3-aminobenzenesulphonic acid

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Genetic toxicity in vitro:

- Ames (NIHSJapan2008) -> negativ

- Chromosome abberation(CHO(V79 cells)) (Morita_2012) ->positiv

Link to relevant study records

Reference

Reference 1

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study, published in peer reviewed literature, minor restrictions in design and/or reporting but otherwise adequate for assessment

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

Principles of method if other than guideline:

The main study was conducted in accordance with “Methods of Testing New Chemical Substances” (Kanpogyo No. 237, Yakuhatsu No. 306, and 62 Kikyoku No. 303 Notifications dated March 31, 1987) and OECD Guidelines for the Testing of Chemicals 471 and 472, and based on chemical substance GLP (Kanpogyo No. 39, Yakuhatsu No. 229, and 59 Kikyoku No. 85 Notifications dated March 31, 1984, and Kankiken No. 233, Eisei No. 38, and 63 Kikyoku No. 823 Notifications revised on November 18, 1988).

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Species / strain / cell type:

E. coli WP2 uvr A

Metabolic activation:

with and without

Metabolic activation system:

S-9: Rat liver, induced with phenobarbital and 5,6-benzoflavone

Test concentrations with justification for top dose:

0, 312.5, 625, 1250,2500, 5000 µg/plate

Vehicle / solvent:

DMSO

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: 2-aminoanthracene

Remarks:

Strain TA100, TA1535, TA98, TA1537, E. coli WP2 uvrA, with metabolic activation

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

9-aminoacridine

Remarks:

Strain TA 1537 without metabolic activation

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

sodium azide

Remarks:

Strain TA1535 without metabolic activation

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: AF-2

Remarks:

Strain TA100, WP2, TA98, without metabolic activation

Details on test system and experimental conditions:

Procedures: Plate incorporation method
Plates/test: 3
Number of replicates: 2

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Species / strain:

S. typhimurium TA 1537

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Species / strain:

E. coli WP2

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Additional information on results:

No toxicity was observed up to a concentration of 5000 µg/plate with or without metabolic activation.

Conclusions:

Gentoxicity: negative

Executive summary:

A bacterial reverse mutation study was conducted to investigate whether or not 3‑aminobenzenesulfonic acid is mutagenic. Using Salmonella typhimurium TA100, TA1535, TA98 and TA1537, and Escherichia coli WP2 uvrA strains as test bacteria, the dose-setting study and the main study were both conducted by the direct method and by the metabolic activation method, using 50-5000 mg/plate in the dose-setting study and 312.5-5000 mg/plate in the main study. The results revealed no increase in the number of revertant colonies in any of the five strains of test bacteria used, at any dose, in either of the two runs of the main study, and so 3‑aminobenzenesulfonic acid was judged not to be mutagenic in the study system used.

Reference 2

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant guideline study, published in peer reviewed literature, minor restrictions in design and/or reporting but otherwise adequate for assessment

Qualifier:

according to guideline

Guideline:

JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals

GLP compliance:

yes

Type of assay:

in vitro mammalian chromosome aberration test

Species / strain / cell type:

Chinese hamster lung fibroblasts (V79)

Details on mammalian cell type (if applicable):

CHL/IU cells used were obtained from Japanese Cancer Research Resources Bank (JCRB).

Metabolic activation:

with and without

Metabolic activation system:

S-9: Rat liver, induced with phenobarbital and 5,6-benzoflavone

Test concentrations with justification for top dose:

-S9 (continuous treatment; 23 and 48 hours): 0, 0.43, 0.85, 1.70 mg/mL
-S9 (short-term treatment; 6- (18) hours): 0, 0.41, 0.83, 1.1, 1.65, 2.2, 4.4 mg/mL
+S9 (short-term treatment; 6- (18) hours): 0, 0.41, 0.83, 1.1, 1.65, 2.2, 4.4 mg/mL

Vehicle / solvent:

0.5% Carboxymethyl cellulose sodium

Untreated negative controls:

yes

Remarks:

At test concentrations 1.1, 2.2, 4.4 without metabolic activation

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

cyclophosphamide

Remarks:

With and without metabolic activation

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

yes

Positive control substance:

mitomycin C

Remarks:

Without metabolic activation

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium

Plates/test: 2

DURATION
- Preincubation period:
CHL/IU cells used were obtained from Japanese Cancer Research Resources Bank (JCRB). The cells were cultured with Eagle’ s minimum essential medium MEM, Nissui Pharmaceutical, Tokyo, Japan) supplemented with 10% fetal calf serum or calf serum. The 2 x 10^4 cells were plated in 5 mL medium on 60 mm plate and cultured for 72 h at 37°C in a humidified incubator (5% CO2) before the treatment with the test substance.

