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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 available key studies performed to assess the potential irritation and corrosion effects of the registered substance, no effect was observed in the three in vitro studies. Hence, according to CLP criteria, ethyl decanoate was not classified for skin and eye irritation.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 24 November 2017 to 14 December 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- Deviations:
- yes
- Remarks:
- No analysis certificate of the episkin model was given.
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: From the sponsor, batch : 16090585
- Expiration date of the lot/batch: 19 september 2018
- Purity test date: 22 September 2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions:at least 6 months from the manufacture date
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: not applicable, the test item was used pure
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable
FORM AS APPLIED IN THE TEST (if different from that of starting material) - Test system:
- artificial membrane barrier model
- Remarks:
- Reconstructed human epidermis
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: not applicable
- Source strain:
- other: not applicable
- Justification for test system used:
- The present test is proposed as an alternative in vitro approach to assess the skin irritant potential of chemicals or cosmetic ingredient.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiSkinTM
- Tissue batch number(s): lot 17-EKIN-047
- Production date: not specified
- Shipping date: not specified
- Delivery date: not specified
- Date of initiation of testing: 21 November 2017
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: 37°C
- Temperature of post-treatment incubation (if applicable): 37°C ± 1°C
REMOVAL OF TEST MATERIAL AND CONTROLS
-Volume and number of washing steps: thoroughly rinsed with PBS
- Observable damage in the tissue due to washing: not specified
- Modifications to validated SOP:no modification
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/ml
- Incubation time: 3 hours
- Spectrophotometer: not specified
- Wavelength: 570nm
- Filter: not filter used
- Filter bandwidth: not applicable
- Linear OD range of spectrophotometer: not specified
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: yes
- Barrier function: yes
- Morphology: stratified differentiated epidermis derived from human keratinocytes
- Contamination: not specified
- Reproducibility:yes
NUMBER OF REPLICATE TISSUES: triplicates were used
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Killed tissues
- Procedure used to prepare the killed tissues (if applicable): Freezed-killed tissue
- N. of replicates : triplicates
- Method of calculation used: % viability = [OD mean of treated condition / OD mean of control condition] x 100
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 2 independant tests :pretest with interference and MTT reduction test and main test
PREDICTION MODEL / DECISION CRITERIA (choose relevant statement)
- The test substance is considered to be irritant to skin if the viability after 30 minutes exposure and 42 hours post incubation is less than 50%.
- The test substance is considered to be non-irritant to skin if the viability after 30 minutes exposure and 42 hours post incubation is greater than or equal to 50%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 50µL/cm2 corresponding to 19 µL (0.38cm2)
- Concentration (if solution): pure
VEHICLE
Not applicable
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 19 µL
- Concentration (if solution): pure
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 19µL
- Concentration (if solution): 5% - Duration of treatment / exposure:
- 15 ± 0.5 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- triplicates were used
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main test - Negative control
- Value:
- 100
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main test - Test item
- Value:
- 100
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Main test - Positive control
- Value:
- 17
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- - OTHER EFFECTS:
- Visible damage on test system: No
- Direct-MTT reduction: No
- Colour interference with MTT: No
DEMONSTRATION OF TECHNICAL PROFICIENCY: the 5% SDS was used as positive control and showed proficiency of the test system to detect cellular cytotoxicity
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: conform
- Acceptance criteria met for positive control: conform
- Acceptance criteria met for variability between replicate measurements: conform
- Range of historical values if different from the ones specified in the test guideline: Historical values of positive control : 14±4% ; Positive control values in the test : 17%. Conform - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the result of this study, the test item when applied on the EpiSkin model for 15 minutes did not induce a decrease of cellular viability. Hence, according to the CLP criteria, the test item, caprate ethyl, was not classified for skin irritation.
- Executive summary:
This GLP compliant study was performed in order to assess the potential skin irritation potential of the test item, caprate ethyl. This study was performed according to the OECD TG 439 method.
EpiSkinTM was used as test system in this study. 19 µL of caprate ethyl was applied on the EpiSkinTM for 15 minutes. Buffered saline solution (PBS) was used as negative control and 5% Sodium dodecyl sulfate (SDS) was used as positive control. Triplicates were used for each condition. The 15 minutes exposure period was followed by a 42 hours post incubation period. After this step, the viability of the EpiSkinTM model was measured by a MTT assay.
The postive control induceda decrease of cellular viability (17% of viability). The negative control did not induced a viability decrease. The viability of the test system was 100% when exposed to the test item.
The acceptance criteria of the assay was considered as validated.
Based on the result of this study, the test item whan applied on the EpiSkin model for 15 minutes did not induce a decrease of cellular viability. Hence, according to the CLP criteria, the test item, caprate ethyl, was not classified for skin irritation.
