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EC number: 240-795-3 | CAS number: 16731-55-8
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Minor deviations without an effect on the results: - The purity and stability are missing. -According to the guideline, the observation period should be at least 14 days. In this study the animals were only observed for 7 days. This was not regarded to influence the results, since no animals died after 24 hours. - According to the guideline, the animals should be acclimatised to the laboratory condition for at least 5 days. This information was missing from the report. - According to the guideline, the volume administered to the animals should not exceed 2ml/100 g. In this report the volume administered was not stated. - The housing and environmental conditions were not stated, which according to the guideline should be included. - According to the guideline, animals should be fasted prior to administration of the test material. It was not stated in the report if the animals were deprived of food before test item administration. - According to the guideline the animals should be observed at least once a day and the body weight determined before administration, weekly thereafter and at death. The animals were not observed daily and the body weight was only determined before administration.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1981-05-12
- Deviations:
- yes
- Remarks:
- , see "rationale for reliablity"
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Dipotassium disulphite
- EC Number:
- 240-795-3
- EC Name:
- Dipotassium disulphite
- Cas Number:
- 16731-55-8
- Molecular formula:
- K2S2O5
- IUPAC Name:
- dipotassium disulfite
- Test material form:
- solid
- Details on test material:
- - Name of test material (as cited in study report): Dipotassium disulphite (K2S2O5)
- Physical state: Solid
- Other: Sales product in wine production and preserving agent
Constituent 1
- Specific details on test material used for the study:
- not specified
Test animals
- Species:
- rat
- Strain:
- other: Gassner
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: mean 170 g (male), 166.0 g (female)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2%, 16%, 20%, 25%, 30%
DOSAGE PREPARATION (if unusual): 90 min prior to dosing
No further information on the oral exposure was stated. - Doses:
- 200, 1600, 2000, 2250, 2500, 3200, 6400 mg/kg bw (2 %, 16 %, 20 % 25 %, 25 %, 30 % and 30 % respectively)
- No. of animals per sex per dose:
- 5 males / 5 females
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 7 days
- Necropsy of survivors performed: yes
- Other examinations performed: Clinical signs, body weight (determined before the study started), and gross pathology - Statistics:
- not stated
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: The LD50 was determined after an observation period of 7 days.
- Mortality:
- 6400 mg/kg bw: 5/5 males within 1 h; 5/5 females within 1 hour
3200 mg/kg bw: 1/5 male within 1 h, 4/5 males within 24 h; 3/5 females within 1 h, 5/5 females within 24 h
2500 mg/kg bw: 2/5 males within 24 h; 3/5 females within 1 h, 5/5 females within 24 h
2250 mg/kg bw: 0/5 males; 3/5 females within 24 h
200 - 2000 mg/kg bw: 0/5 males; 0/5 females
Overall, when animals died they died within 24 hours. - Clinical signs:
- other: The following clinical signs were observed immediately after the beginning of the study up to 20 minutes thereafter: 6400 mg/kg bw: staggering, abdominal position, accelerated respiration,convulsions (Animals died within 15 minutes) 3200 mg/kg bw: stagge
- Gross pathology:
- 6400 mg/kg: Heart: acute cardiac dilation; stomach: filled with thin fluid content, ecchymosis, duodenum is diffused reddened
3200 mg/kg: Heart: acute cardiac dilation, venous congestical hyperemia ; stomach: filled with thin fluid content, ecchymosis, duodenum is diffused reddened; Intestine: light diarrhoeic content; liver: relatively dark; kidneys: lighten kidneys
2500 mg/kg: Heart: acute cardiac dilation, venous congestical hyperemia; stomach: filled with thin fluid content, light diffused reddening, some animals had a bloody mucosa with bloody content; Intestine: moderate diarrhoeic content
2250 mg/kg: Heart: acute cardiac dilation, venous congestical hyperemia; stomach: extented, fluid content, diffused reddened, vessels heavy injected; intestine: slight diarrhoeic content; kidney: bloody imbibition
2000 mg/kg: No gross pathology found
1600 mg/kg: No gross pathology found
200 mg/kg: No gross pathology found - Other findings:
- not stated
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A LD50 >2000 mg/kg bw was found determined for male and female rats after an observation time of 7 days.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route. - Executive summary:
Based on the nearly similar SO2 contents (wt%) of sodium hydrogensulfite (61 wt% SO2) and potassium metabisulfite (58 wt% SO2), it can be assumed that the LD50 value for the substance sodium hydrogensulfite is >2000 mg/kg bw, based on the data given.
Nevertheless, the substance sodium hydrogensulfite is classified according to Regulation (EC) No 1272/2008 ( Acute Tox. 4, H302).
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