Registration Dossier
Registration Dossier
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EC number: 908-343-6 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented GLP study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Version / remarks:
- 1984
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 1981
- GLP compliance:
- yes
- Remarks:
- EPA Good Laboratory Practice Standards
Test material
- Reference substance name:
- reaction mass of calcium carbonate and calcium dihydroxide and calcium peroxide
- EC Number:
- 908-343-6
- Molecular formula:
- The substance is a reaction mass of a number of constituents and so the molecular formula of the substance to be registered is not available
- IUPAC Name:
- reaction mass of calcium carbonate and calcium dihydroxide and calcium peroxide
- Details on test material:
- - Test material: Calcium peroxide (high purity > 75% assay)
- Physical description: Tan powder
- Ref. No.: 804-26
- Storage: room temperature, away from heat
- Purity: 82.1%
- Stability: not determined
- Chemical composition: calcium peroxide
- Date received: 1988-10-21
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazleton Research Animals, Inc., Denver, Pennsylvania
- Received: 1988-12-16
- Age at study initiation: young
- Weight at study initiation: 2.74 ± 0.128 kg (ranging from 2.64 kg to 2.97 kg)
- Housing: individually in stainless stail cages
- Diet: ad libitum (Purina High Fiber Rabbit Chow 5326)
- Water: ad libitum (fresh tap water)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23
- Humidity (%): 34-47
- Photoperiod (hrs dark / hrs light): 12/12:
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- physiological saline
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g - Duration of treatment / exposure:
- approximately 4 h
- Observation period:
- 72 h
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: one test site was located on each side of the spinal column
- Type of wrap if used: semi-occlusive cheesecloth bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): test sites were wiped with clean gauze moistened with methanol, then rinsed with tap water
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize (1944)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable, no irritation observed
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no applicable. no irritation observed
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable. no irritation observed
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable. no irritation observed
- Irritation parameter:
- edema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable. no irritation observed
- Irritation parameter:
- edema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable. no irritation observed
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No irritation was noted on any of the test sites during any of the scoring intervals.
- Other effects:
- All animals remained healthy throughout the study.
Any other information on results incl. tables
Scoring interval (h) |
Overall score |
Edema |
Erythema |
4.5 |
0 |
0 |
0 |
24 |
0 |
0 |
0 |
48 |
0 |
0 |
0 |
72 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study no irritation was observed in any of the animals, on any of the test sites during any of the scoring intervals. As a consequence, the test material is judged to be non-irritating to intact skin when applied topically to New Zealand White rabbits.
- Executive summary:
Three male and three female New Zealand White rabbits were treated topically on each of 2 test sites which were previously clipped free of hair. One-half gram of Calcium peroxide (high purity > 75% assay) was placed in contact with each test site. The test sites were covered with gauze patches and the trunk of each animal was wrapped with a sheet of cheesecloth. The test material was in contact with the skin for 4 h, after which the animals were unwrapped and the test material removed. Approximately 30 min after the end of the exposure period, the test sites were scored for irritation using the method of Draize. The test sites were scored daily thereafter for three days.
No irritation (edema nor erythema) was noted on any of the test sites during any of the scoring intervals.
Under the conditions of this study, the test material is judged to be non-irritating to intact skin when applied topically to New Zealand White rabbits.
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