Reaction mass of calcium carbonate and calcium dihydroxide and calcium peroxide

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Remarks:

no data

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: The cited statement is taken from the European Union Risk Assessment Report for hydrogen peroxide.

Data source

Reference

Reference Type:

review article or handbook

Title:

European Union Risk Assessment Report, Hydrogen Peroxide, CAS-No. 7722-84-1

Author:

European Commission

Year:

2003

Bibliographic source:

European Commission: European Chemicals Bureau, Existing Substances, 2nd Priority List, Vol. 38

Materials and methods

Principles of method if other than guideline:

Not applicable

GLP compliance:

no

Type of study:

not specified

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:

Not applicable

In vivo test system

Test animals

Species:

other: humans

Sex:

male/female

Details on test animals and environmental conditions:

Members of the general Finnish population

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

epicutaneous, open

Vehicle:

other: hair dresser's chemicals

Induction 2

Concentration / amount:

3%

Challenge

Challenge 1

Route:

epicutaneous, open

Vehicle:

other: hair dresser's chemicals

Challenge 2

Concentration / amount:

3%

No. of animals per dose:

Not applicable

Details on study design:

Not applicable

Challenge controls:

Not applicable

Positive control substance(s):

no

Results and discussion

Positive control results:

Not applicable

In vivo (non-LLNA)

Results

Reading:

other: not applicable

Group:

other: not applicable

Dose level:

3%

No. with + reactions:

2

Total no. in group:

158

Clinical observations:

Test persons were also allergic to other substances in the tested mixtures

Remarks on result:

other: Reading: other: not applicable. Group: other: not applicable. Dose level: 3%. No with. + reactions: 2.0. Total no. in groups: 158.0. Clinical observations: Test persons were also allergic to other substances in the tested mixtures.

Applicant's summary and conclusion

Interpretation of results:

not sensitising

Conclusions:

Hydrogen peroxide is not a skin sensitiser.

Executive summary:

The following text is copied from the EU Risk Assessment Report (2003), pg. 114-115:

"The skin sensitising property of nine different 3% hydrogen peroxide preparations was studied with guinea pigs using a modification of the Magnusson-Kligman procedure (Du Pont, 1953). For sensitisation five animals were given six intradermal injections of 0.1 ml 0.1% hydrogen peroxide over a 2-week period; another group of five animals received six times one drop of 3% hydrogen peroxide to the abraded skin. After a 2-week rest period the animals were challenged with a single treatment of the previous type. The skin reactions were observed at 1, 24 and 48 hours. Primary irritancy of substance on intact skin was also studied in the ten animals before the sensitisation treatment and prior to the challenge. The study does not meet modern requirements due to few animals used and inadequate reporting. However, based on summary results, all the nine hydrogen peroxide substances appeared not to sensitise (ten animals used per substance).

There is one clinical report of two cases on positive patch tests to hydrogen peroxide (Aguirre et al., 1994). The first case was a 20-year-old woman, with no previous history of atopy and allergies, who had been working as a hairdresser for 4 years, the other case was a 27-year-old housewife, with no atopy or previous allergies, who had dyed her hair herself at home every 1 to 2 months for the last 6 years. In both cases the skin reactions to 3% hydrogen peroxide were strong; the former patient was positive also for nickel sulfate and 4-aminophenol, the latter for nickel sulfate, PPD, formaldehyde, 4-aminophenol, glyceryl monothioglycolate and cocamidopropylbetaine. The authors reported that 156 other hairdressers patch tested with the hairdresser’s series of chemicals were all negative to hydrogen peroxide 3%. The Dermatological Department at the Finnish Institute of Occupational Health has since 1985 tested dermatitis patients having had exposure to hairdressing chemicals (mainly hairdressers) with a series of test substances containing 3% hydrogen peroxide in water. Computerised records were available concerning test results since 1991: 130 patients have been tested with no allergic reactions, one patient exhibited an irritant reaction. The Finnish Register of Occupational Diseases which was searched from 1975 through 1997 did not contain any cases of allergic dermatosis caused by hydrogen peroxide. The Dermatology Department of the University Central Hospital in Turku, Finland, patch tested 59 patients with 3% hydrogen peroxide during 1995-96, no positive reactions were found (Kanerva et al., 1998).

In spite of two reported cases of positive patch tests to hydrogen peroxide and the uncertainty surrounding an outdated animal study (with a negative result), and on recognition of the widespread occupational and consumer use over many decades, it may be confidently stated that the potential of hydrogen peroxide to cause skin sensitisation is extremely low and therefore do not meet the criteria for classification."