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EC number: - | 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)
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: toxicokinetics assessment
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The assessment of the toxicokinetics of 'Ester Adipic Acid and Neodecanoic acid, 2-oxiranylmethyl ester' is based on physico-chemical properties of the compound and on toxicological data. Experimental toxicokinetic studies were not performed.
- Principles of method if other than guideline:
- assessment on toxicokinetics
Reference
The remarks on the toxicokinetics are based on physico-chemical properties of the compound and on toxicological data (Tegethoff, 2019). Experimental toxicokinetic studies were not performed.
Description of key information
Key value for chemical safety assessment
Additional information
The following remarks on the toxicokinetics of 'Ester Adipic Acid and Neodecanoic acid, 2-oxiranylmethyl ester' are based on physico-chemical properties of the compound and on toxicological data. Experimental toxicokinetic studies were not performed.
The UVCB substance is a clear, viscous organic liquid with a low vapour pressure under normal ambient conditions (3.08 x 10-15 Pa at 20 °C). No spray applications are intended.
The physico-chemical characteristics of the substance, as low water solubility (below 1 mg/L), high log Pow of 5.5 and a molecular mass of > 600 g/mol for the main component, are not favourable for intestinal absorption after oral intake via passive diffusion. However, uptake by micellular solubilisation may be of importance for such highly lipophilic compounds.
A single oral dose of 2000 mg/kg bw was tolerated in rats without mortalities, effects on body weight development and gross pathological findings. However, transiently occurring clinical signs point to systemic availability after oral administration. In a study with repeated oral exposure (OECD 422) clinical signs were observed in the pilot phase of the study at high doses. In the main study effects on male kidneys confirmed systemic availability via gastro-intestinal tract.
Because of the high lipophilicity of the substance accumulation of the compound in fatty tissues is not unlikely. The results of the OECD 422 study, in which oral doses up to 500 mg/kg bw were applied for 29 days to male or up to 64 days to female rats, do not reveal indications of a significant accumulation potential of the substance.
Due to the physico-chemical characteristics of the substance no appreciable dermal or mucosal absorption is anticipated. This is confirmed by an acute limit dose study on rats (OECD 402) with occlusive dermal exposure over 24 hours, in which no signs of local or systemic toxicity were observed. In vitro skin and in vitro/ex vivo eye irritation studies did not reveal any signs of local toxicity as well. Additionally, low skin permeability is predicted in the Toolbox (Schlecker, 2019). Therefore, the inconclusive data base for skin sensitization in chemico/in vitro is expected not to be relevant for the in vivo situation.
Results of in vitro genotoxicity tests in bacteria (OECD 471) showed that ‘Ester adipic acid and neodecanoic acid, 2-oxiranylmethyl ester’ contains a minor constituent, i.e. 2,3-epoxypropyl neodecanoate (EC-No. 247-979-2 / CAS-No. 26761-45-5), that exerts mutagenic effects in the Ames test. Reducing the concentration of this constituent to 0.05 % was proven to change the result from positive to negative in the Ames test. No mutagenic effects were observed in mammalian cells in vitro, i.e. the HPRT test (OECD 476) and the micronucleus test (OECD 487). Thus, it is concluded that DNA-reactive metabolites in the course of hepatic biotransformation may occur via 2,3-epoxypropyl neodecanoate.
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