Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 683-326-1 | CAS number: 68815-17-8
Repeated dose toxicity: oral
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:
- 2 010
- 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- unpublished laboratory studies and information published in the public domain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- data from unpublished laboratory studies and information published in the public domain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- data from unpublished laboratory studies and information published in the public domain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
- 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
Constituent 1
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
