2-aminobenzenesulphonic acid

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

2-aminobenzenesulphonic acid  was found to be non-genotoxic.

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:

PREINCUBATION : 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

Species / strain / cell type:

S. typhimurium TA 100

Additional strain / cell type characteristics:

not specified

Species / strain / cell type:

S. typhimurium TA 1535

Additional strain / cell type characteristics:

not specified

Species / strain / cell type:

S. typhimurium TA 98

Additional strain / cell type characteristics:

not specified

Species / strain / cell type:

S. typhimurium TA 97

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

HAMSTER, LIVER, S-9, AROCLOR 1254 (10 OR 30%)

Test concentrations with justification for top dose:

33-3333 UG/PLATE UG/PLATE

Vehicle / solvent:

DMSO

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

For strains tested with S9

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

For strains TA100 and TA1535 tested in the absence of S9

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

2-nitrofluorene

Remarks:

For strains TA98 tested in the absence of S9

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

yes

Remarks:

DMSO

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

For strains TA97 tested in the absence of S9

Details on test system and experimental conditions:

Test System : AMES SALMONELLA TYPHIMURIUM

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Species / strain:

S. typhimurium TA 97

Metabolic activation:

with and without

Genotoxicity:

negative

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: TA100

Dose	No Activation  (Negative)		No Activation  (Negative)		10% HLI  (Negative)		30% HLI  (Negative)		10% RLI  (Negative)		10% RLI  (Negative)		30% RLI  (Negative)
Protocol	Preincubation		Preincubation		Preincubation		Preincubation		Preincubation		Preincubation		Preincubation
ug/Plate	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM	Mean	± SEM
0	90	2	102	4.6	77	7.8	130	2.4	98	2.7	87	4.7	121	9
33	81	4.2	99	2	91	2.1	112	11.1	72	11.1	73	5.8	121	2.2
100	96	7.8	101	5.7	110	11	115	2	101	12.8	72	3.6	126	12.1
333	91	0.7	95	2	86	2.7	120	2.5	89	6.4	76	3.1	121	9.1
1000	80	7.3	91	7	91	2.7	112	5	84	7.3	78	2.1	116	2.3
3333	85	2.5	93	4.6	84	5.4	115	4	90	5.9	75	0.3	127	5
Positive Control	290	8.1	236	12.8	333	18.8	357	9.7	198	23.4	399	16.7

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	18	3.2	8	0.7	8	0.3	5	0	11	2	9	1.3
33	16	1.3	7	0.3	9	0.9	8	2	9	0.9	12	1.7
100	10	0.3	6	1.5	11	1.5	5	1.7	6	1	7	1.8
333	15	1.8	7	1.8	12	1.5	8	1.2	9	1.8	12	2.1
1000	16	1.2	8	1.5	11	0.9	7	0.9	8	1.8	6	1.5
3333	17	1.2	6	0.7	6	0.9	7	1	5	0.7	9	0.6
Positive Control	186	9.6	56	7.9	52c	2.5	40	4.2	39	2.9	58	3.9

S

Conclusions:

Interpretation of results (migrated information):
negative

In an Ames test , 2-aminobenzenesulphonic acid, in dimethyl sulfoxide from doses 33-3333 UG/PLATE was not mutagenic in Salmonella typhimurium strains TA100,TA1535,TA98 and TA97 with and without addition of S9 liver fractions from Aroclor induced hamsters.

Executive summary:

In an Ames test , 3-diethylaminophenol, in dimethyl sulfoxide from doses 10-666 UG/PLATE was not mutagenic in Salmonella typhimurium strains TA100,TA1535,TA97 and TA98 without metabolic activation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

Additional information from genetic toxicity in vitro:

Genetic toxicity:

No. of studies were reviewed for genetic toxicity from reliable sources having Klimisch rating 2 and 4 for target substance (2-aminobenzenesulphonic acid) and read across substances.

The summary of the results for target and read across substances are presented below

Sr.No	Endpoint	Interpretation of Results	Species/Strain	Sources
1.	In vitro Genetic toxicity	Negative with and without metabolic activation	Salmonella typhimurium strains TA100,TA1535,TA98 and TA97	Experimental data from publication of ‘Environmental and Molecular Mutagenesis’ for target CAS: 88-21-1
2.	In vitro Genetic toxicity	Negative without metabolic activation	S. typhimurium TA 1535	Predicted data from QSAR for target CAS: 88-21-1
3.	Chromosome aberration	Negative without metabolic activation	Chinese hamster Lung (CHL)	Predicted data from QSAR for target CAS: 88-21-1
4.	In vitro Genetic toxicity	Negative with metabolic activation	S. typhimurium TA 98	Experimental data from study report of ‘NATIONAL CANCER INSTITUTE ‘for read across CAS: 88-44-8
5.	Chromosome aberration	Negative with and without metabolic activation	CHL/IU cell	Experimental data from study report of ‘Toxicity Testing Reports of Environmental Chemicals’ for read across CAS: 88-44-8

 

By applying weight of evidence approach to the target substance 2-aminobenzenesulphonic acid and read across substances for Ames test and Chromosome aberration shows negative results, thus it can be concluded that the substance is non-genotoxic as per the CLP criteria.

Justification for selection of genetic toxicity endpoint

In an Ames test , 2-aminobenzenesulphonic acid, in dimethyl sulfoxide from doses 33-3333 UG/PLATE was not mutagenic in Salmonella typhimurium strains TA100,TA1535,TA98 and TA97 with and without addition of S9 liver fractions from Aroclor induced hamsters.Also the chromosome aberration is based on the prediction for in-vitro mammalian chromosome aberration test on Chinese hamster Lung (CHL) without S9 metabolic activation it was estimated that 2-aminobenzenesulphonic acid does not exhibit positive chromosomal effect.

Justification for classification or non-classification

2-aminobenzenesulphonic acid shows negative activity as is the case for Ames test and chromosome aberration thus not considered for further classification for gene toxicity as per the CLP criteria.