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
Description of key information
Based on available data for groups of constituents present in Tall Oil Heads, a conservative 2-year NOAEL of >200 mg/kg/d is set for the oral route.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Additional information
No relevant repeated dose 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 However, data are available for the constituent parts of TOH and related substances (unpublished laboratory studies and information published in the public domain).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/day, rat) |
Duration |
Remarks |
Fatty acids |
62 |
≥12,500 |
90 days |
|
Resin acids and neutrals |
30 |
>200 |
2 year |
Weight of evidence from a number of 90-day and 2-year studies |
Sterols |
- |
≥4100 |
90 days |
|
DTO |
- |
423 |
28 days |
OECD 422 study |
These data are sufficient to demonstrate that none of the constituents of TOH require classification for specific target organ toxicity following repeated oral exposure, and to allow quantitative Derived No Effect Level to be set for risk characterisation.
No further testing for repeated dose toxicity is proposed for TOH.
Justification for classification or non-classification
The available data for constituents of TOH indicate that classification for specific target organ toxicity is not required.
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