Reaction mass of disodium 4-amino-6-[[4-[(2,4-diaminophenyl)diazenyl]phenyl]]-3-((E)-[4-((E)-(2,4-diaminophenyl)diazenyl]phenyl )diazenyl)-5-hydroxynaphthalene-2,7-disulphonate and disodium 4-amino-6-((E)-(4-aminophenyl)diazenyl)-3-((E)-(4-((E)-(2,4-diaminophenyl)diazenyl)phenyl)diazenyl)-5-hydroxynaphthalene-2,7-disulfonate

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

other: experimentakresult on similar substance

Adequacy of study:

key study

Study period:

1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

Materials and methods

Principles of method if other than guideline:

Pre-incubation test. Screening program: strain TA98 placed in standard plates. Evaluation without metabolic activation.

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of diazotised 4,4-diaminodiphenylamine-2-sulfonic acid, subsequently coupled with 6-amino-4-hydroxynaphthalene-2-sulfonic acid, further diazotised and coupled with metaphenylendiamine, sodium salts

EC Number:

939-382-7

Molecular formula:

not applicable

IUPAC Name:

Reaction products of diazotised 4,4-diaminodiphenylamine-2-sulfonic acid, subsequently coupled with 6-amino-4-hydroxynaphthalene-2-sulfonic acid, further diazotised and coupled with metaphenylendiamine, sodium salts

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 98

Metabolic activation:

without

Metabolic activation system:

No

Test concentrations with justification for top dose:

Range 20-5000 µg/plates: 20, 100, 500, 2500, 5000 µg/plate

Controls

Untreated negative controls:

yes

Remarks:

DMSO

Positive controls:

yes

Remarks:

NPD

Results and discussion

Test results

Species / strain:

S. typhimurium TA 98

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

True negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: 2500-5000 µg/plate

Any other information on results incl. tables

	Revertant/plate			Quotient
Dose µg/plate	- S9	M	DS	-S9
Negative control	29 29 18	25	6	1.0
20	19 13 24	19	6	0.7
100	26 26 26	26	0	1.0
500	31 29 28	29	2	1.2
2500	31 30 24	28	4	1.1
5000	32 31 33	32	1	1.3
Positive control	608 572 666	615	47	24.3

Applicant's summary and conclusion

Conclusions:

Negative

Executive summary:

Non mutagen; no increase of revertants has been observed.