Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics in vivo
- Type of 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:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Objective of study:
- absorption
- distribution
- excretion
- 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
- Specific details on test material used for the study:
- UNLABELED TEST MATERIAL
- Name of test material: C12/14 GS-base
- TSIN: SS0001.01
- Substance type: Other
- Physical state: White opaque solid gel
- Stability under test conditions: Not reported
- Storage condition of test material: Room temperature
RADIOLABELED TEST MATERIAL
- Name of test material: n-Lauroyl [14C(U)]-glucose amide (C12-GS-Base)
- TSIN: SS0001.01
- Physical state: Solid
- Substance type: Pure active substance
- Specific activity: 19 mCi/g
- Stability under test conditions: Not reported
- Storage condition of test material: Refrigerated - Radiolabelling:
- yes
- Remarks:
- 14C
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Age at study initiation: Not reported
- Weight: Weighing 175 - 225 g after overnight fasting
- Fasting period before study: Animals were fasted overnight before dosing and until 4 hours after dosing.
- Housing: Animals were housed in Plasite 7122-H coated metabolism cages.
- Individual metabolism cages: Yes
- Diet: Purina rat chow diet, ad libitum
- Water: ad libitum
- Acclimation period: At least 4 days
ENVIRONMENTAL CONDITIONS: Environmental conditions were as per the Standard Operating Procedures of the Test Facility.
STUDY INITIATION DATE: Mar. 05, 1991
STUDY COMPLETION DATE: Mar. 08, 1991 - Route of administration:
- oral: gavage
- Vehicle:
- other: Absolute ethanol/water (20:80) v/v
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: Approximately 10 grams of the dose solution was supplied by Radiochemistry. Dose solution was prepared by mixing 7.7 mg of radio-labeled and 654 mg of unlabeled test substance, and taking to a final weight of 10 grams with a solution of absolute ethanol:distilled water (20:80)(v/v).
- Mean radioactive dose: 13.8 µCi/rat
VEHICLE
- Concentration in vehicle: 30 mg/g solution (approximately 10 µCi/g) - Duration and frequency of treatment / exposure:
- Once
- Dose / conc.:
- 152 mg/kg bw/day (actual dose received)
- Remarks:
- Dose volume: Approximately 1 mL/animal
- No. of animals per sex per dose / concentration:
- 4 male rats
- 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’.
COLLECTION AND STORAGE OF SAMPLES: Urine and faeces were kept in freeze until analyzed. After sacrifice, the tissues and organs were removed, rinsed with water and blotted on a paper towel. Any fat or connective tissue from the organs were removed and placed in tared sample jars. Organs that had internal cavities (the heart and the urinary bladder) were cut open and rinsed with water. Bone sample from both femurs were taken after removing the bone marrow. Adipose tissues were sampled from the area of the psoas muscle. Carcasses were freezed before grinding in Wiley mill.
METABOLITE CHARACTERISATION STUDIES: No metabolite characterisation was performed. - Preliminary studies:
- None
- Type:
- absorption
- Results:
- Oral absorption of the test substance was high (80%).
- Type:
- distribution
- Results:
- A low level of radioactivity was present in all analyzed tissues
- Type:
- excretion
- Results:
- The test substance was excreted principally in the urine
- 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. - Conclusions:
- 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.
- 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.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.7600 (Dermal Penetration)
- Deviations:
- yes
- Remarks:
- (limited animal number (n=2))
- GLP compliance:
- yes
- Radiolabelling:
- yes
- 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 - 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’. - Signs and symptoms of toxicity:
- no effects
- Dermal irritation:
- not specified
- Dose:
- 0.26 mg/cm2
- Parameter:
- percentage
- Absorption:
- < 1 %
- Remarks on result:
- other: 72 hours
- 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.
Referenceopen allclose all
Total Recovery: The % total recovery was 96 ± 0.48% (Mean ± S.E., n=4).
Total Recovery: Recovery was 95 ± 5% (Mean ± S.E., n=2)
Description of key information
No data are available on the absorption, distribution, metabolism or elimination (ADME) of Glucamide OL. However, based on the close structural similarity and generally comparable metabolic pathway, data can be read across from data generated on Glucamide 24 (see also comprehensive read-across justification). For this compound, oral absorption was greater 80% over a 72 hour period with more than 99% excreted in urine. No bioaccumulation potential was detected. Dermal absorption was below 1% over a 72 hour test period and thus negligible.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
- Absorption rate - oral (%):
- 80
- Absorption rate - dermal (%):
- 1
Additional information
No data are available on the absorption, distribution, metabolism or elimination (ADME) of Glucamide OL. However, based on the close structural similarity and common metabolic pathway, data can be read across from data generated on Glucamide 24.After oral application, the absorption, distribution, metabolism and excretion (ADME) of radiolabeled n-lauryl-glucose amide ([14C]-C12-G5 Base (Glucamide 24, radioactive purity 99.1%) was investigated in fasted male Sprague-Dawley rats (4 in total). Following oral administration of 150 mg/kg bw dose in ethanol:water (20:80), 79.7%, 16.03%, 0.31% and 0.18% of radioactivity was recovered in the urine (plus cage wash), feces (plus gastrointestinal tract wash), expired CO2, and tissue plus carcass, respectively, at the end of 72 hours with the largest amount of radioactivity collected in the 8-24 hour test period. Individual tissue distribution at 72 hours indicated that the highest levels in the liver (16x plasma radioactive content) followed by kidneys, spleen, carcass, lungs and gastrointestinal tract. All other tissues were ≤ 3x background. Based on these data oral absorption was estimated to be 80% over the 72-hour period with > 99% of excreted in the urine and 0.3% eliminated in expired CO2with only 0.2% in the tissues and carcass. The assessment of billiary elimination was beyond the scope of the study.
After dermal application, theADME of radiolabeled n-lauryl-glucose amide ([14C]-C12-G5 Base; radiochemical purity 99.8%) was investigated in fasted male Sprague-Dawley rats. Following dermal administration of 9.9 mg/kg bw (0.26 mg/cm2) dose in ethanol, the material balance was 95 ± 5.0% (n=2). At the end of testing (72-hours), 94.4% of radioactivity was recovered at the test site skin (plus dose cell wash), 0.27% in the urine (plus cage wash), 0.19% tissue (plus carcass), 0.1% in the feces (plus gastrointestinal tract wash), and 0.02% in expired CO2. Individual tissue distribution at 72 hours indicated low levels in all tissues with the highest levels in the femur (20x plasma radioactive content) followed by carcass, whole blood, adipose and bone marrow. All other tissues were ≤ 5x background. Based on these data dermal absorption was estimated to be <1% over a 72 hour test period, with the principal route of elimination being urine. The assessment of billiary elimination was beyond the scope of the study.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.