Hydrogen peroxide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation

Remarks:

in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: The study was carried out clearly before current guidelines came into place. It does not meet modern requirments due to too few animals and inadequate reporting.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1953

Materials and methods

Principles of method if other than guideline:

The method used in the study was a modification of the Magnusson-Kligman procedure

GLP compliance:

no

Type of study:

other: Skin sensitization test

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:

A 3 % nonelectrolytic solution of hydrogen peroxide, restabilised according to the Peroxygen Products Bulletin, p. 3-1051

In vivo test system

Test animals

Species:

guinea pig

Strain:

not specified

Sex:

not specified

Details on test animals and environmental conditions:

no data

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal and epicutaneous

Vehicle:

physiological saline

Induction 2

Concentration / amount:

0.1 % solution (intradermal application) or 3 percent solution (epicutaneous application)

Challenge

Challenge 1

Route:

intradermal and epicutaneous

Vehicle:

physiological saline

Challenge 2

Concentration / amount:

0.1 % solution (intradermal application) or 3 percent solution (epicutaneous application)

No. of animals per dose:

10 animals received initial patch; the skin of 5 of these animals was scratched and test material was applied to the scratched skin; the 5 remaining received intradermal injection of test material

Details on study design:

The material was applied six times, either intradermally (0.1 mL) or to the scratched skin (one drop of solution).

Challenge controls:

The animals had a two-week rest period afterwards. Then, the substance was applied once intradermally (0.1 mL) or epicutaneously (1 drop of solution). The skin reactions were observed after 1, 24 and 48 hours.

Positive control substance(s):

no

Results and discussion

In vivo (non-LLNA)

Results

Reading:

rechallenge

Hours after challenge:

48

Group:

test chemical

Dose level:

0.1 mL (0.1 % or 3 % solution)

No. with + reactions:

3

Total no. in group:

10

Clinical observations:

no data

Remarks on result:

other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1 mL (0.1 % or 3 % solution). No with. + reactions: 3.0. Total no. in groups: 10.0. Clinical observations: no data.

Any other information on results incl. tables

Table 1: Results of the test on skin sensitisation induced by hydrogen peroxide.

Test	Animals showing reaction	Animals showing no reaction
Initial patch	3 E -	7 neg
Scratch	2 E -	3 neg
Intradermal	3 E -	2 neg
Final patch	3 E -	7 neg
Scratch	2 E -	3 neg
Intradermal	1 E*, 3 E -	1 neg
Saline	None	5 neg
Control	4 E -	1 neg

Reactions were graded according to intensity of erythema ranging from faint pink (E -) to a definite red (E). Absence of erythema was recorded as “neg”. * Haemorrhagic reaction.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Remarks:

Migrated information

Conclusions:

The testing of nine different solutions of hydrogen peroxide did not result in sensitisation.

Executive summary:

A skin sensitisation test was carried out with guinea pigs according to a modified version of the Magnusson-Kligman procedure. Six sensitising applications of 0.1 % solution of hydrogen peroxide (intradermally) or of 3 % solution of hydrogen peroxide (epicutaneously to abraded skin) were tested on five animals each. After a rest period of two weeks, the solutions were applied once using the same concentrations and application routes. The skin reactions were observed after 1, 24 and 48 hours. None of the solutions was found to be sensitising to the skin of the guinea pigs.