Registration Dossier

Diss Factsheets



Category name:
Phthalamates and Phthalamides

Justifications and discussions

Category definition:
Selected terephthalamic esters and terephthalamides, along with terephthalamic acid and C6-8 amides, corresponding to the breakdown products of the amide.
Category description:
not applicable
Category rationale:
“Read-across” can be utilized to fill data requirements for the registered substance, Pentamid KH (TM), EC 934-047-1, based on two approaches. The first and most basic relates to the presence of common breakdown products or metabolites in biological systems. This is according to Regulation EC No. 1907/2006, Annex XI, Section 1.5, Grouping of substances and read-across; Guidance, Grouping of substances and read-across (ECHA, 2013); and the Read-Across Assessment Framework (AARF, ECHA, 2015). This approach allows the standard testing regime to be adapted when valid data on a metabolic precursor or breakdown product are available. These data are applicable to endpoints pertaining to mammalian systemic toxicity. The second approach relates to mammalian toxicity endpoints which do not involve metabolism; rather, are applicable to topically or dermally applied substances.