Chemical treatment:
In order to examine the metabolic activation of the test substance, the proliferating cells were treated with the test substance for 6 h in serum-free MEM with S9 mix (S9(+)), or without S9 mix (S9(-)), then cultured a further 18 h in the fresh MEM with serum. S9 (Kikkoman, Chiba, Japan) and co-factors were mixed immediately before use, then applied to cultures to expose the cells to the S9 at 5% (v/v). Moreover, the cells were also treated with the test substance for 24 and 48 h continuously in the absence of S9 mix. Duplicate cultures were used for each dose.

Growth inhibition test for cytotoxicity evaluation:
Preliminary growth inhibition test was conducted to determine the cytotoxicity of the test substance. Relative cell confluence or cell number to solvent control was measured with a MonocellaterTM (Olympus Optics, Tokyo, Japan) or a Coulter CounterTM (Coulter Electronics, Bedfordshire, UK), respectively. Relative metaphase frequency (relative mitotic index) to the solvent control was also used as an indicator of cytotoxicity when appropriate. A maximum dose was set for the chromosomal aberration test at 50% or more of the cytotoxic dose determined by the growth inhibition test. When cytotoxicity was 50% or less, 5 mg/mL or 10mM was set as the maximum dose. The other doses were sequential half dilutions.

Chromosome preparation:
Before harvesting, the cells were treated with 0.1 µg/mL of colcemid for 2h, then chromosome specimens were made by the usual air-dry method.

Chromosome analysis:
Chromosome specimens were stained with 3% Giemsa solution for 8 min. The number of cells with chromatid- and chromosome-type breaks and exchanges were scored per 200 cells at each dose. Polyploid cells were also scored per 800 cells at each dose. A polyploid cell was defined as a metaphase with more than 37 chromosomes, i.e. theoretical “hypertriploid cell", containing approximately three times the number of chromosomes than half the modal chromosome number (25) in CHL/IU cells.

Evaluation criteria:

An experiment was classified as(a) positive (+): ≥10% cells with CAs; (b) equivocal (?): ≥ 5 - 10 % cells with CAs, or (c) negative (-): less than 5% cells with CAs.Chemicals showing atleast one positive or equivocal experiment were considered positive or equivocal compound, respectively, in the original report. Statistical significance, reproducibility, culture conditions,or concentration relationship of the response were taken into consideration in some cases. Basically, calls of the classification of a chemical was based on the original calls. However, there are some exceptions to this analysis. lf a chemical was classified equivocal in the original "call" and showed a reproducibility and/or concentration-related response with statistical significance, the chemical was considered positive.
Chemicals that show negative and/or equivocal (without reproducibility or concentration-related response) results were also considered as negative compounds. The percentages of cells with CAs refer to structural aberrations and do not include polyploidy.

Species / strain:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

with

Genotoxicity:

positive

Remarks:

short-term treatment: 0.41 and 0.83 mg/mL (clastogenicity)

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Species / strain:

Chinese hamster lung fibroblasts (V79)

Metabolic activation:

without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Additional information on results:

For the test substance tested for 6 h with metabolic activation, the color of the culture medium shifted from orange or red (pH 7-8) to yellow (pH<6) just after applying the treatment solution, suggesting that CA was generated by the non-physiological culture conditions. Culture medium with low pH (pH<6.4) was known to induce structural CA in CHL/IU cells, but it could not be assumed without confirmation that structural CA in the current tests were caused by lowering pH.

At the concentration of 0.41 mg/mL and 0.83 mg/mL short-term treatments with S9 mix resulted in 6.5% and 17% of the cells, respectively demonstrating structural aberrations (including gaps). However, it was suggested that acidic pH may have been related to the induction of chromosomal aberration.
Lowest concentration producing cytogenetic effects in vitro:
without metabolic activation (continuous treatment ): > 1.70 mg/mL
without metabolic activation (short-term treatment): > 4.4 mg/mL
with metabolic activation (short-term treatment): 0.41 mg/mL (clastogenicity)

Genotoxic effects:
without metabolic activation: clastogenicity (-); polyploidy (-)
with metabolic activation: clastogenicity (+); polyploidy(-)

Conclusions:

Gentoxicity (chinese hamster lung fibroblasts(V/79): Result is positive (with metabolic acitvation) and negativ (without metabolic activation).

