Sodium chlorite

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium chlorite

EC Number:

231-836-6

EC Name:

Sodium chlorite

Cas Number:

7758-19-2

Molecular formula:

ClHO2.Na

IUPAC Name:

sodium chlorite

Test material form:

liquid

Remarks:

Aqueous solution

Details on test material:

Test material: Sodium chlorite (25 % aqueous solution)
Lot/Batch number: 403 D
Description: Pale yellow liquid
Purity: 25.3 % aqueous solution

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Source:Charles River, France
Weight (average) at study initiation: male 150 g; female 133 g

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Postexposure period: 14 days

Doses:

150, 200, 250, 400, 450 and 500 mg/kg
Concentration in vehicle:15, 20, 25, 40, 45 and 50 mg/ml
Total volume applied:10 ml/kg

No. of animals per sex per dose:

5 animals/sex/group

Control animals:

no

Details on study design:

Clinical signs, mortality, body weight and pathology were assessed in the study.

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

284 mg/kg bw

Based on:

test mat.

95% CL:

204 - 347

Remarks on result:

other: LD50 value for sodium chlorite

Effect levels 2

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

212 mg/kg bw

Based on:

act. ingr.

Remarks on result:

other: LD50 value for chlorite

Mortality:

No mortality was observed at doses of 150 and 200 mg/kg. At doses of 250, 400, 450 and 500 mg/kg, mortality appears from the first day, one hour after treatment, and occurs until day 4 (see table A6_1_1(2)-1).

Clinical signs:

other: Effects are observed 15 to 30 minutes after administration of the product. Hypokinesia, cyanosis and prostration were noted. Animals were found in a position of lateral or ventral decubitus.

Gross pathology:

No macroscopic lesions attributable to the treatment were observed for doses of 150 and 200 mg/kg. Brown colouration of the organs of the abdominal and thoracic cavity was observed for animals treated at doses of 250, 400, 450 and 500 mg/kg. Each organ presenting macroscopic abnormalities was removed and conserved in the appropriate fixing agent.

Any other information on results incl. tables

Table A6_1_1(2)-1.        Table for Acute Toxicity
Dose (mg/kg)	% mortality			Time of death (range)		Observations
	male	female	male + female	male	female
150	0	0	0	-	-
200	0	0	0	-	-
250	60	100	80	day 1 day  2	day 0 (1h) day 1 day 3
400	60	60	60	day 0 (3h) day 1	day 0 (3h) day 1 day 2
450	60	100	80	day 0 (3h) day 1	day 0 (3h) day 1
500	100	80	90	day 0 (3h) day 1 day 2	day 0 (1h) day 0 (3h) day 1
LD50 value	238 mg/kg (95% C.L. = 203.70 – 346.50 mg/kg)

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

The LD50 of Sodium chlorite (pure active) administered orally is 284 mg/kg, with 95% confidence limits of 204 and 347 mg/kg (equivalent to 212 mg/kg as chlorite). At doses of 150 and 200 mg/kg the treatment does not cause any effects. At higher doses, the effects appear at least 30 minutes after treatment and include hypokinesia, cyanosis, prostration and piloerection. Certain animals are in a position of lateral or ventral decubitus. There are no dose-related body weight changes at 150 mg/kg, whereas at higher doses there is body weight loss in some animals between days 0 and 4, but this is regained from days 7 to 14. A macroscopic examination of the organs of animals treated at 150 and 200 mg/kg did not reveal any anomalies. At higher doses macroscopic anomalies are observed in organs of the abdominal and thoracic cavity (brown colouration).

Executive summary:

The aim of the study was to determine the oral acute toxicity due to the test material.

The test procedure was performed according to OECD Guideline 401 (Acute Oral Toxicity) under GLP conditions.

Concentrations: 150, 200, 250, 400, 450 and 500 mg/kg.

The results were as follows:

The LD50 of Sodium chlorite (pure active) administered orally is 284 mg/kg, with 95% confidence limits of 204 and 347 mg/kg (equivalent to 212 mg/kg as chlorite).