Hydrogen peroxide

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 study was carried out according to OECD Guideline for Testing of Chemicals No. 404, 1981, and under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen peroxide

EC Number:

231-765-0

EC Name:

Hydrogen peroxide

Cas Number:

7722-84-1

Molecular formula:

H2O2

IUPAC Name:

hydrogen peroxide

Details on test material:

Hydrogen peroxide, 10% w/w

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Species: Rabbit
Strain: New Zealand White
Source: Hazleton Research animals, Inc., Denver, Pennsylvania
Sex: Male and female
Age/weight at study initiation : Young adults 2.70-3.33 kg
Housing: individually in suspended, stainless steel, wire mesh cages
Feeding: Purina High Fibre Rabbit Chow 5326 ad libitum
Water: ad libitum
Room temperature: 69 to 73 °F
Relative humidity: 27 to 64 %
Light cycle: 12 hours light/12 hours darkness

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL of 10 % aqueous solution of hydrogen peroxide prepared by mixing on a stir plate prior to and during administration.

Duration of treatment / exposure:

4 hour(s)

Observation period:

30min after patch removal and at 24, 48 and 72 hours.

Number of animals:

3 males, 3 females

Details on study design:

On the day prior to administration the trunks of three male and three female rabbits were clipped free of hair with an electric clipper. The clipped area extended from the scapular to the pelvic region. One test site was located on each side of the spinal column. Eight-ply, 2x2 inch gauze pads were secured to the test sites with hypoallergenic tape. One half mL of the test material per test site was introduced under each of the gauze pads. The entire trunk of the animals was wrapped with a semi-occlusive cheesecloth bandage. The animals were fitted with plastic Elizabethan collars after treatment.
Approximately 4 hours after administration the wrapping and pads were removed and test sites were wiped with clean gauze moistened with methano, then rinsed with tap water. The collars remained on the animals until termination of the study.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 72 hours

Score:

0.08

Max. score:

8

Reversibility:

fully reversible within: 48 hours

Remarks on result:

other: 10 % solution

Irritant / corrosive response data:

The Primary Irritation Index for the test material was 0.08/8.0. The group irritation scores for each scoring interval were: 4.5 hours, 0.3; 24 hours, 0.2; 48 hours, 0; 72 hours, 0. Slight erythema was noted on two rabbits during the first 24 hours post-dosing. All irritation resolved within 48 hours and the test was terminated following the 72 hours scoring.

Other effects:

All animals remained healthy throughout the study.

Any other information on results incl. tables

Table 1: Individual scores for skin irritation

Time	Erythema
Sex	Male			Female
Animal No	B7480	B7481	B7496	B7504	B7507	B7508
after 0.5 h	1	0	0	0	0	1
after 24 h	1	0	0	0	0	0
after 48 h	0	0	0	0	0	0
after 72 h	0	0	0	0	0	0
mean score 24-72 h	0.5	0	0	0	0	0
	0.16			0
Mean score (male and female)	0.08/8
Time	Oedema
Sex	Male			Female
Animal No	B7480	B7481	B7496	B7504	B7507	B7508
after 0.5 h	0	0	0	0	0	0
after 24 h	0	0	0	0	0	0
after 48 h	0	0	0	0	0	0
after 72 h	0	0	0	0	0	0
mean score 24-72 h	0	0	0	0	0	0
	0			0
Mean score (male and female)	0/8

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

No classification for skin irritation is required for 10% hydrogen peroxide according to Directive 2001/59/EC (adaptation of 67/548/EEC) and to Regulation (EC) No 1272/2008.

Executive summary:

The irritation potential of a 10 % aqueous solution of hydrogen peroxide was tested on three male and three female New Zealand White rabbits according to OECD Guideline No. 404, 1981. After dermal administration of the test material the application sites were covered in a semi-occlusive manner for 4 hours. Test animals were fitted with Elizabethan collars throughout the study. Effects on the skin were assessed according to the method of Draize. Slight erythema occurred in two animals 24 hours post-dosing. The individual erythema scores did not exceed one. All individual oedema scores were zero throughout the study. All irritation resolved within 48 hours and the test was terminated after 72 hours. Based on the test results the tested 10% w/w solution of hydrogen peroxide is considered to be not irritating to the rabbit skin.