Reference
Table 1 :Results
Condtion |
Optical Density Mean |
Cellular viability |
Negative control |
1.522 ± 0.012 |
100 |
Positive control |
0.257 ± 0.015 |
17 |
Test item |
1.523 ± 0.016 |
100 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 10 November 2017 to 6 December 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: supplied by the sponsor, batch no. 16090585
- Expiration date of the lot/batch: 19 September 2018
- Purity test date: 22 September 2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions:at least 6 months from the manufacture date
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: no
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: not applicable
- Preliminary purification step (if any): not applicable
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable
FORM AS APPLIED IN THE TEST (if different from that of starting material)
Pure - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 30±2 µL (60 µL/cm2)
- Concentration (if solution): pure
VEHICLE
No vehicle was used - Duration of treatment / exposure:
- 30 ± 2 minutes
- Duration of post- treatment incubation (in vitro):
- 30 ± 2 minutes
- Number of animals or in vitro replicates:
- Duplicates were used for each condition
- Details on study design:
- - Details of the test procedure used
Prior to the application of the test item, HCE tissues are transferred into 24-well plates filled with EPISKIN maintenance medium. 30µL (±2µL) of test material and/or controls are topically applied on the surface of HCE tissues (0.5cm2) Tissues treated with test item and with control substances tested concurrently to test item are incubated for 30 minutes (±2) at standard culture conditions.
After exposure to the test material to the test material, the treated tissues are rinsed with PBS and transferred into 24 well plates filled with maintenance medium. This rinsing step is followed by a 30 minutes(±2) post exposure immersion in maintenance medium at standard culture conditions, prior to performing the MT assay.
In order to evaluate the tissue viabilit, MTT assay was performed. The inserts are transferred to a 24 well plate containing 300 µL of MTT solution at 1mg/ml in maintenance medium. After 180 minutes, incubation in standard culture conditions, the precipitated blue formazan is then extracted from the tissues using isopropanol. Tissues tested with liquid test items are extracted from both the top and the bottom of the tissues, while tissues with colourd liquids are extracted from the bottom of the tissue only.
- RhCE tissue construct used, including batch number HCE SkinEthicTM ; HCE/S/5 lot 17-HCE-058
- Doses of test chemical and control substances used 30 µL of pure test chemical, positive and negative control were used.
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods (where applicable)
30 minutes exposure period at 37°C ; post exposure immersion 30 minutes at 37°C ; 180 minutes of MTT incubation period
- Justification for the use of a different negative control than ultrapure H2O (if applicable) not applicable. The PBS was required according to the guideline (OECD TG 49 2)
- Justification for the use of a different positive control than neat methyl acetate (if applicable) methyl acetate was used
- Description of any modifications to the test procedure not applicable
- Indication of controls used for direct MTT-reducers and/or colouring test chemicals (if applicable)
Direct MTT reduction controls : 30µL of the test material was added to 300 µL of 1 mg/mL MTT solution and the mixture is incubated for 3 hours at standard culture conditions.
Colour Interference : 10 µL of test material are mixed with 90 µL of distilled water. The solution is incubated for 30 minutes at room temperature
- Number of tissue replicates used per test chemical and controls (positive control, negative control, NSMTT, NSCliving and NSCkilled, if applicable)
duplicates were used
- Wavelength and band pass (if applicable) used for quantifying MTT formazan, and linearity range of measuring device (e.g. spectrophotometer)
570 nm
- Description of the method used to quantify MTT formazan
The optical densities OD from individual replicate tissues are first corrected by substracting the blank mean OD value. The mean from corrected OD values (ODcorr) is calculated in each experimental group.
For normal condition, the percentage of tissue viability (%viab) is calculated from the mean ODcorr values relative to the mean viability of negative control (PBS treated epithelium)
%Viab [Treated] = ([Treated]ODcorr mean / [Negative Control]ODcorr mean) x100
- Description of the qualification of the HPLC/UPLC-spectrophotometry system (if applicable) not applicable
- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model
The eye irritant potential of the test item is predicted by the mean percent tissue viability (mean between 2 tissue replicates) normalised to the negative control which is set at 100%. The percentage tissue viability cut-off value distinguishing classified from non-classified test items according to UN-GHS is 60% (higher than 60% of viability : not classified ; lower than 60% of viability : no prediction can be made)
- Reference to historical positive and negative control results demonstrating suitable run acceptance criteria
not specified
- Complete supporting information for the specific RhCE tissue construct used
Only batch and RhCE tissue was given
- Reference to historical data of the RhCE tissue construct
not specified
- Demonstration of proficiency in performing the test method before routine use by testing of the proficiency chemicals
the methyl acetate showed positive responce and the capability of the test system to measure a decrease of cellular viability.
