Registration Dossier

Administrative data

Description of key information

No skin irritation or corrosion could be observed in a skin irritation test on rabbits (BASF SE, 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.

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

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.

EYE

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.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on these data, the test substance is classified as Eye Irritant Cat 2, H319 (causes serious eye irritation) under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation EC No 2016/1179.