Registration Dossier

Diss Factsheets



Category name:
Dibasic Esters

Justifications and discussions

Category definition:
Methyl, butyl and isobutyl alcohol esters of adipic acid, glutaric acid and succinic acid and mixtures thereof.
Category rationale:
The members of the category are all alcohol esters of dicarboxylic acids. The ester bonds are effectively metabolised by the body releasing the component alcohols and acids. The difference between members involves 3 parameters: 1) the alcohol used to esterify the acids, 2) the length of the acid molecule (4C, 5C or 6C) and 3) the presence of individual esters or mixtures thereof. The toxicity profile of the members (ecotoxicity and human health toxicity and the environmental fate) is consistent. All have low acute toxicity potential, are not sensitising, are mildly irritating to eyes and upper respiratory tract (where vapour pressure allows exposure), are not genotoxic or clastogenic (in vivo) and have minimal systemic toxicity. Data are available predominantly for the methyl esters (individual and mixture), dibutyl adipate and diisobutyl esters (mixture). Within the category, read across is used to cover the higher tier human health toxicity studies predominantly. The category justification is attached in the section below.