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Toxicological information

Repeated dose toxicity: oral

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Administrative data

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

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unpublished laboratory studies and information published in the public domain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data from unpublished laboratory studies and information published in the public domain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data from unpublished laboratory studies and information published in the public domain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

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:
oral: unspecified

Results and discussion

Effect levels

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

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

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 However, data are available for the constituent parts of CTO and related substances (unpublished laboratory studies and information published in the public domain).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