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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
Genetic toxicity in vitro
Description of key information
Based on the available studies performed on the source substances of the category, none of the assessed substances showed mutagenicity effect on bacteria strain. According to CLP criteria and the category approach, the test item Ethyl Palmitate was considered to be not mutagenic for bacteria strain.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- 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 on section 0 Categories and assessment report section 13 for justification and rationale of the category approach.
- Key result
- Species / strain:
- other: S typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. Coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- 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 mutagenic on bacteria strain.
- 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 structural and physic chemical similarities (fatty acids linked with esters), the toxicological profiles between the members of the category are expected to be the same on bacteria strain.
Hence, the members of the category were not considered as mutagenix for bacteria strain.
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 |
In vitro gene mutation study in bacteria (Ames test) |
Isopropyl myristate |
110-27-0 |
C14 |
Isopropanol |
270,46 |
Liquid |
Experimental result: |
Isopropyl palmitate |
142-91-6 |
C16 |
Isopropanol |
298.51 |
Liquid |
no data |
Ethyl linoleate |
544-53-4 |
C18:2 |
ethanol |
308,5 |
Liquid |
Experimental result: |
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 |
no data |
Isopropyl isostearate |
68171-33-5 |
C18iso |
Isopropanol |
326.56 |
Liquid |
no data |
Several Ames test were performed according to OECD 471 guideline. This stain used bacterial strain lines as Salmonella Typhimurium and E.Coli. .These tests were performed on the isopropyl myristate and ethyl linoleate, both of these substances did not showed mutagenicity. The two substances showed structural and physic chemical similarities with the target substance the ethyl palmitate. It can be stated that the ethyl palmitate followed same mutagenic property with source substances of the category on bacteria. Hence, the ethyl palmitate was not considered as mutagenic for bacteria.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
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.
Summary of the available studies for bacteria mutagenicity potential
Isopropyl myristate CAS 110-27-0
Two Ames test were performed in order to evaluate the potential mutagenicity on bacteria strain. The key study was performed according to OECD Guideline 471 (bacterial reverse mutation test) and GLP compliance. E. Coli WP2 uvr 1, S. Typhimurium TA 1535, TA 1537, TA98 and TA 100 were evaluated with and without metabolic activation system, up to 5000 µg/plate during 48 hours. Ethanol was used as vehicle. Number of revertant colony and cytotoxicity were evaluated. No mutagenicity was observed.
The supporting study was performed on S. Typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 1538 with and without metabolic activation system. The test item concentrations used were 4, 20, 100, 500 and 2500 µg/plate, acetone was used as vehicle. Control and positive control were used. Test item was applied in plate incorporation method. Revertant colony was counted. No increase of revertant colony was observed. According to CLP criteria and the two available studies, the Isopropyl myristate was not considered as mutagenic on bacteria strain.
Ethyl linoleate CAS 544 -35-4
An mouse lymphoma assay was performed on the ethyl linoleate in order to assess the potential mutagenicity of the substance on mammalian cells. The experimental study was performed according to OECD TG 476 method, using mouse lymphoma L5178Y cells. The cells were incubated in medium with test substance at different concentrations up to 300 µg/mL during 3 hours in a first experiment and 24 hours in a second experiment. Metabolic activation system was used or not. After 2 days on expression time, cells were selected with trifluorothymidine during 12 days. Cytotoxicity was evaluated too. No significant increase in the mutation frequency at the TK locus was observed after treatment with ethyl linoleate either in the absence or in the presence of metabolic activation system.
A chromosome aberration test was performed according to OECD TG 473 method. Cultured peripheral human lymphocytes were used and exposed up to 333 µg/mL in a first experiment for 3 hours. In a second experiment, cells were exposed up to 800 µg/mL for 24 hours with and without metabolic activation system with 48 hours fixation time. The vehicle used was DMSO. Cyclophosphamide and mitomycin C were used as positive control. Both in the absence and presence of metabolic activation system, the ethyl linoleate did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations.
Justification for classification or non-classification
Based on the available studies performed on the source substances of the category, none of the assessed substances showed mutagenicity effect on bacteria strain. According to CLP criteria and the category approach, the test item Ethyl Palmitate was considered to be not mutagenic for bacteria strain.
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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