Executive summary:

Results described by Morita T., et al.
3-Aminobezenesulfonic acid induced CAs with S9 mix (5.0 and 16.5% at 2.4 and 4.8 mM (0.83 mg/mL), respectively). The pH of the medium was 5.8 or 6.3 at the beginning of the 6-h treatment and 6.2 or 6.5 just after it at 4.8 or 2.4 mM. respectively. Relative cell growth, as measured by monolayer confluence, was about 100% or 90% at 4.8 or 9.5 mM, respectively. However, there were no metaphases at 9.5 mM. Without S9 mix, no CA induction was observed after 6- or 24-h treatment. The reason for this will be due to the short duration in Iow pH culture condition: the pH of the medium without S9 mix was 5.8 or 6.5 at the beginning of the 6-h treatment and 6.6 or 6.9 just after it at 4.8 or 2.4 mM, respectively. Initial pHs of the medium were similar, but the pHs after the treatment without S9 mix were higher than that with S9 mix. The window of the induction of CAs by Iow pH is narrower without S9 mix than that with S9 mix, generally. 3-Aminobenzenesulfonic acid does not possess any DEREK structural alerts. The CAs observed are considered as irrelevant as they were only seen at low pH. and it is supported by all other available data. Thus the Ievel of concern is negligible.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (positive)

Genetic toxicity in vivo

Description of key information

Gentic toxicity in vivo:

- MNT (OECD 474) (BioZoResCent(Japan)) -> negativ

Link to relevant study records

Reference

Endpoint:

in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011 - 2012

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)

GLP compliance:

yes

Type of assay:

mammalian erythrocyte micronucleus test

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material: 45JPG

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
The test substance was analyzed by the study consignee on completion of the animal study, and was confirmed as having been stable throughout the period of the animal study
- Storage condition of test material: Cool dark place (measured value: 2-8°C), tightly sealed

Species:

mouse

Strain:

CD-1

Details on species / strain selection:

SPF mice [Crlj:CD1(ICR), Atsugi Breeding Center, Charles River Laboratories Japan, Inc.]

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Institute of Cancer Research
- Age at study initiation: 7 weeks
- Weight at study initiation: 35.8-41.6 g for the males and 28.7-32.2 g for the females
- Assigned to test groups randomly: [no/yes, under following basis: ] yes
- Housing: The animals were housed individually in plastic cages (W 155  D 245  H 150 mm Clea Japan Inc.) provided with floor covering (white flake, Charles River Laboratories Japan), in an animal rearing room (Rearing Room Number: Room 101 for preliminary study,
- Diet (e.g. ad libitum): . Solid feed CRF-1 (Oriental Yeast )Co., Lot No. 110908
- Water (e.g. ad libitum): drinking water (Gotemba City tap water, using water bottles)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): (acceptable range 50±20%) 46-56% for the preliminary study and 42-55% for the main study
- Air changes (per hr): 10-15 times per hour
- Photoperiod (hrs dark / hrs light): 12 hours a day (07:00-19:00)/12 hours dark (19:00-7:00)

Route of administration:

oral: unspecified

Vehicle:

Sodium carboxymethylcellulose

Dose / conc.:

250 mg/kg bw/day (nominal)

Dose / conc.:

500 mg/kg bw/day (nominal)

Dose / conc.:

1 000 mg/kg bw/day (nominal)

Dose / conc.:

2 000 mg/kg bw/day (nominal)

Key result

Sex:

male/female

Genotoxicity:

negative

Toxicity:

no effects

Negative controls validity:

valid

Positive controls validity:

valid

Conclusions:

