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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Unnamed
Year:
2003
Report Date:
2003
Reference Type:
review article or handbook
Title:
Wasserstoffperoxid
Author:
Deutsche Forschungsgemeinschaft (DFG). Senatskommission zur Prüfung gesundheistschädlicher Arbeitsstoffe
Year:
2006
Bibliographic source:
Wiley Online Library. The MAK Collection for Occupational Health and Safety.
Report Date:
2006

Materials and methods

Test guideline
Guideline:
other: patch test in humans; technical details not reported
Deviations:
not applicable
Principles of method if other than guideline:
- Principle of test: pactch in humans
- Short description of test conditions: not available
GLP compliance:
not specified
Type of study:
patch test
Justification for non-LLNA method:
existing data

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
CAS number: 7722-84-1
Purity: not stated

In vivo test system

Test animals

Species:
other: human
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
-cohort of hairdresses with allergic dermatitis (Leino et al., 1998)
-two cohorts of dermazitis patiemts (Kanerva et al., 1985)

Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
not specified
Concentration / amount:
not specified
Day(s)/duration:
not specified
Adequacy of induction:
not specified
Challenge
No.:
#1
Route:
other: not specified; patch test in humans
Vehicle:
not specified
Concentration / amount:
not specified
Day(s)/duration:
not specified
Adequacy of challenge:
not specified
No. of animals per dose:
- 35 hairdresses with allrgic dermatitis (Leino eta al. 1998)
- 54 hairdressers out of acohort of 355 patients (Leino et al. 1998)
- two studies with 130 and 59 pateints, respectively (Kanerva et al. 1998)
Details on study design:
No other details are reported apart from human patch testing in dermatitis patients without or with conatct to hydrogen peroxide conatining materials (hairdressers)
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
other: study Leino et al. (1998)
Group:
test group
Dose level:
not reported
No. with + reactions:
0
Total no. in group:
35
Clinical observations:
not reported
Remarks on result:
other: hairdressers with allergic dermatitis
Key result
Reading:
other: study Leino et al. (1998b) hairdressers with allergic dermatitis
Group:
test group
No. with + reactions:
0
Total no. in group:
54
Clinical observations:
not reported
Remarks on result:
other: 54 hairdressers in a cohort of 355 patienst
Key result
Reading:
other: study Kaverna et al. (1998)
Group:
test group
No. with + reactions:
0
Total no. in group:
130
Clinical observations:
not reported
Remarks on result:
other: dermatitis patients were examined
Key result
Reading:
other: study Kaverna et al. (1998)
Group:
test group
Dose level:
not reported
No. with + reactions:
0
Total no. in group:
59
Clinical observations:
not reported
Remarks on result:
other: dermatitis patients were examined

Any other information on results incl. tables

References cited in the assesements:

Kanerva L, Jolanki V, Riihimäki V, Kalimo K (1998) Patch test reactions and occupational dermatoses

caused by hydrogen peroxide. Contact Dermatitis 39: 146

Leino T, Estlander T, Kanerva L (1998 a) Occupational allergic dermatoses in hairdressers. Contact Dermatitis 38: 166–167

Leino T, Tammilehto L, Hytönen M, Sala E, Paakulainen H, Kanerva L (1998 b) Occupational skin and respiratory diseases among hairdressers. Scand J Work Environ Health 24: 398–406

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
In several independent studies in patients with allergic dermatitis and/or occupational contact with hydrogen peroxide containing materials no skin sensitising potential of hydrogen peroxide was determined.
Executive summary:

According to the ECB (2005) and DFG (2006) assessment reports, the skin sensitising potential of hydrogen peroxide was examined in several independent studies in patients with allergic dermatitis and/or occupational contact with hydrogen peroxide containing materials.

All tests conducted during 1974-1993 in 35 hairdressers were negative (Leino et al., 1998a), as well as the tests in another 54 hairdressers (Leino et al., 1998b). Negative results were also obtained in another two studies with either 130 or 59 patients, conducted during 1991 and 1997 (Kanerva et al., 1985).

Further, the Finnish Register of Occupational Diseases, which was searched from 1975 through 1997 for cases of allergic dermatosis caused by hydrogen peroxide, did not contain any such case among the total of 29,800 cases of allergic dermatosis.

The finds of the human patch tests are considered to be valid and suitable to demonstrate that hydrogen peroxide lacks a skin sensitising potential.