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EC number: 286-061-6 | CAS number: 85186-76-1
- 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
Short-term toxicity to fish
Administrative data
Link to relevant study record(s)
- Endpoint:
- short-term toxicity to fish
- 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
- Key result
- Duration:
- 96 h
- Dose descriptor:
- LC50
- Effect conc.:
- >= 10 000 mg/L
- Sublethal observations / clinical signs:
Table 1: Results of the key study of each source substances of the category
Name of the substance
CAS
Fatty acids chain length
Type of alcohol
MW
Appareance
Short-term toxicity to fish
Fatty acids, C8-16, 2- ethylhexyl esters
135800-37-2
C8-16
2-ethylhexanol
256.42 – 368.65
Liquid
Experimental result: LC50(96h) > 10000 mg/L(nom.)
Fatty acids, coco, 2-ethylhexyl esters
92044-87-6
C12-14
2-ethylhexanol
312.53 – 340.60
liquid
No data
2-Ethylhexyl palmitate
29806-73-3
C16
2-ethylhexanol
368.65
Liquid
No data
Fatty acids, C16-18 and C18-unsatd., 2-ethylhexyl esters
85049-37-2
C16-18, C18:1
2-ethylhexanol
368.65 – 396.7
Liquid
Experimental result:
LC50(96h) > 10000 mg/L (nom.)Fatty acids, C16-18, 2-ethylhexyl esters
91031-48-0
C16-18
2-ethylhexanol
368.65 - 396.7
Liquid
No data
2-Ethylhexyloleate
26399-02-0
C18:1
2-ethylhexanol
394.67
Liquid
No data
2-Ethylhexylstearate
22047-49-0
C18
2-ethylhexanol
396.7
Liquid
No data
Similar ecotoxicity profile
Based on the experimental data, the category members have low toxicity to aquatic fish organisms.
Additionally, the exposure concentrations of aquatic organisms are expected to be low due to the very low water solubility. In both short and long term studies, no effect occurred up to the water solubility limit.
These substances are also expected to be metabolized in the aquatic organisms; they are first hydrolyzed by lipases (Mattson andVolpenhein, 1972) resulting in free fatty acid and alcohols, which are absorbed from the intestine into blood stream. Fatty acids are either metabolized via Beta-oxidation pathway in order to generate energy for cell or reconstituted glyceride esters stored in the fat depots in the body. 2-ethylhexanolis primarily metabolized in the liver. Consequently, the combined factors of lowbiodisponibilityof these substances due to their low water solubility, with their easy and fullmetabolisation, can explain the lack of adverse effects to fish in short-term tests.
Target substance conclusion
Based on the results obtained on the category members, the 96h-LC50 for freshwater fish of the target substance "Isostearate2 -ethyl hexyl" was considered to be higher than 10000 mg/L(nom.).
- Validity criteria fulfilled:
- yes
- Conclusions:
- Based on the results obtained on the category members, the 96h-LC50 for freshwater fish of the target substance "Isostearate 2 -ethyl hexyl" was considered to be higher than 10000 mg/L(nom.). The target substance was Not Classified for Short Term Toxicity to Fish.
- Executive summary:
According to the Regulation (EC) NO. 1907/2006, Annex XI, 1.5, A Read-Across Category for "Long Chain Fatty Acid, 2-ethylhexyl esters" was performed in order to provide informations on Isostearate 2-Ethylhexyl .
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 reliable key studies are available for the assessment of toxicity to fish of Fatty acids, C8-16, 2-ethylhexyl esters (CAS 135800-37-2) and Fatty acids, C16-18 and C18-unsatured, 2-ethylhexyl esters (CAS 85049-37-2). Lethal Concentration (LC50) was determined greater than 10000 mg/L for 96 hours of exposure. These studies covered C8 to C18 and C18 unsaturated ethylhexyl esters. Considering the molecular weight and the chain length, this LC50 value could be attributed to all the members of the category which are within the covered range. Furthermore, the bioavailability of the category members in the water is expected to be low due to low water solubility. Additionnaly, fatty acids esters are known to be fastly metabolized as energetic source in organisms. Consequently the combined factors of low biodisponibility with their ease and full metabolisation can explain the lack of adverse effects of the category members to fish.
Based on the results obtained on the category members, the 96h-LC50 for freshwater fish of the target substance "Isostearate 2 -ethylhexyl" was considered to be higher than 10000 mg/L(nom.). The target substance was Not Classified for Short-Term Toxicity to Fish.
Reference
Description of key information
Based on the available key studies performed on the category members, the 96h-LC50 to Zebra fish was defined higher than 10000 mg/L.