3-Aminobenzenesulfonic acid was administered at 250, 500, 1000 and 2000 mg/kg/day.. On observation of the general condition, colored urine (orange-yellow) was observed in all males and females in each test substance administration group. There were no deaths. No decrease in body weight related to test substance administration was observed. There were no observed changes in general condition in the negative control group or in the positive control group. There were no observed abnormalities in body weight variation in any test substance administration group compared to the negative control group. There were no observed abnormalities in body weight variation in the positive control group. In the test substance administration groups, the MNPCE frequency was 0.12 ± 0.08% in the 500 mg/kg/day group, 0.14 ± 0.11% in the 1000 mg/kg/day group and 0.11 ± 0.04% in the 2000 mg/kg/day group. Comparing these values with the negative control group of 0.11 ±0.05%, no statistically significant increase or dose dependent change was observed in any of the test substance administration groups. There were no statistically significant (p<0.05) changes in the PCE frequency in 200 total erythrocytes in any test substance administration group compared to the negative control group. The MNPCE frequency in the positive control group was markedly higher than in the negative control group. Furthermore, the MNPCE frequencies in the negative control group and the positive control group were within the range of mean ± 3 S.D. of the study laboratory background data.

Executive summary:

A micronucleus study was conducted using Crlj:CD1(ICR) SPF mice, in order to investigate whether or not 3-aminobenzenesulfonic acid induces chromosomal aberration. In the preliminary study for determining the doses, 250, 500, 1000 and 2000 mg/kg/day,respectively, was administered orally twice at an interval of about 24 hours, to 3 males and 3 females in each group; observation of general condition revealed that, as a result, all males and females in each test substance administration group exhibited colored urine (orange-yellow). There were no deaths. There were no decreases in body weight relating to test substance administration. Based on the above results, there were no deaths in the preliminary study wherein the maximum dose was 2000 mg/kg/day, and so in the main study, 2000 mg/kg/day was set as the high dose, and this was divided by a common ratio of 2 to give doses of 1000 and 500 mg/kg/day; these doses were administered orally twice at an interval of about 24 hours. Bone marrow smear samples were produced and observed about 24 hours after the second administration. Moreover, a negative control group and a positive control group were established; the negative control group received aqueous 0.5% CMC-Na solution at the same administration frequency as in the test substance administration group, and the positive control received a single administration of 1 mg/kg mitomycin C, and at the prescribed time after administration, bone marrow smear samples were prepared and observed. Five male animals were used per group. The results revealed no statistically significant increase in MNPCE frequency in any test substance administration group compared to the negative control group, and no dose-dependent changes were observed. Furthermore, there was no statistically significant change in the PCE frequency in 200 total erythrocytes in any test substance administration group compared to the negative control group. The MNPCE frequencies in the negative control and positive control groups were within the range of mean ± 3 S.D. of the study laboratory background data, and so the test was thought to have been conducted appropriately. It was judged from the above results that, under the conditions of this study, 3-aminobenzenesulfonic acid does not induce chromosomal aberration in the bone marrow of Crlj:CD1(ICR) SPF mice.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

In a GLP complaint study according to the Japanese Guidelines for Screening Mutagenicity Testing of Chemicals, 3-aminobenzenesulfonic acid was investigated using the Salmonella/microsome test for point mutagenic effects in doses of up to 5000 µg per plate with five S.typhimurium TA100, TA1535, TA98, TA1537, E. coli WP2 uvrA  test species. No toxicity was observed up to a concentration of 5000 µg/plate with or without metabolic activation.

 

In a GLP compliant study performed according to OECD 471, 3-aminobenzenesulfonic acid was investigated using the Salmonella/microsome test for point mutagenic effects in doses of up to 5000 µg per plate en four Salmonella typhimurium LT2 mutants (Bayer AG 1992). These comprised the histidine-auxotrophic strains TA 1535, TA 100, TA 1537 and TA 98. Doses of up to and including 200 μg per plate did not cause any bacteriotoxic effects: Total bacteria counts remained unchanged and no inhibition of growth was observed. At higher doses, the substance had a weak strain-specific bacteriotoxic effect, so that this range could nevertheless be used for assessment purposes.

