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Diss Factsheets
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EC number: 940-217-6 | CAS number: -
- 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
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 50
- Absorption rate - dermal (%):
- 50
- Absorption rate - inhalation (%):
- 100
Additional information
In accordance with point 8.8.1 of column 1 (Standard Information Required), Annex VIII of REACH (Regulation EC No. 1907/2006), assessment of the toxicokinetic behaviour of the substance is performed to the extent that can be derived from the relevant available information. A toxicokinetic assessment was performed based on the available physical-chemical data and toxicological information available. Further testing for the assessment of toxicokinetic behaviour is omitted on this basis.
Introduction
Fatty acids, C10-20-neo, potassium salts (iso-naphthenic acids, potassium salts) is an organic UVCB substance and is a dark brown viscous liquid.
No experimental studies of the absorption, metabolism, distribution, or elimination of Fatty acids, C10-20-neo, potassium salts ("the substance") in mammals are available.
However, information is utilized from existing toxicology studies on the substance, or for other very similar materials, and this data is used to infer, as far as possible, the potential toxicokinetics of the substance.Physicochemical properties
Systemic availability of the substance depends on its ability to be absorbed across body surfaces. Factors that affect this process include water solubility, lipophilicity (measured by the partition coefficient, Kow), degree of ionisation (the dissociation constant, pKa), and molecular size. Given the large number of components within the substance, it has a molecular weight in the approximate range of 290-350 g/mol. It is forms a stable dispersion in water, but the actual water solubility could not be measured. Likewise measuring the dissociation constant or log Kow was not technically feasible. Based on the structures however, the estimated log Kow ranged from -0.05 to 8.64. For a typical representative structure, the log Kow was estimated to be 4.22. From the detailed estimate, the higher the MW of each component of the substance, the higher the log Kow.
Absorption
Oral absorption
The acute oral LD50was greater than 2000 mg/kg bw in an OECD 423 oral gavage study, with only non-specific clinical signs in 2/3 animals, and no effect on body weight observed. In addition, no gross abnormalities were observed at necropsy. The clinical signs suggest that absorption may take place.
In an OECD 422 repeat-dose/reproductive toxicity study, treatment with the substance at dose levels up to 750 mg/kg/day was associated with liver toxicity and secondary thyroid toxicity (LOAEL 250 mg/kg/day) suggesting that some absorption took place.
Lower MW components of the substance would be more readily absorbed than the higher MW components.
The physical chemical properties do not preclude absorption. In the absence of quantitative information, 50% bioavailability following oral administration is assumed for the purposes of human risk assessment.
Dermal absorption
The acute dermal LD50for the unsalted naphthenic acids (likely to be worse case for the potassium salt, as they cause metal corrosion, whereas the salts thereof can be used as corrosion inhibitors) was greater than 20000 mg/kg bw in acute dermal toxicity studies, with no clinical signs, effects on body weight or gross abnormalities at necropsy. An in vitro skin irritation study with the substance also showed no toxicity to the test system, and the substance was not a sensitiser in the LLNA. Nothing can be inferred about the nature of dermal absorption from these studies.
Lower MW components of the substance would be more readily absorbed than the higher MW components.
For the purposes of risk assessment however, estimation of mammalian dermal absorption is made in accordance with principles adopted by the EFSA guidance on estimating dermal absorption of pesticide active substances (EFSA, 2012). On this basis, dermal absorption is estimated at 50% for undiluted substance, which is considered conservative.
Inhalation absorption
In the absence of any quantitative data, absorption of inhaled substance is considered to be 100%.
Distribution, Metabolism and Elimination
No information is available to describe the distribution, metabolism or elimination of the substance.
Conclusion
For the purposes of human risk assessment oral absorption of the substance is estimated at 50%, inhalation absorption is estimated at 100% and dermal absorption is estimated at 50%.
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.