- Positive and negative control means and acceptance ranges based on historical data
The mean viability of tissues treated with the positive control (methyl acetate n=2) is =< 30%.
The mean OD of the negative control (NC n=2) is >= 1.4 with an upper acceptance limit of =<2.5
- Acceptable variability between tissue replicates for positive and negative controls
Conform
- Acceptable variability between tissue replicates for the test chemical
Conform - Irritation parameter:
- in vitro irritation score
- Remarks:
- % tissue viability
- Run / experiment:
- Maint test - Negative Control
- Value:
- 100
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- in vitro irritation score
- Remarks:
- % tissue viability
- Run / experiment:
- Main test - Positive Control
- Value:
- 2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- in vitro irritation score
- Remarks:
- % tissue viability
- Run / experiment:
- Main test - Test Item
- Value:
- 100
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: no
DEMONSTRATION OF TECHNICAL PROFICIENCY: The methyl acetate was used as positive control and showed potency of the test system to measured tissue viability
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: conform
- Acceptance criteria met for positive control: conform
- Range of historical values if different from the ones specified in the test guideline: not applicable - Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of this study, the test item ethyl caprate, did not induced decrease of tissue viability. Hence, according to the CLP criteria, the caprate was not classified for eye irritation.
- Executive summary:
This GLP compliant in vitro study was performed in order to assess the potential eye irritation potential of the test item, ethyl caprate. This study was performed according to the OECD TG 492 method.
HCE SkinEthicTM model was used as test system in this study. 30 µL of ethyl caprate was applied on the EpiSkinTM for 30 minutes. Buffered saline solution (PBS) was used as negative control and methyl acetate was used as positive control. Duplicates were used for each condition. The 30 minutes exposure period was followed by a 30 minutes post incubation period. After this step, the viability of the HCE SkinEthicTM model was measured by a MTT assay.
The postive control induced a decrease of cellular viability (2% of viability). The negative control did not induced a viability decrease. The viability of the test system was 100% when exposed to the test item.
The acceptance criteria of the assay was considered as validated.
Based on the results of this study, the test item ethyl caprate, did not induced decrease of tissue viability. Hence, according to the CLP criteria, the caprate was not classified for eye irritation.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- From 14 September 2017 to 6 December 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
- Qualifier:
- according to guideline
- Guideline:
- other: Official method for irritation evaluation by application on chorioallantoic membrane of the egg. Order of the 29 November 1996. Official diary of the French Republic (Journal Officiel de la Republique Française) of the 28 December 1996.
- Deviations:
- no
- GLP compliance:
- yes
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material:
supplied by the sponsor, batch no. 16090585
- Expiration date of the lot/batch: 19 September 2018
- Purity test date: 22 September 2016
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions:at least 6 months from the manufacture date
- Solubility and stability of the test substance in the solvent/vehicle: not applicable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: not applicable
- Preliminary purification step (if any): not applicable
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable
FORM AS APPLIED IN THE TEST (if different from that of starting material)
Pure - Species:
- chicken
- Strain:
- other: White Leghorn
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EGGS
- Source:Couvoir de Cerveloup, Vourey
- Number of animals: 12 eggs were used in this study (50-65g)
- Characteristics: Incubation time 10 days at 37.5°C and 45-60% relative humidity - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.3 mL
- Concentration (if solution): pure
VEHICLE
No vehicle was used - Duration of treatment / exposure:
- 20 seconds
- Observation period (in vivo):
- Observation of the chorioallantoic membrane was performed before application and after 5 minutes exposure period.
- Number of animals or in vitro replicates:
- Four eggs were used per condition except for the negative condition when 2 eggs were used
- Details on study design:
- SELECTION AND PREPARATION OF EGGS:
After 10 days of incubation, the egg shell is carefully scratched around the air space and then pared off. The inner egg membrane is carefully moistened with 0.9% NaCl solution and removed using tapered forceps to ensure accessibility to chorioallantoic membrane (CAM)
QUALITY CHECK OF THE ISOLATED CORNEAS
Eggs which were considered as defective are discarded from the study.
NUMBER OF REPLICATES
Four eggs were used per condition except for the negative condition when 2 eggs were used
NEGATIVE CONTROL USED
0.9% NaCl solution
POSITIVE CONTROL USED
3% SDS Sodium dodecyl Sulfate
APPLICATION DOSE AND EXPOSURE TIME
0.3mL of test chemical, negative or positive control was applied
TREATMENT METHOD: 0.3mL of the test item are added to the CAM and eliminated by irrigation with 5 mL of 0.9% saline solution after 20 seconds
POST-INCUBATION PERIOD: No
METHODS FOR MEASURED ENDPOINTS:
The choriallantoic membrane was observed through a magnifying glass before (to control the integrity) and over 5 minutes after application. The macroscopic examination consisted in monitoring appearance of the following phenomena:
-Hyperaemia : secondary vessel, non visible before test product addition, become visible due to increased blood flow. Visible secondary vessels expand and become redder. This phenomenon may occur in vessels with higher diameter.
