Disodium carbonate, compound with hydrogen peroxide (2:3)

Skin irritation / corrosion

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

Test material information

Constituent 1

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 hydrogen peroxide 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

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 4 hours

Score:

2.2

Results 2

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 hours

Score:

1.2

Results 3

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 96 hours

Score:

1

Results 4

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 7 days

Score:

0.2

Results 5

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 14 days

Score:

0

Results 6

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Remarks on result:

other: very slight edema

Results 7

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.