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EC number: 203-761-9 | CAS number: 110-38-3
- 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
Description of key information
Using the read-across appraoch, according to the Annex XI item 1.5, of Regulation (EC) No 1907/2006, all available acute oral toxicity studies within the category resulted in an acute oral LD50 values higher than 2000 mg/kg bw for oral administration and dermal application, and LC50 was defined to be higher than 5 mg/L for inhalation. Hence, according to CLP criteria and REACh regualtion, the target substance ethyl decanoate is not classified for acute hazard and STOT-SE.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- See "Assessment reports" section 13 or "Categories" section for the justification and rationale document for category approach.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the available experimental studies performed on the source substances of the category, none of these showed adverse effect for acute oral toxicity on rodents. Hence, no classification is required for category substances according to REACh regulation and the category approach.
- 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 decanoate CAS 110-38-3.
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, octanol, hexanol and 2-ethylhexanol. 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.
As expected, none of the acute oral toxicity test performed showed adverse effect. Hence, the category substances are not classified for acute oral hasard according to CLP criteria.
Reference
Table 1: Results of the key studies performed on the source substances of the category
Common name |
CAS |
Fatty acids chain length |
Type of alcohol |
MW |
Appareance |
Acute oral Toxicity |
Ethyl decanoate |
110-38-3 |
C10 |
ethanol |
200.32 |
Liquid |
No data |
Ethyl undecylenate |
692-86-4 |
C11 |
ethanol |
212.33 |
liquid |
No data |
Isopropyl laurate |
10233-13-3 |
C12 |
Isopropanol |
242,41 |
Liquid |
Experimental result: |
Octyl octanoate |
2306-88-9 |
C8 |
octanol(C8) |
256,42 |
Liquid |
Experimental result: |
Isopropyl myristate |
110-27-0 |
C14 |
Isopropanol |
270,46 |
Liquid |
Experimental result: |
Dodecanoic hexyl ester |
34316-64-8 |
C12 |
Hexanol(C6) |
284,49 |
Liquid |
Experimental result: |
Ethyl linoleate |
544-35-4 |
C18:2 |
ethanol |
308,5 |
Liquid |
Experimental result: |
Ethyl oleate |
111-62-6 |
C18:1 |
ethanol |
310.52 |
Liquid |
Experimental result: |
2-ethylhexyl laurate |
20292-08-4 |
C12 |
2 -ethylhexanol |
312,53 |
Liquid |
Experimental result: |
Fatty acids, coco, 2-ethylhexyl esters |
92044-87-6 |
C12-14 |
2-ethylhexanol |
312.53 – |
liquid |
Experimental result: |
All the category substance 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.
All the substances were evaluated for potential acute oral toxicity (expect the target substance and ethyl undecylenate). These experimental studies were performed according to or equivalent to OECD TG 401. Rats or mice were used as model. The LD50 oral were determined as higher than 2000 mg/kg bw to 5000 mg/kg bw.
These experimental studies are consistent with the low toxicity expected for these substances.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- See "Assessment reports" section 13 or "Categories" section for the justification and rationale document for category approach.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 5 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the available experimental studies performed on the source substances of the category, none of these showed adverse effect for acute inhalation toxicity on rodents. Hence, no classification is required for category substances according to REACh regulation and the category approach.
- 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 decanoate CAS 110-38-3.
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, octanol, hexanol and 2-ethylhexanol. 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 inhaled.
As expected, none of the acute inhalation toxicity tests performed showed adverse effect. Hence, the category substances are not classified for acute inhalation hazard according to CLP criteria.
Reference
Table 1: Results of the key studies performed on the source substances of the category
Common name |
CAS |
Fatty acids chain length |
Type of alcohol |
MW |
Appareance |
Acute inhalation Toxicity |
Ethyl decanoate |
110-38-3 |
C10 |
ethanol |
200.32 |
Liquid |
No data |
Ethyl undecylenate |
692-86-4 |
C11 |
ethanol |
212.33 |
liquid |
Experimental result : LC50 > 5,7 mg/L |
Isopropyl laurate |
10233-13-3 |
C12 |
Isopropanol |
242,41 |
Liquid |
Experimental result: |
Octyl octanoate |
2306-88-9 |
C8 |
octanol(C8) |
256,42 |
Liquid |
no data |
Isopropyl myristate |
110-27-0 |
C14 |
Isopropanol |
270,46 |
Liquid |
no data |
Dodecanoic hexylester |
34316-64-8 |
C12 |
Hexanol(C6) |
284,49 |
Liquid |
no data |
Ethyl linoleate |
544-35-4 |
C18:2 |
ethanol |
308,5 |
Liquid |
no data |
Ethyl oleate |
111-62-6 |
C18:1 |
ethanol |
310.52 |
Liquid |
no data |
2-ethylhexyl laurate |
20292-08-4 |
C12 |
2-Ethyl-Hexanol |
312,53 |
Liquid |
no data |
Fatty acids, coco, 2-ethylhexyl esters |
92044-87-6 |
C12-14 |
2-ethylhexanol |
312.53 – |
liquid |
No data |
All the category substance are fatty acid esters. After inhalation, it is expected that substances are hydrolyzed by lipases. Substances that are absorbed through the pulmonary alveolar membrane could enter the systemic circulation directly before joining the liver where hydrolysis basically takes place. They are expected to be metabolized in common energetic pathways or excreted.
