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Diss Factsheets
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EC number: 926-195-0 | CAS number: 1176284-65-3
- 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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Remarks:
- review of the literature
- Type of information:
- other: study report
- Adequacy of study:
- key study
- Study period:
- April-May 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- A paper-based toxicokinetic assessment (TKA) was conducted in accordance with Annex VIII Section 8.8 of Regulation (EC) No. 1907/2006 and based on the Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance (ECHA, 2014).
- Objective of study:
- toxicokinetics
- Qualifier:
- according to guideline
- Guideline:
- other: Annex VIII Section 8.8 of Regulation (EC) No. 1907/2006
- Qualifier:
- according to guideline
- Guideline:
- other: Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance (ECHA, 2014)
- Principles of method if other than guideline:
- Paper-based review of the published scientific literature
- GLP compliance:
- no
- Specific details on test material used for the study:
- no test material used
- Radiolabelling:
- no
- Type:
- absorption
- Results:
- Relatively low by the oral, dermal and inhalation routes
- Type:
- distribution
- Results:
- No systemic toxicity suggests no significant distribution. Theoretically, lipophilic substances can accumulate in body fats and/or breast milk. Fatty acids are distributed into plasma and may appear in the liver
- Type:
- metabolism
- Results:
- The test substance was negative in genotoxicity studies in the presence of rat liver metabolic activation. Fatty acids in the plasma lipid fraction can undergo acylation to triglycerides and are oxidised by the β-oxidation cycle to CO2.
- Type:
- excretion
- Results:
- Primarily by fecal extraction
- Details on absorption:
- ZWA 5496/100 is slightly water soluble, has a relatively high log octanol water partition coefficient with a high molecular weight polymeric structure which suggests somewhat lower potential for absorption across the skin and gastrointestinal tract. Lipophilic substances have limited solubility in gastrointestinal fluids. It is likely that ZWA 5496/100 may be digested to individual fatty acids and esters which are more readily absorbed in the digestive tract. The low vapor pressure exerted is an indication of low potential exposure by the inhalation route as well.
- Details on distribution in tissues:
- No evidence of systemic target organ toxicity was seen in repeat dose studies in the rat given ZWA 5496/100 by the oral route. The low water solubility and relatively high estimated partitioning into octanol of ZWA 5496/100 indicates that it may accumulate in body fats and/or breast milk. Fatty acids are distributed into plasma and therefore will be distributed to highly perfused tissues such as the liver.
- Details on excretion:
- Fecal excretion is likely a major route of elimination of unabsorbed and unchanged ZWA 5496/100. Fecal excretion is also a likely major pathway of elimination of any fatty acids.
- Metabolites identified:
- no
- Details on metabolites:
- ZWA 5496/100 was negative for the ability to induce gene mutations in tester strains of Salmonella typhimurium and Escherichia coli, as measured by reversion of auxotrophic strains to prototrophy. The following five tester strains were used: TA1535, TA1537, TA98, TA100 and WP2 uvrA. Experiments were performed both in the absence and presence of metabolic activation, using liver S9 fraction from rats pre-treated with Phenobarbital and 5-6 Benzoflavone (Allnex, 2015g). ZWA 5496/100 also did not induce gene mutations at the HPRT locus in V79 cells in the absence and presence of metabolic activation by rat liver S9-mix induced by Aroclor 1254 (Allnex, 2016d). ZWA 5496/100 did not induce the formation of micronuclei in human lymphocytes in vitro in the absence and presence of metabolic activation by rat liver S9-mix induced by Aroclor 1254 (Allnex, 2017a). In each of these assays, metabolism by S9 rat liver enzymes did not result in increased mutation frequency.
Individual fatty acids found in the plasma lipid fraction and will be circulated throughout the body, especially in perfused tissues. Fatty acids can undergo acylation by acyl transferases to triglycerides, phosphatidylcholine and cholesteryl ester (Emken, 1994) which are found in the plasma lipid fraction. Fatty acids can also be oxidized via the β-oxidation cycle. Once in the β-oxidation cycle most fatty acids are completely oxidized to carbon dioxide. Β-oxidation is higher in rodents than in humans and is slower with increasing fatty acid saturation (Dupont and Mathias, 1969). - Conclusions:
- The substance ZWA 5496/100 is expected to show low absorption by the oral, dermal and inhalation routes. If absorbed, it may be distributed to highly perfused organs, and the fatty acid components metabolised through the β-oxidation cycle. Metabolites are not expected to be systemically toxic. The substance is expected to show fecal elimination.
Reference
ZWA 5496/100 is a UVCB of multiple individual components, many of a high molecular weight polymeric structure > 1000 d. Estimated behaviour of a model representative compound shows a low water solubility (estimated at 2.03 x 10-6mg/L) and a relatively high log octanol water partition coefficient (estimated at 9.96). This indicates a relatively lower potential for absorption via oral, dermal and inhalation routes of exposure.
Description of key information
A review of existing data relating to toxicokinetics: low absorption by the oral, dermal and inhalation routes.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 50
- Absorption rate - dermal (%):
- 20
- Absorption rate - inhalation (%):
- 10
Additional information
The substance ZWA 5496/100, is expected to show low absorption by the oral, dermal and inhalation routes. If absorbed, it may be distributed to highly perfused organs, and the fatty acid components metabolised through the β-oxidation cycle. The substance is expected to show fecal elimination.
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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