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EC number: 233-915-0 | CAS number: 10433-41-7
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
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:
- Potassium dimethyl 5-sulphonatoisophthalate
- EC Number:
- 233-915-0
- EC Name:
- Potassium dimethyl 5-sulphonatoisophthalate
- Cas Number:
- 10433-41-7
- Molecular formula:
- C10H10O7S.K
- IUPAC Name:
- potassium 3,5-bis(methoxycarbonyl)benzene-1-sulfonate
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot number of test material: manufacturer, 60320
- Purity: 97.8 %
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature (permissible range: 10° to 30°C, actual value: 17.4° to 22.7°C), in a tightly closed container in a dark place.
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage:
- Stability: The sponsor confirmed stability of the lest substance with KBr tablet method for infrared absorption spectrometry (IR spectrometry) before the first administration and after the final administration. As a result, the test substance used in this study was confirmed with no changes in its characteristics.
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Remarks:
- SPF
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Japan, Inc. (Tsukuba breeding center)
- Females (if applicable) nulliparous and non-pregnant: yes
- Rationale for use of males: this strain is widely used in rodent toxicology studies, there is plenty of historical data, and a !arge number of animals are available.
- Age at study initiation: 8 weeks old
- Microbiological status: SPF
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22.1 - 23.5
- Humidity (%): 46.2 - 60.2
- Air changes (per hr): 6 to 20 times/hr, all fresh filtered air
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5 w/v% CMC-Na solution
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 2x3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: before dosing, 10 and 30 minutes, 1, 3, and 6 hours after dosing (6 times in total) on the day ofthe first administration, and before dosing, 10 and 30 minutes, 2, 3, and 6 hours after dosing (6 times in total) on the day of the second administration.
- Necropsy of survivors performed: yes
- Clinical signs including body weight: yes
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths were noted.
- Clinical signs:
- other: Diarrhea was observed transiently on the administration day. It was observed in all animals of the first adminsitration group and in 1 animal of the second administration group until 6 hours after dosing. This abnormal sign tended to recover and disappear
- Gross pathology:
- No abnmmalities in necropsy findings were noted in any animals of either the first or second administration.
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- This study was conducted to assess the acute oral toxicity of IS-K, when administered via oral gavage to female Crl:CD(SD) rats aged 8 weeks according to the OECD 423. A single dose level of 2000 mg/kg was employed for the first and second administrations.
As a result, no deaths or abnormalities were found in the clinical observation, body weight gain, or necropsy.
Therefore, the approximate LD50 of IS-K under the conditions of this study was estimated to be above 2000 mg/kg, and classified in Category 5 (>2000-5000 mg/kg b.w.) of the GHS and no classification under CLP.
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