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Diss Factsheets
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EC number: 940-373-5 | 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1991
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well documented study according to GLP. Limitations due to low number of evaluated animals (n=2), but overall result plausible based on all available data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.7600 (Dermal Penetration)
- Deviations:
- yes
- Remarks:
- (limited animal number (n=2))
- GLP compliance:
- yes
Test material
- Reference substance name:
- A 3:1 mixture of: 1-deoxy-1-[methyl-(1-oxododecyl)amino]-D-glucitol; 1-deoxy-1-[methyl-(1-oxotetradecyl)amino]-D-glucitol
- EC Number:
- 407-290-1
- EC Name:
- A 3:1 mixture of: 1-deoxy-1-[methyl-(1-oxododecyl)amino]-D-glucitol; 1-deoxy-1-[methyl-(1-oxotetradecyl)amino]-D-glucitol
- Cas Number:
- 287735-50-6
- Molecular formula:
- C19H39NO6 (C12 derivative) C21H43NO6 (C14 derivative)
- IUPAC Name:
- D-Glucitol, 1-deoxy-1-(methylamino)-, N-C12-14 acyl derivs.
- 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
- Radiolabelling:
- yes
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
- Type of coverage:
- open
- Vehicle:
- other: absolute ethanol:water (80:20)
- Duration of exposure:
- single dermal application for 72 hours
- Doses:
- 9.9 mg/kg body weight (0.26 mg/cm2)
- No. of animals per group:
- initially 4 males; 2 animals accidentally ingested residual test material from exposed test side were removed from evaluation
- Control animals:
- no
- Details on study design:
- 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, Carcass, skin (test site) and skin (adjacent).
- 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
- Signs and symptoms of toxicity:
- no effects
- Dermal irritation:
- not specified
Percutaneous absorption
- Dose:
- 0.26 mg/cm2
- Parameter:
- percentage
- Absorption:
- < 1 %
- Remarks on result:
- other: 72 hours
Any other information on results incl. tables
Total Recovery: Recovery was 95 ± 5% (Mean ± S.E., n=2)
Applicant's summary and conclusion
- Conclusions:
- The extent of radioactivity absorption following dermal administration of n-Lauryl [14C(U)]-glucose amide ([14C]-C12-GS-Base) at 9.9 mg/kg bw (0.26 mg/cm2) to rat was estimated to be <1% over 72-h test period. A very low amount of residual radioactivity was detected in all tissues and the principle route of elimination was urine.
- Executive summary:
The absorption, distribution and excretion of n-Lauryl [14C(U)]-glucose amide ([14C]-C12-GS-Base) after dermal administration was determined by following the methods similar to the OECD guideline 417 (Toxicokinetics).
Male Sprague Dawley rats (from Charles River) were used in study. One group (number of animals= 2) of rats was used in the study to determine absorption, distribution and excretion (ADE) of test substance. Animals were housed in metabolism cages during the study period.
Test formulation (19.3 mg/g solution) was prepared in absolute ethanol. Animals were treated once with dose of 9.9 mg/kg bw (0.26 mg/cm2). Approximately 0.1 mL of test solution was applied within a glass ring glued on the hair clipped backs of animals, with the help of a syringe. The radioactive dose administered to animals was approximately 9 µCi/animal.
Animals were sacrificed by an overdose of CO2 after 72 hours of treatment. Urine and faeces were collected at 24, 48 and 72 h time intervals after treatment. Tissue samples were collected after sacrifice of the animals.
The extent of absorption following dermal administration of the radio-labeled test substance at 9. 9 mg/kg bw (0.26 mg/cm2) was estimated to be < 1% over a 72-hour test period.
Inspection of individual tissue radioactivity distribution at 72 hours showed the presence of very low levels of residual radioactivity in all tissues. The femur contained the highest radioactive content [20 times background (plasma radioactive content)] followed by carcass, whole blood, adipose and bone marrow. AII other tissues were five times background or less.
At the end of the 72-hour test period, 94.4% of the dosed radioactivity was recovered in the test site skin plus dose cell wash, 0.27% in the urine plus cage wash, 0.19% in the tissues plus carcass, 0.1% in the feces plus Gl tract wash and 0.02% in the expired carbon dioxide.Theprincipal route of radioactivity elimination was urine.
The % total recovery of test substance was 95±5% after treatment.
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