3-amino-4-hydroxybenzenesulphonic acid

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Weight of evidence:

A standard Ames test was carried out with the btest item using Salmonella typhimurium strains TA 98, TA 100, TA 1535, and TA 97. The test was performed with and without matabolic activation. The concentrations were 33, 100, 333, 666, 1000 and 2000 µg/plate.

The substance did not show any mutagenic effect under test conditions.

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)

Rationale for reliability incl. deficiencies:

other: Test within the National Toxicology Program’s mutagenicity testing program and according to GLP.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

yes

Remarks:

(Only 4 strains were tested)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Specific details on test material used for the study:

Source: Fluka Chemical
Purity: 90%

Species / strain / cell type:

S. typhimurium, other: TA 98, TA 100, TA 1535 and TA 97

Metabolic activation:

with and without

Metabolic activation system:

S-9 mix (fractions of Aroclor 1254-induced, male Sprague-Dawley rat and male Syrian hamster livers)

Test concentrations with justification for top dose:

33, 100, 333, 666, and 1000, 2000 µg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: Distilled water

Negative solvent / vehicle controls:

yes

Remarks:

(Distilled water)

Positive controls:

yes

Remarks:

(Without metabolic activation)

Positive control substance:

sodium azide

Remarks:

(For strains TA 1535 and TA 100)

Positive controls:

yes

Remarks:

(Without metabolic activation)

Positive control substance:

9-aminoacridine

Remarks:

(For strain TA 97)

Positive controls:

yes

Remarks:

(Without metabolic activation)

Positive control substance:

other: 4-nitro-o-phenylenediamine

Remarks:

(For strain TA 98)

Positive controls:

yes

Remarks:

(With metabolic activation)

Positive control substance:

other: 2-aminoanthracene

Remarks:

(For all strains)

Details on test system and experimental conditions:

The test chemical (0.05 mL), overnight culture of Salmonella (0.05 mL), and S-9 mix or buffer (0.5 mL), were incubated at 37 ºC, without shaking, for 20 min.
The top agar was added and the contents of the tubes were mixed and poured onto the surface of petri dishes containing Vogel-Bonner medium.

Histidine-independent colonies arising on these plates were counted following two days incubation at 37 ºC.

Number of replications: 3 plates/dose

Evaluation criteria:

Test substance was judged mutagenic or weakly mutagenic if it produced a reproducible, dose-related response over the solvent control, under a single metabolic activation condition, in replicate trials.
Test substance was judged questionable if the results of individual trials were not reproducible, if increases in his+ revertants did not meet the criteria for a weakly mutagenic response, or if only single doses produced increases in his+ revertants in repeat trials.
Test substance was judge nonmutagenic if it did not meet the criteria for a mutagenic or questionable response.

Key result

Species / strain:

S. typhimurium, other: TA 98, TA 100, TA 1535, and TA 97

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

cytotoxicity

Remarks:

(at 2000 µg/plate)

Vehicle controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

The test item did not show any mutagenic effect under test conditions, with and without metabolic activation.

Conclusions:

Interpretation of results (migrated information):
negative
The test item did not show any mutagenic effect under test conditions, with and without metabolic activation.

Executive summary:

A standard Ames test was carried out with the btest item using Salmonella typhimurium strains TA 98, TA 100, TA 1535, and TA 97. The test was performed with and without matabolic activation. The concentrations were 33, 100, 333, 666, 1000 and 2000 µg/plate.

The substance did not show any mutagenic effect under test conditions.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)