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Description of key information

Three Key studies and one supporting study for oral acute toxicity:
-Key study. OECD guideline. With rats. LD50= 284 mg/kg bw (pure active)
-Key study. EPA guideline. With rats. LD50= 390 mg/kg bw (31% aqueous solution)
-Supporting study. No data on test guideline. With rats. LD50 (male)=158 mg/kg bw. LD50 (female)= 177 mg/kg bw

-Key study. OECD guideline. With rats. 300 > LD50 < 2000 mg/kg bw (9% aqueous solution)

Two Key studies for dermal acute toxicity:
-Key study. EPA guideline. With rabbits. LD50= 134 mg//kg bw (male/female) (pure active)
-Key study. EPA guideline. With rabbits. Dermal LD50 >2000 mg//kg bw (31% aqueous solution)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Referenceopen allclose all

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

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)

 

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).

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 27th December 1984 to 7th February 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to
Guideline:
other: EPA 1978 40 CFR, Part 163
Deviations:
not specified
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Adult albino Sprague-Dawley rats, both sexes, weights 200g.
-rabbit food and water ad libitum
-12 hour night-day lighting cycle
-relative humidity 40-50%
-temperature of animal room 20-25ºC
-indirect bedding of absorbent liners over pine shavings-stainless steel wire cages of USDA specifications-animal quarantine and acclimitization prior to dosing
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
10% solution
Details on oral exposure:
Vehicle: water, volume: 0.97 cc/200g rat, route: per os
Doses:
0.5 g/kg bw0.25 g/kg bw
No. of animals per sex per dose:
10 animals per dose ( 5 male, 5 female)
Control animals:
no
Details on study design:
The rats were fasted for 24 hours and then individually marked.Animals were observed twice daily for signs of illness and death to a total of 14 days.
Statistics:
Dead rats:
-dose 0.5 g/kg: 70%
-dose 0.25 g/kg: 10%
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
390 mg/kg bw
Based on:
test mat.
Mortality:
-dose 0.5 g/kg: 70% dead rats-dose 0.25 g/kg: 10% dead rats
Body weight:
-dose 0.5 g/kg : average weight gain (males): +120.7g
-dose 0.25 g/kg: average total weight change: +72.8 g
Gross pathology:
Death of the animals occurred up to 6 days after dosing.The deaths were categorized as acute gastrointestinal poisoning.
Organs:-liver, spleen: normal-lungs: hepatization-stomach: erosion of epithelial lining, hemorrhage-small intestine: inflammation, hyperemia-large intestine: inflammation, hyperemia-kidney: spotted
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The result was as follows: LD50= 390 mg/kg bw (31% aqueous solution)
Executive summary:

The purpose of the study is to determine the oral dose that is lethal to 50% of adult rats.

The test was performed according to method EPA 1978 40 CFR, Part 163.

10 adult albino Sprague-Dawley rats per dose were used (both sexes, weights 200g).

Doses were: 0.5 g/kg and 0.25 g/kg.

The rats were fasted for 24 hours and they were observed twice daily to a total of 14 days.

The result was as follows:

LD50= 390 mg//kg bw (31% aqueous solution)

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
11 July 2017 - 08 August 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
no
Species:
rat
Strain:
Sprague-Dawley
Remarks:
(SPF Caw)
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Elevage Janvier Labs (53940 Le Genest St Isle - France)
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: 8-9- weeks
- Weight at study initiation: 213.5 g (mean)
- Fasting period before study: Food was removed on D-1 and then redistributed 4 hours after test item administration.
- Housing: Group of three in solid bottomed clear polycarbonate cages with a stainless steel mesh lid.
- Diet (e.g. ad libitum): Ad libitum (Envigo-2016)
- Water (e.g. ad libitum): Ad libitum (tap water)
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 (07.00 to 19.00)
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
distilled water
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 1.82 mL/kg bw

