Registration Dossier

Administrative data

Description of key information

Not expected to be a carcinogen, based upon an absence of mutagenic and clastogenic activity in vitro and no evidence of hyperplasia and/or

pre-neoplastic lesions following repeated sub-chronic exposure.

Key value for chemical safety assessment

Additional information

There were no chronic repeat-exposure studies conducted with Resin acids and rosin acids, hydrogenated, Me esters available for review. Based on the minimal target organ effects observed in a subchronic exposure study in which groups of male and female rats were exposed to dietary concentrations up to 10000 ppm for 13 weeks, the test material is unlikely to pose a significant risk for the development of a carcinogenic effect. In addition, no mutagenic or clastogenic potential was observed in bacterial and mammalian cells in vitro.

Justification for classification or non-classification

There is no evidence that Resin acids and rosin acids, hydrogenated, Me esters requires classification for carcinogenicity according to UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.