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Toxicological information

Skin irritation / corrosion

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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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
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
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
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
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.