Ethyl undecylenate and isopropyl myristate were evaluated for acute inhalation toxicity. The studies were performed, respectively, according to OECD TG 403 (limit test) and 436 methods (acute toxic class method – limit test). Rats were exposed for 4 hours in nose-only. The LD50 were defined to be higher than 5 mg/L.
These experimental studies are consistent with the low toxicity expected for these substances.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- 5 000 mg/m³
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- See "Assessment reports" section 13 or "Categories" section for the justification and rationale document for category approach.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the available experimental study performed on one source substance of the category, none of these showed adverse effect for acute dermal toxicity on rodents. Hence, no classification is required for category substances according to REACh regulation and the category approach.
- 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 decanoate CAS 110-38-3.
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, octanol, hexanol and 2-ethylhexanol. 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 hydrolyzed in same way when applied dermally.
As expected, none of the acute dermal toxicity tests performed showed adverse effect. Hence, the category substances are not classified for acute dermal hazard according to CLP criteria.
Reference
Table 1: Results of the key studies performed on the source substances of the category
Common name |
CAS |
Fatty acids chain length |
Type of alcohol |
MW |
Appareance |
Acute dermal Toxicity |
Ethyl decanoate |
110-38-3 |
C10 |
ethanol |
200.32 |
Liquid |
No data |
Ethyl undecylenate |
692-86-4 |
C11 |
ethanol |
212.33 |
liquid |
No data |
Isopropyl laurate |
10233-13-3 |
C12 |
Isopropanol |
242,41 |
Liquid |
no data |
Octyl octanoate |
2306-88-9 |
C8 |
octanol (C8) |
256,42 |
Liquid |
no data |
Isopropyl myristate |
110-27-0 |
C14 |
Isopropanol |
270,46 |
Liquid |
no data |
Dodecanoic hexyl ester |
34316-64-8 |
C12 |
Hexanol (C6) |
284,49 |
Liquid |
no data |
Ethyl linoleate |
544-35-4 |
C18:2 |
ethanol |
308,5 |
Liquid |
Experimental result: |
Ethyl oleate |
111-62-6 |
C18:1 |
ethanol |
310.52 |
Liquid |
no data |
2-ethylhexyl laurate |
20292-08-4 |
C12 |
2-Ethyl-Hexanol |
312,53 |
Liquid |
no data |
Fatty acids, coco, 2-ethylhexyl esters |
92044-87-6 |
C12-14 |
2-ethylhexanol |
312.53 – |
liquid |
No data |
All the category substances are fatty acid esters. After dermal exposure, it is expected that substances are hydrolyzed by lipases. Substances that are absorbed through the skin could enter the systemic circulation directly before joining the liver where hydrolysis basically takes place. They are expected to be metabolized in common energetic pathways or excreted.
One dermal acute study was performed for ethyl linoleate, according to OECD 402 method. Rats were exposed and the LD50 was defined to be higher than 2000 mg/kg bw.
The experimental study is consistent with the experimental studies performed for skin irritation. No toxicity was observed when the substances were applied dermally. Hence, no acute dermal toxicity is expected.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
This category groups covers esters (including ethanol, isopropanol, octanol, hexanol and 2-ethylhexanol) linked to fatty acids chain satured and unsatured (C8 to C18). This category includes monoconstituent substances and UVCB substances varying fatty acid chain length and based on the alcohol sources. This category group was made in order to provide sufficient information for physico-chemical, environmental, ecotoxicological and toxicological caracterisation of ethyl decanoate (CAS 110-38-3). This approach covers these endpoints including skin irritation, eye irritation, and in vitro gene mutation study in bacteria for which data on the target substance of the category are available.
This category includes:
- Target substance:
o Ethyl decanoate (CAS 110-38-3)
- Source substances:
o Ethyl undecylenate (CAS 692-86-4)
o Isopropyl laurate (CAS 10233-13-3)
o Octyl octanoate (CAS 2306-88-9)
o Isopropyl myristate (CAS 110-27-0)
o Dodecanoic hexyl ester (CAS 34316-64-8)
o Ethyl linoleate (CAS 544-35-4)
o Ethyl oleate (CAS 111-62-6)
o 2-Ethylhexyl laurate (CAS 20292-08-4)
o Fatty acids, coco, 2-ethylhexyl esters (CAS 92044-87-6)
Summary of available studies for acute oral toxicity
Isopropyl laurate CAS 10233 -13 -3
One study is available. The study was performed with a method equivalent to OECD TG 401 limit test method. NMRI mice were exposed in single administration to 5000 mg/kg bw of test substance. After 6 days of observations, no adverse effect was releved. Hence, the LD50 was defined to be higher than 5000 mg/kg bw.
