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EC number: 215-664-9 | CAS number: 1338-41-6
- 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
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given (no data on test substance purity).
Data source
Reference
- Reference Type:
- publication
- Title:
- The effect of emulsifying agents (tween 60 and span 60) on the gastrointestinal tract
- Author:
- Steigmann, F. et al.
- Year:
- 1 954
- Bibliographic source:
- Am J Dig Dis 20/12: 380-384
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- repeated dose toxicity: oral
- Principles of method if other than guideline:
- The study was undertaken to determine the effect of 2 emulsifying agents, Span 60 (the test substance) and Tween 60, in doses of 6 g/person/day for 28 days on changes in the gas pattern of the bowel, intestinal motility and gallbladder function as well as subjective symptoms.
- GLP compliance:
- no
Test material
- Reference substance name:
- Sorbitan stearate
- EC Number:
- 215-664-9
- EC Name:
- Sorbitan stearate
- Cas Number:
- 1338-41-6
- Molecular formula:
- Molecular formula cannot be given as substance is a mixture.
- IUPAC Name:
- 1,4-anhydro-6-O-stearoyl-D-glucitol
- Details on test material:
- - Name of test material (as cited in study report): sorbitan monostearate (span 60)
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 9
- Known diseases: Patients were examined to exclude gastrointestinal diseases. Furthermore, a complete physical examination and battery of laboratory tests on urinalysis, hemogram and chemical parameters (non-protein nitrogen, creatinine, blood urea nitrogen, total protein, albumin, globulin, alkaline phosphatase, cholesterol, cholesterol esters, thymol turbidity, gamma globulin and bromsulphalein retention) was performed and any patient showing significant abnormal laboratory findings was eliminated. Patients with gross abnormalities demonstrable by roentgenologic studies including flat plate, barium meal without fluoroscopy and cholecystography were also eliminated.
- Other: Subjects for the study, that appeared willing and able to cooperate, were choosen fom patients at the Oak Forest Infirmary, Oak Forest, Illinois, USA. These patients were institutionalised because of their degenerative diseases and belonged therefore mainly to the older age groups. - Route of exposure:
- oral
- Reason of exposure:
- intentional
- Details on exposure:
- Each subject was given 3 g of the test substance in a capsule twice daily by a nurse, who controlled the ingestion of the capsules (corresponding to 100 mg/kg bw, based on the assumption of an average body weight of 60 kg).
- Examinations:
- - Other: A 14x17" film of the abdomen was obtained by standard techniques at the beginning, middle and end of the medication period. The films were taken at these various times to check the amount of gas appearing in the abdomen.
Gallbladder visualisation was attempted by the technique of Graham-Cole. Following this test, patients received an iodine containing compound which is radiopaque in the evening prior to the examination. Then, the patient was fasted overnight and in the morning the concentration of the dye within the gallbladder was visualised by spot films of the gallbladder area. Following a fatty meal and 45 minutes later, another x-ray of the gallbladder area was taken. Emptying of the gallbladder was evaluated by reduction of the size of the gallbladder. Finally, the films were compared and checked for concentration and emptying of the gallbladder.
Regarding motility of the gut, the patients were given a pint of thin barium and standard x-ray films were obtained of the stomach and small intestines immediately after ingestion. Four films were taken: two of the anteroposterior and two oblique exposures. Six hours later, a 14x17" flat plate of the abdomen was obtained to determine the barium passage time to locate the position of the head of the barium column within the intestine. These studies were repeated after 28 days of medication. All films were interpreted with special regard to passage time, rate of emptying of stomach amount of gas and barium in the intestine and location of the head of the barium column.
Results and discussion
- Results of examinations:
- - Other: No change was noted in the gas pattern in seven patients. There appeared to be more and less gas at the end of the observation period in one other person. There were no changes in the gallbladder function in seven cases; the emptying time appeared better in one person, and the visualisation was fainter in a second one. The stomach appeared unchanged in six patients; in two patients, it emptied slower and in one case, faster after the medication period. The intestinal pattern was unchanged in eight patients. It appeared "more normal" in one patient at the final examination. The passage of the barium column was unchanged in five patients, it was slower in two and more rapid in two at the end of the test period.
Applicant's summary and conclusion
- Conclusions:
- Administration of 6 g (corresponding to 100 mg/kg bw, based on the assumption of an average body weight of 60 kg) of the test substance for 28 days to humans had no significant effect on the physiologic activity of the gastro-intestinal tract as measured by changes in the gas pattern of the bowel, by gastric emptying time, by passage of barium through the gastro-intestinal tract and by gallbladder visualisation.
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