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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
Long-term toxicity to aquatic invertebrates
Administrative data
Link to relevant study record(s)
- Endpoint:
- long-term toxicity to aquatic invertebrates
- 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:
- 21 d
- Dose descriptor:
- NOEC
- Effect conc.:
- >= 100 mg/L
- Nominal / measured:
- nominal
- Conc. based on:
- test mat. (dissolved fraction)
- Basis for effect:
- reproduction
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on the category approach and the available studies, the 21d-NOEC (No Observed Effect Level) of Ethyl Palmitate on Daphnia magna reproduction was defined as ≥ 100 mg/L (nominal, filtered).
The registered substance was Not Classified for long-term Toxicity to Invertebrates - 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.
None of the long-term toxicity tests to aquatic invertebrates performed on the source substances of the category (isopropyl myristate and Fatty acids C16 -18, C18 unsat. isobutyl esters) has shown adverse effect up to the highest concentration tested. These results confirm the lack of toxicity to Daphnia magna observed in acute tests on the category members. Since Ethyl palmitate is surrounded by the two substances tested in chronic assays and based on the category approach, the target substance Ethyl Palmitate was not classified for long-term toxicity to aquatic invertebrates according to CLP criteria and its 21d-NOEC on Daphnia reproduction was determined ≥ 100 mg/L (nominal, WAF filtrated).
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 |
Long-term toxicity to aquatic invertebrates |
Isopropyl myristate |
110-27-0 |
C14 |
Isopropanol |
270,46 |
Liquid |
Experimental result:NOEC(21d) ≥ 100 mg/L (nom., filt.) |
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: NOELR (21d)>= 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 show no chronic toxicity to aquatic invertebrates. No adverse effects on the reproduction was observed for the two tested source substances and their 21d-NOEC was determined as ≥ 100 mg/L (nominal, WAF filtrated).
The exposure concentrations of aquatic organisms to category members are expected to be low due to the very low water solubility. The combined factors of the low biodisponibility of these substances due to their low water solubility, with their potential metabolisation can explain the lack of adverse effects on aquatic invertebrates in long-term ecotoxicity tests.
Conclusion on target substance
Based on the results obtained on the category members, the 21d-NOEC on Daphnia magna reproduction for the target substance "Ethyl Palmitate" was defined as ≥ 100 mg/L (nominal., filtrated).
Description of key information
Based on the available experimental studies on the source substances and the category approach, the target substance Ethyl palmitate was considered to induce no adverse effect on the reproduction of Daphnia Magna. The 21d-NOEC was defined as ≥ 100 mg/L (nominal., WAF filtrated).
The target substance was not classified for long-term toxicity to aquatic invertebrates according to CLP criteria..
Key value for chemical safety assessment
Fresh water invertebrates
Fresh water invertebrates
- Effect concentration:
- 100 mg/L
Additional information
Justification and rationale of the category approach for Ethyl palmitate
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 physicalchemical, 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 chronic toxicity to aquatic invertebrates
Isopropyl myristate CAS 110-27-0
One key study was performed according to OECD 202 part II with Isopropyl myristate. Daphnia magna was exposed during 21 days to nominal concentrations 0, 1 and 100 mg/L under semi-static conditions. No adverse effect on the reproduction and on the mortality of daphnids was observed. The 21d-NOEC of Isopropyl myristate on Daphnids reproduction was defined as ≥ 100 mg/L (nominal, WAF filtered).
Fatty acids, C16 -18 and C18 -unsatured isobutyl esters CAS 84988 -79 -4
One chronic study on invertebrates is available for Fatty acids, C16-18 and C18-unsaturated isobutyl esters. This key study was performed according to OECD guideline 202 part II and GLP. The test organism Daphnia magna was exposed to the test substance in a semi-static system for 21 days, at the loadings of 1 and 100 mg/L. The test solutions were prepared as water accommodated fractions (WAF) followed by a step of filtration. At 1 mg/L no mortality and no significant effect on reproduction was observed. At 100 mg/L reproduction was significantly increased compared to the control. Thus, the test substance had no adverse effects on reproduction at the tested concentrations, and the 21d-NOELR is reported to be ≥ 100 mg/L (nominal, WAF filtered).
Conclusion on the target substance
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 according to OECD 202 part II with Isopropyl myristate and Fatty acids, C16-C18 and C18-unsatured, isobutyl esters. No toxicity was observed for both sources substances on the reproduction of daphnids exposed to the soluble fraction of the highest tested concentration 100 mg/L. The 21d-NOEC on reproduction was defined as ≥ 100 mg/L (nominal; WAF filtrated) for the category members, since the variability of the fatty acids chain lenght from C14 to C18 is covered through these two studies.
Based on the available results and the category approach, the target substance Ethyl Palmitate can be considered as not toxic to Daphnia magna during chronic exposure. The 21d-NOEC on reproduction of Ethyl palmitate was defined as ≥ 100 mg/L (nominal; WAF filtrated) taking into account its structure, molecular weight and fatty acids chain length compared to those of the tested substances.
Hence, Ethyl palmitate was not classified for chronic toxicity to aquatic invertebrates.
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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