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EC number: 233-321-1 | CAS number: 10117-38-1
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:
- weight of evidence
- 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: Not stated: - purity and stability - Observation period 7 days - Acclimatisation period - Volume administered - Housing and environmental conditions - Fasting period In addition: - The animals were not observed daily and the body weight was only determined before administration.
- 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:
- 1 974
- 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 reliability"
- GLP compliance:
- no
- 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:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Sodium disulfite
- Molecular formula: Na2S2O5
- Physical state: solid (powder)
- Other: Sales product: reducing and preserving agent
Constituent 1
- Specific details on test material used for the study:
- not specified
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Gassner
- Weight at study initiation: mean weight males: 170.0 g (range of weight: 147 - 188 g); mean weight females: 164.2 g (range of weight: 148 - 178 g)
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 2%, 16%, 30%
DOSAGE PREPARATION (if unusual): The dosage were prepared 90 min prior to dosing. - Doses:
- 200, 1600, 3200, 6400 mg/kg bw
- 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
- Examinations performed: Clinical signs and gross pathology were recorded. Body weight was determined at the beginning of the study. - Statistics:
- No data
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- ca. 3 200 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: The observation time was 7 days. No animal died after 24 hours.
- Mortality:
- 6400 mg/kg bw: 5/5 males within 15 min; 5/5 females within 15 min
3200 mg/kg bw: 1/5 male within 24 h; 3/5 females within 1 h; 4/5 females within 24 h
1600 mg/kg bw: 1/5 female within 1 h; all males survived
200 mg/kg bw: All males and females survived. - Clinical signs:
- other: 6400 mg/kg bw: Immediatley after application accelerated respiration, dyspnea, staggering, lateral position, convulsions; All animals died within 15 min 3200 mg/kg bw: Ca. 5 minutes after application females showed accelerated respiration and lateral posi
- Gross pathology:
- 6400 mg/kg bw (gross pathological findings of males and females which died during the observation period):
- Heart: Acute dilation of right/left ventrical, general hyperemia
- Stomach: Atonia, liquid content
- Intestine: Diarrhetic content
3200 mg/kg bw (gross pathological findings of male and females which died during the observation period):
No findings
1600 mg/kg bw (gross pathological findings of female which died during the observation period):
- Heart: acute dilation of right ventrical, venous hyperemia
- Stomach: liquid content
- Intestine: atonia, diarrhetic content
3200 mg/kg bw (gross pathological findings of males and female which survived until the end of the observation period:
No findings were made.
1600 mg/kg bw (gross pathological findings of males and females which survived until the end of the observation period:
No findings were made. - Other findings:
- No data
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 (female and male rats): ca. 3200 mg/kg bw.
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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