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EC number: 231-673-0 | CAS number: 7681-57-4
- 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:
- 1987-08-05 to 1987-09-04
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Stability of the test material was missing.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1987-02-24
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Disodium disulphite
- EC Number:
- 231-673-0
- EC Name:
- Disodium disulphite
- Cas Number:
- 7681-57-4
- Molecular formula:
- Na2S2O5
- IUPAC Name:
- disodium disulphite
- Test material form:
- other: solid: microcrystalline powder
- Details on test material:
- - Name of test material (as cited in study report): Natriumbisulfit-Pulver (Sodium disulfite- powder)
- Chemical description: Sodium pyrosulfit
- Molecular formula: Na2S2O5
- Molecular weight: 190.12 g/mol
- Physical state: white, microcrystalline powder
- Use: Preserving agent, bleaching agent, and reducing agent
- Decomposition temperature: > 150°C
- Density: 1.48 kg/l
- pH-value in water: 4.4 - 4.9 (20%)
- Solubility: 650 g/l in water
Constituent 1
- Specific details on test material used for the study:
- - Storage condition of test material: In the dark in a fume hood at 22°C
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastenfrund, SPF-Breed
- Age at study initiation: Males: ca. 7 weeks; females: ca.8 weeks
- Weight at study initiation: Males (n = 15): Mean weight: 195 g +/- 13 g (max. 215 g, min. 179 g); females (n = 15): Mean weight: 178 g +/- 5 g (max. 185 g, min. 168 g)
- Fasting period before study: Ca. 16 hours before administration and 3-4 hours after administration.
- Housing: Animals were housed in groups of five in Makroloncages (Type 4) on granulat of softwood.
- Diet (ad libitum): Rat diet Altromin 1324 (Altromin-GmbH, Lage/Lippe)
- Water (ad libitum): Tap water in plastic drinking bottles
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS - fully airconitioned rooms
- Temperature:: 22+/- 3°C
- Relative humidity: 50% +/- 20%
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- deionised water
- Details on oral exposure:
- RANGE-FINDING STUDY:
Doses of the main study were selected based on a range-finding studies. The following doses were tested in one male and one female: 500, 1000, and 2000 mg/kg bw in deionised water (25% Concentration).
The following findings were made:
Both male and female died 120 minutes after the administration of 2000 mg/kg bw.
On the application day the animals showed reduced spontaneous activity, crouching, drawn in flanks, long-legged gait and irregular breatching. The symptoms of surviving animals were reversible from Day 1 on.
The animals, which died during the study had reddened mucous coat of the stomach as well as haematoma in the gastro-intestinal tract. The macroscopically examined animals, which were killed at the end of the study showed no changes.
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg bw.
DOSAGE PREPARATION: Sodium disulfite was dissolved in deionised water.
Concentrations:
8.0% (w/v) (Dose: 800 mg/kg bw.)
12.5% (w/v) (Dose: 1250 mg/kg bw.)
16.0% (w/v) (Dose: 1600 mg/kg bw.)
20.0% (w/v) (Dose: 2000 mg/kg bw.) - Doses:
- Males: 1250, 1600, and 2000 mg/kg bw
Females: 800, 1250, and 1600 mg/kg bw - No. of animals per sex per dose:
- Males: 5 per dose
Females: 5 per dose - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The body weight of the animals were recorded weekly. The clinical signs and mortality were observed at least 10 and 30 minutes after administration, and 1, 2, 4 and 6 hours after administration. Afterwards the clinical signs and mortality were observed daily.
- Necropsy of survivors performed: Yes
The animals, which died during the study, were dissected and macrosopically examined. The animals, which survived until the end of the observation period, were killed with carbon dioxide. They were also dissected and macroscopically examined.
- Examinations performed: The symptoms and the mortality were recorded. - Statistics:
- The LD50, the confidence interval, and the equation of the grade of the probit were calculated from the observed death rates using a probit analysis.
