4,4'-oxydi(benzenesulphonohydrazide)

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

Study period:

1999

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study was performed in accordance with the OECD guideline 471 and the GLP standard.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

not specified

Principles of method if other than guideline:

NA

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

4,4'-oxydi(benzenesulphonohydrazide)

EC Number:

201-286-1

EC Name:

4,4'-oxydi(benzenesulphonohydrazide)

Cas Number:

80-51-3

Molecular formula:

C12H14N4O5S2

IUPAC Name:

4-[4-(hydrazinesulfonyl)phenoxy]benzene-1-sulfonohydrazide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name of test material (as cited in study report):4,4'-Oxybis(benzenesulfonyl hydrazide)
- Analytical purity: no data
- Purity test date: > 99%
- Lot/batch No.: no data

Method

Target gene:

no data

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Details on mammalian cell type (if applicable):

NA

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

Male rat, liver, S9 mix induced with Aroclor 1254

Test concentrations with justification for top dose:

11.1, 33.3, 100, 300, 1,000, and 3,000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: no data

Controls

Untreated negative controls:

yes

Remarks:

solvent

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

2-nitrofluorene

sodium azide

other: 4-nitroquinoline and 2-aminoanthracene

Details on test system and experimental conditions:

Description of follow up repeat study: Dose range finding experiment was carried out using dose levels with 5-fold intervals of 1.6, 8, 40, 200, 1,000, and 5,000 µg/plate both in the absence and in the presence of metabolic activation system.

Evaluation criteria:

The number of revertant colonies increased significantly in at least one strain at one or more concentrations or the data set showed a dose related correlation.

Statistics:

no data

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 98

Metabolic activation:

without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 3000 µg/plate

Test results 2

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Test results 3

Species / strain:

S. typhimurium TA 100

Metabolic activation:

without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 3000 µg/plate

Test results 4

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Test results 5

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

at 3000 µg/plate

Test results 6

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Test results 7

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

above 300 µg/plate

Test results 8

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Test results 9

Species / strain:

E. coli WP2 uvr A

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Additional information on results:

none

Any other information on results incl. tables

Table.Result of bacterial reverse mutation assay with4,4’-oxybis(benzenesulfonyl hydrazide)

Tester strain	Chemical treated	Dose (mg/plate)	Colonies/plate (mean±SD)
			without S9 mix	with S9 mix
TA 98	Test item	0	31±1	32±3
		11.1	20±6	29±3
		33.3	24±5	35±2
		100	34±3	40±6
		300	101±2	30±10
		1,000	305±74^1	44±4
		3,000	0±0^4	41±9
TA 100	Test item	0	100±16	113±0
		11.1	189±83	169±16
		33.3	219±7	269±12
		100	315±13	439±18
		300	349±1	438±68
		1,000	302±12	318±8
		3,000	0±0^4	349±8
TA 1535	Test item	0	10±0	8±4
		11.1	73±8	120±10
		33.3	118±3	295±13
		100	243±2	437±61
		300	187±20	320±61
		1,000	12±3^2	259±15
		3,000	0±0^4	449±47
TA 1537	Test item	0	14±3	16±1
		11.1	24±2	13±4
		33.3	18±1	17±1
		100	12±6	17±0
		300	-  ^3	18±4
		1,000	-  ^3	24±1
		3,000	0±0^4	16±4
E. coli WP2uvrA	Test item	0	15±1	15±2
		11.1	12±1	21±1
		33.3	13±6	15±6
		100	22±4	13±1
		300	19±1	15±3
		1,000	22±6	15±3
		3,000	13±2	22±2
Positive control
TA 98	2-NF	1.0	209±1
	2-AA	2.0		550±88
TA 100	SA	0.5	502±62
	2-AA	2.0		699±13
TA 1535	SA	0.5	251±24
	2-AA	5.0		131±9
TA 1537	9-AA	50.0	355±8
	2-AA	5.0		259±39
WP2uvrA	4-NQ	2.0	926±86
	2-AA	10		297±115

¹;Colony counting and slight thin lawn, some very slight toxicity                                                                   

²;Colony counting and thin lawn but microcolonies still evident

³;No colony count and thin lawn and probably macroscopic colonies grown from microcolonies

⁴;Complete killing

2-NF; 2-Nitrofluorene, 2-AA; 2-Aminoanthracene, SA; Sodium azide, 9-AA; 9-Aminoacridine, 4-NQ; 4-Nitroquinoline

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
positive

OBSH showed mutagenic effects in Salmonella typhimurium TA 98, TA 100, and TA 1535 without metabolic activation and in Salmonella typhimurium TA 100 and TA 1535 with metabolic activation system.

Executive summary:

The genetic toxicity in vitro of OBSH was evaluation in a bacterial reverse mutation assay. The study was performed in accordance with the OECD guideline 471. OBSH showed mutagenic effects in Salmonella typhimurium TA 98, TA 100, and TA 1535 without metabolic activation and in Salmonella typhimurium TA 100 and TA 1535 with metabolic activation system.