Registration Dossier

Toxicological information

Endpoint summary

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Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Based on read-across from the related substance disodium dihydrogen EDTA, tripotassium hydrogen EDTA was found to be non-sensitizing. Both sodium and potassium ions have low toxicity levels. E.g. the recommended daily intake for humans is 1 – 3g sodium and 2 – 3.4g potassium with symptoms reported for insufficient (hypokaliaemy) as well as overdoses (hyperkaliaemy) of potassium only. The potassium ion therefore does not contribute to the toxicity or ecotoxicity of the tripotassium salt of EDTA.

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.


Based on read-across, K3EDTA is not a skin sensitizer.

Justification for classification or non-classification