Registration Dossier

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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The test was carried out according to the Health Effects Test Guidelines of the US Environmental Protection Agency Office of Pesticides and Toxic Substances, pp. 41-48 (August 1982) and following the conditions of GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Health Effects Test Guidelines of the US Environmental Protection Agency Office of Pesticides and Toxic Substances, pp. 41-48 (August 1982)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium carbonate, compound with hydrogen peroxide (2:3)
EC Number:
239-707-6
EC Name:
Disodium carbonate, compound with hydrogen peroxide (2:3)
Cas Number:
15630-89-4
Molecular formula:
CH2O3.3/2H2O2.2Na
IUPAC Name:
tetrasodium tris(peroxol) dicarbonate
Details on test material:
- Name of test material (as cited in study report): FB sodium percarbonate
- Physical state: white granules
- Analytical purity: sponsor assumes responsibility for purity and stability determinations (including under test conditions)
- Lot/batch No.: I2439101

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
Young adult rabbits were procured, maintained individually in screen-bottom cages in temperature- and humidity-controlled (64-78 °F, 33-65 % humidity), provided access to water ad libitum and a measured amount of High Fiber Rabbit Chow 5326, Purina Mills, Inc., and held for an acclimation period of at least 7 days.
Six acclimated animals, weighing from 2608 to 2914 g, were chosen at random for the test, treated and maintained during the observeation period as specified for the acclimation period. Within 24 hours before treatment the hair was clipped from the back and flanks of each animal.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
The test material was applied to the intact skin of each rabbit in the amount of 0.5 g and moistened with 0.9 % physiological saline.
Duration of treatment / exposure:
4 h
Observation period:
0.5; 24; 48; 72 and 96 hours and day 7 and 14 after patch removal
Number of animals:
6
Details on study design:
The treated area was covered with a 2.5 x 2.5 cm gauze patch secured with paper tape, loosely overwrapped with Saran Wrap and secured with Elastoplast tape to provide a semiocclusive dressing. Collars were applied to restrain the test animals for the 4-hour exposure period.
After the exposure period, the patches were removed. The test site was washed using lukewarm water and disposable paper towels. The test materiaal was removed from the test sites as thoroughly as possible. Thirty minutes following removal of the test material, the degree of erythema and edema was read according to the Draize technique. Subsequent examinations were made at 24, 48, 72 and 96 hours and days 7 and 14 after patch removal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 4 hours
Score:
2.2
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 24 hours
Score:
1.2
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 96 hours
Score:
1
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 7 days
Score:
0.2
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: 14 days
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
other: very slight edema
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Remarks on result:
probability of weak irritation
Irritant / corrosive response data:
The dermal application of the test material caused at least very slight erythema in all of the test animals and at least very slight edema in four of six test animals.
Other effects:
No other effects were reported.

Any other information on results incl. tables

Table 1: Individual dermal irritation scores.

Animal number

Sex

Hours after patch removal

Days after patch removal

4

24

48

72

96

7

14

Erythema

F30068

Male

1

0

0

0

0

0

0

F30069

Male

2

1

1

1

1d

0

0

F30070

Male

2a,b

2a,b

2a,b

2a,b

2a,b

1d

0

F30071

Female

1

0

0

0

0

0

0

F30072

Female

1

1

1

1

1

0

0

F30073

Female

1

1

1

1

1

0

0

Edema

F30068

Male

0

0

0

0

0

0

0

F30069

Male

1

0

0

0

0

0

0

F30070

Male

2

2

2

2

1

0

0

F30071

Female

0

0

0

0

0

0

0

F30072

Female

1

0

0

0

0

0

0

F30073

Female

1

0

0

0

0

0

0

a – subcutaneous haemorrhaging

b – blanching

d – desquamation

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Application of FB sodium percarbonate to rabbit skin under 4-hour semioccluded conditions resulted in slight to moderate erythema and edema reactions. Only one test animal had mean erythema and oedema scores of 2 from gradings at 24, 48 and 72 hours after patch removal. All other test animals had mean erythema and oedema scores of 1 or below from gradings at 24, 48 and 72 hours. The substance is therefore considered as non-irritating to the skin.
Executive summary:

A skin irritation test was performed with sodium percarbonate applied to the skin of six female and male rabbits for 4 -hour semioccluded conditions in accordance with the Health Effects Test Guidelines of the US Environmental Protection Agency Office of Pesticides and Toxic Substances, pp. 41-48 (August 1982) and following the conditions of GLP.

Only one test animal had mean erythema and oedema scores of 2 from gradings at 24, 48 and 72 hours after patch removal. All other test animals had mean erythema and oedema scores of 1 or below from gradings at 24, 48 and 72 hours. The substance is therefore considered as non-irritating to the skin.