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EC number: 231-836-6 | CAS number: 7758-19-2
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:
- 1 994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- 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
Constituent 1
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
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 |
|||
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.
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