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EC number: 500-336-2 | CAS number: 157348-58-8
- 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:
- Assessment, based on physico-chemical properties of the test item and on toxicological data. Experimental toxicokinetic studies were not performed.
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see Remarks
- Remarks:
- The assessment of the toxicokinetik of the test item is based on physico-chemical properties of the compound and on toxicological data. Experimental toxicokinetic studies were not performed.
Reference
Description of key information
There were no studies available in which the toxicokinetic properties (absorption, distribution, metabolism, elimination) of
2,3-Epoxypropyl neodecanoate, oligomeric reaction products with phosphorous acid were investigated. A data waiver is claimed.
Based on the molecular structure, molecular weight, water solubility, vapour pressure and octanol-water partition coefficient it can be expected that only oral absorption rates is significantly existent.The results from the acute and repeated oral toxicity dose studies confirm that the substance has moderate oral absorption rates. Based on a low log Kow which indicates only moderate lipophilicity of the test item, significant dermal absorption is not expected. Additionally, due to the low vapour pressure of the test item significant respiratory absorption via vapour is also not expected.
The test item could be distributed in the body in a moderate amount.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
There were no studies available in which the toxicokinetic properties (distribution, metabolism, elimination) of the test item were investigated. Therefore the following remarks on the toxicokinetics of 2,3-Epoxypropyl neodecanoate, oligomeric reaction products with phosphorous acid are based on physicochemical properties of the test item and on toxicological data.
The test item is a colourless viscous liquid with a molecular weight of Mw = 530 g/mol. It is moderately soluble in water (2.7 mg/L; Infracor GmbH, 2002) and has a low vapour pressure (1 Pa; Infracor GmbH, 2002) under normal ambient conditions. The partition coefficient octanol/water was determined as log Kow = 3.58 at 24.5 °C (Lange, 2017), indicating that a significant bioaccumulation is not to be expected.
With regard to hydrolysis, the test item was tested for hydrolysis according to OECD Guideline No. 111 (2004) and was found to be slightly hydrolytically unstable at pH 7.0. Therefore, slightly dissociation is expected at physiological pH values.
Oral and GI absorption:
Due to the fact, that the test item is only slightly hydrolytically unstable, it is not expected that it is significantly hydrolysed in the gastro-intestinal tract. In fact, the acute oral toxicity is low (LD50 (rat ) > 2000 mg/kg bw) and only slight signs of toxicity were observed (BSL Bioservice, 2004). No mortality occured. However, oral absorption could not be excluded based on the results of the repeated dose toxicity study (LPT, 2018). In this study according to OECD 422 with Wistar rats exposed to 75, 225, and 750/600/450 mg/kg bw/day, the test item caused some mortality in the adults at 750 mg/kg/day. Therefore, the high dose level was stepwise reduced due to mortality. In the Mid dose group of the parental generation also minor clinical effects were observed. Thus, an indication of oral uptake of the substance is given.
Dermal absorption:
Based on the log Kow which indicates only a moderate lipophilicity of the test item, significant dermal absorption is not expected. In fact, the test item shows neither skin irritating nor skin sensitizing properties (both LPT, 2016).Acute or long-term dermal toxicity studies are not available for the test substance.
Respiratory absorption:
Due to the low vapour pressure of the test item significant respiratory absorption via vapour is not expected.
Distribution:
The physico-chemical information (high molecular weight, moderate lipophilicity and water solubility) indicates that the test item could be distributed only in a moderate amount.
Accumulative potential:
The partition coefficient octanol/water was determined as log Kow = 3.58 at 24.5 °C (Lange, 2017), indicating that a significant bioaccumulation is not to be expected.
Excretion:
No data are available regarding the excretion of absorbed 2,3-Epoxypropyl neodecanoate, oligomeric reaction products with phosphorous acid.
Based on the results of two mammalian in vitro genotoxicity tests (both LPT, 2016; all performed with and without metabolic activation) it is concluded that DNA-reactive metabolites of the test item will not be generated in mammals in the course of hepatic biotransformation.
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