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Toxicological information

Acute Toxicity: oral

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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:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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 levelsopen allclose all
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
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:
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.
Body weight:
At doses of 150 mg/kg, there are no treatment-related body weight changes. At doses of 200 mg/kg, body weight loss was observed between days 0 and 4 in two males and one female. At higher doses body weight loss of the survivors was observed on day 4 for males and one female at 400 mg/kg.
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).