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Diss Factsheets
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EC number: 946-420-6 | 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
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:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Human Studies on Polyglycerol Polyricinoleate (PGPR)
- Author:
- R. WILSON and M. SMITH
- Year:
- 1 998
- Bibliographic source:
- Food and Chemical Toxicology 36 (1998) 743±745
Materials and methods
- Study type:
- study with volunteers
- Endpoint addressed:
- repeated dose toxicity: oral
- Principles of method if other than guideline:
- During 1964 and 1965, PGPR was fed to 19 human volunteers whose diet contained constant levels of fat and protein. Up to 10 g/day PGPR was fed to each volunteer in soups, cakes and toffee bars for 2 weeks. Pre-exposure normal values of biochemical parameters were established. Fat balance tests confirmed that digestion and absorption of PGPR took place.
- GLP compliance:
- no
Test material
- Reference substance name:
- 9-Octadecenoic acid, 12-hydroxy-, (9Z,12R)-, polymer with 1,2,3-propanetriol
- Cas Number:
- 29894-35-7
- IUPAC Name:
- 9-Octadecenoic acid, 12-hydroxy-, (9Z,12R)-, polymer with 1,2,3-propanetriol
- Test material form:
- liquid
- Details on test material:
- Hydroxyl value 85±100
Acid value 2.0 max.
Iodine value 80±90
Refractive index at 658C 1.4635±1.4665
"the polyglycerol moiety shall be composed of not less than 75 percent of the di-, tri- and tetraglycerols and shall contain not more than 10 percent of polyglycerols equal to or higher than heptaglycerol'' (FAO, 1992).
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Route of exposure:
- oral
- Reason of exposure:
- intentional
- Exposure assessment:
- measured
- Details on exposure:
- PGPR was introduced into three items: (1) soups (5 g/pint); (2) cakes (10 g/cake or 2.5 g/portion); (3) toffee bars (5 g/bar). The soups and cakes were supplied to the hospital in the form of a dry mix which
was freshly prepared each day in the hospital kitchens. The toffee bars were prepared at the Unilever Research Laboratory, Colworth House. The amount of PGPR fed to the volunteers was carefully regulated over a 3-wk period as follows: wk 1: none; wk 2: 5 g PGPR/day; wk 3:10 g PGPR/day.
The diet was designed to maintain constant intakes of fat (150 g/day, excluding PGPR) and protein (75 g/day) with a flexible level of carbohydrates to suit individual requirements. - Examinations:
- Blood samples were taken at twice-weekly intervals throughout the study. The following serum clinical chemistry parameters were determined:
albumin, globulin, serum electrophoresis, thymol turbidity, bilirubin, cholesterol, alanine aminotransferase, cholinesterase and creatine clearance.
Faeces and urine samples were collected throughout the study and pooled for individuals as weekly samples. The faeces samples were analysed for fat and faecal nitrogen, while the urine samples were analysed for creatinine. The means and standard deviations were calculated.
Results and discussion
- Results of examinations:
- While some individuals occasionally deviated from the normal ranges for the liver function parameters, none of these deviations were attributable to the consumption of PGPR.
Creatinine clearance was included as a relatively simple test of kidney function which establishes the glomerular filtration rate. The consumption of PGPR was not associated with any detectable disruption of renal function.
Cholesterol levels were monitored and, once again, although there were individual variations, none were attributable to the consumption of PGPR.
The level of faecal fat was determined to investigate whether there was any evidence of interference with fat digestion. Most of the results were within the normal limits. Where there were deviations from normal, these could not be ascribed to the consumption of PGPR. Nitrogen determinations on the faeces provide an indicator of digestion and absorption in the alimentary tract. Analysis of randomly selected samples did not indicate any consistent effect produced by PGPR.
Applicant's summary and conclusion
- Conclusions:
- The range of clinical chemistry parameters measured as part of these human studies on PGPR is not as extensive as that which would be available for such an investigation today. The range of analyses were simply not available within an automated system at that time. However, the tests still are considered as appropriate indicators of any abnormalities in liver and renal function induced by PGPR as well as changes in fat balance.
The fat balance tests confirmed that the digestion and absorption of fat took place without any interference from PGPR. There was no consistent effect of PGPR on the clinical chemistry parameters or creatinine clearance and hence no indication of renal or kidney dysfunction.
PGPR was consumed at quantities of up to 10 g/day or 167 mg/kg/day for a 60-kg person. This amount is approximately 63 times the estimated maximum per capita mean daily intake by man of 2.64 mg/kg body weight/day. It is therefore concluded from this study that the consumption of PGPR has no adverse effects in man.
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