Potassium sulphite

Acute Toxicity: oral

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

Test material information

Constituent 1

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.