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Description of key information

An acute oral LD50 value of >5000 mg/kg was reported in rat in a study which was carried out according to a protocol similar to current guideline (Hazleton Labs 1979a). The study was not GLP compliant and no necropsy of surviving animals was carried out.
An acute inhalation LD50 of >4.17 mg/l (dust) was reported; this was the maximum achievable concentration (Inveresk 1980). The study was reliable and carried out according to a protocol similar to guideline, but not compliant with GLP.
An acute dermal toxicity LD50 value of >5000 mg/kg was reported in a study carried out according to protocol comparable to current guideline, but not in compliance with GLP (Hazelton Labs, 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 acute oral and acute dermal toxicity, 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 acute oral and dermal toxicity endpoints, although the second reference would have been equally valid for assessment as a key study. The results of both studies indicate the low acute toxicity of the EDTMP calcium potassium salt.

A study for acute inhalation was also available (Inveresk 1980), which reports the maximum achievable concentration and LC50 of >4.17 mg/l (dust) in rat. This maximum concentration falls below the classification threshold for acute inhalation, but supports the over all low acute toxicity of the test substance.

Justification for classification or non-classification

Based on the available information on EDTMP calcium sodium salt, no classification is required for the acute toxicity endpoints in accordance with current regulation (EC 1272/2008).

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