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EC number: 240-834-4 | CAS number: 16803-97-7
- 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:
- 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:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- The substance "Sulfamid" was tested for mutagenicity in the Ames test by Standard plate metod.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 4-amino-N-(4-aminophenyl)benzenesulphonamide
- EC Number:
- 240-834-4
- EC Name:
- 4-amino-N-(4-aminophenyl)benzenesulphonamide
- Cas Number:
- 16803-97-7
- Molecular formula:
- C12H13N3O2S
- IUPAC Name:
- 4-amino-N-(4-aminophenyl)benzenesulphonamide
- Test material form:
- solid
- Details on test material:
- - Name of test material : 4-amino-N-(4-aminophenyl)benzenesulphonamide
- Molecular formula : C12H13N3O2S
- Molecular weight : 263.32 g/mol
- Smiles notation : O=S(=O)(c1ccc(cc1)Nc1ccc(cc1)N)N
- InChl : 1S/C12H13N3O2S/c13-9-1-3-10(4-2-9)15-11-5-7-12(8-6-11)18(14,16)17/h1-8,15H,13H2,(H2,14,16,17)
- Substance type : Organic
- Physical state : Solid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material : 4-amino-N-(4-aminophenyl)benzenesulphonamide
- Molecular formula : C12H13N3O2S
- Molecular weight : 263.32 g/mol
- Smiles notation : O=S(=O)(c1ccc(cc1)Nc1ccc(cc1)N)N
- InChl : 1S/C12H13N3O2S/c13-9-1-3-10(4-2-9)15-11-5-7-12(8-6-11)18(14,16)17/h1-8,15H,13H2,(H2,14,16,17)
- Substance type : Organic
- Physical state : Solid
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: J. 9045, V . 134
- Purity : 100%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material;+4C
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 100, TA 1537 , TA 1538 and TA 9 8
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- other: All strains have a defective excision repair system (uvrB) and reduced hydrophilic polysaccharide layer(rfa)
- Cytokinesis block (if used):
- Not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix is prepared by injecting male Sprague-Dawley rats liver with Aroclor 1254
- Test concentrations with justification for top dose:
- 0, 20, 100, 500, 2500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle:Complete solubility of the test substance in DMSO .
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: + S-9 mix ;2-aminoanthracene for TA 100, TA 98, TA 1538, TA 153T and T - S-9 mix ; N-methyl-N'-nitro-N-nitrosoguanidine for TA 100 and TA 153 5 4-nitro-o-phenylendiamine for TA 98 and TA 153 8 9-aminoacridine chloride monohydrate for TA 153T.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Standard plate test
DURATION
- Exposure duration:48 hours
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth
- OTHER:3 test plates per dose or per control was observed - Rationale for test conditions:
- Not specified .
- Evaluation criteria:
- In general, a substance to be characterized as positive in the Ames test has to fulfill the following requirements:
- doubling of the spontaneous mutation rate (control)
- dose-response relationshi p
- reproducibility of the results . - Statistics:
- Mean± Standard deviation was observed.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 1538, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- ADDITIONAL INFORMATION ON CYTOTOXICITY: A weakly bacteriotoxic effect (slight decrease in the number of his+ revertants) was observed depending on the strain and test conditions at doses, ≥2500 µg/plate .
