Registration Dossier
Registration Dossier
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EC number: 266-039-2 | CAS number: 65997-03-7 The low boiling fraction obtained by the distillation of tall oil. Contains fatty acids such as palmitic, stearic, oleic and linoleic as well as neutral materials.
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Additional information
No relevant reproductive toxicity studies have been conducted for Tall Oil Heads (TOH) as whole product. However, data are available for the constituent parts of TOH and related substances (unpublished laboratory studies and information published in the public domain). The available data are summarised in the table below. Details are given in the attached expert report (PFA, 2010).
Constituent type |
Proportion in TOH (%) |
NOAEL mg/kg/d (rat) |
Remarks |
Fatty acids |
62 |
≥5000 |
OECD 416 |
Resin acids and neutrals |
30 |
275 |
OECD 421 |
Sterols |
- |
>1500 |
Similar to OECD 416. Calculated as phytosterol. |
DTO |
- |
423 |
OECD 422 study |
These data are sufficient to demonstrate that none of the constituents of TOH require classification for reproductive toxicity. Any effects that were observed on reproductive parameters in the available studies were minor and associated with dose levels where systemic effects were observed.
No further testing for reproductive toxicity is proposed for TOH.
Short description of key information:
No reproductive toxicity studies are available for Tall Oil Heads (TOH) as whole product. Data are, however, available for groups of constituents present in TOH. In these studies, any effects that were observed on reproductive parameters in the available studies were minor and associated with dose levels where systemic effects were observed.
Effects on developmental toxicity
Description of key information
No developmental toxicity studies are available for Tall Oil Heads (TOH) as whole product. Data are, however, available for groups of constituents present in TOH. In these studies, any effects that were observed on developmental parameters in the available studies were minor and associated with dose levels where systemic effects were observed.
Additional information
No relevant developmental toxicity studies have been conducted for Tall Oil Pitch (TOP) as whole product. However, data are available for the constituent parts of TOP and related substances (unpublished laboratory studies and information published in the public domain). The available data are summarised in the table below. Details are given in the attached expert report (PFA, 2010).
Constituent type |
Proportion in TOH (%) |
NOAEL mg/kg/d (rat) |
Remarks |
Fatty acids |
62 |
≥5000 |
OECD 416 |
Resin acids and neutrals |
30 |
275 |
OECD 421 |
Sterols |
- |
>2400 |
OECD 414 |
DTO |
- |
423 |
OECD 422 dietary study |
These data are sufficient to demonstrate that none of the constituents of TOH require classification for developmental toxicity. Any effects that were observed on developmental parameters in the available studies were minor and associated with dose levels where systemic effects were observed.
No further testing for developmental toxicity is proposed for TOH.
Justification for classification or non-classification
There is no evidence to suggest that TOH should be classified for reproductive or developmental toxicity.
Additional information
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