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EC number: 204-486-7 | CAS number: 121-61-9
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Experimental study was conducted by Punya Temcharoenet al. (Mutation Research, 1994) for target chemical N4-acetylsulfanilamide (121-61-9) to evaluate its mutagenic potential. N4-acetylsulfanilamide were tested by using preincubation method for their mutagenic potential in the Salmonella typhimurium strains TA98 and TA100at concentration0.00, 1, 4 and 8 mg/plate. The substance was tested, with and without metabolic activation. DMSO was used as negative control. Sodium azide and 4NQO used as positive control for TA100 and TA98 respectively with metabolic activation and AFB (0.003 µ/plate) for both TA100 and TA98 without metabolic activation. A number of revertant colonies in treated cultures greater than 2 times the solvent control revertant colonies is considered a positive response. But there was no increase in revertant colonies in test substance, when compare to solvent control. Therefore, the substanceN4-acetylsulfanilamide was considered to be not mutagenic in S. typhimurium strains TA98 and TA100. Hence the substance cannot be classified as gene mutant in vitro.
Link to relevant study records
- 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:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Data is from publication.
- Qualifier:
- according to guideline
- Guideline:
- other: As mention below
- Principles of method if other than guideline:
- Evaluate mutagenicity effect of substance N4-acetylsulfanilamide in S. typhimurium strains TA98 and TA100 by using Ames test.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- - Name of test material : N-(4-sulfamoylphenyl) acetamide
- Molecular formula : C8H10N2O3S
- Molecular weight : 214.244 g/mol
- Smiles notation : c1(ccc(NC(C)=O)cc1)S(N)(=O)=O
- InChl : 1S/C8H10N2O3S/c1-6(11)10-7-2-4-8(5-3-7)14(9,12)13/h2-5H,1H3,(H,10,11)(H2,9,12,13)
- Substance type: Organic
- Physical state: Solid - Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium, other: strains TA98 and TA100
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 metabolic activation
- Test concentrations with justification for top dose:
- 0.00, 1, 4 and 8 mg/plate
- Vehicle / solvent:
- DMSO
- Untreated negative controls:
- yes
- Remarks:
- DMSO
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: Without metabolic activation: sodium azide (0.5 µg/plate) and 4NQO (0.5 µg/plate) for TA100 and TA98 With metabolic activation: AFB (0.003 µ/plate) for both TA100 and TA98
- Details on test system and experimental conditions:
- Details on test system and conditions
METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: Triplicate - Rationale for test conditions:
- Not specified
- Evaluation criteria:
- A number of revertant colonies in treated cultures greater than 2 times the solvent control revertant colonies is considered a positive response.
- Statistics:
- Not
- Key result
- Species / strain:
- S. typhimurium, other: strains TA98 and TA100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: No mutagenic effect were observed.
- Conclusions:
- The substance N4-acetylsulfanilamide (121-61-9) was considered to be not mutagenic in S. typhimurium strains TA98 and TA100 by AMES test .
- Executive summary:
N4-acetylsulfanilamidewere tested by using preincubation method for their mutagenic potential in theS. typhimurium strains TA98 and TA100at concentration0.00, 1, 4 and 8 mg/plate. The substance was tested , with and without metabolic activation. DMSO was used as negative control.Sodium azide and 4NQO used as positive control for TA100 and TA98 respectively with metabolic activation and AFB (0.003 µ/plate) for both TA100 and TA98 without metabolic activation.A number of revertant coloniesin treated cultures greater than 2 times the solventcontrol revertant colonies is considered apositive response. But there was no increase in revertant colonies in test substance, when compare to solvent control. Therefore, the substanceN4-acetylsulfanilamide was considered to be not mutagenic in S. typhimurium strains TA98 and TA100. Hence the substance cannot be classified as gene mutant in vitro.
Reference
Mutagenic effect of seven newly synthsized sulfa drugs on S. typhimurium TA98 and TA100 using the ames test (preincubation method)
Compound |
Amount (mg/ plate) |
Number of his revertant colonies / plate |
|||
N4- Acetylsulfanilamide |
-S9 |
+S9 |
-S9 |
+S9 |
|
|
TA 98 |
TA 100 |
|||
0.00 |
33 |
43 |
146 |
138 |
|
1.00 |
38 |
44 |
133 |
134 |
|
4.00 |
36 |
42 |
136 |
134 |
|
8.00 |
32 |
39 |
134 |
138 |
|
Positive control (tz g /plate)
|
|||||
Sodium azide
|
0.5 |
ND |
ND |
942 |
ND |
4NQO
|
0.5 |
427 |
ND |
ND |
ND |
AFB
|
0.003 |
NDND254 ND 859 |
254 |
ND |
859 |
This concentration is the maximum solubility. ND, not detected; k – Killing effect
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Various publications and prediction model were reviewed to determine the mutagenic nature of N4-acetylsulfanilamide (121-61-9). The studies are as mentioned below:
Experimental study was conducted by Punya Temcharoenet al. (Mutation Research, 1994) for target chemical N4-acetylsulfanilamide (121-61-9) to evaluate its mutagenic potential. N4-acetylsulfanilamide were tested by using preincubation method for their mutagenic potential in the Salmonella typhimurium strains TA98 and TA100at concentration0.00, 1, 4 and 8 mg/plate. The substance was tested, with and without metabolic activation. DMSO was used as negative control. Sodium azide and 4NQO used as positive control for TA100 and TA98 respectively with metabolic activation and AFB (0.003 µ/plate) for both TA100 and TA98 without metabolic activation. A number of revertant colonies in treated cultures greater than 2 times the solvent control revertant colonies is considered a positive response. But there was no increase in revertant colonies in test substance, when compare to solvent control. Therefore, the substanceN4-acetylsulfanilamide was considered to be not mutagenic in S. typhimurium strains TA98 and TA100. Hence the substance cannot be classified as gene mutant in vitro.
