Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 614-257-7 | CAS number: 68071-40-9
- 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
The skin irritation potential of Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs was evaluated in vitro in the EpiSkinTM Small Model (EpiSkinTMSM) in accordance to OECD 439. The testing material (Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs) was concluded not to have skin irritating properties, thus no classification applies.
The eye irritation potential of Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs was evaluated in vitro in the Bovine Corneal Opacity and Permeability test method (BCOP) in accordance to OECD 437. The testing material (Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs) was concluded not to eye irritating properties, thus no classification applies.
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:
- 04 - 06 Feb 2015
- 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)
- Version / remarks:
- 28 July 2015
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Version / remarks:
- 06 July 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- OGYÉI, Országos Gyógyszerészeti és Élelmezés-egészségügyi Intézet, Budapest, Hungary
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, closed container, protected from sunlight - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- The EPISKIN model has been validated for irritation testing. It is used as a replacement for the Draize Skin Irritation test (OECD TG 404) for the purposes of distinguishing between skin irritating and non-skin irritating test substances.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: EpiSkinTM Small Model (EpiSkinTMSM), manufactured by EPISKIN SNC Lyon, France
- Tissue batch number(s): 15-EKIN-005
- Date of initiation of testing: 09 Feb 2015
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature
- Temperature of post-treatment incubation: 37°C
REMOVAL OF TEST MATERIAL AND CONTROLS
- Volume of washing steps: rinsed thoroughly with 25 mL PBS
- Observable damage in the tissue due to washing: no
- Modifications to validated SOP: no
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 0.3 mg/mL
- Incubation time: 3 hours (± 5 min)
- Wavelength: 570 nm
FUNCTIONAL MODEL CONDITIONS WITH REFERENCE TO HISTORICAL DATA
- Viability: 21.9 ± 0.4
- Barrier function: 2.2 mg/mL
- Morphology: Well-differentiated epidermis consisting of a basal layer, several spinous and granular layers and a thick stratum corneum
- Contamination: no
- Reproducibility: yes
NUMBER OF REPLICATE TISSUES: 3
CONTROL TISSUES USED IN CASE OF MTT DIRECT INTERFERENCE
- Method of calculation used:
Blank: The mean of the 6 blank optical density (OD) values is calculated
Negative control:
- Individual negative control OD values are corrected with the mean blank OD:
OD Negative Control (ODNC) = ODNCraw – ODblank mean
- The corrected mean OD of the 3 negative control values is calculated: this corresponds to 100% viability
Positive control:
- Individual positive control OD values are corrected with the mean blank OD: :
OD Positive Control (ODPC) = ODPCraw – ODblank mean
- The corrected mean OD of the 3 positive control values is calculated
- The % viability for each positive control replicate is calculated relative to the mean negative control:
% Positive Control 1 = (ODPC1 / mean ODNC) ×100
- The mean value of the 3 individual viability % for positive control is calculated:
Mean PC % = (%PC1 + %PC2 + %PC3) / 3
Test item:
- Individual test item OD values are corrected with the mean blank OD: :
OD Treated Tissue (ODTT) = ODTTraw – ODblank mean
- The corrected mean OD of the 3 test item values is calculated
- The % viability for each test item replicate is calculated relative to the mean negative control:
% Treated Tissue 1 = (ODTT1 / mean ODNC) ×100
% Treated Tissue 2 = (ODTT2 / mean ODNC) ×100
% Treated Tissue 3 = (ODTT3 / mean ODNC) ×100
- The mean value of the 3 individual viability % for test item is calculated
Mean TT % = (%TT1 + %TT2 + %TT3) / 3
NUMBER OF INDEPENDENT TEST SEQUENCES / EXPERIMENTS TO DERIVE FINAL PREDICTION: 1
PREDICTION MODEL / DECISION CRITERIA
- The test substance is considered to be corrosive or irritant to skin if the mean relative viability after 15 minutes exposure and 42 h post incubation is less or equal to 50% of the negative
control.
- The test substance is considered to be non-corrosive or non-irritant to skin if the tissue viability after exposure and post-treatment incubation is more than 50% of the negative control. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 10µL
- Concentration: 100%
NEGATIVE CONTROL
- Amount(s) applied: 10 μL
POSITIVE CONTROL
- Amount(s) applied:10 μL
- Concentration: 5% - Duration of treatment / exposure:
- 15 min
- Duration of post-treatment incubation (if applicable):
- 42 ± 1 h
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean value of negative control (PBS)
- Value:
- 100
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean value of positive control (5% SDS)
- Value:
- 20
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- mean value of test item (100%)
- Value:
- 99
- Vehicle controls validity:
- not applicable
- 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: yes
ACCEPTANCE OF RESULTS:
The mean OD value of the three negative control tissues should be between 0.6 and 1.5 and the standard deviation value (SD) of the % viability should be ≤ 18.
The acceptable mean percentage viability range for positive controls is 0-40% and the standard deviation value (SD) of the % viability should be ≤ 18.
For test chemicals, the standard deviation value (SD) of the % viability should be ≤ 18.
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Acceptance criteria met for variability between replicate measurements: yes - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The skin irritation potential of Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs was evaluated in vitro in the EpiSkinTM Small Model (EpiSkinTMSM) in accordance to OECD 439. The testing material (Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs) was concluded not to have skin irritating properties, thus no classification applies.
- Executive summary:
The skin irritation potential of Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs was evaluated in vitro in the EpiSkinTM Small Model (EpiSkinTMSM) in accordance to OECD 439.
