Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

No information is available for Tall Oil Heads. However, there is information available for the analogous substances Crude Tall Oil CAS 8002-26-4 and Distilled Tall Oil from reliable studies for all the required in vitro endpoints. The results of all the studies were in agreement. Both Distilled Tall Oil and Tall Oil Heads are derived from Crude Tall Oil by distillation, and so contain only constituents that are also present in Crude Tall Oil. The concentration of components varies between these products, but as no effects were seen in Crude Tall Oil or DIstilled Tall Oil, it is justifiable to read-across the results to Tall Oil Heads. Tall Oil Heads includes a high percentage of fatty acids (typically 58%). Tall Oil Fatty Acids have been evaluated in the US EPA HPV program (US EPA 2004), and were negative for genetic toxicity, supporting the data for Crude Tall Oil and Distilled Tall Oil.


Short description of key information:
In vitro:
Gene mutation (Bacterial reverse mutation assay / Ames test): read-across from analogous substance Crude Tall Oil CAS 8002-26-4: negative with and without activation in all strains tested (OECD TG 471)
Gene mutation (Bacterial reverse mutation assay / Ames test): read-across from analogous substance Distilled Tall Oil CAS 8002-26-4: negative with and without activation in all strains tested (OECD TG 471)
Cytogenicity in mammalian cells: read-across from analogous substance Crude Tall Oil CAS 8002-26-4: negative in cultured human lymphocytes (OECD TG 473)
Cytogenicity in mammalian cells: read-across from analogous substance Distilled Tall Oil CAS 8002-26-4: negative in Chinese hamster overy (CHO) cells (OECD TG 473)
Mutagenicity in mammalian cells: read-across from analogous substance Crude Tall Oil CAS 8002-26-4: negative in L5178Y cells (OECD TG 476)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The available information for the analogous substance Crude Tall Oil CAS 8002-26-4 indicates that when tested in vitro, Crude Tall Oil (CAS number 8002 -26 -4) does not induce mutations in bacterial or mammalian cells, nor chromosome aberrations in mammalian cells. In addition, the analogous substance Distilled Tall Oil does not induce mutations in bacterial cells or chromosome aberrations in mammalian cells. There is no justification from in vitro results for testing in vivo. Therefore it is considered that classification for mutagenicity is not required.