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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
Based on the category approach and on the available experimental results, the NOAEL value applied for the category is higher than 800 mg/kg bw. Hence, the category substances and the target substance did not required classification for STOT-RE in absence of adverse effects according to CLP criteria.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- sub-chronic 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
- Dose descriptor:
- NOAEL
- Effect level:
- > 800 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- Key result
- Critical effects observed:
- no
- Conclusions:
- Based on the category approach and on the available experimental results, the NOAEL value applied for the category is higher than 800 mg/kg bw. Hence, the category substances did not required classification for STOT-RE in absence of adverse effects.
- 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.
Based on the category approach and on the available experimental results, the NOAEL value applied for the category is higher than 800 mg/kg bw. Hence, the category substances did not required classification for STOT-RE in absence of adverse effects according to CLP criteria.
Reference
Table 1: Results of the key studies performed on the source substances of the category
Common name |
CAS |
Fatty acid chain length |
Type of alcohol |
MW |
Appareance |
Repeated dose 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 |
Experimental result: |
Dodecanoic hexylester |
34316-64-8 |
C12 |
Hexanol(C6) |
284,49 |
Liquid |
Experimental |
Ethyl linoleate |
544-35-4 |
C18:2 |
ethanol |
308,5 |
Liquid |
no data |
Ethyl oleate |
111-62-6 |
C18:1 |
ethanol |
310.52 |
Liquid |
Experimental result: |
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 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 not bioaccumulable after repeated administration.
Three relevant studies are available for assessment. None of these studies, performed according to OECD TG 407 and 408 methods, showed adverse effect to rats during the entire treatment period.
These experimental studies are consistent with the low toxicity expected for these substances.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 800 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- System:
- other: no effect
- Organ:
- not specified
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 some 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 oçleate (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 oral repated dose toxicity
Isopropyl myristate CAS 110 -27 -0
The first key study was performed with the isopropyl myristate using rats according to the OECD 407 Guideline. The animals were exposed once a day for 28 days at 100, 500 and 1000 mg/kg bw/day in corn oil by gavage. No death or adverse effects were observed. The NOAEL was defined to be higher than 1000 mg/kg bw/day.
Ethyl oleate 111 -62 -6
Another repeated dose toxicity study was available for ethyl oleate equivalent to OECD TG 408 guideline method. Sprague-Dawley rats were treated orally with test item in food, which is provided ad libitum during 91 days. The doses applied were 2.0, 3.9 and 6.1 g/kg bw/day (females) and 1.8, 3.6, 5.5 g/kg bw/day (males). No adverse effects were related to treatment during and after the treatment period. Hence the NOAEL was defined at the high dose level, 5500 mg/kg bw/day.
Dodecanoic ethylhexyl esters CAS 34316 -64 -8
The third reliable and relevant study was performed on the dodecanoic ethylhexyl esters, according to OECD TG 408 method. Rats were exposed during 90 days to the substance in food at 10.000 ppm (corresponding to 800 mg/kg bw/day). No adverse effect was observed during the treatment period. Hence, the NOAEL was defined to be higher than 800 mg/kg bw/day. Based on the category approach, the NOAEL of 800 mg/kg bw/day is applied to the target substance.
Justification for classification or non-classification
Based on the category approach and on the available experimental results, the NOAEL value applied for the category is higher than 800 mg/kg bw. Hence, the category substances did not required classification for STOT-RE in absence of adverse effects according to CLP criteria.
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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