Registration Dossier

Administrative data

Description of key information

No skin irritation or corrosion could be observed in a skin irritation test on rabbits (BASF 1973). No classifiable eye irritation could be observed in a test by BASF (1973). However, the test deviates from the OECD guideline in some details: only 50 mg of edetic acid were instilled (instead of 100 mg), only 2 animals were used (instead of 3), the BASF study used occlusive conditions (instead of semi-occlusive) and the 72 h reading time point was missing the classification of Annex 1 to Directive 67/548/EEC is followed.

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

In a skin irritation study performed by BASF (1973) two rabbits were exposed occlusively for 1, 5 or 15 minutes on the back to a 50% aqueous solution of edetic acid. Two additional rabbits were exposed to the same solution for 20 h on the back and at the ear. The skin of the animals was observed for 8 days. No skin irritation was observed on the back of the animals at any exposure period tested. Solely a slight erythema could be observed on the ear of the animals which was fully reversible within 48 h.

In an eye irritation test performed by BASF (1973) 50 mg of solid edetic acid were instilled into the conjunctival sac of one eye of two animals. The other eye served as control and was treated with 50 mg talcum powder. The test substance was not washed out and the animals were observed for 8 days. The animals showed an average opacity grade 1.5, an average conjunctivae score of 1.3 and average chemiosis grade 0.5. All effects were fully reversible within 8 days.

Effects on eye irritation: irritating

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, R36 and eye irritant cat 2, respectively, has to be done with respect to irritation or corrosion.