fischer Titration
0.1% inorganic impurities by sulphated ash
- Name of test material : N-[4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]phenyl]acetamide- Molecular formula): C22H16N2O4- Molecular weight : 372.378 g/mol- Smiles notation : O=C(Nc1ccc(Nc2c3c(c(O)cc2)C(=O)c2c(cccc2)C3=O)cc1)C- InChl: 1S/C22H16N2O4/c1-12(25)23-13-6-8-14(9-7-13)24-17-10-11-18(26)20-19(17)21(27)15-4-2-3-5-16(15)22(20)28/h2-11,24,26H,1H3,(H,23,25)- Substance type: Organic- Physical state: Powder
Constituent 1
Method
- Target gene:
- Histidine for Salmonella typhimurium strains and tryptophan for E.coli strains
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:
- other: Salmonella typhimurium strains TA98: hisD3052 rfa uvr B+R TA100: hisG46 rfa uvr B+R Ta1535: hisG46 rfa uvrB TA1537: hisC3076 rfa uvrB Escherichia coli WP2uvrA: pKM101
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: pKM101
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 metabolic activation system was prepared from liver of male Sprague Dawley rat homogenate
- Test concentrations with justification for top dose:
- Plate incorporation assay:
With: 0, 50, 160, 500, 1600 or 5000 µg/plate
Without: 0, 50, 160, 500, 1600 or 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test chemical was solube in DMSO
Controls
- Untreated negative controls:
- yes
- Remarks:
- Untreated control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- sodium azide
- other: 2-nitrofluorene (TA98, -S9), 2-aminoanthracene (All strains, +S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding (if applicable): No data
DURATION
- Preincubation period: No data
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): 48 hrs
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): No data
STAIN (for cytogenetic assays): No data
NUMBER OF REPLICATIONS: Triplicate
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: No data
NUMBER OF CELLS EVALUATED: No data
NUMBER OF METAPHASE SPREADS ANALYSED PER DOSE (if in vitro cytogenicity study in mammalian cells): No data
CRITERIA FOR MICRONUCLEUS IDENTIFICATION: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: Yes
- Any supplementary information relevant to cytotoxicity: Toxicity was assessed after microscopic thinning of the bacterial lawn and/or reduction of the number of spontaneously occuring mutants compared to the corresponding solvent control value
OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Methods, such as kinetochore antibody binding, to characterize whether micronuclei contain whole or fragmented chromosomes (if applicable): No data
- OTHER: No data - Rationale for test conditions:
- No data
- Evaluation criteria:
- The test chemical was considered positive if-
- it produces atleast 2-fold increase in the mean number of revertants/plate of atleast one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control at complete bacterial background lawn
- it induces a dose related increase in the mean number of revertants per plate of at least one of the test strains over the mean number of revertants per plate of the appropriate vehicle in atleast two or three concentrations of the test item at complete bacterial background lawn
If the aboce critera is not achieved, it is considered to show no mutagenic activity in the system - Statistics:
- No data
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No data
- Effects of osmolality: No data
- Evaporation from medium: No data
- Water solubility: No data
- Precipitation: Visible precipitation was observed on plates at 160 µg/plate and above
