Reaction mass of Resin acids and Rosin acids, hydrogenated, potassium salts and potassium [1R-(1α,4aβ,10aα)]-1,2,3,4,4a,9,10,10a-octahydro-7-isopropyl-1,4a-dimethylphenanthren-1-carboxylate

Endpoint summary

Additional information

The related substance "Resin 835 A" gave negative results in one bacterial gene mutation test, in one mammalian gene mutation test and in one mammalian cytogenetic study. All studies were performed under GLP and according to current guidelines. Therefore the test item was non-mutagenic in all three assays and no further mutagenicity testing is required.

Short description of key information:
Results from studies with a related substance (Resin 835 A, Reaction mass of Rosin, hydrogenated and [1R-(1a,4aß,10aa)]-1,2,3,4,4a,9,10,10a-octahydro-7-isopropyl-1,4a-dimethylphenanthren-1-carboxylic acid) are presented and used.
Bacterial reverse mutation test (OECD 471, EU method B.13/14): negative
In vitro mammalian cytogenetic study (OECD 483, EU method. B.10): negative
In vitro mammalian cell gene mutation test (OECD 476, EU method B.17): negative

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

As there were negative results obtained in three in vitro genotoxicity tests "Resin 835 A" has not to be classified as mutagenic.