- Remarks on result:
- other: No mutagenic effect were observed .
Any other information on results incl. tables
Table 1
Strain : TA 1535
Dose MCG/Pl |
Revertants / plate |
Titer Dil Exp-6 |
Quotient |
||||||
-S9 |
M |
SD |
+S9 |
M |
SD |
-S9 |
+S9* |
||
Negative control DMSO |
14 |
17 |
3 |
15 |
17 |
2 |
35 |
1.0 |
1.0 |
17 |
|
|
18 |
|
|
42 |
|
|
|
20 |
|
|
19 |
|
|
47 |
|
|
|
20 |
13 |
14 |
3 |
17 |
19 |
2 |
|
0.8 |
1.1 |
18 |
|
|
20 |
|
|
|
|
|
|
12 |
|
|
19 |
|
|
|
|
|
|
100 |
15 |
16 |
1 |
21 |
18 |
3 |
|
0.9 |
1.1 |
15 |
|
|
15 |
|
|
|
|
|
|
17 |
|
|
19 |
|
|
|
|
|
|
500 |
22 |
18 |
5 |
10 |
11 |
3 |
33 |
1.0 |
0.7 |
20 |
|
|
9 |
|
|
38 |
|
|
|
18 |
|
|
5 |
|
|
41 |
|
|
|
2500 |
23 |
18 |
5 |
10 |
11 |
3 |
3 |
1.0 |
0.7 |
14 |
|
|
9 |
|
|
|
|
|
|
16 |
|
|
15 |
|
|
|
|
|
|
5000 |
12 |
12 |
2 |
13 |
12 |
2 |
17 |
0.7 |
0.7 |
11 |
|
|
12 |
|
|
24 |
|
|
|
14 |
|
|
10 |
|
|
21 |
|
|
|
Positive control 2-AA 10 |
|
|
|
351 |
305 |
40 |
|
|
17.6 |
|
|
|
289 |
|
|
|
|
|
|
|
|
|
276 |
|
|
|
|
|
|
Positive control MNNG 5 |
1940 |
2030 |
82 |
|
|
|
|
119.4 |
|
2100 |
|
|
|
|
|
|
|
|
|
2050 |
|
|
|
|
|
|
|
|
*S-9 Fraction/Co-factor=3.7 EXP:EXP to 10
Table : 2 Strain: TA100
Dose MCG/Pl |
Revertants / plate |
Titer Dil Exp-6 |
Quotient |
||||||
-S9 |
M |
SD |
+S9 |
M |
SD |
-S9 |
+S9* |
||
Negative control DMSO |
118 |
115 |
10 |
107 |
112 |
6 |
63 |
1.0 |
1.0 |
124 |
|
|
119 |
|
|
67 |
|
|
|
104 |
|
|
110 |
|
|
52 |
|
|
|
20 |
115 |
113 |
10 |
124 |
121 |
7 |
|
1.0 |
1.1 |
105 |
|
|
127 |
|
|
|
|
|
|
120 |
|
|
113 |
|
|
|
|
|
|
100 |
109 |
108 |
3 |
109 |
113 |
8 |
|
0.9 |
1.0 |
105 |
|
|
108 |
|
|
|
|
|
|
110 |
|
|
122 |
|
|
|
|
|
|
500 |
113 |
118 |
6 |
131 |
124 |
7 |
|
1.0 |
1.1 |
117 |
|
|
117 |
|
|
|
|
|
|
124 |
|
|
123 |
|
|
|
|
|
|
2500 |
126 |
120 |
16 |
109 |
108 |
7 |
35 |
1.0 |
1.0 |
131 |
|
|
115 |
|
|
47 |
|
|
|
102 |
|
|
101 |
|
|
53 |
|
|
|
5000 |
87 |
79 |
7 |
87 |
72 |
16 |
23 |
0.7 |
0.6 |
73 |
|
|
56 |
|
|
29 |
|
|
|
76 |
|
|
74 |
|
|
41 |
|
|
|
Positive control 2-AA 10 |
|
|
|
2400 |
2283 |
126 |
|
|
20.4 |
|
|
|
2150 |
|
|
|
|
|
|
|
|
|
2300 |
|
|
|
|
|
|
Positive control MNNG 5 |
1850 |
1780 |
62 |
|
|
|
|
15.4 |
|
1730 |
|
|
|
|
|
|
|
|
|
1760 |
|
|
|
|
|
|
|
|
Table : 3 Strain: TA1537
Dose MCG/Pl |
Revertants / plate |
Titer Dil Exp-6 |
Quotient |
||||||
-S9 |
M |
SD |
+S9 |
M |
SD |
-S9 |
+S9* |
||
Negative control DMSO |
10 |
10 |
2 |
8 |
9 |
2 |
28 |
1.0 |
1.0 |
12 |
|
|
11 |
|
|
37 |
|
|
|
9 |
|
|
9 |
|
|
31 |
|
|
|
20 |
8 |
11 |
3 |
12 |
10 |
2 |
|
1.1 |
1.1 |
14 |
|
|
11 |
|
|
|
|
|
|
11 |
|
|
8 |
|
|
|
|
|
|
100 |
12 |
12 |
1 |
10 |
9 |
2 |
|
1.2 |
1.0 |
13 |
|
|
7 |
|
|
|
|
|
|
12 |
|
|
11 |
|
|
|
|
|
|
500 |
9 |
10 |
1 |
13 |
10 |
3 |
|
0.9 |
1.1 |
11 |
|
|
9 |
|
|
|
|
|
|
9 |
|
|
8 |
|
|
|
|
|
|
2500 |
10 |
9 |
1 |
10 |
8 |
2 |
44 |
0.8 |
0.9 |
8 |
|
|
8 |
|
|
32 |
|
|
|
8 |
|
|
7 |
|
|
36 |
|
|
|
5000 |
3 |
3 |
2 |
7 |
6 |
2 |
14 |
0.3 |
0.6 |
2 |
|
|
6 |
|
|
21 |
|
|
|
5 |
|
|
4 |
|
|
22 |
|
|
|
Positive control 2-AA 10 |
|
|
|
127 |
130 |
12 |
|
|
13.9 |
|
|
|
143 |
|
|
|
|
|
|
|
|
|
119 |
|
|
|
|
|
|
Positive control MNNG 100 |
568 |
674 |
93 |
|
|
|
|
65.3 |
|
713 |
|
|
|
|
|
|
|
|
|
742 |
|
|
|
|
|
|
|
|
Table No. 4 Strain: TA 98
