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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:
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.

Justification for classification or non-classification