Registration Dossier

Administrative data

Description of key information

The key studies for skin and eye irritation found the potassium salt not irritating to the skin or eye of rabbits (Springborn Laboratories, 2000;rel 1).

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:
no adverse effect observed (not irritating)

Additional information

The key studies were selected and deemed sufficient for the irritation endpoints as they were recent, conducted according to guideline and of high reliability (1).

Justification for classification or non-classification

The tested ATMP salts do not exhibit extreme pH (=<2 or =>11.5), therefore local effects on the skin and eye due primarily to high or low pH would not be anticipated. Reliable studies on several different formulations consistently demonstrate a low degree of irritation, well below the threshold for classification.

No data are available on lower or higher pH salts with x=1 or x=6. For these it is more appropriate to base classification on that proposed for ATMP acid.

It is concluded that classification for eye irritation or corrosion is not required for ATMP salts with x=2-5.

For ATMP salts where x=1 or x=6, classification for eye irritation in Category 2 (H319) may be appropriate.

Since ATMP acid does not exhibit skin irritation or corrosion leading to classification, these salts would also be expected to exhibit only mild irritant effects on the skin.It is concluded that classification for skin irritation or corrosion is not required for ATMP salts.