Registration Dossier

Categories

Categories

Category name:
Isobutyl Ketones and Carbinols

Justifications and discussions

Category definition:
Isobutyl ketones and their corresponding carbinol metabolites. THe primary purpose of the read across is for the repeated dose and reproductive/developmental toxicity endpoints.
Category order description:
Methyl Isobutyl Ketone, Methyl Isobutyl Carbinol, Diisobutyl ketone, diisobutyl Carbinol
Category rationale:
The rationale is 2 fold:
1) The Isobutyl Ketones have the same isobutyl ketone functional group and a common metabolic pathway to the isobutyl carbinols as demonstrated by the available metabolsim data. The metabolism data also demonstrates the carbinols are metabolised back to the ketones.
2) the available toxicity data on each substance for the repeated dose and reproductive developmental toxicity demonstrate a high level of consistency across the group, with the same target organs being affected )liver and Kidney) and a low order of reproductive/developmental effects.
Due to the structural similarities, the similarities in metabolic pathways it is justified to group these substances together for the purpose of read across.
Other isobutyl ketones may also fit into this category, however there are currenltly no other substances identified that have data on the reproductive/developmental endpoints that could form the basis of a read across.