- Definition of acceptable cells for analysis: No data
- Other confounding effects: No data
RANGE-FINDING/SCREENING STUDIES: No data
CYTOKINESIS BLOCK (if used)
- Distribution of mono-, bi- and multi-nucleated cells: No data
NUMBER OF CELLS WITH MICRONUCLEI
- Number of cells for each treated and control culture: No data
- Indication whether binucleate or mononucleate where appropriate: No data
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: No data
- Negative (solvent/vehicle) historical control data: No data
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: No data
- Other observations when applicable: No data - Remarks on result:
- other: No mutagenic potential
Any other information on results incl. tables
Table: Results of the mutagenicity test for the test chemical
TA100 |
||||||||
S9 |
Dose levelsµg/plate |
Number of revertants/plate |
Mean |
SD |
Ratio dose/control |
p |
||
Plate 1 |
Plate 1 |
Plate 3 |
||||||
+ |
2-Aminoanthracene |
1703 |
1512 |
1460 |
1558.3 |
128.0 |
12.7 |
|
+ |
Negative control |
124 |
128 |
119 |
123.7 |
4.5 |
- |
|
+ |
DMSO |
111 |
134 |
122 |
122.3 |
11.5 |
- |
|
+ |
50 |
135 |
116 |
126 |
125.7 |
9.5 |
1.0 |
|
+ |
160 |
137 |
130 |
151 |
139.3 |
10.7 |
1.1 |
P |
+ |
500 |
135 |
125 |
127 |
129.0 |
5.3 |
1.1 |
P |
+ |
1600 |
129 |
127 |
139 |
131.7 |
6.4 |
1.1 |
P |
+ |
5000 |
122 |
104 |
110 |
112.0 |
9.2 |
0.9 |
p |
- |
Sodium azide |
586 |
539 |
620 |
581.7 |
40.7 |
5.4 |
|
- |
Negative control |
123 |
115 |
119 |
119.0 |
4.0 |
- |
|
- |
DMSO |
109 |
119 |
98 |
108.7 |
10.5 |
- |
|
- |
50 |
109 |
109 |
104 |
107.3 |
2.9 |
1.0 |
|
- |
160 |
109 |
103 |
130 |
114.0 |
14.2 |
1.0 |
P |
- |
500 |
109 |
98 |
109 |
105.3 |
6.4 |
1.0 |
P |
- |
1600 |
103 |
108 |
115 |
108.7 |
6.0 |
1.0 |
P |
- |
5000 |
109 |
98 |
79 |
95.3 |
15.2 |
0.9 |
P |
P: Precipitated
TA1535 |
||||||||
S9 |
Dose levelsµg/plate |
Number of revertants/plate |
Mean |
SD |
Ratio dose/control |
p |
||
Plate 1 |
Plate 1 |
Plate 3 |
||||||
+ |
2-Aminoanthracene |
440 |
439 |
456 |
445.0 |
9.5 |
47.7 |
|
+ |
Negative control |
4 |
7 |
10 |
7.0 |
3.0 |
- |
|
+ |
DMSO |
10 |
9 |
9 |
9.3 |
0.6 |
- |
|
+ |
50 |
8 |
8 |
4 |
6.7 |
2.3 |
0.7 |
|
+ |
160 |
11 |
7 |
5 |
7.7 |
3.1 |
0.8 |
P |
+ |
500 |
11 |
5 |
4 |
6.7 |
3.8 |
0.7 |
P |
+ |
1600 |
7 |
10 |
8 |
8.3 |
1.5 |
0.9 |
P |
+ |
5000 |
12 |
6 |
7 |
8.3 |
3.2 |
0.9 |
p |
- |
Sodium azide |
193 |
1889 |
143 |
175.0 |
37.8 |
32.8 |
|
- |
Negative control |
13 |
6 |
11 |
10.0 |
3.6 |
- |
|
- |
DMSO |
6 |
4 |
6 |
5.3 |
1.2 |
- |
|
- |
50 |
7 |
4 |
5 |
5.3 |
1.5 |
1.0 |
|
- |
160 |
6 |
7 |
5 |
6.0 |
1.0 |
1.1 |
P |
- |
500 |
10 |
7 |
3 |
6.7 |
3.5 |
1.3 |
P |
- |
1600 |
6 |
8 |
5 |
6.3 |
1.5 |
1.2 |
P |
- |
5000 |
8 |
5 |
10 |
7.7 |
2.5 |
1.4 |
P |
P: Precipitated
TA1537 |
||||||||
S9 |
Dose levelsµg/plate |
Number of revertants/plate |
Mean |
SD |
Ratio dose/control |
p |
||
Plate 1 |
Plate 1 |
Plate 3 |
||||||
+ |
2-Aminoanthracene |
99 |
102 |
93 |
98.0 |
4.6 |
5.9 |
|
+ |
Negative control |
19 |
17 |
12 |
16.0 |
3.6 |
- |
|
+ |
DMSO |
18 |
16 |
16 |
16.7 |
1.2 |
- |
|
+ |
50 |
28 |
22 |
17 |
22.3 |
5.5 |
1.3 |
|
+ |
160 |
20 |
23 |
26 |
23.0 |
3.0 |
1.4 |
P |
+ |
500 |
24 |
24 |
20 |
22.7 |
2.3 |
1.4 |
P |
+ |
1600 |
19 |
23 |
24 |
22.0 |
2.6 |
1.3 |
P |
+ |
5000 |
14 |
17 |
27 |
19.3 |
6.8 |
1.2 |
p |
- |
9-aminoacridine |
270 |
222 |
153 |
215.0 |
58.8 |
23.0 |
|
- |
Negative control |
12 |
15 |
8 |
11.7 |
3.5 |
- |
|
- |
DMSO |
7 |
9 |
12 |
9.3 |
2.5 |
- |
|
- |
50 |
13 |
11 |
16 |
13.3 |
2.5 |
1.4 |
|
- |
160 |
9 |
11 |
8 |
9.3 |
1.5 |
