Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Based on available data for groups of Crude Tall Oil constituents, for Tall Oil, polymd., oxidized a conservative 2-year NOAEL of >200 mg/kg/d is set for the oral route (see read across justification report)

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
sub-chronic toxicity: oral
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data from unpublished laboratory studies and information published in the public domain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data from unpublished laboratory studies and information published in the public domain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:
oral: unspecified
Dose descriptor:
NOAEL
Effect level:
> 200 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
not specified
Basis for effect level:
other: not specified
Critical effects observed:
not specified
Conclusions:
Based on available data for groups of constituents, for Crude Tall Oil a conservative 2-year NOAEL of >200 mg/kg/d is set for the oral route.
Executive summary:

No relevant repeated dose toxicitystudies 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 However, data are available for the constituent parts of CTO and related substances (unpublished laboratory studies and information published in the public domain).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)    Duration   Remarks

 Fatty acids

 47.5 > = 12,500  90 days   
 Resin acids and neutrals  37.9  > 200 2 years  Weight of evidence from a number of 90-day and 2-year studies 
 Sterols  3.0  > = 4,100  90 days  
 DTO (distilled tall oil)  -  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.

Endpoint conclusion
Dose descriptor:
NOAEL
200 mg/kg bw/day
Study duration:
chronic
Species:
rat

Repeated dose toxicity: inhalation - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: inhalation
Data waiving:
exposure considerations
Justification for data waiving:
a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: inhalation
Data waiving:
exposure considerations
Justification for data waiving:
a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: dermal
Data waiving:
exposure considerations
Justification for data waiving:
a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Link to relevant study records
Reference
Endpoint:
short-term repeated dose toxicity: dermal
Data waiving:
exposure considerations
Justification for data waiving:
a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Endpoint conclusion
Endpoint conclusion:
no study available

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:

   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 years  Weight of evidence from a number of 90-day and 2-year studies 
 Sterols  3.0  > = 4,100  90 days  
 DTO (distilled tall oil)  -  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.

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

Justification for classification or non-classification

Based on the results of the studies on CTO constituents, the classification for specific target organ toxicity is not required for Tall oil, polymerized, oxidized (see read across justification report).