DOSAGE PREPARATION (if unusual):
Dose of 2000 mg/kg bw: 1.82 mL/k bw (unchanged)
Dose of 300 mg/k bw: 0.27 and 0.57 mL of the test item (corresponding to 300 mg) were added to 1.55 mL and 3.10 mL of distilled water respectively. The preparations were stirred by vortex to obtain colorless solutions just before the administration. Each preparation was administered under a volume of 1.82 mL/kg bw.
Doses:
2000 mg/kg bw
300 mg/kg bw
No. of animals per sex per dose:
2000 mg/kg bw: 1 female rat
300 mg/kg bw: 5 female rats
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Systemic examinations: 30 min, 1h, 3h, 4h, 1d and 2d and during 14 days following administration of the test item.
Clinical observations and mortality: Everyday for 14 days.
Parameters observed: Spontaneous activity, Preyer's reflex (noise), respiration rate, convulsions, tremors, body temperature, muscle tone, palpebral opening, pupil appearance, salivation, lachrymation, righting reflex, back hair appearance, mortality.
Weighing: D0 (just before administration), D2, D7 and D14.
- Necropsy of survivors performed: yes
Only those organs likely to be modified in cases of acute toxicity were examined: Oesophagus, stomach, duodenum, jejunum, ileon, caecum, colon, rectum, spleen, liver, thymus, trachea, lungs, heart, kidneys, urinary bladder, ovaries, uterus, adrenals, pancreas.
- Other examinations performed:
Systemic observations were compared to historical control data.
The body weight evolution of animals treated with the test item was compared with the body weight evolution of the historical control group.
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
> 300 - <= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
The animal treated at the dose of 2000 mg/kg bw was found dead on day 5.
No mortality was noted in animals treated at the dose of 300 mg/kg bw.
Clinical signs:
2000 mg/kg bw: Mortality was preceded by an absence or a decrease in spontaneous activity, muscle tone, Preyer's reflex and righting reflex, associated with bradypnea, eyes partly closed, piloerection, hypothermia, myosis, and dark yellow to brown coloration of urines.
300 mg/kg bw: No clinical signs observed.
Body weight:
2000 mg/kg bw: Decrease of body weight (-15%) was noted on day 2 versus day 0.
300 mg/kg bw: Normal body-weight evolution throughout the study.
Gross pathology:
2000 mg/kg bw: A blue abdomen was noted before the necropsy. Macroscopic observations on day 6 revealed a thinning of forestomach and a thinning of greenish corpus. Furthermore, lysis of the main organ was noted.
300 mg/kg bw: No treatment related changes observed.
Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
The LD50 of sodium chlorite 9% water solution between 300 and 2000 mg/kg bw by oral route in the rat.
Executive summary:

An acute toxicity test was performed on sodium chlorite 9% water solution according to OECD Guideline 420 (GLP study). The test item was administered to 1 female rat at a dose of 2000 mg/kg bw and then to a group of 5 females at a dose of 300 mg/kg bw. Systemic examinations, clinical observations and mortality were performed during 14 days. Body weight evolution was also analysed (weighing at D0, D2, D7 and D14). On day 14, the animals were euthanized and macroscopic observations were performed. The animal treated at the dose of 2000 mg/kg bw was found dead on day 5. The mortality was preceded by an absence or a decrease in spontaneous activity, muscle tone, Preyer's and righting reflex, associated with bradypnea, eyes partly closed piloerection, hypothermia, myosis and dark yellow to brown coloration of urines. A decrease of body weight (-15%) was also noted on day 2 versus day 0. A blue abdomen was noted before necropsy. The macroscopic examination of the animal, performed on day 6, revealed a thinning of forestomach and thinning of greenish corpus. Furthermore lysis of the main organ was noted. On the other hand, no mortality was noted in animals treated at the dose of 300 mg/kg bw. No clinical signs were related to the test item and the body weight evolution remained normal throughout the study. Macroscopic examinations did not reveal treatment related changes. In conclusion, the LD50 of sodium chlorite 9% water solution between 300 and 2000 mg/kg bw by oral route in the rat.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
284 mg/kg bw
Quality of whole database:
Klimisch 1. This study was carried out in accordance with internationally valid GLP principles.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
134 mg/kg bw
Quality of whole database:
Klimisch 1. This study was carried out in accordance with internationally valid GLP principles.

Additional information

Acute inhalation toxicity:

In accordance with column 2 of REACH Annex VIII, an acute inhalation toxicity study is not required since exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. Although sodium chlorite is a solid, there is no exposure to sodium chlorite in this form. The products containing sodium chlorite are all supplied as aqueous solutions. Based on its low vapour pressure there will be no release of sodium chlorite to the atmosphere from aqueous solutions.

Justification for classification or non-classification

Oral toxicity:

LD50 = 284 mg/kg bw (Acute oral toxicity Category 3)

Dermal toxicity:

LD50 = 134 mg/kg bw (Acute oral toxicity Category 2)