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EC number: 939-649-8 | CAS number: 1474044-69-3
- 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

Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: In accordance with REACH Annex VIII (8.8.1) an assessment of toxicokinetic behavior has been conducted to the extent that can be derived from the relevant available information.
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Relevant studies were reviewed by a qualified toxicologist with a view to fulfilling the requirements of Annex VIII (8.8.1).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- In accordance with REACH Annex VIII (8.8.1) an assessment of toxicokinetic behaviour has been conducted to the extent that can be derived from the relevant available information. The assessment is based on the Guidance on information requirements and chemical safety assessment R.7c: Endpoint specific guidance (ECHA, November 2012)
- GLP compliance:
- no
- Remarks:
- Not relevant for assessment
Test material
- Reference substance name:
- Esterification products of Fatty acids C18 unsaturated and triethanolamine
- EC Number:
- 939-649-8
- Cas Number:
- 1474044-69-3
- Molecular formula:
- Not applicable (a generic molecular formula cannot be provided for this specific UVCB substance)
- IUPAC Name:
- Esterification products of Fatty acids C18 unsaturated and triethanolamine
- Details on test material:
- Details on the test material used in the studies assessed are presented in the respective endpoint study records.
Constituent 1
Results and discussion
Any other information on results incl. tables
Toxicokinetic Behaviour
The substance is composed as in section 1.2 of IUCLID. It is an amber coloured slightly viscous liquid and the molecular weight of the constituents range from 149.19 - 942.53 g/mol. The low vapour pressure value (2.2 x 10-3 Pa at 25°C) and predicted negative explosive and oxidising properties shows that the substance is non volatile therefore inhalation is not a significant route of exposure.
The substance has a high log octanol/water partition coefficient value (Log10 Pow -2.48 – 23.1) and low water solubility 1.42 x 10-5– 6.92 x 10-5 g/l). The test item is considered not to be a skin sensitiser however mild/moderate dermal irritation was evident therefore skin penetration may be possible. The available acute oral study as well as the repeated dose reproductive screening study did not show any evidence of absorption, metabolism or excretion.
The test item was non-mutagenic in bacteria, non-clastogenic in mammalian cells in vitro and non-mutagenic in mammalian (CHO) cells in vitro in either the absence or presence of an auxiliary metabolising system.
Absorption
The lipophilic nature of the substance (log10 Pow of -2.48 – 23.1) would suggest that the gastro-intestinal tract provides a route of absorption, following oral administration, before entering the circulatory system via the blood. The molecular size of the substance may also allow absorption through passive diffusion. One rate limiting factor is the extreme value for log Pow which may in fact serve as an inhibitor of significant absorption or reduce the rate of passage.
Absorption may also take place via the skin; the lipophilicity of the test item may allow penetration of the dermal membrane. The substance is considered not to be corrosive or a skin sensitizer however there is evidence of dermal irritation. Therefore damage to the skin surface may allow for increased penetration of the substance through the skin.
The low vapour pressure value (2.2 x 10-3 Pa at 25°C) shows that the substance is not available as a vapour therefore inhalation is not a significant route of exposure.
Distribution
Once absorbed, under normal circumstances a high log octanol/water partition coefficient value (Log10 Pow -2.48 - 23.1) would suggest an affinity to accumulate in the adipose tissue, however at extreme values (>10) then this may well not happen.
Metabolism
The results of the repeated dose reproductive screening study did not show evidence to indicate any test item influenced hepatic metabolism. The results of the genotoxicity assays have shown that genotoxicity is neither enhanced or diminished in the presence of the S9 metabolising system.
Excretion
There is no evidence to indicate the route of excretion but poorly water-soluble products are not favourable for urinary excretion and therefore biliary excretion may well be a significant route for this material. Any test item that is not absorbed will be excreted in the faeces.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: See summary in conclusions section
The available information suggests that absorption of the test substance from the gastrointestinal tract may take place but may be limited by water solubility and molecular size, primarily as a consequence of the high log octanol/ water coefficient of the test item. Some absorption may also take place via the skin. Once absorbed, the substance may result in accumulation in the adipose tissues. Biliary excretion may well be significant route for the substance. There is no evidence to suggest that the test substance may be metabolised, however no studies have been conducted to identify metabolites. - Executive summary:
The available information suggests that the substance is readily available via the oral route; however absorption via the skin is also possible. This is supported by the physicochemical properties of the substance. If absorbed, the substance may result in accumulation in the adipose tissues. Biliary excretion is considered to be the significant route for the substance.
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