Registration Dossier

Administrative data

Description of key information

No irritation/corrosion data are available for Tall Oil Heads.  However, good quality, reliable data are available for the two related substances Crude 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.
Crude Tall Oil was found to be not irritant to rabbit skin and eyes in reliable studies conducted according to the appropriate OECD test guidelines and in compliance with GLP (Wolf, 2005). In the key skin irritation study (ARC, 2005b), Tall Oil Pitch was not irritant to rabbit skin. The test was conducted in accordance with OECD 404 and in compliance with GLP. Mean scores for erythema and oedema at 24, 48 and 72 hours were all zero.
In the key eye irritation study (Sanders, 2010), Tall Oil Pitch was not irritant to rabbit eyes. The test was conducted in accordance with OECD 405 and in compliance with GLP. Minimal conjunctival redness was seen up to the 24 hour observation. There were no corneal or iridial effects. Both treated eyes appeared normal by the 48 hour observation.
It can therefore be concluded that Tall Oil Heads is not irritant to rabbit skin and eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

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

Tall Oil Heads is 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 fatty acids and neutrals (excluding sterol-type constituents, which are not present in Tall Oil Heads), whereas Crude Tall Oil contains a higher proportion of resin acids and sterols.

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 Crude 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 and eye irritation studies with Crude 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 adverse effects were recorded for either substance. 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 irritating to rabbit skin and eyes.


Effect level: empty Endpoint conclusion: Adverse effect observed

Justification for classification or non-classification

Based on reliable in vivo skin and eye irritation data for two related substances, it can be concluded that Tall Oil Heads does not meet the criteria for classification as irritant according to EU Directive 67/548/EEC and Regulation 1272/2008.