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Toxicological information

Skin irritation / corrosion

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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:
1989
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

Constituent 1
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

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

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
animal: all animals
Time point:
other: 4.5, 24, 48 and 72 hours
Score:
0
Max. score:
8
Reversibility:
other: not applicable, no irritation observed
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.