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EC number: 234-390-0 | CAS number: 11138-47-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987-04-28 to 1987-05-01
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
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 Perborate Monohydrate
- IUPAC Name:
- Sodium Perborate Monohydrate
- Details on test material:
- -Physical state: white granules
-Analytical purity: not stated
-Lot/batch No.: not stated
-Storage condition of test material: ambient room temperature and humidity
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Source: Clifford Roedel
-Age at study initiation: no data
-Weight at study initiation: no data
-Housing: 1 per cage
-Diet: ad lib.
-Water: ad lib.
-Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
-Temperature (°C): controlled
-Humidity (%): controlled
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- not specified
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
-Amount(s) applied (volume or weight with unit): 0.5 gram
VEHICLE
-Amount(s) applied (volume or weight with unit): test item was moistened with a suitable vehicle - Duration of treatment / exposure:
- 4 hrs
- Observation period:
- Animals were observed for skin reactions at 30 to 60 min after removal of wrappings and again at 24, 48 and 72 hrs
- Number of animals:
- 3
- Details on study design:
- TEST SITE
-Area of exposure: 6 cm
-Type of wrap: semi-adhesive dressing which was secured with non-irritating tape
REMOVAL OF TEST SUBSTANCE
-Washing: yes
-Time after start of exposure: 4 hrs
SCORING SYSTEM
according to Draize
The general health of the animals was monitored at each observation time.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 1, 2 and 3
- Time point:
- other: 0.5 - 1 h; 24, 48 and 72 hrs
- Score:
- 1 - 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 72 hrs (2 animals)
- Remarks on result:
- other: for details see table below
- Irritation parameter:
- edema score
- Basis:
- animal: 1, 2 and 3
- Time point:
- other: 0.5 - 1 h; 24, 48 and 72 hrs
- Score:
- 0 - 1
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48 hrs (2 animals)
- Remarks on result:
- other: for details see table below
- Irritant / corrosive response data:
- Erythema (slight at 30 min and 24/48 hrs after patch removal) was absent to slight after 72 hrs. Oedema was absent to slight at all observation periods. No corrosive effects noted.
Any other information on results incl. tables
|
Animal 1 |
Animal 2 |
Animal 3 |
Erythema / Eschar formation |
Score |
Score |
Score |
0.5 - 1 h |
2 |
2 |
2 |
24 hrs |
2 |
2 |
1 |
48 hrs |
1 |
2 |
1 |
72 hrs |
1 |
0 |
0 |
|
|
|
|
Oedema |
|
|
|
0.5 - 1 h |
1 |
1 |
0 |
24 hrs |
1 |
1 |
0 |
48 hrs |
0 |
1 |
0 |
72 hrs |
0 |
1 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- Category 3 (mild irritant) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Sodium Perborate Monohydrate was mild irritating to the skin of rabbits according to the GHS classification system (Category 3, reversible effects in dermal tissue, Draize score >= 1.5 to < 2.3).
- Executive summary:
In a skin irritation/corrosion study according to OECD 404, three rabbits were dosed with Sodium Perborate Monohydrate under semi-occlusive conditions to the intact clipped skin at a dose level of 0.5 g/animal.
After an exposure period of 4 hours, patches were removed and sites washed. Dermal reactions were scored according to Draize at 1, 24, 48 and 72 hours after patch removal.
Erythema, slight at 30 min and 24 and 48 hours, was absent to slight after 72 hours. Oedema was absent to slight at all observation periods.
According to GHS, the test item can be classified as mild irritant (Category 3).
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