3-amino-4-hydroxybenzenesulphonic acid

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The substance 3-amino-4-hydroxybenzenesulphonic acid was found to be non mutagenic.

Link to relevant study records

Reference

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)

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

Target gene:

Histidine manufacturing gene

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

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

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

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

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

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

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:

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

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.Other Weight of evidence studies also shows negative result as shown below:

Sr. No	Test name	Species	Metabolic activation	Result
1.	Ames test	S. typhimurium TA 1535	With and without	Negative
2	Ames test	S. typhimurium TA 98	With and without	Negative
3	Ames test	S. typhimurium TA 100	with	Negative
4	Ames test	S. typhimurium TA 1535	without	Negative
5	chromosome aberration	Chinese hamster Lung (CHL)	without	Negative
6	DNA damage and repair assay	Rat hepatocytes	-	Negative

Thus considering the above results, the substance3-amino-4-hydroxybenzenesulphonic acid was found to be non mutagenic.

Justification for selection of genetic toxicity endpoint
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.