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Diss Factsheets
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EC number: 271-653-9 | CAS number: 68603-38-3 This substance is identified by SDA Substance Name: C16-C18 and C18 unsaturated alkyl carboxylic acid amide diethanol and SDA Reporting Number: 11-024-00.
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Read across study hence maximum reliability rating of 2 assigned according to ECHA guidance, although study is well documented, meets generally accepted scientific principles, acceptable for assessment.
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- publication
- Title:
- Lauramide diethanolamine absorption, metabolism and disposition in rats and mice after oral, intravenous and dermal administration
- Author:
- Mathews JM, deCosta K and Thomas BF
- Year:
- 1 996
- Bibliographic source:
- Drug Metab. Dispos. 24(7):702-710
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 427 (Skin Absorption: In Vivo Method)
- Deviations:
- not specified
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- not specified
Test material
- Reference substance name:
- N,N-bis(2-hydroxyethyl)dodecanamide
- EC Number:
- 204-393-1
- EC Name:
- N,N-bis(2-hydroxyethyl)dodecanamide
- Cas Number:
- 120-40-1
- Molecular formula:
- C16H33NO3
- IUPAC Name:
- N,N-bis(2-hydroxyethyl)dodecanamide
- Details on test material:
- - Name of test material (as cited in study report): Lauramide diethanolamine (LDEA)
- Radiochemical purity (if radiolabelling): 96 to 97%
- Specific activity (if radiolabelling): 841 µCi/mmol
- Locations of the label (if radiolabelling): On the DEA moiety
- Other: Identity confirmed by mass spectrometry and proton NMR
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- - Source: Charles River Laboratories, Inc. (Raleigh, NC)
- Age at study initiation: 72 to 75 d
- Housing: Individual glass metabolism chambers, which allowed separate collection of carbon dioxide, urine, and feces.
- Individual metabolism cages: Yes
- Diet: Purina Rodent Chow (no. 5002), ad libitum
- Water: Ad libitum
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- ethanol
- Duration of exposure:
- 72 h
- Doses:
- - Actual doses: 50, 100, 200 and 800 mg/kg bw
- Dose volume: 50 µL of 50, 100 and 200 mg/kg bw and 30 µL of 800 mg/kg bw
- No. of animals per group:
- Four
- Control animals:
- no
- Details on study design:
- DOSE FORMULATION: 2 to 17 µCi radiolabel, an appropriate amount of unlabelled LDEA and 95 % ethanol for a total volume of about 50 µL per dose
VEHICLE
- Concentration (if solution): 95%
TEST SITE
- Preparation of test site: Application site had been clipped of hair the previous day
- Area of exposure: 1 x 1 inch
- Type of cover / wrap if used: A non-occlusive protective appliance, glued over the dose area with cyanoacrylate adhesive.
SITE PROTECTION / USE OF RESTRAINERS FOR PREVENTING INGESTION: No
REMOVAL OF TEST SUBSTANCE: No
SAMPLE COLLECTION: Dose site skin was excised and thoroughly rinsed with ethanol, then gently wiped with cotton gauzes soaked with soapy water. Gauzes and aliquots of urine, dermal rinse solutions, feces, tissues (liver and kidney) and digested skin samples (in 2N ethanolic sodium hydroxide) were collected and analysed for radiochemical content by adding to vials containing scintillation cocktail (Ultima Gold, Packard Instrument Company).
ANALYSIS
- Method type(s) for identification: Liquid scintillation counting - Details on in vitro test system (if applicable):
- Not applicable
Results and discussion
- Signs and symptoms of toxicity:
- not examined
- Dermal irritation:
- not examined
- Absorption in different matrices:
- - In 72 h of exposure, 50 to 70% of the applied doses were absorbed, and there were no statistically significant differences in absorbance across the range of doses.
- The disposition of LDEA in the tissues was approximately the same for the four dose levels. (For details see Table 1 in the attached document).
- Total recovery:
- - No significant differences in total recovery were observed for the four dose levels (approx. 91, 85, 88 and 85% at 50, 100, 200 and 800 mg/kg bw respectively). For details see Table 1 in the attached document.
Percutaneous absorptionopen allclose all
- Dose:
- 50 mg/kg bw
- Parameter:
- percentage
- Absorption:
- ca. 49.1 %
- Remarks on result:
- other: 72 h
- Remarks:
- In 50 mg/kg dose group, disposition of radioactivity after dermal application of radiolabelled LDEA to male mice
- Dose:
- 100 mg/kg bw
- Parameter:
- percentage
- Absorption:
- ca. 66.8 %
- Remarks on result:
- other: 72 h
- Remarks:
- In 100 mg/kg dose group, disposition of radioactivity after dermal application of radiolabelled LDEA to male mice
- Dose:
- 200 mg/kg bw
- Parameter:
- percentage
- Absorption:
- ca. 69.1 %
- Remarks on result:
- other: 72 h
- Remarks:
- In 200 mg/kg dose group, disposition of radioactivity after dermal application of radiolabelled LDEA to male mice
- Dose:
- 800 mg/kg bw
- Parameter:
- percentage
- Absorption:
- ca. 50.2 %
- Remarks on result:
- other: 72 h
- Remarks:
- In 800 mg/kg dose group, disposition of radioactivity after dermal application of radiolabelled LDEA to male mice
- Conversion factor human vs. animal skin:
- No data
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- The study indicates 50 to 70 % of the applied doses were absorbed, and there were no statistically significant differences in absorption across the range of doses. The disposition of the test substance in the tissues was also similar for the four dose levels.
- Executive summary:
A dermal absorption study was conducted to evaluate the absorption of the radiolabelled (14C) lauramide diethanolamine (LDEA) in the B6C3F1 mice.
50 µL of 50, 100 and 200 mg/kg bw and 30 µL of 800 mg/kg bw of LDEA was applied to an area of 1x1 inch previously clipped skin, covered with a non-occlusive patch. After 72 h of exposure, gauzes and aliquots of urine, faeces, dermal rinse solutions and digested skin samples (in 2N ethanolic sodium hydroxide) were collected and analysed for radiochemical content.
After 72 h of exposure, 50 to 70 % of the applied doses were absorbed, and there were no statistically significant differences in absorption across the range of doses. The disposition of LDEA in the tissues was also similar across the four dose levels of 50, 100, 200 and 800 mg/kg bw.
The study indicates 50 to 70 % of the applied doses were absorbed, and there were no statistically significant differences in absorption across the range of doses. The disposition of the test substance in the tissues was also similar for the four dose levels.
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