4'-sulphamoylacetanilide

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:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Justification for type of information:

Data is from publication.

Data source

Reference

Reference Type:

publication

Title:

Mutagenic activity of newly synthesized sulfa drugs to Salmonella typhimurium

Author:

Punya Temcharoen, Suwanna Nerapattanakid, Chaivat Toskulkao, Thirayudh Glinsukon, Chitkawee Paovaro, Somsak Ruchirawat

Year:

1994

Bibliographic source:

Mutation Research 321 (1994) 187- 195

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

4'-sulphamoylacetanilide

EC Number:

204-486-7

EC Name:

4'-sulphamoylacetanilide

Cas Number:

121-61-9

Molecular formula:

C8H10N2O3S

IUPAC Name:

4'-sulphamoylacetanilide

Test material form:

solid

Details on test material:

- 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

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

Method

Target gene:

Histidine

Species / strain

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

Controls

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

Results and discussion

Test results

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.

Any other information on results incl. tables

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
N^4- 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

Applicant's summary and conclusion

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.