4-amino-5-hydroxynaphthalene-1,7-disulphonic acid

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:

weight of evidence

Reliability:

2 (reliable with restrictions)

Data source

Reference

Reference 1

Reference Type:

publication

Title:

The Ames Salmonella/microsome mutagenicity assay

Author:

Mortelmans K, Zeiger E.

Year:

2000

Bibliographic source:

The Ames Salmonella/microsome mutagenicity assay. Mutat Res. 2000 Nov 20;455(1-2):29-60

Reference 2

Reference Type:

other: Authoritative data base

Title:

Study ID: 941907

Author:

NTP database

Year:

2012

Bibliographic source:

NTP (National Toxicological Program)by Mortelmans K, Zeiger E. The Ames Salmonella/microsome mutagenicity assay. Mutat Res. 2000 Nov 20;455(1-2):29-60

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other:

Principles of method if other than guideline:

In the standard protocol (preincubation) for conducting the Ames assay, a test tube containing a suspension of one strain of Salmonella typhimurium (or E. coli) plus S9 mix or plain buffer without S9, is incubated for 20 minutes at 37º C with the test chemical. Control cultures, with all the same ingredients except the test chemical, are also incubated. In addition, positive control cultures are prepared; these contain the particular bacterial tester strain under investigation, the various culture ingredients, and a known potent mutagen*. After 20 minutes, agar is added to the cultures and the contents of the tubes are thoroughly mixed and poured onto the surface of Petri dishes containing standard bacterial culture medium. The plates are incubated, and bacterial colonies that do not require an excess of supplemental histidine appear and grow. These colonies are comprised of bacteria that have undergone reverse mutation to restore function of the histidine-manufacturing gene. The number of colonies is usually counted after 2 days.

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

3-amino-4-hydroxybenzenesulphonic acid

EC Number:

202-662-8

EC Name:

3-amino-4-hydroxybenzenesulphonic acid

Cas Number:

98-37-3

Molecular formula:

C6H7NO4S

IUPAC Name:

3-amino-4-hydroxybenzenesulfonic acid

Test material form:

solid: crystalline

Details on test material:

- Name of test material : 3-amino-4-hydroxybenzenesulphonic acid
-Substance type-organic
-physical state-crystalline solid.

Method

Target gene:

Histidine manufacturing gene

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535

Additional strain / cell type characteristics:

other: All the bacterial strains used in the Ames test carry a defective (mutant) gene that prevents them from synthesizing the essential amino acid histidine from the ingredients in standard bacterial culture medium

Metabolic activation:

with and without

Metabolic activation system:

S9

Test concentrations with justification for top dose:

0 - 2000 ug/Plate

Vehicle / solvent:

No data

Controls

Controls 1

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

Dimethyl Sulfoxide

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

with

Controls 2

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

Dimethyl Sulfoxide

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

without

Details on test system and experimental conditions:

No data

Evaluation criteria:

No data

Statistics:

No data

Results and discussion

Test results

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

10% RLI = induced male Sprague Dawley rat liver S9 ; 10% HLI = induced male Syrian hamster liver S9

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

No data

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

Strain: TA1535

Dose	No Activation (Negative)		No Activation (Negative)		10% HLI (Negative)		30% HLI (Negative)		10% RLI (Negative)		30% RLI (Negative)
Protocol	Preincubation		Preincubation		Preincubation		Preincubation		Preincubation		Preincubation
ug/Plate	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM
0	13	2.1	26	4.1	6	1.7	15	0.3	8	0.7	13	2.6
33	10	1.7	22	4.1	6	1.2	13	2.3	6	1.5	13	2.2
100	11	1.2	29	3.2	8	0.6	8	1.7	5	1.2	15	1.5
333	11	1.8	26	3.3	9	1.2	15	1.9	11	4.2	16	2.3
1000	12	2.5	22	4.4	9	0.9	13	1.5	7	2.1	16	2.3
2000	14	1.5	25	0.9	11	2.9	9	2.4	7	2.7	8	2.3
Positive Control	112	8.7	142	1.7	55	2.9	58	3.2	164	7.8	68	7.6

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Genetic toxicity in vitro for 3-amino-4-hydroxybenzenesulphonic acid in S. typhimurium TA 1535 is found to be negative at dose concentration of 0 - 2000 ug/Plate with and without metabolic activation

Executive summary:

Gene mutation toxicity study was performed to evaluate the mutagenic nature of the test compound 3-amino-4-hydroxybenzene sulphonic acid (RA CAS no 98 -37 -3). Genetic toxicity in vitro for 3-amino-4-hydroxybenzene sulphonic acid in S. typhimurium TA 1535 is found to be negative at dose concentration of 0 - 2000 ug/Plate with and without metabolic activation and hence is likely to be not classified for gene mutation in vitro..