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EC number: 252-512-0 | CAS number: 35325-02-1
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 2 017
- 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
- 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
Constituent 1
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.
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