Tetrapotassium ethylenediaminetetraacetate

Endpoint summary

Description of key information

Treatment of the intact rabbit skin with an 80% aqueous preparation of Na4 EDTA resulted in mild or no irritation. These data demonstrate that there is no need to classify and label the substance for skin irritating properties according to EU or GHS regulations. However, irreversible opacity is caused by instillation of undilluted test substance into the eye of rabbits. Therefore, undiluted Na4EDTA has to be labeled according to EU and GHS regulations.

Based on the read across on EDTA 4Na, it is expected that EDTA 4K may have the same effects.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Skin irritation:

In the key study which was performed according to OECD guideline 404 the skins of 2 male and 1 female rabbits were exposed to 0.5 g of an 80% aqueous preparation of Trilon B Powder (edetic acid tetrasodium salt, 80% aqueous preparation) for an occlusive exposure period of 4 hours. For erythema medium scores after 24/48/72 hours of 1/0/0.3 were documented, redness had resolved after 8 days. No edema was noted (BASF, 1982).

After treatment of skin of 2 rabbits with Trilon B liquid (40% aqueous solution of edetic acid tetrasodium salt) for 1, 5, 15 minutes and 20 hours on the back and for 20 hours on the ear skin readings were performed 24 and 48 h after removal of the test substance. A mild redness (score 0.5) on back and ear of one rabbit after a 20-hour exposure period. Those effects were fully reversible within 48 h. After exposure periods of 15 minutes or less no effects were observed (BASF, 1978).

Eye irritation:

Approximately 50 mg of the test substance were applied to the conjunctival sac of one eye of 2 animals. 24 to 72 h after application a mild redness (score 1), mild edema (scale 0.8) and mild opacity (scale 1.3) was present and after 8 days mild redness and mild oedema and mild opacity persisted. During all these observation times a grease-like layer was observed

(BASF, 1978)

Instillation of 50 mg of of the substance to the eye of one rabbit resulted redness (score 1.75), oedema (score 1.25) and opacity (score 1.3) and pus formation as average 24 -72 h after application. After 8 days a mild opacity was seen (BASF, 1970).

Effects on eye irritation: corrosive

Justification for classification or non-classification

Based on the results obtained in the toxicity studies and taking into account the provisions laid down in Council Directive 67/548/EEC and CLP, a classification as Xi, R41 and Eye Damage Cat 1, respectively, has to be done with respect to irritation or corrosion.