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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
Toxicity to reproduction
Administrative data
- Endpoint:
- screening for reproductive / developmental toxicity
- 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.
Data source
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 1993 FDA draft "Redbook II" guidelines (Toxicological Principles for the Safety Assessment of Direct Food Additives and Color Additives Used in Food).
Test material
- Reference substance name:
- Ethyl decanoate
- EC Number:
- 203-761-9
- EC Name:
- Ethyl decanoate
- Cas Number:
- 110-38-3
- Molecular formula:
- C12H24O2
- IUPAC Name:
- ethyl decanoate
- Test material form:
- liquid
Constituent 1
Results and discussion
Results: P0 (first parental generation)
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- > 5 500 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- mortality
- reproductive function (oestrous cycle)
- reproductive function (sperm measures)
Target system / organ toxicity (P0)
- Key result
- Critical effects observed:
- no
Results: P1 (second parental generation)
Effect levels (P1)
- Key result
- Remarks on result:
- not measured/tested
Results: F1 generation
Effect levels (F1)
- Key result
- Remarks on result:
- not measured/tested
Overall reproductive toxicity
- Key result
- Reproductive effects observed:
- no
Any other information on results incl. tables
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 |
Toxicityto |
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 |
no data |
Ethyl oleate |
111-62-6 |
C18:1 |
ethanol |
310.52 |
Liquid |
Experimental |
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.
One study was available for reprotoxicity assessment for ethyl oleate. Rats were exposed during 91 days and reproductive functions were analyzed. No adverse effect was observed. Hence, the NOAEL was defined to be higher than 5500 mg/kgbw/day. The result is consistent with expected low toxicity of the category substances.
Applicant's summary and conclusion
- Conclusions:
- Based on the structural similarities between the substances and on the category approach, the NOAEL value for reprotoxicity as higher than 5500 mg/kg bw/day is validated for the category substances.
- 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.
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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