Registration Dossier

Administrative data

Description of key information

Based on available data for groups of constituents present in Crude Tall Oil, 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 Crude Tall Oil (CTO) as whole product. However, data are available for the constituent parts of CTO and related substances (unpublished laboratory studies and information published in the public domain).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 CTO (%)

NOAEL (mg/kg/day, rat)

Duration

Remarks

Fatty acids

47.5

≥12,500

90 days

 

Resin acids and neutrals

37.9

>200

2 year

Weight of evidence from a number of 90-day and 2-year studies

Sterols

3.0

≥4100

90 days

 

DTO

-

423

28 days

OECD 422 study

 

These data are sufficient to demonstrate that none of the constituents of CTO 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 CTO.

Justification for classification or non-classification

The available data for constituents of CTO indicate that classification for specific target organ toxicity is not required.