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Registration Dossier
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EC number: 233-469-7 | CAS number: 10192-30-0
Toxicological information
Acute Toxicity: oral
Currently viewing:
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across based on grouping of substances (category approach)
- 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 with no effect on the results: - The purity and stability were missing. - The number of animals showing signs of toxicity was missing. -The method for LD50 calculation was not stated.
- Justification for type of information:
- see attachment “Read-across concept – Human Health/Environment - Category approach for Inorganic sulfites/thiosulfates/dithionite" in section 13.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
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 reliability"
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Sodium sulphite
- EC Number:
- 231-821-4
- EC Name:
- Sodium sulphite
- Cas Number:
- 7757-83-7
- Molecular formula:
- NA2SO3
- IUPAC Name:
- disodium sulfite
- Test material form:
- not specified
- Details on test material:
- - Name of test material (as cited in study report): sodium sulphite water-free Z
Constituent 1
- Specific details on test material used for the study:
- not specified
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga, Sulzfeld
- Age at study initiation: ca. 12 weeks
- Weight at study initiation: mean weight males : 210 g (Individual weights of males: 230 g, 180 g, and 220 g); mean weights females: 190 g ( individual weights of females: 180 g, 180 g, and 210 g)
- Fasting period before study: The animals were given no food for 16 hours before administration, but water was available ad libitum.
- Housing: Animals were housed in groups of 5. They were housed in V-II-A- stainless steel wire mesh cages, Type DK-III (supplied by Becker & Co., Castrop-Rauxel); Animals of comparable weights (+/- 10 g) in one cage.
- Diet: ssniff R; Firma ssniff, Versuchstierdiaeten; 4470 Soest
- Water (ad libitum): Fully demineralized water each workday; tap water on public holidays
- Acclimation period: Acclimatization in the animal care unit for at least one week.
ENVIRONMENTAL CONDITIONS
- Temperature: 20-26°C
- Relative humidity: 45-75 %
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 31.6 % (Dosis: 3160 mg/kg), 26.1 % (Dosis: 2610), and 21.5 % (Dosis: 2150 mg/kg)
- Justification for choice of vehicle:: Aqueous preparation corresponding to the physiological medium.
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg - Doses:
- 2150, 2610, 3160 mg/kg
- No. of animals per sex per dose:
- 5 males / 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Groups were weighed before administration, and on days 3, 7, and 13 after application. Recording of signs and symptoms <15 min, 15 min, 30 min, 1 h, 2 h, 4 h and 5 h after test substance administration and then once each workday. Check for moribund and dead animals twice each workday and once daily on public holidays.
- Necropsy of survivors performed: yes
- Pathology: Withdrawal of food 16 hours before sacrifice with CO2; then necropsy with gross-pathological examination. All animals that die are necropsied as early as possible. - Statistics:
- No data
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 610 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 150 - < 2 610 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: 5 % level of significance
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- ca. 2 746 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: Value obtain through interpolation.
- Mortality:
- Please refer to table below ("Any other infromation on results incl. tables")
- Clinical signs:
- other: The following symptoms were observed: MALES 3160 mg/kg: - Dyspnoea: 15 minutes - 3 days - Apathy: 30 minutes - 3 days - Abnormal position: 4 hours - Staggering: 30 minutes - 3 days - Tremor: 4 hours - 3 days - Tremble: 4 hours - 3 days - Jumping convuls
- Gross pathology:
- MALE ANIMALS:
Animal that died:
3160 mg/kg: dilated intensely reddened mucosa, filled with blood-colored liquid; small intestine: atonic, intensely reddened mucosa, blood-red liquid content.
2160 mg/kg: congestive hyperemia; stomach: in the glandular stomach reddened mucosa, filled with liquid; intestine: atonic, intensely filled with liquid.
Sacrificed animals: no findings
FEMALE ANIMALS:
Animal that died:
3160 mg/kg: dilated intensely reddened mucosa, filled with blood-colored liquid; small intestine: atonic, intensely reddened mucosa, blood-red liquidcontent.
2160 mg/kg: congestive hyperemia; stomach; in the glanduar stomach reddened mucosa, filled with liquid; intestine: atonic, intensely filled with liquid.
Sacrificed animals: no findings - Other findings:
- No data
Any other information on results incl. tables
Body weights (mean weights in g):
| Male animals | Start of the study | After 3 days | After 7 days | After 13 days | |
| 3160 mg/kg | 230 | 178 | |||
| 2610 mg/kg | 180 | 212 | 248 | 292 | |
| 2150 mg/kg | 220 | 260 | 295 | 321 | |
| Female animals | Start of the study | After 3 days | After 7 days | After 13 days | |
| 3160 mg/kg | 180 | ||||
| 2610 mg/kg | 180 | ||||
| 2150 mg/kg | 210 | 232 | 240 | 245 |
Mortality:
| Male animals | 3160 mg/kg | 2610 mg/kg | 2150 mg/kg | |
| Dead animals after | 1 hour | 0/5 | 0/5 | 0/5 |
| 1 day | 4/5 | 1/5 | 0/5 | |
| 2 days | 4/5 | 1/5 | 0/5 | |
| 7 days | 5/5 | 1/5 | 0/5 | |
| 14 days | 5/5 | 1/5 | 0/5 | |
| Female animals | 3160 mg/kg | 2610 mg/kg | 2150 mg/kg | |
| Dead animals after | 1 hour | 0/5 | 0/5 | 0/5 |
| 1 days | 5/5 | 5/5 | 0/5 | |
| 2 days | 5/5 | 5/5 | 0/5 | |
| 7 days | 5/5 | 5/5 | 0/5 | |
| 14 days | 5/5 | 5/5 | 0/5 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.
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