Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

In silico mutagenicity prediction:

No alert for DFPP-malate was found by DEREK, Leadscope and VITIC.

Genetic toxicity in vivo

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

No testing data are available for the substance.


In silico assessments on the mutagenic potential using (Q)SAR methologies according to ICH M7 Guideline are accepted in the pharmaceutical context by regulators as valid tools for detecting DNA reactive substances (ICH=International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use; M7 Guideline is on "Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk").

With regard to the prediction models used (Leadscope, DEREK, VITIC) the substance raised no structural alert for mutagenicity (Negative prediction in DEREK, Leadscope and VITIC) [Result, February 2020]. Thus, no mutagenic potential is concluded for the substance.

Justification for classification or non-classification

Based on an in silico assessment no mutagenic potential is concluded for the substance.