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Diss Factsheets
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EC number: 683-326-1 | CAS number: 68815-17-8
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
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
- 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.
Reference
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
- 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
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Link to relevant study records
- 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
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- 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
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Link to relevant study records
- 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
Reference
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).
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.
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