 

In a GLP complaint study according to the Japanese Guidelines for Screening Mutagenicity Testing of Chemicals, 3-aminobenzenesulfonic acid was tested in the in vitro chromosomal aberration test in Chinese hamser CHL/IU cells (NIHS 2008, Morita 2012, Kusakabe 2002). In order to examine the metabolic activation of the test substance, the proliferating cells were treated with the test substance for 6 h in serum-free MEM with S9 mix (S9(+)), or without S9 mix (S9(-)), then cultured a further 18 h in the fresh MEM with serum. Moreover, the cells were also treated with the test substance for 24 and 48 h continuously in the absence of S9 mix. Duplicate cultures were used for each dose. For the test substance tested for 6 h with metabolic activation, the color of the culture medium shifted from orange or red (pH 7-8) to yellow (pH<6) just after applying the treatment solution, suggesting that CA was generated by the non-physiological culture conditions. Culture medium with low pH (pH<6.4) was known to induce structural CA in CHL/IU cells, but it could not be assumed without confirmation that structural CA in the current tests were caused by lowering pH. At the concentration of 0.41 mg/mL and 0.83 mg/mL short-term treatments with S9 mix resulted in 6.5% and 17% of the cells, respectively demonstrating structural aberrations (including gaps). However, it was suggested that acidic pH may have been related to the induction of chromosomal aberration.

Lowest concentration producing cytogenetic effects in vitro:

without metabolic activation (continuous treatment ): > 1.70 mg/mL

without metabolic activation (short-term treatment): > 4.4 mg/mL

with metabolic activation (short-term treatment): 0.41 mg/mL (clastogenicity) 3-Aminobezenesulfonic acid induced CAs with S9 mix (5.0 and 16.5% at 2.4 and 4.8 mM (0.83 mg/mL), respectively). The pH of the medium was 5.8 or 6.3 at the beginning of the 6-h treatment and 6.2 or 6.5 just after it at 4.8 or 2.4 mM. respectively. Relative cell growth, as measured by monolayer confluence, was about 100% or 90% at 4.8 or 9.5 mM, respectively. However, there were no metaphases at 9.5 mM. Without S9 mix, no CA induction was observed after 6- or 24-h treatment. The reason for this will be due to th short duration in Iow pH culture condition: the pH of the medium without S9 mix was 5.8 or 6.5 at the beginning of the 6-h treatment and 6.6 or 6.9 just after it at 4.8 or 2.4 mM, respectively. Initial pHs of the medium were similar, but the pHs after the treatment without S9 mix were higher than that with S9 mix. The window of the induction of CAs by Iow pH is narrower without S9 mix than that with S9 mix, generally. 3-Aminobenzenesulfonic acid does not possess any DEREK structural alerts. The CAs observed are considered as irrelevant as they were only seen at low pH and it is supported by all other available data. Thus the Ievel of concern is negligible.

 

In a GLP compliant study performed according to OECD 474, 3-aminobenzenesulfonic acid was administered at 250, 500, 1000 and 2000 mg/kg/day. On observation of the general condition, colored urine (orange-yellow) was observed in all males and females in each test substance administration group. There were no deaths. No decrease in body weight related to test substance administration was observed. There were no observed changes in general condition in the negative control group or in the positive control group. There were no observed abnormalities in body weight variation in any test substance administration group compared to the negative control group. There were no observed abnormalities in body weight variation in the positive control group. In the test substance administration groups, the MNPCE frequency was 0.12 ± 0.08% in the 500 mg/kg/day group, 0.14 ± 0.11% in the 1000 mg/kg/day group and 0.11 ± 0.04% in the 2000 mg/kg/day group. Comparing these values with the negative control group of 0.11 ±0.05%, no statistically significant increase or dose dependent change was observed in any of the test substance administration groups. There were no statistically significant (p<0.05) changes in the PCE frequency in 200 total erythrocytes in any test substance administration group compared to the negative control group. The MNPCE frequency in the positive control group was markedly higher than in the negative control group. Furthermore, the MNPCE frequencies in the negative control group and the positive control group were within the range of mean ± 3 S.D. of the study laboratory background data.

 

Short description of key information:
3-Aminobenzenesulfonic acid was considered to be non-mutagenic in the Salmonella/microsome test, without and with S9 mix.

3-Aminobezenesulfonic acid induced CAs with S9 mix in the in vitro Chromosomal Aberration test. However, the aberration may be induced by acidity and may not be linked to physiological DNA damage.

3-Aminobenzenesulfonic acid was considered to be non-mutagenic in the in vivo MNT.

Endpoint Conclusion:

Although 3-Aminobenzenesulfonic acid was positive in vitro, such an effect has not been observed in vivo. All in all, the substance is considered negativ.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered not to be classified for genetic toxicity under Regulation (EC) No. 1272/2008, as amended for the 13th time in Regulation (EU) 2018/1480.