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Toxicological information

Acute Toxicity: oral

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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:
1974
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

Constituent 1
Chemical structure
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
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.