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 1 420 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 040 - <= 2 110
- Remarks on result:
- other: Confidence interval: P = 0.05
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 1 630 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 210 - <= 2 260
- Remarks on result:
- other: Confidence interval: P = 0.05
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 1 540 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 1 290 - <= 1 960
- Remarks on result:
- other: Confidence interval: P = 0.05
- Mortality:
- The following death rates were observed:
800 mg/kg bw.: Females: 0/5 (0%)
1250 mg/kg bw.: Males: 1/5 (20%; death after 60 minutes of administration); Females: 1/5 (20%; death after 70 minutes of administration)
1600 mg/kg bw.: Males: 2/5 (40%; death after 75 and 180 minutes of administration, respectively); Females: 4/5 (80%, death after 60 minutes of administration)
2000 mg/kg bw.: Males: 4/5 (80%; death after 70 minutes of administration) - Clinical signs:
- other: The following clinical signs were observed in the males and females, respectively: reduced spontaneous activity, crouching, flanks drawn-in, ruffled fur, irregular breathing, and long-legged gait. In addition, latero-abdominal position, constricted palpeb
- Gross pathology:
- The macroscopically examination of the males and females, which died during the study, showed the following:
- gastro-intestinal tract filled with blood (Males in the 1250, 1600 and 2000 mg/kg bw. dose; females: 1250 and 1600 mg/kg bw. dose)
- Mucous coat of the stomach reddened (Males in the 1250 and 2000 mg/kg bw. dose; females: 1250 and 1600 mg/kg bw. dose)
- Liver dark discoloured (Males in the 1250, 1600 and 2000 mg/kg bw. dose; females: 1600 mg/kg bw. dose)
- Marked liver lobules (Females: 1600 mg/kg bw. dose
The animals, which were killed at the end of the observation period, were free of macroscopical changes.
Any other information on results incl. tables
The following clinical signs were observed.
Clinical sigs of the males:
1250 mg/kg bw.:
- Reduced spontaneous activity: One male after at least 30 minutes and four males after 1 hour of administration until Day 1 after administration.
- Long-legged gait: Four males at least 30 minutes after administration until Day 1 after administration.
- Crouching: Four males at least 30 minutes after administration until Day 1 after administration.
- Irregular breathing: Four males 1 hour after administration until Day 1 after administration.
- Ruffled fur: Two males 2 hours after administration.
1600 mg/kg bw.:
- Reduced spontaneous activity: Five males after at least 30 minutes, four males after 1 hour and three males after 2 hour of administration until Day 1 after administration.
- Long-legged gait: Two males at least 30 minutes and three males 1 hour after administration until Day 1 after administration.
- Crouching: Five males at least 30 minutes, four males 1 hour and 3 males 2 hours after administration until Day 1 after administration.
- Irregular breathing: Four males 1 hour after administration until 2 hours after administration.
- Ruffled fur: Two males 2 hours after administration.
- Flank drawn-in: 3 males after at least 30 minutes after administration until Day 1 after administration.
- Constricted palpebral fissure: 1 male after 1 hour of administration until 2 hours after administration
- Abdominal or lateral position: 1 male at 2 hours after administration
-Drowsiness: 1 male at 2 hours after administration
2000 mg/kg bw.:
- Reduced spontaneous activity: Five males after at least 30 minutes, one male after 1 hour of administration until 4 hours after administration.
- Crouching: Four males at least 30 minutes, and one male 1 hour after administration until 4 hours after administration.
- Irregular breathing: Four males at least 30 minutes, five males 1 hour, and onemale 2 hours after administration until 4 hours after administration.
- Ruffled fur: One male 4 hours after administration.
- Flank drawn-in: Four males after at least 30 minutes and one male 1 hour after administration until Day 1 after administration.
- Constricted palpebral fissure: 1 male at least 30 miuntes after administration until 1 hour after administration
- Abdominal or lateral position: Four males at 1 hour after administration
-Drowsiness: Four males at 4 hours after administration
Clinical sigs of the females:
800 mg/kg bw.:
- Reduced spontaneous activity: five females after 1 hour of administration until Day 1 after administration.
1250 mg/kg bw.:
- Reduced spontaneous activity: Five females after at least 30 minutes and four females after 1 hour of administration until Day 1 after administration.
- Crouching: Two females after at least 30 minutes and four females after 1 hour of administration until Day 1 after administration.
- Flank drawn-in: Two females after at least 30 minutes and four females after 1 hour of administration until Day 1 after administration.
- Irregular breathing: Two females after at least 30 minutes and four females after 1 hour of administration until Day 1 after administration.
- Ruffled fur: One female after 2 hours of administration until 4 hours after administration.
1600 mg/kg bw.:
- Reduced spontaneous activity: One female after at least 30 minutes of administration until Day 1 after administration.
- Long-legged gait: Five females at least 30 minutes and 1 female after 1 hour of administration until Day 1 after administration.
- Crouching: One females after at least 30 minutes of administration until Day 1 after administration.
- Flank drawn-in: One females after at least 30 minutes of administration until Day 1 after administration.
- Irregular breathing: One females after 2 hours of administration until Day 1 after administration.
- Ruffled fur: One females after 2 hours of administration until Day 1 after administration.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is classified as Category 4.
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