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EC number: 940-422-0 | 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well documented study conducted according to valid scientific standards including GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
- Objective of study:
- absorption
- distribution
- excretion
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Deviations:
- yes
- Remarks:
- (one dose level was used in this study against the guideline recommendation of minimum 2 dose levels).
- GLP compliance:
- yes
Test material
- Reference substance name:
- Glucamide 24
- IUPAC Name:
- Glucamide 24
- Reference substance name:
- 287735-50-6
- Cas Number:
- 287735-50-6
- IUPAC Name:
- 287735-50-6
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): N-Lauroyl [14C]-glucose amide (C12-GS-Base)
- Physical state: white solid
- Radiochemical purity (if radiolabelling): 99.1%
- Specific activity (if radiolabelling): 19 mCi/g
- Storage condition of test material: room temperature
Constituent 1
Constituent 2
- Radiolabelling:
- yes
- Remarks:
- (14C)
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Weight at study initiation: 175 - 225 g
- Fasting period before study: overnight before dosing
- Individual metabolism cages: yes
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 4 days
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: ethanol:water (20:80)
- Details on exposure:
- Administration of the dosing solution by a syringe
- Duration and frequency of treatment / exposure:
- Single administration via gavage followed by 3 day collecting period in metabolism cages designed for separation of urine, faeces and expired CO2
Doses / concentrations
- Remarks:
- Doses / Concentrations:
150 mg/kg body weight
- No. of animals per sex per dose / concentration:
- 4 males
- Control animals:
- no
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: Urine, faeces, CO2, blood, plasma, tissues, cage washes, GI tract wash. Tissue collected were liver (entire), kidneys, testes or (Ovaries and uterus), heart, lung (entire), spleen, pancreas, brain, bone marrow, muscle (Hind limb; right), bone (femur; both), adipose (at the psoas), Gl tract and Carcass.
- Time and frequency of sampling: Urine and feces were collected at 24, 48 and 72 hours after treatment. CO2 was collected from the rats at 24, 48 and 72 hours. CO2 safety trap (one/rat) was collected at the end of the 72 hour test period. At the end of the 24-, 48- and 72-hour collection period, cages were washed with 3A alcohol followed by distilled water. These cage washes were submitted separately to Radiochemistry for analysis. Tissue samples were collected after sacrifice of animals.
- Blood sampling and sacrifice: At the end of the 72 hour test period, rats were sacrificed with an overdose of carbon dioxide. Blood was collected from the inferior vena cava in a heparinized syringe. A portion of this sample was submitted to Radiochemistry as ‘blood’. The plasma fraction from the remainder of the blood was prepared by centrifugation. This sample was submitted to Radiochemistry as ‘plasma’.
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- oral absorption was high (greater 80%) over the 72 hour period
- Type:
- distribution
- Results:
- An overall low level of radioactivity was present in all analyzed tissues. Individual tissue distribution at 72 hours indicated highest levels in liver followed by kidneys, spleen, carcass, lungs and GI-tract
- Type:
- excretion
- Results:
- Excretion occurred primaryl via urine (greater 99% of absorbed dose).
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- - The extent of radioactivity absorption following the oral administration of the radio-labeled test substance at 150 mg/kg bw was estimated to be 80% over the 72-hour test period.
- Details on distribution in tissues:
- - Inspection of individual tissue radioactivity distribution at 72 hours showed the presence of low levels of radioactivity in all tissues.
- The liver contained the highest radioactivity [16 times background (plasma radioactive content) followed by kidneys, spleen, carcass, lungs and GI tract.
- All other tissues were ≤ 3 times background level.
- Details on excretion:
- - At the end of the 72-hour test period, 79.7% of the dosed radioactivity was recovered in the urine plus cage wash, 16.03% in the feces plus GI tract wash, 0.31% in the expired carbon dioxide and 0.18% in the tissues plus carcass.
- The amount of radioactivity recovered in urine plus cage wash, expired carbon dioxide and feces decreased during each 24- hour collection period with the largest amount of radioactivity collected in the 0-24 hour test period.
- Of the absorbed radioactivity, >99% was excreted in the urine, 0.3% was eliminated in the expired CO2 and residual radioactivity detected in tissues and carcass at 72 hours accounted for 0.2% of the absorbed radioactivity
Metabolite characterisation studies
- Metabolites identified:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
N-Lauryl [14C(U)]-glucose amide ([14C]-C12-GS-Base) when administered once orally to Sprague-Dawley rats was rapidly and extensively absorbed (80%) from the gastrointestinal tract. Of the absorbed radioactivity, >99% was excreted in the urine, 0.3% was eliminated in the expired CO2 and residual radioactivity detected in tissues and carcass at 72 hours accounted for 0.2% of the absorbed radioactivity. - Executive summary:
The absorption, distribution and excretion of n-Lauryl [14C(U)]-glucose amide ([14C]-C12-GS-Base) after oral administration was determined by following the methods similar to the OECD guideline 417 (Toxicokinetics).
Male Sprague Dawley rats (from) were used in study. One group (number of animals = 4) of rats was used in the study to determine absorption, distribution and excretion (ADE) of the test substance. Animals were housed in metabolism cages during the study period.
Test formulation (30 mg/g solution) was prepared in absolute ethanol:distilled water (20:80)(v/v). Animals were treated once orally with 152 mg/kg bw (Dose volume: Approximately 1 mL/animal). Urine and faeces were collected at 24, 48 and 72 h after treatment. CO2 was collected from the rats at 24, 48 and 72hours. Animals were sacrificed by an overdose of CO2 after 72 hour of treatment. Tissue samples were collected after sacrifice of animals.
The extent of radioactivity absorption following oral administration of the radio-labeled test substance at 150 mg/kg bw was estimated to be 80% over the 72-hour test period.
Inspection of individual tissue radioactivity distribution at 72 hours showed the presence of low levels of radioactivity in all tissues. The liver contained the highest radioactivity [16 times background (plasma radioactive content) followed by kidneys, spleen, carcass, lungs and GI tract. All other tissues were ≤ 3 times background level.
Of the absorbed radioactivity, >99% was excreted in the urine, 0.3% was eliminated in the expired CO2 and residual radioactivity detected in tissues and carcass at 72 hours accounted for 0.2% of the absorbed radioactivity.
The radioactivity material balance (% Total recovery) was 96 ± 0.48% (Mean ± S.E., n=4) in the study.
In conclusion, n-Lauryl [14C(U)]-glucose amide ([14C]-C12-GS-Base) when administered once orally to Sprague-Dawley rats was rapidly and extensively absorbed (80%) from the gastrointestinal tract. Of the absorbed radioactivity, >99% was excreted in the urine, 0.3% was eliminated in the expired CO2 and residual radioactivity detected in tissues and carcass at 72 hours accounted for 0.2% of the absorbed radioactivity.
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