1.0 |
P |
- |
500 |
8 |
7 |
12 |
9.0 |
2.6 |
1.0 |
P |
- |
1600 |
15 |
13 |
10 |
12.7 |
2.5 |
1.4 |
P |
- |
5000 |
10 |
13 |
11 |
11.3 |
1.5 |
1.2 |
P |
P: Precipitated
TA98 |
||||||||
S9 |
Dose levelsµg/plate |
Number of revertants/plate |
Mean |
SD |
Ratio dose/control |
p |
||
Plate 1 |
Plate 1 |
Plate 3 |
||||||
+ |
2-Aminoanthracene |
1054 |
1120 |
1076 |
1083.3 |
33.6 |
54.2 |
|
+ |
Negative control |
18 |
23 |
23 |
21.3 |
2.9 |
- |
|
+ |
DMSO |
19 |
21 |
20 |
20.0 |
1.0 |
- |
|
+ |
50 |
21 |
18 |
14 |
17.7 |
3.5 |
0.9 |
|
+ |
160 |
28 |
27 |
21 |
25.3 |
3.9 |
1.3 |
P |
+ |
500 |
30 |
21 |
28 |
26.3 |
4.7 |
1.3 |
P |
+ |
1600 |
32 |
26 |
34 |
30.7 |
4.2 |
1.5 |
P |
+ |
5000 |
20 |
34 |
34 |
29.3 |
8.1 |
1.5 |
p |
- |
2-nitrofluorene |
301 |
299 |
301 |
300.3 |
1.2 |
26.5 |
|
- |
Negative control |
12 |
14 |
9 |
11.7 |
2.5 |
- |
|
- |
DMSO |
14 |
13 |
7 |
11.3 |
3.8 |
- |
|
- |
50 |
14 |
14 |
8 |
12.0 |
3.5 |
1.1 |
|
- |
160 |
8 |
14 |
13 |
11.7 |
3.2 |
1.0 |
P |
- |
500 |
16 |
13 |
12 |
13.7 |
2.1 |
1.2 |
P |
- |
1600 |
13 |
4 |
12 |
9.7 |
4.9 |
0.9 |
P |
- |
5000 |
7 |
11 |
10 |
9.3 |
2.1 |
0.8 |
P |
P: Precipitated
E.coli WP2uvrA |
||||||||
S9 |
Dose levelsµg/plate |
Number of revertants/plate |
Mean |
SD |
Ratio dose/control |
p |
||
Plate 1 |
Plate 1 |
Plate 3 |
||||||
+ |
2-Aminoanthracene |
125 |
97 |
88 |
103.3 |
19.3 |
7.0 |
|
+ |
Negative control |
15 |
18 |
11 |
14.7 |
3.5 |
- |
|
+ |
DMSO |
16 |
11 |
17 |
14.7 |
3.2 |
- |
|
+ |
50 |
17 |
19 |
17 |
17.7 |
1.2 |
1.2 |
|
+ |
160 |
16 |
15 |
15 |
15.3 |
0.6 |
1.0 |
P |
+ |
500 |
15 |
11 |
18 |
14.7 |
3.5 |
1.0 |
P |
+ |
1600 |
14 |
16 |
14 |
14.7 |
1.2 |
1.0 |
P |
+ |
5000 |
16 |
13 |
12 |
13.7 |
2.1 |
0.9 |
p |
- |
9-NQO |
529 |
578 |
572 |
559.7 |
26.7 |
31.7 |
|
- |
Negative control |
17 |
17 |
23 |
19.0 |
3.5 |
- |
|
- |
DMSO |
26 |
14 |
13 |
17.7 |
7.2 |
- |
|
- |
50 |
21 |
15 |
15 |
17.0 |
3.5 |
1.0 |
|
- |
160 |
18 |
14 |
17 |
16.3 |
2.1 |
0.9 |
P |
- |
500 |
15 |
20 |
20 |
18.3 |
2.9 |
1.0 |
P |
- |
1600 |
19 |
17 |
15 |
17.0 |
2.0 |
1.0 |
P |
- |
5000 |
12 |
19 |
18 |
16.3 |
3.8 |
0.9 |
P |
P: Precipitated
Applicant's summary and conclusion
- Conclusions:
- The registered substance was tested non-mutagenic (negative) both in the presence and absence of S9 metabolic activation in Salmonella typhimurium TA1535, TA1537, TA98 and TA100 and Escherichia coli WP2uvrA tester strains. The test was performed according to OECD TG 471 and in compliance with OECD Principles of Good Laboratory Practice.
- Executive summary:
Salmonella/microsome mutagenicity test (Ames test) was performed to assess the mutagenic nature of theregistered substance. The study was conducted according to the plate incorporation method and in the presence and absence of S9 metabolic activation system using Salmonella typhimurium TA1535, TA1537, TA98 and TA100 and Escherichia coli WP2uvrA tester strains. The test chemical was dissolved in DMSO and used at concentrationsof 0, 50, 160, 500, 1600 or 5000 µg/plate. The plates were incubated for 48 hrs and observed for revertant colonies. Concurrent solvent(Dimethyl sulfoxide),negative controland positive control substances were also included in the study. The test chemical did not induce a relevant or dose-dependent increase in the number of revertants colonies at any concentrations tested either in the presence or absence of S9 metabolic activation system using Salmonella typhimurium TA1535, TA1537, TA98 and TA100 and Escherichia coli WP2uvrA tester strains.
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.