Registration Dossier

Categories

Categories

Category name:
ISOCARB

Justifications and discussions

Category definition:
ISOCARB are aliphatic branched carboxylic acids and include substances with carbon chain lengths of C11 to C24. Their only functional group is the carboxyl group, which they share in common. All ISOCARB have a single branching at the C2 position, where the branches differ in chain length from methyl to decyl. In addition, carboxylic acids which do not have the branching can be used as Source substances. Common physical and biological pathways result in structurally similar breakdown products and are responsible for similar environmental behaviour and essentially identical hazard profiles with regard to human health. The structural similarities result in the same mode of ecotoxicological action.
Category order description:
The chemicals included into the category are aliphatic branched carboxylic acids with carbon chain length of C11 to C24 and a single branching at the C2 position.
Category rationale:
ISOCARB will be registered under REACh Regulation (EC) No. 1907/2006 as Category members. The following report summarizes all available and relevant data for all category members and details the rationale behind the category. Similarly, the endpoint summaries within the technical dossier, which are also implemented in the chemical safety report, reflect and review the available and relevant data for the respective endpoints of the complete category as it now stands. The most relevant “Source” substance(s) were chosen and their study records were entered into the individual category member technical dossiers.
On the basis of all evaluated data, the similarity of all category members of the ISOCARB is justified on basis of the physico-chemical properties, toxicological and ecotoxicological profiles. There is convincing evidence that these chemicals possess an overall common category profile. The only exceptions are that Category member 1, ISOCARB 11, and Source substance 1, ISOCARB L11 have skin and eye irritating properties whereas the others do not have this property what is shown in in vivo tests.