Tall oil, polymd., oxidized

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

In available studies on groups of constituents present in Crude Tall Oil, any effects that were observed on reproductive parameters were minor and associated with dose levels where systemic effects were observed. Based on these studies, Tall Oil, polymd. oxidized is predicted not to cause adverse effects on fertility.

Link to relevant study records

Reference

Reference 1

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

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data from unpublished laboratory studies and information published in the public domain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data from unpublished laboratory studies and information published in the public domain

Species:

rat

Strain:

not specified

Sex:

not specified

Route of administration:

not specified

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks on result:

not determinable due to absence of adverse toxic effects

Reproductive effects observed:

no

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 However, data are available for the constituent parts of CTO and related substances (unpublished laboratory studies and information published in the public domain).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.

Reference 2

Endpoint:

screening for reproductive / developmental toxicity

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Justification for type of information:

See attached read-across justification report

Reason / purpose for cross-reference:

read-across source

Species:

rat

Strain:

not specified

Sex:

not specified

Remarks on result:

not determinable due to absence of adverse toxic effects

Remarks on result:

not determinable due to absence of adverse toxic effects

Reproductive effects observed:

no

Conclusions:

Based on available data for groups of Crude Tall Oil constituents, there is no evidence to suggest that Tall Oil, polymd., oxidized should be classified for reproductive or developmental toxicity (see read-across justification report)

Effect on fertility: via oral route

Endpoint conclusion:

no adverse effect observed

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:

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	-	423	OCED 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.

Effects on developmental toxicity

Description of key information

In available studies on groups of constituents present in Crude Tall Oil, any effects that were observed on developmental parameters were minor and associated with dose levels where systemic effects were observed. Based on these studies, Tall Oil, polymd. oxidized is predicted not to cause developmental toxicity.

Additional information

No relevant develpmental 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	>2400	OECD 414
DTO	-	423	OECD 422 dietary studies

hese 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.

Justification for classification or non-classification

Based on the results of the studies on CTO constituents, there is no evidence to suggest that Tall oil, polymerized, oxidized should be classified for reproductive or developmental toxicity (see read across justification report).