According to the CLP criteria, the registered substance is not classified for short-term toxicity to fish.
Key value for chemical safety assessment
Fresh water fish
Fresh water fish
- Effect concentration:
- 10 000 mg/L
Additional information
Justification and rationale of the category approach for the Isostearate, 2-ethyl hexyl :
This category group covers 2-ethyl hexyl esters linked with fatty acid chains (C8 to C18) unsatured and satured. This category includes monoconstituent substances and UVCB substances with varying fatty acid chain length and based on the same alcohol source (2-ethylhexanol). This category was made in order to provide sufficient information for physicochemical, ecotoxicological and toxicological caracterisation of the Fatty acids, C14-18 and C18-unsatd., branched and linear, 2-ethylhexyl esters (CAS No 85186-76-1).
The category group includes:
- Fatty acids, C8-16, 2-ethylhexyl esters (CAS No 135800-37-2)
- Fatty acids, coco, 2-ethylhexyl esters (CAS No 92044-87-6)
- 2-Ethyl hexyl palmitate (29806-73-3)
- Fatty acids, C16-18 and C18-unsatd., 2-ethylhexyl esters (CAS No 85049-37-2)
- Fatty acids, C16-18, 2-ethylhexyl esters (CAS No 91031-48-0)
- 2-Ethylhexyl oleate (CAS No 26399-02-0)
- 2-Ethyl hexyl stearate (CAS No 22047-49-0)
Target substance for Category Approach : Fatty acids, C14-18 and C18-unsatd., branched and linear, 2-ethylhexyl esters (CAS No 85186-76-1)
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 studies on source substances for short-term toxicity to fish
Fatty acids, C8-C16, 2-ethylhexyl esters CAS No 135800-37-2
Two studies are available and considered as reliable.
The key study was performed according to EU Method C.1 and to GLP compliance. The test substance was brought directly into the fish bassins and then treated with ultraturrax. Zebra fish (Danio Rerio) was used and exposed for 96 hours at 1000, 3000 and 10000 mg/L. With increasing test substance concentrations an increasing turbidity of the test solutions was observed. No mortalities was observed at any concentration and observation time. The LC50 was defined higher than 10000 mg/L.
The second study, considered as a supporting study, was performed according to OECD guideline 203 and GLP compliance. Scrophthalmus Maximus was used and exposed in semi-static system to 0, 320, 1000, 3200 and 5600 mg/mL (nominal) for 96 hours. No mortality was observed. The LL50 was defined as higher 5600 mg/L. This supporting study demonstrates the lack of adverse effect of the tested substance also to marine fish.
Fatty acid, C16-18 and C18-unsatd., 2-ethylhexyl esters CAS No 85049 -37 -2
Two studies were performed with the Fatty acid, C16 -18 and C18 -unsatd., 2 -ethylhexyl esters on short-term toxicity to fish.
The key study was conducted on Danio rerio according to OECD 203 with the selected nominal concentrations of 1000, 3000 and 10000 mg/L (Richterich 2001). The test substance was mixed into the dilution water by ultraturax without further preparation. No effects were observed up to the highest test concentration and a LC50(96h) > 10000 mg/L was stated.
In a supporting study with Danio rerio, a limit test was performed according to OECD 203, and an LC50(96h) >100 mg/L was reported (Van der Kerken 1995).
Conclusion
According to the Regulation (EC) NO. 1907/2006, Annex XI, 1.5, A Read-Across Category for "Long Chain Fatty Acid, 2-ethylhexyl esters" was performed in order to provide informations on Isostearate 2-Ethylhexyl .
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 reliable key studies are available for the assessment of toxicity to fish of Fatty acids, C8-16, 2-ethylhexyl esters (CAS 135800-37-2) and Fatty acids, C16-18 and C18-unsatured, 2-ethylhexyl esters (CAS 85049-37-2). Lethal Concentration (LC50) was determined greater than 10000 mg/L for 96 hours of exposure. These studies covered C8 to C18 and C18 unsaturated ethylhexyl esters. Considering the molecular weight and the chain length, this LC50 value could be attributed to all the members of the category which are within the covered range. Furthermore, the bioavailability of the category members in the water is expected to be low due to low water solubility. Additionnaly, fatty acids esters are known to be fastly metabolized as energetic source in organisms.Consequently the combined factors of low biodisponibility with their ease and full metabolisation can explain the lack of adverse effects of the category members to fish.
Based on the results obtained on the category members, the 96h-LC50 for freshwater fish of the target substance "Isostearate 2 -ethylhexyl" was considered to be higher than 10000 mg/L(nom.). The target substance was Not Classified for Short-Term Toxicity to Fish.
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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