Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin
Justification for type of information:
It is accepted that there is no dermal absorption of metal salts such as chromium III from dermal contact. The data for citric acid demonstrates no potential for toxicity by the dermal route. No further animal testing can be justified

The low oral toxicity also suggests low biological impact from contact with chromium III. It is not considered to be justified to perform further animal tests. Skin penetration experiments on chromium chloride and chromium sulfate (1.2% chromium labelled with 51Cr) with skin chambers glued to the skin of normal volunteers. These chambers were removed at 6, 12, or 24 hours and analysis for radioactive chromium was performed at the site of the chamber as well as in the underlying epidermis and dermis. As no label was found in the lower levels of skin, it was concluded that chromium(III) salts did not permeate through the intact epidermis. Some blood samples and 24-h urine were also examined, and no radioactive chromium was detected.[Mali JWH, Van Kooten WJ, Van Neer CJ (1963) Some aspects of the behaviour of chromium compounds in the skin. Journal of Investigative Dermatology, 41:111–122].

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion