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EC number: 211-064-6 | CAS number: 628-97-7
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- See attached report for justification and rationale of the category approach
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Test material
- Reference substance name:
- Ethyl palmitate
- EC Number:
- 211-064-6
- EC Name:
- Ethyl palmitate
- Cas Number:
- 628-97-7
- Molecular formula:
- C18H36O2
- IUPAC Name:
- ethyl hexadecanoate
Constituent 1
Results and discussion
In vivo
Results
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Table 1: Results from key studies performed on the source substances of the category
Common name |
CAS |
Fatty acid chain length |
Type of alcohol |
MW |
Appareance |
Skin irritation or skin corrosion |
Isopropyl myristate |
110-27-0 |
C14 |
Isopropanol |
270,46 |
Liquid |
Experimental result: |
Isopropyl palmitate |
142-91-6 |
C16 |
Isopropanol |
298.51 |
Liquid |
Experimental result: |
Ethyl linoleate |
544-53-4 |
C18:2 |
ethanol |
308,5 |
Liquid |
Experimental result: |
Ethyl oleate |
111-62-6 |
C18:1 |
ethanol |
310.52 |
Liquid |
Experimental result: |
Fatty acids, C16-18, butyl esters |
85408-76-0 |
C16-18 |
Butanol |
312.53 – |
Paste |
no data |
Fatty acids, C16-18 and C18-unsatured, isobutyl esters |
84988-79-4 |
C16-18, |
Isobutanol |
312.53 – |
Liquid |
no data |
Isopropyl isostearate |
68171-33-5 |
C18iso |
Isopropanol |
326.56 |
Liquid |
Experimental result: |
According to the current literature, esterase enzymes were present into the skin of different mammalian species (as human, rodents orminpigs). These enzymes, as carboxylesterase, hydrolyzed different substrates as xenobiotic or different ester as fatty acids esters (C. Jewell, 2007; J.J.Prusakiewicz, 2006). Based on this principle, when applied on skin, the source and the target substances are expected to be substrates of these carboxylesterase. They are hydrolyzed into fatty acids and alcohols. In the case that the products of hydrolysis could across the dermal barrier to reach systemic system, they have the same behavior as oral ingestion. The potential toxicity should bebringby these hydrolyzed products.
They are expected to be metabolized in common energetic pathways or excreted.
No experimental study was available for the target substance the Ethyl palmitate. However, several experimental in vivo studies were performed for skin irritation assessment. None of these studies showed irritation properties. The source substances and the target substance are structurally similar and showed common physic-chemical properties. Based on these properties, it can be stated that the target substance followed the same health effect for skin irritation. Hence, the ethyl palmitate was considered as not irritant to skin.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the category approach and according to the results of the available studies of the source substances, the target substance was considered to be not irritant. Hence, the ethyl palmitate was not classified for skin irritation.
- Executive summary:
According to the Regulation (EC) NO. 1907/2006, Annex XI, 1.5, A Read-Across Category was performed in order to provide informations on the Ethyl Palmitate.
This category was based on common and shared physico-chemical and structural properties as:
- common functional group,
- common precursors and the likehood of common impurities as well as common breakdown products via biological processes, which are chemically structurally similar, and
- constant pattern in the changing of the potency of the properties across the category.
Based on the available studies on the source substances for skin irritation assessment, none of these susbtances showed adverse effect when applied dermally on rabbit and guinea pigs skin. According to physic-chemical similarities betsween source substances and target substance, it can be stated that the ethyl palmitate showed same toxicological profile. Hence, no classification was made for the ethyl palmitate for skin irritation.
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.
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