Octyl octanoate CAS 2306 -88 -9
One study is available. The study was performed with a method equivalent to OECD TG 401. Wistar male rats were exposed in single administration to 1000 and 5000 mg/kg bw of test substance. After 14 days of observations, no adverse effect was releved. Hence, the LD50 was defined to be higher than 5000 mg/kg bw.
Isopropyl Myristate CAS 110 -27 -0
Three studies were available for acute oral toxicity assessment. The key study was performed according to 401 OECD Guideline, EU Method B.1 and GLP compliance. Wistar rats were exposed orally to 2000 mg/kg bw of the susbtance. No effect was observed. Hence, the LD50 was defined to be higher than 2000 mg/kg bw.
Two additional supporting studies were performed. In one study, rats were exposed to 4300 mg/kg bw and to 5000 mg/kg bw in the second. None of the treated animals died and no adverse effect were observed.
Dodecanoic hexyl ester CAS 34316 -64 -8
One study is available. The study was performed with a method equivalent to OECD TG 401 limit test method. Male NMRI mice were exposed in single administration to 5 mL/kg bw of test substance (equivalent to 4360 mg/kg bw). After observation period, no adverse effect was releved. Hence, the LD50 was defined to be higher than 4360 mg/kg bw.
Ethyl linoleate CAS 544-35-4
One study was performed which was quoted as key study. Five Swiss female mice were treated in single administration at 2000 mg/kg bw with ethyl linoleate according to OECD TG 401 limit test method. No mortality occured during the study period. Hence, the LD50 was defined to be higher than 2000 mg/kg bw.
Ethyl oleate CAS 111-62 -6
The key study was performed with a method similar to the OECD TG 401 limit test method. NMRI female mice were orally treated with test item ethyl oleate at 5 mL/kg bw (equivalent to 4360 mg/kg bw calculated with a density of 0.872 g/mL for ethyl oleate). No mortality and clinicals signs occured during the study period. Hence, the LD50 was defined to be higher than 4360 mg/kg bw.
2 -ethylhexyl laurate CAS 20292 -08 -4
One study is available for assessment/ The experimental study was peformed with a method similar to OECD TG 401 limit test method. Female Swiss mice were exposed in single administration to 2000 mg/kg bw. After 14 days of observation period, no adverse effect related to the test substance was observed. Hence, the LD50 was defined to be higher than 2000 mg.kg bw.
Fatty acids, coco, 2 -ethylhexyl esters CAS 92044 -87 -6
Two experimental studies were performed. The key study was performed according to OECD TG 401 method. Wistar rats were treated in single administration to 560, 1400, 1800, 3200 and 5600. No adverse effect was obersed until the end of observation period of 14 days. Hence the oral LD50 was defined to be higher than 5000 mg/kg bw.
The supporting study was performed with a method similar to the OECD TG 401 limit test method. NMRI mice were orally treated with test item ethyl oleate at 5 mL/kg bw (equivalent to 4360 mg/kg bw of test substance). No mortality and clinicals signs occured during the study period. Hence, the LD50 was defined to be higher than 4360 mg/kg bw.
Summary of available studies for acute inhalation toxicity
Ethyl undecylenate CAS 692 -86 -4
Ethyl undecylenate was evaluated for acute inhalation toxicity. The study was performed, according to OECD TG 403 (limit test). Rats were exposed to the test substance by inhalation at 5.7 mg/L for 4 hours in nose-only. No adverse effect was observed up to the end of observation period. The LC50 were defined to be higher than 5.7 mg/L.
Isopropyl myristate CAS 110 -27 -0
Isopropyl myristate was evaluated for acute inhalation toxicity. The study was performed, according to OECD TG 436 (limit test). Rats were exposed to the test substance by inhalation at 5 mg/L for 4 hours in nose-only. No adverse effect was observed up to the end of observation period. The LC50 were defined to be higher than 5 mg/L.
Summary of available study for acute dermal toxicity
Ethyl linoleate CAS 544 -35 -4
One dermal acute study was performed for ethyl linoleate, according to OECD 402 method. Rats were exposed at 2000 mg/kg bw by dermal route. The LD50 was defined to be higher than 2000 mg/kg bw.
None of the tested substances showed adverse effect at the high dose tested. Hence, the target substance is expected to have same acute toxicity behavior according to the category approach.
Justification for classification or non-classification
Using the read-across appraoch, according to the Annex XI item 1.5, of Regulation (EC) No 1907/2006, all available acute oral toxicity studies within the category resulted in an acute oral LD50 values higher than 2000 mg/kg bw for oral administration and dermal application, and LC50 was defined to be higher than 5 mg/L for inhalation. Hence, according to CLP criteria and REACh regualtion, the target substance ethyl decanoate is not classified for acute hazard and STOT-SE.
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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