Dose MCG/Pl |
Revertants / plate |
Titer Dil Exp-6 |
Quotient |
||||||
-S9 |
M |
SD |
+S9 |
M |
SD |
-S9 |
+S9* |
||
Negative control DMSO |
24 |
23 |
3 |
37 |
34 |
4 |
36 |
1.0 |
1.0 |
26 |
|
|
34 |
|
|
44 |
|
|
|
20 |
|
|
30 |
|
|
29 |
|
|
|
20 |
28 |
23 |
4 |
31 |
35 |
6 |
|
1.0 |
1.0 |
20 |
|
|
33 |
|
|
|
|
|
|
21 |
|
|
42 |
|
|
|
|
|
|
100 |
23 |
24 |
3 |
32 |
36 |
5 |
|
1.0 |
1.1 |
27 |
|
|
36 |
|
|
|
|
|
|
21 |
|
|
41 |
|
|
|
|
|
|
500 |
18 |
21 |
2 |
30 |
32 |
4 |
|
0.9 |
1.1 |
22 |
|
|
29 |
|
|
|
|
|
|
22 |
|
|
37 |
|
|
|
|
|
|
2500 |
21 |
21 |
3 |
32 |
37 |
4 |
21 |
0.9 |
1.1 |
19 |
|
|
38 |
|
|
23 |
|
|
|
24 |
|
|
40 |
|
|
41 |
|
|
|
5000 |
8 |
9 |
4 |
17 |
15 |
5 |
17 |
0.4 |
0.5 |
13 |
|
|
19 |
|
|
12 |
|
|
|
6 |
|
|
10 |
|
|
19 |
|
|
|
Positive control 2-AA 10 |
|
|
|
1250 |
1180 |
66 |
|
|
35.0 |
|
|
|
1120 |
|
|
|
|
|
|
|
|
|
1170 |
|
|
|
|
|
|
Positive control MNNG 5 |
833 |
903 |
65 |
|
|
|
|
38.7 |
|
915 |
|
|
|
|
|
|
|
|
|
961 |
|
|
|
|
|
|
|
|
Table No. 5 Strain: TA 1538
Dose MCG/Pl |
Revertants / plate |
Titer Dil Exp-6 |
Quotient |
||||||
-S9 |
M |
SD |
+S9 |
M |
SD |
-S9 |
+S9* |
||
Negative control DMSO |
14 |
14 |
1 |
30 |
28 |
2 |
50 |
1.0 |
1.0 |
14 |
|
|
27 |
|
|
48 |
|
|
|
15 |
|
|
26 |
|
|
39 |
|
|
|
20 |
15 |
17 |
2 |
21 |
26 |
5 |
|
1.2 |
0.8 |
17 |
|
|
26 |
|
|
|
|
|
|
18 |
|
|
30 |
|
|
|
|
|
|
100 |
10 |
13 |
3 |
28 |
29 |
6 |
|
0.9 |
0.1 |
13 |
|
|
35 |
|
|
|
|
|
|
16 |
|
|
24 |
|
|
|
|
|
|
500 |
13 |
12 |
2 |
23 |
23 |
2 |
|
0.8 |
0.8 |
10 |
|
|
24 |
|
|
|
|
|
|
12 |
|
|
21 |
|
|
|
|
|
|
2500 |
10 |
7 |
3 |
24 |
19 |
6 |
16 |
0.5 |
0.7 |
4 |
|
|
20 |
|
|
36 |
|
|
|
7 |
|
|
12 |
|
|
6 |
|
|
|
5000 |
4 |
4 |
1 |
14 |
12 |
2 |
0 |
0.3 |
0.4 |
4 |
|
|
11 |
|
|
0 |
|
|
|
3 |
|
|
12 |
|
|
0 |
|
|
|
Positive control 2-AA 10 |
|
|
|
800 |
989 |
241 |
|
|
35.8 |
|
|
|
908 |
|
|
|
|
|
|
|
|
|
1260 |
|
|
|
|
|
|
Positive control MNNG 5 |
760 |
592 |
147 |
|
|
|
|
41.3 |
|
531 |
|
|
|
|
|
|
|
|
|
486 |
|
|
|
|
|
|
|
|
Applicant's summary and conclusion
- Conclusions:
- The substance "Sulfamid" (16803-97-7)was tested for mutagenicity in the Ames test (standard plate test) both in the presence and in the absence of a metabolizing system obtained from rat liver (S-9 mix)using the strains TA 1535, TA 100, TA 153T, TA 1538 and TA 98. The test result was considered to be negative both in the presence and absence of metabolic activation.
- Executive summary:
In Vitro genetic toxicity study "Sulfamid" (16803-97-7) was assessed for its possible mutagenic potential. For this purpose is Bacterial Reverse mutation assay was performed according to OECD guideline 471. The test substance was exposed to the Salmonella Typhimurium strains TA 1535, TA 100, TA 153T, TA 1538 and TA 98 at the concentration of 0, 20, 100, 500, 2500 and 5000 µg/plate. The test substance was tested by standard plate method both in the presence and in the absence of a metabolizing system obtained from rat liver (S-9 mix). Cytotoxicity was also observed. No mutagenic effects were observed in the test. Therefore "Sulfamid" was considered to be non mutagenic in the strains TA 1535, TA 100, TA 153T, TA 1538 and TA 98. Hence the substance cannot be classified as gene mutant in vitro.
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.
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