Registration Dossier

Administrative data

Description of key information

Under the conditions of the tests, the test substance is not classified according to EU or GHS criteria for skin or eye irritation.

Key value for chemical safety assessment

Additional information

Based on read across to a similar substance, disodium dihydrogen 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate, tripotassium hydrogen EDTA is non-irritating to the eyes and skin of rabbits.

A well defined erythema was observed on the ear of both animals which was fully reversible within 48 h. Both animals showed some redness of the conjunctivae (score 1), 24 h after application of the TS. The same effect was observed in the talcum powder treated eye. This effect was fully reversible 48 h in animal 1 and at least within 8 days. In the naturally-buffered conditions in the plasma in the human body and in animals, the anions will dissociate from the EDTA, leaving the EDTA anion available to chelate with other cations (as is its function).  This is also true in in vitro experiments that are buffered.  So, it does not matter what the cationic component of the salt is.  Therefore, using the available study data for the disodium salt of EDTA is valid for registration purposes for the tripotassium salt of EDTA.

Justification for classification or non-classification