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Diss Factsheets
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EC number: 248-329-0 | CAS number: 27214-38-6
- 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Final report of the amended safety assessment of Glyceryl Laurate, (…), Glyceryl Isostearate/Myristate, (…)
- Author:
- Johnson, W.
- Year:
- 2 004
- Bibliographic source:
- Interntional Journal of Toxicology, 23(Suppl. 2):55-94
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
- Principles of method if other than guideline:
- - Principle of test: In a single-blind, repeat-insult patch test, a 50% dilution of the test substance in liquid paraffin oil was applied to the back skin of volunteers for 47 h under occlusive conditions. A total of nine induction applications were made, at unspecified intervals. The skin reaction was assessed prior to application of the new patch and 1 h after patch removal on the last day. Challenge patches were applied to the upper back (distant from induction site) of each subject on day 36. The patches were removed and discarded at the end of the 47-h contact period. Reactions were evaluated at 1 and 49 h after challenge patch removal.
- Parameters analysed / observed: skin reactions following exposure to the test substance. - GLP compliance:
- not specified
Test material
- Reference substance name:
- Glycerol monomyristate
- EC Number:
- 248-329-0
- EC Name:
- Glycerol monomyristate
- Cas Number:
- 27214-38-6
- Molecular formula:
- C17H34O4
- IUPAC Name:
- 2-hydroxy-1-(hydroxymethyl)ethyl myristate
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- not specified
- Subjects:
- - Number of subjects exposed: 93
- Age: 18 - 65
-Other: 107 subjects were recruited to the study, of which 93 completed - Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: patch test (epicutaneous test)
ADMINISTRATION
- Type of application: occlusive
- Description of patch: Finn chamber on Scanpore tape
- Vehicle / solvent: liquid paraffin oil
- Concentrations: 50%
- Volume applied:
- Testing/scoring schedule: A total of nine induction applications were made, at unspecified intervals. Following patch removal, the skin reaction was assessed prior to application of the new patch and 1 h after patch removal on the last day. Challenge patches were applied to the upper back (distant from induction site) of each subject on day 36. The patches were removed and discarded at the end of the 47-h contact period. Reactions were evaluated at 1 and 49 h after challenge patch removal.
EXAMINATIONS
- Grading/Scoring system: scored on a scale from 0 (no visible reaction) to 5 (bullous reaction)
Results and discussion
- Results of examinations:
- NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 93
Applicant's summary and conclusion
- Conclusions:
- The test substance did not cause skin sensitisation under the relevant test conditions.
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