[No public or meaningful name is available]

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:

other: see 'Remark'

Remarks:

Comparable to guideline study reliable with restrictions 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.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

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:

Sodium sulphite

EC Number:

231-821-4

EC Name:

Sodium sulphite

Cas Number:

7757-83-7

Molecular formula:

H2O3S.2Na

IUPAC Name:

disodium sulfite

Test material form:

other: solution in water

Details on test material:

- Name of test material (as cited in study report): sodium sulphite water-free Z

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 % (Dose: 3160 mg/kg bw), 26.1 % (Dose: 2610 mg/kg bw), and 21.5 % (Dose: 2150 mg/kg bw)
- 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 bw

No. of animals per sex per dose:

5

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 levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 2 610 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male

Dose descriptor:

LD50

Effect level:

ca. 2 746 mg/kg bw

Based on:

test mat.

Remarks on result:

other: interpolation value

Effect levels 3

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

Mortality:

see "Any other information on results"

Clinical signs:

The following symptoms were observed:
MALES
3160 mg/kg bw:
- 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 convulsions: 4 hours
- Opisthotonus: 4 hours
- Clonic convulsions: 4 hours
- Ruffled fur: 2 hours - 3 days
- Diarrhea: 4 hours - 5 hours
- Cyanosis: 4 hours - 5 hours
- Exsiccosis: 4 hours - 3 days
- Salivation: 4 hours - 5 hours
- Cachexia: 3 days
- Poor general state: 30 minutes - 3 days

2610 mg/kg bw:
- Dyspnoea: 1 hour - 1 day
- Apathy: 1 hour - 1 day
- Staggering: 1 hour - 1 day
- Ruffled fur: 2 hours - 1 day
- Poor general state: 1 hour - 1 day

2150 mg/kg bw:
- Dyspnoea: 1 hour - 5 hours
- Apathy: 1 hour - 5 hours
- Staggering: 1 hour - 5 hours
- Ruffled fur: 1 day
- Poor general state: 1 hour - 5 hours

FEMALES:
3160 mg/kg bw
- Dyspnoea: 15 minutes - 4 hours
- Apathy: 15 minutes - 4 hours
- Abnormal position: 2 hours - 4 hours
- Staggering: 15 minutes - 4 hours
- Atony: 4 hours
- Tremble: 4 hours - 3 days
- Ruffled fur: 2 hours - 4 hours
- Diarrhea: 4 hours
- Cyanosis: 4 hours
- Exsiccosis: 4 hours
- Salivation: 4 hours
- Ptosis: 2 hours - 4 hours
- Poor general state: 15 minutes - 4 hours

2610 mg/kg bw:
- Dyspnoea: 1 hour - 2 hours
- Apathy: 1 hour - 2 hours
- Staggering: 1 hour - 2 hours
- Biting convulsions: 2 hours
- Ruffled fur: 2 hours
- Poor general state: 1 hour - 2 hours

2150 mg/kg bw:
- Dyspnoea: 15 minutes - 5 hours
- Apathy: 15 minutes - 5 hours
- Staggering: 15 minutes - 5 hours
- Tremble: 4 hours - 5 hours
- Ruffled fur: 4 hours - 2 days
- Poor general state: 15 minutes - 5 hours

Body weight:

see "Any other information on results"

Gross pathology:

MALE ANIMALS:
Animal that died:
3160 mg/kg bw: dilated intensely reddened mucosa, filled with blood-colored liquid; small intestine: atonic, intensely reddened mucosa, blood-red liquid content.
2160 mg/kg bw: 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 bw: dilated intensely reddened mucosa, filled with blood-colored liquid; small intestine: atonic, intensely reddened mucosa, blood-red liquidcontent.
2160 mg/kg bw: 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 bw	230	178
	2610 mg/kg bw	180	212	248	292
	2150 mg/kg bw	220	260	295	321
Female animals		Start of the study	After 3 days	After 7 days	After 13 days
	3160 mg/kg bw	180
	2610 mg/kg bw	180
	2150 mg/kg bw	210	232	240	245

Mortality:

Male animals		3160 mg/kg bw	2610 mg/kg bw	2150 mg/kg bw
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 bw	2610 mg/kg bw	2150 mg/kg bw
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 criteria specified by Directive 67/548/EEC and subsequent regulations, the test item is not classified as acute toxic via the oral route.
According to the EC Regulation No. 1272/2008 and subsequent regulations, the test item is not classified as acute toxic via the oral route.