Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

No sensitisation data are available for Tall Oil Heads. Reliable skin sensitisation studies are, however, available for the related substances Distilled Tall Oil (CAS 8002 -26 -4) and Tall Oil Pitch (8016 -81 -7).

Tall Oil Heads and Distilled Tall Oil are both obtained by physical separation (distillation) of Crude Tall Oil, and the two substances are multiconstituent products containing the same constituents in different proportions (the main categories being fatty acids, resin acids, sterols and other neutrals). Tall Oil Heads contains a higher proportion of neutrals whereas Distilled Tall Oil contains a higher proportion of fatty acids.

Tall Oil Pitch is also a product of the distillation of Crude Tall Oil, and contains a higher proprtion of neutrals (sterols and others) than either Distilled Tall Oil or Tall Oil Heads, as well as fatty acids, resin acids and a significant proportion of polymeric acids and neutrals.

The results of skin sensitisation studies with Distilled Tall Oil and Tall Oil pitch gave clear negative results for both endpoints in tests according to the relevant OECD test guidelines and in compliance with GLP. No positive skin reactions were observed for test animals in either test. These two substances contain all constituents present in Tall Oil Heads at concentrations covering the range that is relevant for the registered substance. It is therefore considered appropriate to take a weight of evidence approach and conclude that Tall Oil Heads is not a skin sensitiser.


Migrated from Short description of key information:
No sensitisation data are available for Tall Oil Heads. However, good quality, reliable data are available for the two related substances Distilled Tall Oil (CAS 8002-26-4) and Tall Oil Pitch (CAS 8016-81-7). A weight of evidence approach is therefore used to fill data gaps for Tall Oil Heads.

Distilled Tall Oil was not sensitising to skin in a guinea pig maximisation test carried out in accordance with OECD Test Guideline 406 and in compliance with GLP (Huntingdon, 1992).

The key skin sensitisation study (ARC, 2007) was carried out in accordance with OECD 406 (Buehler method) and in compliance with GLP. Tall Oil Pitch was not sensitising under the conditions of the test. No positive skin reactions were observed in any animals in the test and control groups at challenge.

Justification for classification or non-classification

According to the criteria set out in EU Directive 67/548/EEC and Regulation 1272/2008 Tall Oil Heads is not classified as a skin sensitiser on the basis of a reliable in vivo data for two related substances.