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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The sodium salt of EDTMP is structurally analogous to the EDTMP – acid for which reason read across is considered valid. The sodium ions are not expected to contribute significantly to toxicity.

The key study (Monsanto 1985) was the most recent and reliable study available for assessment for EDTMP sodium salt.

0.3 ml of the test material was applied at induction and challenge undiluted. The test material, Dequest 2046 is known to have 35.7% active salt content at pH 6 -8, and a specific gravity of 1.3 -1.36 g/ cm3.The pKa of the salt at pH 7.3 is estimated to be 6. The conversion factor to determine the salt to acid equivalent for mass for EDTMP-6Na salt is 0.768. Therefore, based on the known active salt proportion of the substance, it is calculated that the at application to animal skin amount of active salt is 400 mg, and active acid 300 mg.

Migrated from Short description of key information:
No data were available for EDTMP - xCaxNa and the key study was therefore read across from the sodium salt of EDTMP (CAS 22036-77-7). A reliability 2 study in guinea pig reports the test material as not sensitising (Monsanto 1985).

Justification for classification or non-classification

Based on the available information on the structurally analogous read across substance, sodium salt of EDTMP (CAS 22036 -77 -7) no classification for sensitisation is proposed for EDTMP calcium sodium salt in accordance with current regulation (EC 1272/2008).