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EC number: 800-906-3 | CAS number: 1402434-48-3
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: Based on available physico-chemical properties and toxicological data of the substance
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP assessment based on physico-chemical properties and toxicological data of the substance.
Data source
Reference
- Reference Type:
- other: Expert judgment
- Title:
- No information
Materials and methods
- Objective of study:
- other: Toxicokinetic assessment
- Principles of method if other than guideline:
- An expert assessment was made based on all data available.
- GLP compliance:
- no
Test material
- Reference substance name:
- Morpholine, 4-C12-14-alkyl derivs.
- EC Number:
- 800-906-3
- Cas Number:
- 1402434-48-3
- Molecular formula:
- Not applicable
- IUPAC Name:
- Morpholine, 4-C12-14-alkyl derivs.
Constituent 1
Administration / exposure
- Details on study design:
- A toxicokinetic assessment has been performed based on available physico-chemical properties and toxicological data of the substance.
Results and discussion
Main ADME results
- Type:
- absorption
- Results:
- Based on available physico-chemical properties and toxicological data , the oral, dermal and inhalation absorption for C12-14 alkylmorpholine is expected to be greater than 50%. For DNEL derivation purposes, absorption of 100% was assumed via all routes.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): low bioaccumulation potential based on study results
Based on available physico-chemical properties and toxicological data , the oral, dermal and inhalation absorption for C12-14 alkylmorpholine is expected to be greater than 50%. For DNEL derivation purposes, absorption of 100% was assumed via all routes. - Executive summary:
No specific toxicokinetics data is available for C12-14 alkylmorpholine. The toxicokinetic assessment is therefore based on available physico-chemical properties and toxicological data of C12-C14 alkylmorpholine.
The molecular weight of C12-C14 alkylmorpholine (255-284 g/mol) and the octanol-water partition coefficient (i.e., Log Kow) of 4 favors the absorption in the gastrointestinal tract. Therefore, based on the available physical/chemical properties of C12-C14 alkylmorpholine, the oral absorption is expected to be ≥ 50%. For DNEL derivation purposes a 100% oral absorption has been assumed. This is further supported by the human intestinal absorption (HIA) values which were obtained via QSAR toolbox (version 2.3). The % of HIA for all the components of C12-C14 alkylmorpholine has been modeled to be 91-93%.
The moderate molecular weight and its log Kow of 4 also favors the absorption of C12-C14 alkylmorpholine via the dermal route. According to the criteria given in the REACH Guidance, the MW and the log Kow requires consideration a dermal penetration of 100%. Moreover, while inhalation exposure is considered unlikely as a result of the manufacturing conditions and the low vapor pressure (i.e., 0.18 Pa) of C12-C14 alkylmorpholine, in can be assumed that once the substance is inhaled, it will become readily bioavailable. Hence, for DNEL derivation purposes and inhalatory absorption of 100% has been assumed.
Once systemically available, C12-C14 alkylmorpholine is expected to be readily metabolized, most likely by beta-oxidation of the carbon chain and Calkyl-N cleavage as the most likely initial reaction pathways. Excretion will occur via the urine and the bile. Due its moderate log Kow and its potential to readily metabolize into more water soluble compounds, C12-C14 alkylmorpholine may show only very little tendency to accumulate in adipose tissue. This is assessment is further supported by available biodegradability studies which show that C12-C14 alkylmorpholine is readily biodegradable.
Additionally, in the attacheddocument themolecular profiling, estimation of possible metabolism, available data and results from QSARs are compared between C12-14 alkylmorpholine and ethylmorpholine, which serves in support of additional reference to data on ethyl-morpholine made in section 7.8.1 toxicity to reproduction.
Form this can be concluded that chemical structure of C12 -C14-alkylmorpholine and Ethyl Ethyl-morpholine are similar (i.e 4-alkyl morpholine), leading to comparable molecular profiles. Estimation of possible metabolism indicates a similar profile for C12-14 alkylmorpholine and ethylmorpholine.
Also available data for human health hazard end points show comparable results.
Repeated dose studies no indication for accumulative toxicity for either C12-14-alkylmorpholine and Ethyl-morpholine. The reproduction screening study indicates no concerns for reproduction toxicity.
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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