Registration Dossier

Categories

Categories

Category name:
Technical category ANGUS

Justifications and discussions

Category definition:
In this document arguments are given for a category approach for four 2-amino-1,3-propane-diols. These substances share a common propane backbone with an amine group at 2-carbon position and primary alcohols at 1 and 3 positions. Proposed members of the aminopropanediol category are: 2-amino-1,3-propanediol (APD, CAS No. 534-03-2), 2-amino-2-methyl-1,3-propane-diol (AMPD, CAS No. 115-69-5), 2-amino-2-ethyl-1,3-propanediol (AEPD, CAS No. 115-70-8), and 2-amino-2-(hydroxymethyl)-1,3-propanediol (trometamol, CAS No. 77-86-1).
Category order description:
Analogues differ in length of the alkyl side-chain at position 2: from 0 carbon atoms (APD) through 1 (AMPD) to 2 (AEPD). Only structural difference between trometamol and AEPD: replacement of a hydroxymethyl group with a ethyl group.
Category rationale:
It is expected that the four substances share similar physico-chemical properties, as well as properties in regard to environmental fate, environmental toxicology, and mammalian toxicology. Their class with respect to the mode of action in the environment can be characterised as narcotic aliphatic amines. These substances are rapidly absorbed in-vivo, are not metabolised and rapidly excreted via urine. The available data support this hypothesis and underpin the read-across between the category members to fill data gaps while minimising additional animal testing where possible.