Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Based on available data, it might be concluded that the substance is not a skin sensitizer. Thus, it is deemed that further studies on skin sensitization are not scientifically justified.

According to the EU Risk Assessment Report (2003), pg. 114-115, in spite of two reported cases of positive patch tests to hydrogen peroxide and the uncertainty surrounding an outdated animal study (with a negative result), and on recognition of the widespread occupational and consumer use over many decades, it may be confidently stated that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.

Moreover, there is no evidence of any sensitization potential for calcium compounds. Calcium is abundantly available in the environment, in food and extensively distributed throughout the human body. Sensitisation by or intolerance to an abundantly available essential element such as calcium would be grossly implausible and can therefore safely be excluded.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion