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EC number: 202-767-9 | CAS number: 99-57-0
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- publication
- Title:
- In vitro gene toxicity study for test chemical in Salmonella Typhimurium TA98, TA 100, TA 1535 and 1537 by AMES test.
- Author:
- National Toxicology Program
- Year:
- 2 018
- Bibliographic source:
- NTP, Chemical effects in biological system
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- To evaluate the mutagenic potential of test chemical in Salmonella Typhimurium TA98,TA 100,TA 1535 and TA 1537 by AMES test.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-amino-4-nitrophenol
- EC Number:
- 202-767-9
- EC Name:
- 2-amino-4-nitrophenol
- Cas Number:
- 99-57-0
- Molecular formula:
- C6H6N2O3
- IUPAC Name:
- 2-amino-4-nitrophenol
- Details on test material:
- - Name of test material (as cited in study report): 2-Amino-4-nitrophenol
- Molecular formula (if other than submission substance): C6H6N2O3
- Molecular weight (if other than submission substance): 154.13gm/mole
- Substance type: organic
Constituent 1
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA98,TA 100,TA 1535 and TA 1537
- Details on mammalian cell type (if applicable):
- not specified
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- RLI = induced male Sprague Dawley rat liver S9 HLI = induced male Syrian hamster liver S9
- Test concentrations with justification for top dose:
- 0,10,30,100, 333,1000 and 3333µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: 95% Ethanol
- Justification for choice of solvent/vehicle: The test substance is soluble in 95% Ethanol.
Controls
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 95% Ethanol
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: -S9 mix;4 nitro-O phenylenediamine (TA 98), Sodium azide (TA1535and TA 100) and 9-Aminoacridine(TA1537) +S9 mix; 2-Aminoanthracene(all strains)
- Details on test system and experimental conditions:
- Details on test system and conditions
METHOD OF APPLICATION: Pre incubation method
NUMBER OF REPLICATIONS: Duplicate - Evaluation criteria:
- The plates were observed for revertents mutants colonies per plates
- Statistics:
- Yes, SD ± Mean was observed.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA100, TA1535, TA98 and TA1537
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Remarks on result:
- other: Mutagenic effect were observed
Any other information on results incl. tables
Strain: TA100 |
||||||||||||
|
||||||||||||
Dose |
No Activation |
No Activation |
10% RLI |
10% RLI |
10% HLI |
10% HLI |
||||||
Protocol |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
||||||
ug/Plate |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
0 |
139 |
7.8 |
107 |
4 |
142 |
4.3 |
112 |
7.9 |
129 |
6.9 |
163 |
8.8 |
10 |
121 |
5.4 |
146 |
3.2 |
||||||||
33 |
135 |
9.5 |
114 |
4.7 |
133 |
4.9 |
162 |
7.7 |
164 |
10.3 |
156 |
8.4 |
100 |
145 |
8.4 |
117 |
11.8 |
132 |
14.2 |
169 |
10.2 |
210 |
8.7 |
223 |
11 |
333 |
142 |
6.2 |
101 |
7.4 |
134 |
10 |
191 |
6.4 |
268 |
2.9 |
247 |
9 |
1000 |
146 |
10.3 |
97 |
11.6 |
122 |
2.7 |
180 |
3.5 |
289 |
17.3 |
282 |
5.9 |
3333 |
86 s |
49.7 |
t |
0 s |
0 |
0 s |
0 |
|||||
Positive Control |
434 |
3.7 |
407 |
18.7 |
690 |
15.4 |
551 |
3.5 |
1290 |
45.3 |
1796 |
23.7 |
Strain: TA1535 |
||||||
Dose |
No Activation |
10% RLI |
10% HLI |
|||
Protocol |
Preincubation |
Preincubation |
Preincubation |
|||
ug/Plate |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
0 |
27 |
.9 |
46 |
3.8 |
42 |
4.5 |
33 |
29 |
3.7 |
28 |
1.7 |
41 |
2.1 |
100 |
25 |
3.5 |
21 |
1.8 |
36 |
.3 |
333 |
27 |
3 |
16 |
1.2 |
37 |
2.2 |
1000 |
28 |
5.2 |
0 s |
0 |
32 |
3.5 |
3333 |
9 s |
3.1 |
t |
0 s |
0 |
|
Positive Control |
427 |
7.1 |
277 |
7.1 |
536 |
12.8 |
Strain: TA1537 |
||||||
Dose |
No Activation |
10% RLI |
10% HLI |
|||
Protocol |
Preincubation |
Preincubation |
Preincubation |
|||
ug/Plate |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
0 |
5 |
.9 |
10 |
1 |
5 |
.6 |
33 |
6 |
1 |
7 |
1.2 |
12 |
2.8 |
100 |
6 |
1.7 |
7 |
.9 |
12 |
4 |
333 |
6 |
.3 |
11 |
1.2 |
15 |
1.3 |
1000 |
10 |
2 |
12 |
2.3 |
10 |
2 |
3333 |
5 |
.3 |
9 |
1.7 |
0 s |
0 |
Positive Control |
172 |
4.7 |
167 |
14.8 |
500 |
5.5 |
Strain: TA98 |
||||||||||||
Dose |
No Activation |
No Activation |
10% RLI |
10% RLI |
10% HLI |
10% HLI |
||||||
Protocol |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
||||||
ug/Plate |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
0 |
21 |
2 |
29 |
2.2 |
40 |
1.7 |
37 |
3.5 |
37 |
3.7 |
37 |
4.3 |
10 |
27 |
1.5 |
44 |
1.3 |
||||||||
33 |
26 |
3.1 |
52 |
7.2 |
38 |
4.2 |
53 |
.7 |
50 |
3 |
54 |
3.2 |
100 |
30 |
2.7 |
64 |
4.6 |
50 |
2.3 |
57 |
1.9 |
67 |
3.6 |
62 |
3.7 |
333 |
17 |
2.3 |
64 |
6.6 |
55 |
3.5 |
75 |
6.8 |
94 |
4.7 |
86 |
.3 |
1000 |
17 |
1 |
84 |
7.1 |
56 |
4.7 |
83 |
1.2 |
242 |
19.6 |
113 |
13.5 |
3333 |
t |
0 s |
0 |
t |
0 s |
0 |
||||||
Positive Control |
724 |
34 |
724 |
7.1 |
425 |
15.3 |
382 |
27 |
1514 |
107.5 |
1027 |
53.1 |
Abbreviations:
RLI =
induced male Sprague Dawley rat liver S9
HLI = induced male Syrian hamster liver S9
s = Slight Toxicity; p = Precipitate; x = Slight Toxicity and
Precipitate; t = Toxic;
Applicant's summary and conclusion
- Conclusions:
- Test chemical was evaluated for its mutagenic potential in Salmonella typhimurium TA100, TA1535, TA98 and TA1537 by AMES test. The test result was considered to be positive in all strain in the presence and absence of metabolic activation S9.
- Executive summary:
Genetic toxicity in vitro study was assessed for test chemical. For this purpose AMES test was performed .The test material was exposed to Salmonella typhimurium TA100, TA1535, TA98 and TA1537in the presence and absence of metabolic activation S9. The concentration of test material used in the presence and absence of metabolic activation were 0, 10, 30,100, 333, 1000 and 3333 µg/plate. Mutagenic effects were observed in all strains, in the presence and absence of metabolic activation. Therefore test chemical was considered to be mutagenic in Salmonella typhimurium TA100, TA1535, TA98 and TA1537by AMES test. Hence the substance can be classified as gene mutant in vitro.
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