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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Toxicity to aquatic algae and cyanobacteria
Administrative data
Link to relevant study record(s)
- Endpoint:
- toxicity to aquatic algae and cyanobacteria
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Category Approach
- Justification for type of information:
- See attached report in Section 0 "Categories" or Section 13 "Assessment reports" for justification and rationale of the category approach
- Key result
- Duration:
- 72 h
- Dose descriptor:
- EC50
- Effect conc.:
- > 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Remarks:
- WAF
- Basis for effect:
- growth rate
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on the category approach and the results obtained on source substances, the 72h-EC50(biomass or growth rate) of the target substance "Ethyl Palmitate" to the freshwater algae was considered to be higher than 100 mg/L (nom., filtrated).
Hence the target substance was not classified for acute toxicity to aquatic algae according to CLP criteria. - 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 properties as:
- common functional group,
- common precursors and the likelihood of common impurities resulting from common process of manufacturing,
- chemically structurally similar breakdown products obtained via the same biological processes into the organisms, and
- constant pattern in the changing of the potency of the properties across the category.
Two key and reliable studies were performed according to EU Method C.3 on Isopropyl myristate and on Fatty acids, C16-18 and C18-unsatured, isobutyl ester.
The EC50 (biomass or growth rate) for the green algae, Desmodesmus subspicatus, during 72 hours exposure period was defined as > 0.05 mg/L (limit of water solubility for isopropyl myristate) and > 100 mg/L (nominal, filtered for fatty acids, C16-C18 and C18unsatured, isobutyl esters). So no toxicity to algae was observed for the tested substances up to their limit of solubility.
These studies covered the variability of the fatty acid chain length in the category from C14 to C18. Considering the molecular weight and the similarity of structures between the tested substances and the target substance, the toxicity of the target substance “Ethyl Palmitate” to the freshwater green algae can be established as 72h-EC50 (biomass or growth rate > 100 mg/L (nom., filtrated).
Hence, Ethyl Palmitate was not classified for acute toxicity to aquatic algae according to CLP criteria.
Reference
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 |
Toxicity to aquatic algae |
Isopropyl myristate |
110-27-0 |
C14 |
Isopropanol |
270,46 |
Liquid |
Experimental result: ErC50(72h) > 0.05 mg/L (meas.Limit of WS) |
Isopropyl palmitate |
142-91-6 |
C16 |
Isopropanol |
298.51 |
Liquid |
no data |
Ethyl linoleate |
544-53-4 |
C18:2 |
ethanol |
308,5 |
Liquid |
no data |
Ethyl oleate |
111-62-6 |
C18:1 |
ethanol |
310.52 |
Liquid |
no data |
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: ErC50(72h) > 100 mg/L (nom., WAF) |
Isopropyl isostearate |
68171-33-5 |
C18iso |
Isopropanol |
326.56 |
Liquid |
no data |
Similar ecotoxicity profile
Based on the experimental data, the category members have low toxicity to aquatic algae. Additionally, the exposure concentrations of aquatic organisms are expected to be low due to the very low water solubility of the category members. Due to their very poor water solubility, these substances are difficult for aquatic testing. If undissolved test material is not properly removed from test vessels, it may cause physical effects, such as decreasing algae growth by increased turbidity of test solutions, or algae cells getting trapped into oil film or by particles. These effects do not reflect real toxicity of the substances towards the organisms. Therefore the tests are performed on filtrated solutions obtained from WAF to avoid such mechanical effects. These tests performed on filtrated solution show a 72h-EC50 (biomass or growth rate) > 100 mg/L (nom., filtrated) and demonstrated no adverse effects to algae.
Conclusion on target substance
Based on the results obtained with the category members, the 72h-EC50(biomass or growth rate) of the target substance "Ethyl Palmitate" to the freshwater algae was considered to be higher than 100 mg/L (nom., filtrated).
Description of key information
According to the experimental studies, none of the assessed source substances has shown adverse effect to the growth of algae up to their limit of solubility. Based on the category approach and the results obtained on source substances, the 72h-EC50(biomass or growth rate) of the target substance "Ethyl Palmitate" to the green algae was considered to be higher than 100 mg/L (nom., filtrated).
Hence the target substance was not classified for acute toxicity to aquatic algae according to CLP criteria.
