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Description of key information

The key study for skin irritation reports all readings to be 0 at 24 and 72 hours when test material was applied onto intact skin, in a study conducted according to a protocol which is equivalent to current guideline but not compliant with GLP (Hazleton Laboratories 1979a).
The key study for eye irritation found the test material mildly irritating in a study conducted according to a protocol which was equivalent to guideline, but not compliant with GLP (Hazleton Laboratories 1979a)

Key value for chemical safety assessment

Additional information

Reliable studies equivalent to current guideline, conducted before GLP were available for assessment of acute toxicity potential of EDTMP calcium potassium salt.

For skin and eye irritation, two studies by Hazleton Laboratories were available (1979a and 1979b). The first study tested the substance in solid form (1979a), where as the second study reports the test material to be 15% active in water, 40% solid.

The active acid in content of the test material is known to be 15% and the active salt content 37.9%. The Hazleton Laboratories (1979a) was chosen as the key study for the irritation endpoints, although the second reference would have been equally valid for assessment as a key study. The results of both studies indicate the low irritation potential of the EDTMP calcium potassium salt.

Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Based on the available studies on EDTMP x-calcium y-sodium salt, only a low degree of irritation is seen which is well below the threshold for classification.

However, based on available pKa values, extrapolation of typical pHs is possible. It is suggested that EDTMP x-calcium y-sodium salt is classified accordingly based on the following equation:

Skin Irritant Cat. 2 for 2xCa+yNa=1, Skin Irritant Cat.1 for 2xCa+ yNa=8 and Eye Irritant Cat.1 for 2xCa+ yNa= 1 or 8.