Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 December 1988 - 18 December 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Calcium peroxide
EC Number:
215-139-4
EC Name:
Calcium peroxide
Cas Number:
1305-79-9
Molecular formula:
CaO2
IUPAC Name:
calcium peroxide
Constituent 2
Chemical structure
Reference substance name:
Calcium dihydroxide
EC Number:
215-137-3
EC Name:
Calcium dihydroxide
Cas Number:
1305-62-0
Molecular formula:
CaH2O2
IUPAC Name:
calcium dihydroxide
Test material form:
solid

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.
- Age at study initiation: Young adult
- Weight at study initiation: 2.64 kg to 2.97 kg
- Housing: Individually in stainless steel cages.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23.3
- 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:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): Saline (just for moisturising)
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
6
Details on study design:
TEST SITE
- Area of exposure: Trunk (from the scapular to the pelvic region).
- % coverage: 100
- Type of wrap if used: Cheesecloth bandage
0.5 g test item was applied to 2 x 2 gauze pad and moistened with physiological saline. The gauze pad was secured to each test site with hypoallergenic tape. The entire trunk was wrapped with a semi-occlusive cheesecloth bandage. The animals were fitted with plastic collars to prevent disturbance of the test sites.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with clean gauze moistened with methanol, then rinsed with tap water.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
30 min after unwrapping, at 24, 48 and 72 hours.

SCORING SYSTEM:
- Method of calculation: Draize method.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #5
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
animal #6
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
No irritation was noted on any of the test sites during any of the scoring intervals.
Other effects:
All the animals remained healthy throughout the study.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was determined to be not irritating to the skin.
Executive summary:

An in-vivo skin irritation/corrosion test was performed according to the OECD Guideline 404 (GLP study). Three male and three female New Zealand White rabbits were treated topically on each of two test sites which were previously clipped free of hair. 0.5 g of test item was place in contact with eact 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 hours, after which the animals were unwrapped and the test item removed. The test sites were scored for irritating using the method of Draize at 30 minutes after unwrapping, at 24, 48 and 72 hours. No irritation was notes on any of the test sites during any of the scoring intervals (erythema and edema scores of 0). All the animals remained healthy throughout the study. Based on these results, the test item was determined to be not irritating to the skin.