Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 917-830-2 | CAS number: 1186514-91-9
- 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 existing data
- Type of information:
- other: review of existing data
- Adequacy of study:
- key study
- Study period:
- 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:
- absorption
- distribution
- excretion
- metabolism
- Qualifier:
- according to guideline
- Guideline:
- other: Regulation (EC) No. 1907/2006, Annex VIII Section 8.8
- Qualifier:
- according to guideline
- Guideline:
- other: ECHA, 2014, Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance
- Principles of method if other than guideline:
- Paper-based review of the available literature
- GLP compliance:
- no
- Radiolabelling:
- no
- Type:
- absorption
- Results:
- Low absorption via oral, dermal and inhalation routes
- Type:
- distribution
- Results:
- Low observed toxicity suggests minimal distribution or absorption into the systemic compartment. Theoretically, absorbed material may be broken down into fatty acid derivatives, which are distributed through the systemic circulation and metabolised.
- Type:
- metabolism
- Results:
- In in vitro mutagenicity studies, metabolism by rat hepatic S9 fraction did not result in formation of mutagenic products.
- Type:
- excretion
- Results:
- Elimination of unabsorbed and unchanged ZEF 6099/100, as well as fatty acid esters, is likely via fecal excretion.
- Details on absorption:
- ZEF 6099/100 is very slightly water soluble, has a relatively high log Kow with a high molecular weight polymeric structure which suggests low potential for absorption across the skin and gastrointestinal tract. Lipophilic substances have limited solubility in gastrointestinal fluids. While dermal absorption data for ZEF 6099/100 are not available, topically applied fatty acid methyl esters are theoretically able to penetrate to the living cells of normal epidermis, enter into metabolism and significantly modify endogenous epidermal lipids. Due to its molecular weight, ZEF 6099/100 will not readily penetrate the epidermis and due to the low water solubility, ZEF 6099/100 will not readily pass from epidermis to dermis. 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 a repeated dose study in the rat with ZEF 6099/100 by oral administration. The low water solubility and relatively high partitioning into octanol of ZEF 6099/100 indicates that it may accumulate in body fats and/or breast milk. Fatty acid esters are distributed into plasma and 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 ZEF 6099/100. Fecal excretion is also a likely major pathway of elimination of any fatty acid esters.
- Metabolites identified:
- no
- Details on metabolites:
- ZEF 6099/100 is not active in mutagenicity assays in the absence and presence of metabolic activation by rat liver S9-mix induced by Aroclor 1254. ZEF 6099/100 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, nor did it 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, 2016, 2017). 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 will be circulated throughout the body, especially in perfused tissues. Fatty acids can undergo acylation by acyl transferases to triglycerides, phosphatidylcholine and cholesteryl ester 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. - Conclusions:
- The substance ZEF 6099/100 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 as triglycerides through the β-oxidation cycle. Metabolites are not expected to be systemically toxic. The substance is expected to show significant fecal elimination.
Reference
ZEF 6099/100 is a UVCB of complex reaction products, many of which are polymers/oligomers which have a high molecular weight over 1000 d. Results from computer models ((QSAR, EPI-Suite and OECD QSAR Toolbox) of the individual components of the UVCB show high log Kow values ranging from 10.46 -16.95.
Description of key information
A literature review of toxicokinetics was undertaken with low absorption via oral, dermal and inhalation routes, and possible moderate absorption of breakdown products of the fatty acid residues. The potential for bioaccumulation is low.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
- Absorption rate - oral (%):
- 50
- Absorption rate - dermal (%):
- 10
- Absorption rate - inhalation (%):
- 10
Additional information
ZEF 6099/100 is not toxic by the oral route in animal studies. Low water solubility, relatively high log octanol water partition coefficients and high molecular weight polymeric structure would suggest somewhat lower potential for absorption across the skin, gastrointestinal tract and respiratory tract. It is likely that ZEF 6099/100 may be digested to individual fatty acid esters which are more readily absorbed in the digestive tract. ZEF 6099/100 would be absorbed by the gastrointestinal tract with an absorption rate < 50%. Dermal absorption rate is likely <10%. Low volatility, the lack of hydrolysis, and limited solubility do not favor respiratory tract absorption. Inhalation absorption rate is also likely < 10%.
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.