Tall oil, polymd., oxidized

Toxicity to reproduction

Administrative data

Endpoint:

screening for reproductive / developmental toxicity

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Data source

Reference

Reference Type:

other: Expert Report

Title:

Expert Report

Author:

PFA

Year:

2010

Bibliographic source:

unpublished laboratory studies and information published in the public domain

Report date:

2010

Materials and methods

Principles of method if other than guideline:

data from unpublished laboratory studies and information published in the public domain

GLP compliance:

not specified

Remarks:

data from unpublished laboratory studies and information published in the public domain

Test material

Test material information

Constituent 1

Reference substance name:

Crude Tall Oil (CTO) is obtained from the wood pulping industry. It is a dark brown viscous liquid extracted and processed from softwoods and hardwoods. CTO has a complex composition of fatty acids, resin acids, and neutrals.

EC Number:

931-433-1

Molecular formula:

Not known an UVCB substance

IUPAC Name:

Crude Tall Oil (CTO) is obtained from the wood pulping industry. It is a dark brown viscous liquid extracted and processed from softwoods and hardwoods. CTO has a complex composition of fatty acids, resin acids, and neutrals.

Test material form:

liquid: viscous

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Administration / exposure

Route of administration:

not specified

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Remarks on result:

not determinable due to absence of adverse toxic effects

Results: F1 generation

Effect levels (F1)

Remarks on result:

not determinable due to absence of adverse toxic effects

Overall reproductive toxicity

Reproductive effects observed:

no

Applicant's summary and conclusion

Conclusions:

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

Executive summary:

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:

Constituent type	Proportion in CTO (%)	NOAEL mg/kg/day (rat)	Remarks
Fatty acids	47.5	> = 5000	OECD 416
Resin acids and neutrals	37.9	275	OECD 421
Sterols	3	>1500	Similar to OECD 416. Calculated as phytosterol
DTO (distilled tall oil)	-	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.