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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- 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 category rationale and justification
Data source
Materials and methods
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
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
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 |
Acute oral Toxicity |
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 |
Experimental result: |
Isopropyl isostearate |
68171-33-5 |
C18iso |
Isopropanol |
326.56 |
Liquid |
Experimental result: |
All category members are subject to enzymatic hydrolysis by pancreatic lipases resulting in free acids and alcohol. Based on current literature, when absorbed from intestines and carried through blood stream, fatty acids are oxidized by beta-oxydationpathway in order to provide energy for cell and stored as glycerides esters in fat deposit. The alcohols are primarily metabolized in the liver.
Hence, it can be stated that the members of the category have the same toxicity due to the same metabolic pathways when absorbed in the organisms.
Several studies were performed in members of the category for acute oral toxicity. For acute oral toxicity studies, results showed an LD50 value greater than 2000 mg/kgbw.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the results of the key studies on the source substances of the category, the LD50 value for the ethyl palmitate was defined to be higher than 2000 mg/kg bw. Hence, the target substance was not classified according to CLP regulation.
- 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 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.
The fatty acids linked with esters have a common metabolic fate in organisms as glycolytic and fatty acid pathways after first hydrolysis step which led in breakdown products. The common toxicokinetic properties and behavior are expected due to the constant pattern (esters and the fatty acid chain). The toxicological profiles between the members of the category are expected to be the same.
Several reliable studies were available (GLP, accordingly to OECD 401 guideline method). The experimental studies were performed in rodents (rat and mouse) which were treated orally (gavage) by
single dose. Lethal Dose 50 (LD50 ) values were found to be greater than 2000 mg/kg bw, or 5000 mg/ kg bw in the differents test performed.
According to the results from experimental study performed on the substances of the category, the LD50 value for the Ethyl Palmitate was defined higher than 2000 mg/kg bw. Hence, according to the CLP criteria and the category approach, the registered substance was not classified for Acute Oral Hazard.
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.