-Haemorrhage : blood flows out the blood vessels. Various aspect mùay indicate haemorrhage: diffuse fog, "cauliflower" aspect, dotty aspect (blood flows out from different points of the membrane).
-Coagulation : Opacity and/or thrombosis (opacity : opalescent shadow on the membrane or direct opacity due to protein denaturation.) (Thrombosis: blood flow holds up)
SCORING SYSTEM: See table 1 below in "Any other information on materials and methods incl. tables" section
DECISION CRITERIA: See table 2 below in "Any other information on materials and methods incl. tables" section - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Main test - Negative control
- Value:
- 0
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Main test - Positive control
- Value:
- 12
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Main test - Test item
- Value:
- 0
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Based on the results of the study, the test item did not induced adverse effect when applied on the chorioallantoic membrane of eggs. According to the REACh regulation, no prediction can be made. Indeed, the HET-CAM assay can only classified a substance as Category 1 UN-GHS.
- Executive summary:
The GLP compliant in vitro study was performed to assess the potential eye irritation potential of the caprate ethyl. This HET-CAM (Hen's Egg Test Chorioallantoic Membrane) was performed according to the natoinal standard Journal Officiel de la République Française of 29 November 1996.
White Leghorn eggs were used. They were incubated 10 days before preparation. When prepared, 0.3 mL of test item, positive or negative control was applied on the chorioallantoic membrane for 5 minutes. Evaluation was thereafter performed using magnifying glass for hyperaemia, haemorrhage and coagulation.
The test item did not induced adverse effect when applied on the chorioallantoic membrane of eggs. According to the REACh regulation, no prediction can be made. Indeed, the HET-CAM assay can only classified a substance as Category 1 UN-GHS.
Referenceopen allclose all
Table 1 :Results
Condtion |
Optical Density Mean |
Cellular viability |
Negativecontrol |
1.759 ± 0.011 |
100 |
Positive control |
0.041 ± 0.001 |
2 |
Test item |
1.766 ± 0.017 |
100 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
A GLP compliant study was performed in order to assess the potential skin irritation potential of the test item, ethyl decanoate (ethyl caprate).
This study was performed according to the OECD TG 439 method. EpiSkinTM was used as test system in this study. 19 µL of ethyl caprate was applied on the EpiSkinTM for 15 minutes. Buffered saline solution (PBS) was used as negative control and 5% Sodium dodecyl sulfate (SDS) was used as positive control. Triplicates were used for each condition. The 15 minutes exposure period was followed by a 42 hours post incubation period. After this step, the viability of the EpiSkinTM model was measured by a MTT assay.The postive control induceda decrease of cellular viability (17% of viability). The negative control did not induced a viability decrease. The viability of the test system was 100% when exposed to the test item. Hence the substance is considered as non irritant for the skin.
Two key studies are available to assess potential eye irritation of the test item:
- The first study was performed according to the OECD TG 492 method. HCE SkinEthicTM model was used as test system in this study. 30 µL of ethyl caprate was applied on the EpiSkinTM for 30 minutes. Buffered saline solution (PBS) was used as negative control and methyl acetate was used as positive control. Duplicates were used for each condition. The 30 minutes exposure period was followed by a 30 minutes post incubation period. After this step, the viability of the HCE SkinEthicTM model was measured by a MTT assay. The postive control induced a decrease of cellular viability (2% of viability). The negative control did not induced a viability decrease. The viability of the test system was 100% when exposed to the test item.
- As the second key study, a HET-CAM (Hen's Egg Test Chorioallantoic Membrane) was performed according to the natoinal standard Journal Officiel de la République Française of 29 November 1996. White Leghorn eggs were used. They were incubated 10 days before preparation. When prepared, 0.3 mL of test item, positive or negative control was applied on the chorioallantoic membrane for 5 minutes. Evaluation was thereafter performed using magnifying glass for hyperaemia, haemorrhage and coagulation. The test item did not induced adverse effect when applied on the chorioallantoic membrane of eggs.
Additionally, ethyl decanoate belongs to category groups ( Long chain fatty acids (C8 to C18) alcohol esters (ethanol, isopropanol, octanol, hexanol and 2-ethylhexanol)). The results from studies performed on ethyl decanoate are consitent with negative results from source substances studies. The very similar behavior for skin and eye effects reinforces the category approach.
Justification for classification or non-classification
Based on the available key studies performed to assess the potential irritation and corrosion effects of the registered substance, no effect was observed in the three in vitro studies. Hence, according to CLP criteria, ethyl decanoate was not classified for skin and eye irritation.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.