Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Additional information

No relevant reproductive 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 However, data are available for the constituent parts of CTO and related substances (unpublished laboratory studies and information published in the public domain).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/d (rat)

Remarks

Fatty acids

47.5

≥5000

OECD 416

Resin acids and neutrals

37.9

275

OECD 421

Sterols

3.0

>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 CTO 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 CTO.


Short description of key information:
No reproductive toxicity studies are available for Crude Tall Oil as whole product. Data are, however, available for groups of constituents present in CTO. 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 Crude Tall Oil as whole product. Data are, however, available for groups of constituents present in CTO. 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 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 However, data are available for the constituent parts of CTO and related substances (unpublished laboratory studies and information published in the public domain).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/d (rat)

Remarks

Fatty acids

47.5

≥5000

OECD 416

Resin acids and neutrals

37.9

275

OECD 421

Sterols

3.0

>2400

OECD 414

DTO

-

423

OECD 422 dietary study

 

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

Justification for classification or non-classification

There is no evidence to suggest that CTO should be classified for reproductive or developmental toxicity.