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EC number: 258-061-6 | CAS number: 52636-67-6
- 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: Expert statement
- Adequacy of study:
- key study
- Study period:
- 2013-05-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Expert statement, no study available
Data source
Reference
- Reference Type:
- other: Expert statement
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Expert statement
- GLP compliance:
- no
Test material
- Reference substance name:
- Morpholinium sulphamate
- EC Number:
- 258-061-6
- EC Name:
- Morpholinium sulphamate
- Cas Number:
- 52636-67-6
- Molecular formula:
- C4H9NO.H3NO3S
- IUPAC Name:
- morpholin-4-ium sulfamate
- Test material form:
- solid
Constituent 1
Test animals
- Details on test animals or test system and environmental conditions:
- not applicable
Administration / exposure
- Details on exposure:
- not applicable
- Duration and frequency of treatment / exposure:
- not applicable
Doses / concentrations
- Remarks:
- Doses / Concentrations:
not applicable
- No. of animals per sex per dose / concentration:
- not applicable
- Positive control reference chemical:
- not applicable
- Details on study design:
- not applicable
- Details on dosing and sampling:
- not applicable
- Statistics:
- not applicable
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Generally, oral absorption is favoured for molecular weights below 500 g/mol. This characteristic combined with a log Pow value between -1 and 0 and a high water solubility allow dissolution of Morpholinium sulphamate in the gastro-intestinal fluids and contact with the mucosal surface. However, diffusion through biological membranes might be limited by the ionic properties of the substance. Due to its low pKa value (1.0) sulphamidic acid is estimated to be absorbed in the acidic milieu of the stomach (~ pH 1.4 to 4.5). Based on its pKs value (8.4) morpholine might be absorbed in the small intestine due to the present basic milieu (~ pH 5 to 8). Passage through aqueous pores or carriage through the epithelial barrier by the bulk passage of water is assumed to be an alternative pathway of absorption for small, water soluble substances like the test substance. Oral administration of morpholinium sulphamate revealed no adverse effects. However, increased mean concentrations of serum bile acids in female animals and decreased activated partial thromboplastin time and prothrombin time in male animals at 1000 mg/kg bw/day might be associated with the bioavailability of the test item. This assumption is in line with experimental data of Tanaka et al. (1978) who have shown bioavailability of 14C labelled morpholine after oral administration in rats.
Inhalation exposure of vapour was considered to be not relevant as morpholinium sulphamate is manufactured in an aqueous solution (50 %, w/v) and evaporation of the dissociated test substance can be excluded. However, the substance might reach the respiratory tract in form of mist and might dissolve in the mucous. As passive diffusion of ionic substance through the respiratory tract epithelium is limited carriage through aqueous pores is assumed to be an entry route to systemic circulation.
Dermal penetration of morpholinium sulphamate is estimated to be low due to its high water solubility (> 900 g/L) and low log Pow value (< 0). It is general accepted that if a compound’s water solubility is higher than 10 g/L and the log Pow value is below 0 absorption can be anticipated to be low. The ionic properties of morpholinium sulphamate in aqueous solution further limit uptake through the skin. No enhanced dermal penetration is expected as morpholinium sulphamate has no skin irritation properties. - Details on distribution in tissues:
- Assuming that morpholinium sulphamate is absorbed into the organism following oral intake, it may be widely distributed via the blood stream due to its hydrophilic properties and in turn the extracellular concentration may be higher than the intracellular one. In a toxicokinetic study with 14C labelled morpholine palmitate (Tanaka et al., 1978) the highest tissue concentration of morpholine after oral administration was found in the muscle and in the intestine. Intravenous administration of radio labelled morpholine (Stee et al., 1981) revealed a high tissue concentration in the kidney.
Particularly, due to the high water solubility and low log Pow value a long biological half-life in tissues is not expected. This assumption is supported by experimental data of Tanaka et al. (1978) and Sohn et al. (1982). 90 % of the original dose was found in the urine after 3 days and 0.08 to 0.14 % was found in the faeces after oral administration of morpholine salts (200 mg/kg bw) on rats (Tanaka et al., 1978). After intraperitoneal administration of 125 mg/kg bw 14C Morpholine (Sohn et al., 1982) the blood plasma half-lives in the rat, hamster and guinea pig were 115, 120 and 300 min, respectively. In all three species, approximately 80 % of the radioactivity was excreted in the urine in 24 hours.
- Details on excretion:
- Based on the high water solubility, morpholinium sulphamate is expected to be excreted via urine. This assumption is supported by Tanaka et al. (1978), Sohn et al. (1982) and van Stee et al. (1981) who have shown that 90 to 99% of administered morpholine was renal excreted. Less than 1 % was found in faeces.
Metabolite characterisation studies
- Details on metabolites:
- Generally, the function of xenobiotic metabolism is to increase water solubility of highly lipophilic substances to facilitate their excretion from the organism. As morpholinium sulphamate is already a small, highly water soluble molecule, no metabolic conversion is expected. This assumption is in line with excretion data of morpholine published by Sohn et al. (1982). While non-metabolized 14C Morpholine constituted up to 99 % of the urinary radioactivity in the rat and hamster, a significant portion of the dose (approximately 20 %) appeared as N-methylmorpholine-N-oxide in the urine of guinea pigs after i.p. administration of morpholine. As no or only minor metabolite formation is expected for morpholinium sulphamate, there is no indication for metabolic activation of the test substance.
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- Taken together, physico-chemical properties and experimental data indicate bioavailability of morpholinium sulphamate via oral route and to a less extent via inhalation route. Dermal uptake is estimated to be low.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
Based on physico-chemical characteristics, particularly water solubility and octanol-water partition coefficient and experimental data absorption via oral route and to a less extent via inhalation route is likely to occur. However, bioavailability after dermal exposure is low. Extracellular concentration is likely to be higher than intracellular due to the hydrophilicity of morpholinium sulphamate. As morpholinium sulphamate is already a small, highly water soluble molecule, no metabolic conversion is expected. Based on the molecular weight and the high water solubility morpholinium sulphamate is excreted via the urine. Bioaccumulation of the test substance is not likely to occur based on their physico-chemical properties.
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