Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

There were no reliable studies on the genetic toxicity for ATMP-xNa (CAS number 27794 -93 -0) Reliable studies are available for the 5-sodium salt of ATMP (CAS number 2235 -43 -0) and for ATMP-acid (CAS 6419 -19 -8). Read across from these other members of the ATMP category to the registered substance is considered scientifically justified, as there is no reason to consider that a potassium salt will be genotoxic where the sodium salt and the parent acid are not: both potassium and sodium are abundant minerals and play an important role in metabolism, and the socium salt has been shown to lack genetic toxicity in the available studies. The results of all of the studies are in agreement.


Short description of key information:
In vitro:
Gene mutation (Bacterial reverse mutation assay / Ames test): Read across from ATMP acid: negative with and without activation in all strains tested (Cytogenicity in mammalian cells: Read across from sodium salt of ATMP CAS 2235-43-0: negative in CHO cells (similar to OECD 473
Mutagenicity in mammalian cells: Read across from neutralised ATMP acid: negative with and without activation in L5178Y mouse lymphoma cells (similar to OECD TG 476).
In vivo:
Read across from sodium salt of ATMP CAS 2235-43-0: negative in mouse micronucleus assay (OECD TG 474)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

There is no information available for the registered substance, [nitrilotris(methylene)trisphosphonic acid, potassium salt, CAS 27794 -93 -0. Reliable information is availble for other members of the ATMP category for all the required in vitro genetic toxicity endpoints. The negative conclusion from the in vitro studies has been confirmed in an in vivo study on a sodium salt of ATMP. Therefore it is considered that classification for mutagenicity is not required.