Gene mutation toxicity was predicted for N-(4-sulfamoylphenyl)acetamide (121 -61 -9)using the battery approach from Danish QSAR database (2017). The study assumed the use of Salmonella typhimurium bacteria in the Ames test. The end point for gene mutation has been modeled in the Danish QSAR using the three software systems Leadscope, CASE Ultra and SciQSAR. Based on predictions from these three systems, a fourth and overall battery prediction is made. The battery prediction is made using the so called Battery algorithm. With the battery approach it is in many cases possible to reduce “noise” from the individual model estimates and thereby improve accuracy and/or broaden the applicability domain. Gene mutation toxicity study as predicted by Danish QSAR for N-(4-sulfamoylphenyl)acetamide is negative and hence the chemical is predicted to not classify as a gene mutant in vitro.
In a study for structurally and functionally similar read across chemical, Gene mutation toxicity study was performed by Errol Zeiger et al.( Environmental Mutagenesis,1987) to determine the mutagenic nature of pyrazine-2-carboxamide (RA CAS no98-96-4). The read across substances share high similarity in structure and log kow .Therefore, it is acceptable to derive information on mutation from the analogue substance. Mutagenicity effect of Pyrazinamide was evaluated in Salmonella typhimurium. Salmonella typhimurium strains TA100, TA1535, TA1537, TA98 were used in the study. Mutagenic assay was performed by preincubationmethod. The assay performed in presence and absence pf metabolic activator i.e. Aroclor 1254-induced rat liver S-9 and Aroclor 1254-induced hamster liver S-9.DMSO was used as solvent for test substance.The test chemical, Salmonella culture and S-9 mix or buffer incubated at 37 °C for 20 min without shaking. Agar was added on plate, content of tubes were mixed poured on surface of petri dish that contain Vogel Bonner medium. The mutant colonies on plates were counted after 2 days post incubation. Doses of test substance 0, 100, 333, 1000, 3333, 10000 ug/plate were tested in triplicate. Experiments were repeated 1 week following of initial trial. Sodium azide was used as positive control substance in absence of metabolic activation for strains TA100, TA1535. 9-aminocaridine and 4-nitro-o-phenylenediamine were positive control in absence of metabolic activation for strains TA1537 and TA98 respectively. The positive control with metabolic activation for all strains was 2-aminoanthracene. In results of study, there was no increase in dose related mean number of revertant colonies compared to solvent control across all strains.Therefore, Pyrazinamide was not mutagenic in bacteria Salmonella typhimurium. Hence Pyrazinamide not likely to be classified as gene mutation in vitro.
In a study for structurally and functionally similar read across chemical, Gene mutation toxicity study was performed by Jean-Luc Garrigue et al.( Mutation Research, 2006) to determine the mutagenic nature ofN-(4-acetamidophenyl)acetamide ( 140-50-1). The read across substances share high similarity in structure and log kow .Therefore, it is acceptable to derive information on mutation from the analogue substance. Gene mutation toxicity study was performed to determine the mutagenic nature of N,N- diacetyl-para-phenylenediamine. The study was performed using Salmonella typhimurium strainsTA98, TA100, TA1535, TA1537 and TA102 in the absence of S9 metabolic activation system. The chemical was dissolved in DMSO as solvent and used at dose levels 1.6 to 5000µg/plate in experiment 1 by the plate incorporation method and at a narrow dose range of 156.3 – 5000µg/plate in experiment 2 by the preincubation method. Concurrent solvent and positive control chemicals were also included in the study. N,N- diacetyl-para-phenylenediaminedid not induce mutation in Salmonella typhimuriumTA98, TA100, TA1535, TA1537 and TA102 in the absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.
Based on the data available for the target chemical and its read across substance N4-acetylsulfanilamide (121-61-9) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.
Justification for classification or non-classification
Thus based on the above annotation and CLP criteria on the data available for the target chemical . N4-acetylsulfanilamide (121-61-9) does not exhibit gene mutation in vitro. Hence the test chemical is not likely to classify as a gene mutant in vitro.
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