Dipotassium disulphite

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

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 without an effect on the results: - The purity and stability are missing. -According to the guideline, the observation period should be at least 14 days. In this study the animals were only observed for 7 days. This was not regarded to influence the results, since no animals died after 24 hours. - According to the guideline, the animals should be acclimatised to the laboratory condition for at least 5 days. This information was missing from the report. - According to the guideline, the volume administered to the animals should not exceed 2ml/100 g. In this report the volume administered was not stated. - The housing and environmental conditions were not stated, which according to the guideline should be included. - According to the guideline, animals should be fasted prior to administration of the test material. It was not stated in the report if the animals were deprived of food before test item administration. - According to the guideline the animals should be observed at least once a day and the body weight determined before administration, weekly thereafter and at death. The animals were not observed daily and the body weight was only determined before administration.

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 reliablity"

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dipotassium disulphite

EC Number:

240-795-3

EC Name:

Dipotassium disulphite

Cas Number:

16731-55-8

Molecular formula:

K2S2O5

IUPAC Name:

dipotassium disulfite

Test material form:

solid

Details on test material:

- Name of test material (as cited in study report): Dipotassium disulphite (K2S2O5)
- Physical state: Solid
- Other: Sales product in wine production and preserving agent

Specific details on test material used for the study:

not specified

Test animals

Species:

rat

Strain:

other: Gassner

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: mean 170 g (male), 166.0 g (female)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2%, 16%, 20%, 25%, 30%

DOSAGE PREPARATION (if unusual): 90 min prior to dosing
No further information on the oral exposure was stated.

Doses:

200, 1600, 2000, 2250, 2500, 3200, 6400 mg/kg bw (2 %, 16 %, 20 % 25 %, 25 %, 30 % and 30 % respectively)

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
- Other examinations performed: Clinical signs, body weight (determined before the study started), and gross pathology

Statistics:

not stated

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: The LD50 was determined after an observation period of 7 days.

Mortality:

6400 mg/kg bw: 5/5 males within 1 h; 5/5 females within 1 hour
3200 mg/kg bw: 1/5 male within 1 h, 4/5 males within 24 h; 3/5 females within 1 h, 5/5 females within 24 h
2500 mg/kg bw: 2/5 males within 24 h; 3/5 females within 1 h, 5/5 females within 24 h
2250 mg/kg bw: 0/5 males; 3/5 females within 24 h
200 - 2000 mg/kg bw: 0/5 males; 0/5 females
Overall, when animals died they died within 24 hours.

Clinical signs:

other: The following clinical signs were observed immediately after the beginning of the study up to 20 minutes thereafter: 6400 mg/kg bw: staggering, abdominal position, accelerated respiration,convulsions (Animals died within 15 minutes) 3200 mg/kg bw: stagge

Gross pathology:

6400 mg/kg: Heart: acute cardiac dilation; stomach: filled with thin fluid content, ecchymosis, duodenum is diffused reddened
3200 mg/kg: Heart: acute cardiac dilation, venous congestical hyperemia ; stomach: filled with thin fluid content, ecchymosis, duodenum is diffused reddened; Intestine: light diarrhoeic content; liver: relatively dark; kidneys: lighten kidneys
2500 mg/kg: Heart: acute cardiac dilation, venous congestical hyperemia; stomach: filled with thin fluid content, light diffused reddening, some animals had a bloody mucosa with bloody content; Intestine: moderate diarrhoeic content
2250 mg/kg: Heart: acute cardiac dilation, venous congestical hyperemia; stomach: extented, fluid content, diffused reddened, vessels heavy injected; intestine: slight diarrhoeic content; kidney: bloody imbibition
2000 mg/kg: No gross pathology found
1600 mg/kg: No gross pathology found
200 mg/kg: No gross pathology found

Other findings:

not stated

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

A LD50 >2000 mg/kg bw was found determined for male and female rats after an observation time of 7 days.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.

Executive summary:

Based on the nearly similar SO2 contents (wt%) of sodium hydrogensulfite (61 wt% SO2) and potassium metabisulfite (58 wt% SO2), it can be assumed that the LD50 value for the substance sodium hydrogensulfite is >2000 mg/kg bw, based on the data given.

Nevertheless, the substance sodium hydrogensulfite is classified according to Regulation (EC) No 1272/2008 ( Acute Tox. 4, H302).