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Skin sensitisation

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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

Constituent 1
Chemical structure
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)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
0.1 % solution (intradermal application) or 3 percent solution (epicutaneous application)
Challengeopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
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 β€œneg”. * 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.