Sodium chlorite

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

In vivo study, the test was conducted in 1994 before REACH Regulation (EC) 1907/2006 entered into force.

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:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

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

Details on test material:

Test material: Sodium chlorite (34.5 % solution)
Lot/Batch number: Tank R7151 Elf Atochem
Description: Yellow liquid
Purity: 34.5% aqueous solution of sodium chlorite

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Source:Elevage Cunicole de Val de Selle, Prouzel, France
Sex:Male
Weight at study initiation:2.6 ± 0.2 kg

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: No vehicle was used as the test material is an aqueous solution

Controls:

other: Animals 02 and 03 did not receive any test substance on the left flank, and served as controls.

Amount / concentration applied:

The test substance was applied to a 6 cm2 dry hydrophilic gauze patch, which was then applied to the posterior left flank of the animals (animal No.01) or the right flank of all 3 animals.Total volume applied: 0.5 mL

Duration of treatment / exposure:

The test substance was applied in a first assay for a period of 3 minutes in animal 01. As the test substance was non corrosive, it was applied in a second assay for 4 h. The results were then confirmed on 2 additional animals (nos. 02 and 03).

Observation period:

10 days

Number of animals:

3 rabbits/group

Details on study design:

SCORING SYSTEM:Dermal irritation was evaluated for each animal according to the following scoring scale:
Erythema and eschar formation:
No erythema 0
Very slight erythema (barely perceptible)1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth)4

Oedema formation:
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond area of exposure) 4

Examination time points: 1 h, 24 h, 48 h, 72 h after removal of the dressing and then daily until day 10.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: Mean score from days 2, 3 and 4

Score:

0

Remarks on result:

other: 3 minute treatment

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: Mean score from days 2, 3 and 4

Score:

1

Remarks on result:

other: 4 hour treatment

Results 3

Irritation parameter:

erythema score

Basis:

animal: 2 and 3

Time point:

other: Mean score from days 2, 3 and 4

Score:

0

Remarks on result:

other: 4 hour treatment

Results 4

Irritation parameter:

edema score

Basis:

animal: 1, 2 and 3

Time point:

other: Mean score from days 2, 3 and 4

Score:

0

Remarks on result:

other: 4 hour treatment

Irritant / corrosive response data:

Treatment for 3 minutes – only a dryness of the skin was observed on days 4 and 5.Treatment for 4 hours – No cutaneous reactions were observed during the study in 2 animals given the test substance for 4 h. In one animal treated with the test substance during 4 hours, very slight reversible erythema and / or dryness of the skin was noted within 9 days. No necrosis or ulceration was observed.

Any other information on results incl. tables

Table A6_1_4i-1             Table for skin irritation study
	time	Erythema	Edema
average score per animal	01	1.0	0.0
	02	0.0	0.0
	03	0.0	0.0
reversibility: *		C	N/A
average time for reversibility
*      c :      completely reversible      n c :      not completely reversible         n :      not reversible

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Not classified according to CLP criteria.

Conclusions:

A 34.5 % aqueous solution of sodium chlorite is a non-irritant when administered by cutaneous route in rabbits.

Executive summary:

Study in rabbits according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion).

A 34.5 % aqueous solution of sodium chlorite is a non-irritant when administered by cutaneous route in rabbits.