N,N'-dithiodi-o-phenylenedibenzamide

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The test was based on OECD Guideline for Testing of Chemicals [No.471. Bacterial Reverse Mutation Test(Ames test), July. 1997]. This final report and the original raw data were reviewed for adherence to ISO/IEC17025: 2005 General Requirements for the competence of Testing Calibration Laboratories. OECD Guideline for Testing of Chemicals (No.471. Bacterial Reverse Mutation Test(Ames test), July. 1997);State Environmental Protection Administration : The Guidelines for the Testing of Chemicals ; Ministry of Health, 2005: Technical standards for testing of chemicals .

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N,N'-dithiodi-o-phenylenedibenzamide

EC Number:

205-201-9

EC Name:

N,N'-dithiodi-o-phenylenedibenzamide

Cas Number:

135-57-9

Molecular formula:

C26H20N2O2S2

IUPAC Name:

N-{2-[(2-benzamidophenyl)disulfanyl]phenyl}benzamide

Method

Target gene:

Histidine requiring strains of salmonella typhimurium TA97, TA98, TA100 and TA102.

Species / strain

Species / strain / cell type:

S. typhimurium TA 97

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

0.5ml of S9-mixture. The used active system is a cofactor-supplemented post-mitochondrial fraction (S9-mix). The used concentrations of S9-mix are 18.5%(v/v) in final concentration.

Test concentrations with justification for top dose:

According to the preliminary experiment,which indicated that antibacterial effects were found to the tested bacteria at the concentrations of 5000 and 2500 μg/plate, this study set four lower concentrations for the tested substance, the final concentrations were 1250, 625, 312 and 156 μg/plate separately.

Controls

Controls 1

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

CAS: 26628-22-8

Controls 2

Positive controls:

yes

Positive control substance:

other: 2-aminofluorene

Remarks:

CAS: 153-78-6

Controls 3

Positive control substance:

other: fenaminosulf

Remarks:

CAS: 140-56-7

Controls 4

Positive controls:

yes

Positive control substance:

mitomycin C

Remarks:

CAS: 50-07-07

Controls 5

Positive controls:

yes

Positive control substance:

other: 1,8-dihydroxyanthraquinone

Remarks:

CAS: 117-10-2

Results and discussion

Test results

Species / strain:

S. typhimurium TA 97

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Any other information on results incl. tables

__

Results(X ±SD)

Table 1

Groups	Dosage* (μg/plate)	With or not withS9	TA97	TA98	TA100	TA102
Spontaneous reverse mutation	-	Yes	140±12	35±3	154±11	263±14
		No	153±13	37±3	181±15	291±23
Solvent control	-	Yes	157±9	36±4	152±12	280±18
		No	163±16	40±2	169±7	287±9
Test substance	1250	Yes	142±11	33±3	115±4	164±16
		No	147±7	38±2	132±8	136±14
	625	Yes	146±12	39±4	127±8	212±5
		No	141±15	36±2	145±11	157±11
	312	Yes	137±5	38±5	129±5	201±10
		No	155±6	39±2	156±15	141±19
	156	Yes	144±13	37±2	151±4	172±13
		No	151±13	35±1	140±6	138±13
Positive controls	Sodium azide (1.5μg/plate)	Yes	-	-	2286±115	-
		No	-	-	-	-
	2-Aminofluorene (10.0μg/plate)	Yes	-	-	-	-
		No	2030±88	1973±96	1758±124	-
	Fenaminosulf (50.0μg/plate)	Yes	1838±114	1764±98	-	-
		No	-	-	-	-
	Mitomycin C (4.0μg/plate)	Yes	-	-	-	1848±136
		No	-	-	-	-
	1,8-Dihydroxyanthraquinone (50.0μg/plate)	Yes	-	-	-	-
		No	-	-	-	1070±104

Note: *:According to the preliminary experiment,which indicated that antibacterial effects were found to the tested bacteria at the concentrations of 5000 and 2500μg/plate, this study set four lower concentrations for the tested substance.- means not available.

 

 

 

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

pepton 22 has been shown to be not mutagenic