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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The in vitro genetic toxicity assessment of SPE1415 is based on a combination of data on the substance itself and read-across data from the structural analogues ATMP (acid/sodium salt) and DTPMP (acid/sodium salt). Additional supporting data on another confidential analogue substance is discussed in Additional Information.

There are a total of ten in vitro genetic toxicity studies presented. This includes four in vitro bacterial mutation studies, three in vitro mammalian cell gene mutation studies and three in vitro cytogenetics studies. One in vitro bacterial mutation study was conducted on the substance itself and the other nine studies were all conducted on the structural analogues. All of the studies were reliable and all except one gave negative results.

The in vitro cytogenetics assay on DTPMP sodium salt was the only study which gave a positive result however this finding was not supported by the negative result from the in vivo cytogenetics assay on DTPMP acid. It is probable that the positive response for DTPMP sodium salt does not reflect an ability to interact with DNA due to (1) lack of structural alerts for mutagenicity, (2) lack of evidence for gene mutation potential in sub-mammalian systems and (3) lack of potential to induce gene mutations in another well-conducted assay investigating mutations at the hprt locus in CHO cells. It is also inconsistent with the gentoxicity findings from the various studies on ATMP and SPE1415 itself.



Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Genetic toxicity in vivo

Description of key information

The in vivo genetic toxicity assessment of SPE1415 is based on read-across data from the structural analogues ATMP (sodium salt) and DTPMP (acid). Additional supporting data on another confidential analogue substance is discussed in Additional Information.

There are a total of three in vivo genetic toxicity studies presented. This includes an in vivo micronucleus study on ATMP (sodium salt), and in vivo cytogenetics study on DTPMP (acid) and in vivo micronucleus assay on another analogue substance. All of the studies were reliable and all gave negative results.


Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (negative)

Additional information

Justification for classification or non-classification

The substance and its structural analogues overwhelmingly give negative results in a variety of reliable in vitro and in vivo gentoxicity assays. Therefore there is no justification for classification of the substance.