N-(2-hydroxypropyl)benzenesulphonamide

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

N-(2-hydroxypropyl)benzenesulphonamide

EC Number:

252-512-0

EC Name:

N-(2-hydroxypropyl)benzenesulphonamide

Cas Number:

35325-02-1

Molecular formula:

C9H13NO3S

IUPAC Name:

N-(2-hydroxypropyl)benzenesulphonamide

Test material form:

liquid: viscous

Method

Target gene:

the following strains will be used in the Ames test:
S. typhimurium TA 1535 his G46 rfa- Δ uvr B- (base –pair substitutions)
S. typhimurium TA 1537 his C3076 rfa- Δ uvr B- ( frame shift mutations)
S. typhimurium TA 98 his D3052 rfa- Δ uvr B- R+ (frame shift mutations)
S. typhimurium TA 100 his G46 rfa- Δ uvr B- R+ (base –pair substitutions)
E.coli: WP2 uvrA:trp;uvrA- (base –pair substitutions and others)

Species / strain

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Details on mammalian cell type (if applicable):

Tester strain of TA 98,TA 1535, and E coli were obtained from MOLTOX, INC NC 28607 USA.
Test strains TA 100 and TA 1537 were obtained from Xenometrix AG, Switzerland.

Additional strain / cell type characteristics:

DNA polymerase A deficient

Metabolic activation:

with and without

Metabolic activation system:

S9Tester

Test concentrations with justification for top dose:

31.6,100,316,1000,2500,and 5000 µg/plate

Vehicle / solvent:

- solvent(s) used: dimethylsulphoxide
- Justification for choice of solvent:

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

Positive controls:

yes

Positive control substance:

sodium azide

Details on test system and experimental conditions:

METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
bacterial suspension and sodium phosphate buffer added to sterile bijou bottles.
the test compound added to cultures at 5 concentrations separated by half-log 10 intervals.
histidine-deficient agar added to each bottles, thoroughly mixed and overlaid onto previously prepared plates containing minimal agar.

DURATION
- Preincubation period: 72 hours
- Exposure duration: 72 hours
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent): no selection agent
- Fixation time (start of exposure up to fixation or harvest of cells):

Evaluation criteria:

colonies will be counted using a Biotran Automatic Colony Counter, and the mean number of revertant colonies per treatment group assessed.

Statistics:

No data

Results and discussion

Test results

Key result

Species / strain:

other: S.typhimurium TA 98,TA 100,TA 1535,TA 1537 and E.coli WP2.

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, N-(2-hydroxypropyl)benzenesulfonamide did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used.
Therefore, N-(2-hydroxypropyl)benzenesulfonamide is considered to be non-mutagenic in this bacterial reverse mutation assay.

Executive summary:

The test item N-(2-hydroxypropyl)benzenesulfonamide was investigated for its potential to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) using Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and tester strain E. coli WP2 uvrA. In two independent experiments several concentrations of the test item were used. Each assay was conducted with and without metabolic activation. The concentrations, including the controls, were tested in triplicate. The following concentrations of the test item were prepared and used in the experiments: 31.6, 100, 316, 1000, 2500 and 5000 µg/plate No precipitation of the test item was observed in any tester strain used in experiment I and II (with and without metabolic activation). No toxic effects of the test item were noted in any of the five tester strains used up to the highest dose group evaluated with and without metabolic activation in experiment I and II. No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed following treatment with N-(2-hydroxypropyl)benzenesulfonamide at any concentration level, neither in the presence nor absence of metabolic activation in experiment I and II.