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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
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
- 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.
- 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)
Referenceopen allclose all
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).
Additional information
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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