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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Based on the available study, and on the category approach, the target substance was not considered as reprotoxic. Hence, ethyl palmitate did not required hazard classification for reprotoxicity according to CLP criteria.
Link to relevant study records
- Endpoint:
- screening for reproductive / developmental toxicity
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Justification for type of information:
- See "Assessment reports" section 13 or "Categories" section for the justification and rationale document for category approach.
- Qualifier:
- according to guideline
- Guideline:
- other: 1993 FDA draft "Redbook II" guidelines (Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food).
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 5 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- reproductive function (oestrous cycle)
- reproductive function (sperm measures)
- Key result
- Critical effects observed:
- no
- Remarks on result:
- other: no data provided
- Remarks on result:
- other: no data provided
- Remarks on result:
- other: no data provided
- Key result
- Reproductive effects observed:
- no
- Conclusions:
- Based on the structural similarities between the substances and on the category approach, the NOAEL value for reprotoxicity as higher than 5500 mg/kg bw/day is validated for the category substances.
- Executive summary:
According to the Regulation (EC) NO. 1907/2006, Annex XI, 1.5, A read-across category for short chain fatty acid 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 category substances are fatty acid esters covering chain length C8 to C18 satured or unsatured linked to alcohol including ethanol, isopropanol and (iso)butanol. These substances showed similar physico-chemical properties as very low solubility in water, not volatile, ready biodegradable and high log Kow. The substances are expected to have same toxicity behavior according to the common structural and physico-chemical similarities. Indeed, they are expected to be metabolized or excreted in same way when orally administered in organism.The available information are consistent with expected low toxicity of the category substance.
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 |
Isopropyl myristate |
110-27-0 |
C14 |
Isopropanol |
270,46 |
Liquid |
no data |
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 |
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 |
no data |
All the category substances are fatty acid esters. After oral ingestion, it is expected that substances are hydrolyzed by pancreatic lipases. The degradation products are free fatty acids and free alcohol which could be distributed in organism through systemic circulation. They are expected to be metabolized in common energetic pathways or excreted and notbioaccumulableafter repeated administration.
One study was available forreprotoxicityassessment for the ethyloleate. Rats were exposed during 91 days and reproductive functions were analyzed. No adverse effect was observed. Hence, the NOAEL was defined to be higher than 5500 mg/kgbw/day. The result is consistent with expected low toxicity of the category substances.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 5 500 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
The category group covers alcohol linked with fatty acid chains unsatured and satured. This category includes monoconstituent chemicals and UVCB substances varying acid chain length (C14 to C18) and based on alcohol function type (including ethanol, butanol and isopropanol). This approach was performed in order to provide sufficient information for physicochemical, ecotoxicological and toxicological characterizations of the ethyl palmitate. Based on structural and physic-chemicals 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.
One available relevant study was performed on the ethyl oleate to assess the potential reprotoxicity. The study was performed according 1993 FDA draft “Redbook II” guideline. Rats were exposed in diet at 1.8, 3.6 and 5.5 g/kg bw/day during 91 days. Signs of toxicity, reproductive functions were assessed on parental animals. No treatment related effects on reproductive capacity of the animals was observed. Hence, the NOAEL was defined to be higher than 5500 mg/kg bw/day. Based on the structural similarities between the substances and on the category approach, the NOAEL value is validated for the category substances.
Justification for classification or non-classification
Based on the available study, and on the category approach, the target substance was not considered as reprotoxic. Hence, the ethyl palmitate was not classified for reprotoxicity according to CLP criteria
Additional information
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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