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EC number: 700-740-0 | CAS number: 1103234-56-5
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Nov-Dec 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: test report performed under GLP and according to OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,6-difluoro-3-(propane-1-sulfonamido)benzoic acid
- EC Number:
- 700-740-0
- Cas Number:
- 1103234-56-5
- Molecular formula:
- C10H11F2NO4S
- IUPAC Name:
- 2,6-difluoro-3-(propane-1-sulfonamido)benzoic acid
- Details on test material:
- -Substance type: organic
-Physical state: white powder
-Storage condition of test material: at room temerature, protected from light
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Source: Harlan LAboratories B.V., NM Horst, The Netherlands
-Age (when treated): 10 weeks
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Details on oral exposure:
- Dose level (volume): 2000 mg/kg (10 mL/kg) body weight
- Doses:
- Single dose: 2000 mg/kg b.w.
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- The animals received a single dose of the test item by oral gavage administration 2000 mg/kg
body weight after being fasted for approximately 16 to 18 hours (access to water was permitted).
Food was provided again approximately 3 hours after dosing.
The dosing volume was 10 mL/kg body weight.
Viability I Mortality:
Daily during the acclimatization period, within the
first 30 minutes and at approximately 1, 2, 3 and 5
hours after administration on test day 1 (in common
with the clinical signs) and twice daily during days 2-15.
Clinical Signs:
Daily during the acclimatization period, within the
first 30 minutes and at approximately 1, 2, 3 and 5
hours after administration on test day 1, depending
on the occurrence of clinical signs of toxicity. Once
daily during days 2-15.
Body Weights:
On test days 1 (prior to administration), 8 and 15.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality occurred
- Clinical signs:
- other: No clinical signs were recoreded throughout the entire observation period
- Gross pathology:
- No macroscopic abnormalities were noted
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 value of SAC-Sulfonamidsäure in Wistar rats was established to exceed 2000 mg/kg body weight.
- Executive summary:
Two groups, each consisting of three female RccHan:WIST (SPF) rats, were treated with SACSulfonamidsaure by a single oral gavage administration of 2000 mg/kg body weight. The test item was formulated in PEG 300 at a concentration of 0.2 g/mL and administered at a dosing volume of 10 mL/kg. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs within the first 30 minutes and approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded within the first 30 minutes and approximately 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. No intercurrent deaths occurred during the course of the study. No clinical signs were recorded throughout the entire observation period. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy. The median lethal dose of SAC-Sulfonamidsaure after single oral administration to female rats, observed over a period of 14 days, is: LD50 (female rat): greater than 2000 mg/kg body weight Based upon the referred classification criteria (Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008), SAC-Sulfonamidsaure is not classified with respect to acute oral toxicity in the rat.
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