Key value for chemical safety assessment
- EC50 for freshwater algae:
- 100 mg/L
- EC10 or NOEC for freshwater algae:
- 100 mg/L
Additional information
The category group covers alcohol linked to fatty acid chains unsatured and satured, via an ester function. This category includes mono-constituent chemicals and UVCB substances with varying acid chain lengths (from C14 to C18) and alcohol types (ethanol, isopropanol, butanol and isobutanol). This approach was performed in order to provide sufficient information for physical-chemical, ecotoxicological and toxicological characterizations of ethyl palmitate. Based on structural and physical-chemical similarities, available experimental studies from source chemicals could be used for the target substance, ethyl palmitate.
This category group includes:
- Isopropyl myristate CAS 110-27-0
- Isopropyl palmitate CAS 142-91-6
- Ethyl linoleate CAS 544 -35 -4
- Ethyl oleate CAS 111-62-6
- Fatty acids, C16-18, butyl esters CAS 85408-76-0
- Fatty acids, C16-18 and C18-unsatured, isobutyl esters CAS 84988-79-4
- Isopropyl isostearate CAS 68171-33-5
- Target substance : Ethyl palmitate CAS 628-97-7
In accordance with article 13 (1) of Regulation (EC) No. 1907.2006, “information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met. In particular for human toxicity, environmental fate and ecotoxicity, information shall be generated whenever possible by means other than vertebrate animal tests which includes the use of information from structurally related substances (grouping or read across)”. Therefore, the available experimental data were collected and evaluated according to Annex XI requirements
Summary of available experimental studies for short-term toxicity to toxicity to aquatic algae
Isopropyl myristate CAS 110 -27 -0
In the key study, Desmodesmus subspicatus was tested as a limit test according to EU Method C.3 and to GLP. No effects on cell growth were stated at concentrations up to the water solubility (ErC50 > 0.05 mg/L) in the filtered solutions, while presumably physical effects were observed in the emulsion without filtration. Hence, the 72h-ErC50 value was defined as higher than 100 mg/L (nominal, filtrated).
Fatty acids, C16 -18 and C18-unsatured isobutyl esters CAS 84988-79-4
One study is available on the algal toxicity of Fatty acids, C16-18 and C18 unsaturated isobutyl esters. This key study was performed as a limit test according to the EU guideline 92/69/EWG and GLP (Berger, 1995). The test organism Scenedesmus subspicatus was exposed to the test substance in a static system for 72 hours, at the nominal test concentration 100 mg/L. The test was performed with and without separation of undissolved test material. With undissolved test substance present, algal growth was significantly inhibited. However, when the undissolved phase was separated, no effects on growth were observed. The inhibition of the algal growth can be thus regarded as associated to physical effects caused by the undissolved material present. It can be concluded that the substance has no toxic effects on test organism up to its limit of solubility.
Conclusion
According to the Regulation (EC) NO. 1907/2006, Annex XI, 1.5, a Read-Across Category for "Long Chain Fatty Acid (from C14 to C18) and short chain alcohol esters (from C2 to C4) " was performed in order to provide information on Ethyl Palmitate.
This category was based on common and shared properties as:
- common functional group,
- common precursors and the likelihood of common impurities resulting from common process of manufacturing,
- chemically structurally similar breakdown products obtained via the same biological processes into the organisms, and
- constant pattern in the changing of the potency of the properties across the category.
Two key and reliable studies were performed with Isopropyl myristate and Fatty acids C16 -18 & C18 unsat. isobutyl esters, according to EU Method C.3 and EU guideline 92/69/EWG respectively. The EC50 (biomass or growth rate) for the green algae, Desmodesmus subspicatus, during 72 hours exposure period was defined as > 0.05 mg/L (limit of water solubility for isopropyl myristate) and > 100 mg/L (nominal, filtered, for the fatty acids, C16 -18 and C18unsat., isobutyl esters). So no toxicity to algae was observed for the tested substances up to their limit of solubility.
These studies covered the variability of the fatty acid chain length in the category from C14 to C18. Considering the molecular weight and the similarity of structures between the tested substances and the target substance, no toxicity is expected from the target substance “Ethyl Palmitate” to the freshwater green algae and a 72h-EC50 (biomass or growth rate > 100 mg/L (nom., filtrated) can be established.
Hence, Ethyl Palmitate was not classified for acute toxicity to aquatic algae according to CLP criteria.
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.