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EC number: 208-761-2 | CAS number: 540-92-1
- 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
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:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Sodium 2-hydroxypropane-2-sulphonate
- EC Number:
- 208-761-2
- EC Name:
- Sodium 2-hydroxypropane-2-sulphonate
- Cas Number:
- 540-92-1
- Molecular formula:
- C3H8O4S.Na
- IUPAC Name:
- sodium 2-hydroxypropane-2-sulphonate
- Details on test material:
- - Name of test substance : Natrium-2-hydroxypropan-2-sulfonat
- CAS No.: 540-92-1
- Batch No.: 13./14.01.2001
- Date of production: Jan. 13./14.200 1
- Degree of purity/Composition: 13 g/ 100 g (elemental analysis); 87.2 g / 100 g water (Karl-Fischer titration)
- Physical state/appearance: Liquid/colorless, clear
- Homogeneity: The test substance was homogeneous.
- Storage conditions : Room temperature, covered with N2
- Stability: The analytical characterization was run in parallel to the administration phase of the study. Therefore the results of this analysis represent the composition of the test substance and no reanalysis is necessary. According to the sponsor the stability of the test substance was given until Feb. 10, 2001
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: Young adult animals (male animals approx. 8 - 12 weeks, female animals approx. 14 - 18 weeks)
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight); males, mean: 229 g; females, mean: 215 g
- Fasting period before study: at least 16 hours before administration
- Housing: single housing in stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiät, Provimi Kliba SA, Kaiseraugst, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- Aqueous solution as supplied
- Details on oral exposure:
- DOSE VOLUME APPLIED: 15.4 ml/kg
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays. Individual body weights were determined shortly before administration (day 0), weekly thereafter and at the end of the study (before fasting period). Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: Signs of toxicity comprised impaired and poor general state, dyspnoea, apathy, staggering and piloerection and were observed until including hour 5 after administration.
- Gross pathology:
- No macroscopic pathologic abnormalities were noted.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of this study the median lethal dose of the test substance after oral administration was found to be greater than 2000 mg/kg body weight for male and female rats.
- Executive summary:
The study was performed to assess the acute toxicity following oral administration of Natrium-2-hydroxypropan-2-sulfonat in Wistar rats. Single doses of 2000 mg/kg body weight of the test substance in form of the aqueous solution supplied by the sponsor were given to two dose groups of three fasted animals, each (males and females) by gavage. No mortality occurred in the dose groups. Clinical signs and findings in the dose groups comprised impaired and poor general state, dyspnoea, apathy, staggering and piloerection. Findings were observed until including study hour 5 after administration. The mean body weights of the dose groups increased throughout the study period. No macroscopic pathologic abnormalities were noted in the animals examined at the end of the observation period. Under the conditions of this study the median lethal dose of the test substance after oral administration was found to be greater than 2000 mg/kg body weight for male and female rats.
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