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EC number: 204-807-0 | CAS number: 126-83-0
- 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:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- yes
- Remarks:
- Analytical confirmation of the concentration, homogeneity, and stability of the dosing formulations was not performed. Due to the short duration of the study, this exception would not have an impact on the interpretation of the study results.
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
Test material
- Reference substance name:
- Sodium 3-chloro-2-hydroxypropanesulphonate
- EC Number:
- 204-807-0
- EC Name:
- Sodium 3-chloro-2-hydroxypropanesulphonate
- Cas Number:
- 126-83-0
- Molecular formula:
- C3H7ClO4S.Na
- IUPAC Name:
- sodium 3-chloro-2-hydroxypropanesulphonate
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Raleigh, North Carolina
- Females nulliparous and non-pregnant: yes
- Age at study initiation: approximately 9-11 weeks
- Weight at study initiation: 182.4 to 228.8 g
- Fasting period before study: yes, overnight
- Housing: all animals were housed individually in clean, stainless steel, wire-mesh cages containing bedding material, and enrichment devices were provided to all animals
- Diet: ad libitum except during fasting
- Water: ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22.4 to 22.6°C
- Humidity: 36.1 to 58.3%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% methylcellulose in deionized water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
- Doses:
- 300 and 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: The rats were observed twice daily, once in the morning and once in the afternoon, for mortality and moribundity. The rats were observed at time of dosing, at approximately 15 ± 5 minutes and 1, 2, and 4 hours post-dosing on study Day 0, and once daily thereafter for 14 days.
- Frequency of observations and weighing: Body weights were obtained and recorded on study days 0 (initiation), 7, and 14 (termination)
- Necropsy of survivors performed: 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:
- All animals survived to the scheduled necropsy
- Clinical signs:
- There were no test substance-related clinical observations at 300 mg/kg. Test substance-related clinical findings of soft feces, rectal mucous exudate, and/or wet yellow material around the anogenital area were noted in 4/5 animals dosed at 2000 mg/kg at 1, 2 and/or 4 hours following dose administration on Study Day 0. No clinical observations were noted during the 14-day observation period.
- Body weight:
- There were no remarkable body weight changes noted during the study. All animals surpassed their initial body weight by Study Day 14.
- Gross pathology:
- There were no test substance-related macroscopic findings at the scheduled necropsy. Macroscopic findings were limited to a small thyroid gland in a single 2000 mg/kg group animal.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 (female): >2000 mg/kg
- Executive summary:
The objectives of this study were to determine the estimated acute oral median lethal dose range and evaluate potential systemic toxicity of the test substance when administered as a single dose to albino rats according to OECD Guideline 420. The acute oral toxicity of the test substance was evaluated in this single-dose study in rats. The test substance was administered once orally via gavage to 1 fasted female albino rat at a dose level of 300 mg/kg. No mortality was observed, and another female rat was dosed at 2000 mg/kg (limit dose). No mortality was observed, and 4 additional female animals were dosed at 2000 mg/kg. Mortality, clinical observations, and body weight changes were evaluated over a 14-day observation period. All animals were subjected to a gross necropsy.
There were no deaths, remarkable body weight changes, or test substance-related gross necropsy findings. There were no test substance-related clinical observations at 300 mg/kg. Test substance-related clinical findings of soft feces, rectal mucous exudate, and/or wet yellow material around the anogenital area were noted in 4/5 animals dosed at 2000 mg/kg at 1, 2 and/or 4 hours following dose administration on Study Day 0. No clinical observations were noted during the 14-day observation period. Based on the results of this study, the estimated LD50 of the test substance was greater than 2000 mg/kg when administered once orally via gavage to fasted female albino rats.
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