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EC number: 261-619-1 | CAS number: 59130-69-7
- 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
Additional information
Justification for grouping of substances and read-across
There are sufficient data available for the genetic toxicity of Hexadecyl 2-ethylhexanoate (CAS No. 59130-69-7). In order to fulfil the standard information requirements set out in Annex IX in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted.
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, 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).
Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, 1.5, of Regulation (EC) No 1907/2006, whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.
Genetic toxicity
CAS |
59130-69-7 |
26399-02-0 |
Chemical name |
Hexadecyl 2-ethylhexanoate |
2-ethylhexyl oleate |
MW |
368.7 g/mol |
394.7 g/mol |
Genetic Toxicity in vitro: gene mutation in bacteria |
Experimental result: negative |
- |
Genetic Toxicity in vitro: cytogenicity in mammalian cells |
RA: CAS 26399-02-0 |
Experimental result: negative |
Genetic Toxicity in vitro: gene mutation in mammalian cells |
RA: CAS 26399-02-0 |
Experimental result: negative |
The above mentioned substances are considered to be similar on the basis of the structural similarity resulting in similar properties and/or activities. The available endpoint information is used to predict the same endpoints for Hexadecyl 2-ethylhexanoate (CAS No. 59130-69-7).
A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Discussion
Genetic toxicity in vitro
In vitro gene mutation in mammalian cells
Gene mutation in bacteria byHexadecyl 2-ethylhexanoatewas analyzed in a GLP study performed according to OECD guideline 471 (Haddouk, 2007). Bacteria strains S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102 were treated with the test substance (diluted in ethanol) at concentrations of 312.5, 625, 1250, 2500, 5000 µg/plate with and without metabolic activation. As no increase in revertant colonies was noted in any strain at any concentration,Hexadecyl 2-ethylhexanoate was considered to be not mutagenic in bacteria under the condition of this test.
In vitro cytogenicity:
There are no data available on the in vitro clastogenicity ofHexadecyl 2-ethylhexanoatein mammalian cells.In order to fulfil the standard information requirements set out in Annex VIII, 8.4.2, in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5 read-across from the structurally related analogue substance2-ethylhexyl oleateis conducted.
The structural analogue 2-ethylhexyl oleate was tested in an in vitro mammalian chromosome aberration test with cultured peripheral human lymphocytes performed in accordance to OECD guideline 473 (Buskens, 2010). 2-ethylhexyl oleate was applied at concentration of 3, 10 and 33 µg/mL (diluted in ethanol) to the cultured lymphocytes with and without metabolic activation. Both in the absence and presence of S9-mix ethylhexyl oleate did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations in two independent experiments. No effects on the number of polyploid cells and no increase in cells with endoreduplicated chromosomes were observed both in the absence and presence of S9-mix. Thus, ethylhexyl oleate did not disturb mitotic processes and cell cycle progression and did not induce numerical chromosome aberrations under the experimental conditions described.
In vitro gene mutation in mammalian cells:
There are no data available on the in vitro mutagenicity ofHexadecyl 2-ethylhexanoatein mammalian cells.In order to fulfil the standard information requirements set out in Annex VIII, 8.4.3, in accordance with Regulation (EC) No 1907/2006 Annex XI, 1.5 read-across from the structurally related analogue substance2-ethylhexyl oleateis conducted.
Data on gene mutation in mammalian cells is available from a study with the structural analogue 2-ethylhexyl oleate, which was tested in a GLP study perfomed according to OECD guideline 476 (Verspeek-Rip, 2010). Mouse lymphoma L5178Y cells were treated with 2-ethylhexyl oleate(diluted in ethanol) ata concentration of 0.03, 0.1, 0.3, 1, 3, 10, 33, and 100 µg/mL for 3 or 24 h with and without metabolic activation. As result, no significant increase in the mutation frequency in the presence or absence of S9-mix was found, independent of incubation time or composition of the S9 mix. Thus, 2-ethylhexyl oleate did not induce gene mutations in mammalian cells under the condition of the test.
Conclusion
In conclusion, the available data on the genetic toxicity ofHexadecyl 2-ethylhexanoate and structural analogue substances indicate that Hexadecyl 2-ethylhexanoate is neither mutagenic nor clastogenic in vitro.
Justification for selection of genetic toxicity endpoint
Hazard assessment is conducted by means of read-across from a structural analogue. No study was selected, since all available in vitro genetic toxicity studies were negative. All available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties between source and target substance and overall quality assessment (refer to the endpoint discussion for further details).
Short description of key information:
In vitro:
Gene mutation (Ames test): S. typhimurium TA 1535, TA 1537, TA 98, TA 100, and TA 102: negative with and without metabolic activation (according to OECD TG 471)
Mammalian cytogenicity (chromosome aberration): peripheral human lymphocytes: negative (OECD TG 473)
Mammalian mutagenicity (MLA): negative with and without metabolic activation (OECD TG 476)
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
The available data on genetic toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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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