Acceptance criteria for negative and positive controls as well as variability between replicate measures was met and the study was therefore considered valid.
The relative viability scores for the testing material (Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs) was comparable to the negative control group and therefore concluded not to have skin irritating properties.
Thus, no classification applies in acordance to CLP (Regulation (EC) No 1272/2008).
Reference
Table 1: MTT assay after 3 hours (± 5 min) exposure
Substance |
Tissue No. |
OD570 |
OD570(mean) |
Relative viability |
Relative viability (mean) [%] |
Standard Deviation of relative viability |
Negative |
1 |
0.854 |
0.850 |
100 |
100 |
1.67 |
2 |
0.862 |
101 |
||||
3 |
0.835 |
98 |
||||
Positive |
1 |
0.212 |
0.171 |
25 |
20 |
6.32 |
2 |
0.110 |
13 |
||||
3 |
0.192 |
23 |
||||
Test |
1 |
0.801 |
0.839 |
94 |
99 |
6.02 |
2 |
0.897 |
106 |
||||
3 |
0.820 |
96 |
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:
- 30 Jan 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- see above
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hess. Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, closed container, away from sunlight - Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Schlachthof Bensheim, Bensheim, Germany
- Characteristics of donor animals: at least 9 month old donor cattle
- Storage, temperature and transport conditions of ocular tissue: The isolated eyes were transported in HBSS (with streptomycin / penicillin) at ambient temperature.
- Time interval prior to initiating testing: The comea were isolated on the same day after delivery of the eyes and were directly used in the BCOP test.
- indication of any existing defects or lesions in ocular tissue samples: no
- Indication of any antibiotics used: streptomycin / penicillin - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 750 µL
- Concentration: undiluted - Duration of treatment / exposure:
- 10 min at 32 ± 1 °C
- Observation period (in vivo):
- not applicable
- Duration of post- treatment incubation (in vitro):
- 2 h at 32 ± 1 °C
- Number of animals or in vitro replicates:
- Number of eyes for the test item/ negative control/ positive control: 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS: A careful macroscopic examination was performed on all eyes to detect the presence of any defects (opacity, scratches, pigmentation, vascularization etc). Eyes with defects were discarded. The cornea was carefully removed from the eye using a scalpel and rounded scissors. A rim of about 2 mm of tissue (sclera) was left for stability and handling of the isolated cornea. The cornea were directly used in the BCOP test on the same day.
QUALITY CHECK OF THE ISOLATED CORNEAS: yes, eyes were free of defects
TREATMENT METHOD: corneas were incubated horizontally, in a water-bath
REMOVAL OF TEST SUBSTANCE
After incubation the test item or control item, respectively, was rinsed off from the application side with saline.
- POST-EXPOSURE INCUBATION: The incubation medium consisted of MEM (supplemented with 1.1 g / 500 mL sodium bicarbonate, 5 mL / 500 mL L-glutamine, 100 units/mL penicillin, and 100 μg/mL streptomycin). Immediately before starting the test, MEM was supplemented with 1 % fetal calf serum (FCS)). The OECD foresees the use of EMEM which is in composition and osmolarity equivalent to the
MEM, thus MEM can be used without restriction.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Corneal opacity was determined by the amount of light transmission through the cornea using an opacitometer (OP_KiT opacitometer, Electro Design, 63-Riom France).
- Corneal permeability: Passage of sodium fluorescein dye measured with the aid of spectrophotometry (OD490) (Versamax® Molecular Devices). Prior to application of the test item or controls, the corneae in the holder were incubated in a vertical position for about 1 h at 32 ± 1 °C in a water-bath. At the end of the incubation period, the basal opacity was determined (to). After exposure of the corneae to the test groups, after rinsing and further incubation of the corneae for two hours, the opacity value was determined again (t130).
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
The following formula is used to determine the IVIS of the positive control and the test item:
IVIS = (opacity value - opacity value mean negative control) + (15 x corrected OD490 value)
Depending on the score obtained, the test item is classified into one of the categories according to OECD 437.
DECISION CRITERIA: The decision criteria as indicated in the TG (OECD 437) was used.
VALIDATION CRITERIA: The test will be acceptable if
- the positive control gives an IVIS that falls within two standard deviations of the current historical mean (updated every three months), and if
- the negative control responses result in opacity and permeability values that are less than the established upper limits for background opacity and permeability values for bovine corneae treated with the respective negative control - Irritation parameter:
- cornea opacity score
- Run / experiment:
- negative control - mean out of all 3 eyes
- Value:
- 0.33
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- positive control - mean out of all 3 eyes
- Value:
- 55.67
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: value is corrected
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- test item - mean out of all 3 eyes
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: value is corrected
- Irritation parameter:
- fluorescein leakage
- Remarks:
- permeability
- Run / experiment:
- negative control - mean out of all 3 eyes
- Value:
- 0.054
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein leakage
- Remarks:
- permeability
- Run / experiment:
- positive control - mean of all 3 eyes
- Value:
- 0.812
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: value is corrected
- Irritation parameter:
- fluorescein leakage
- Remarks:
- permeability
- Run / experiment:
- test item - mean out of all 3 eyes
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: value is corrected
- Irritation parameter:
- in vitro irritation score
- Remarks:
- (IVIS)
- Run / experiment:
- negative control - mean out of all 3 eyes
- Value:
- 1.15
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- in vitro irritation score
- Remarks:
- (IVIS)
- Run / experiment:
- positive control - mean out of all 3 eyes
- Value:
- 67.84
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- in vitro irritation score
- Remarks:
- (IVIS)
- Run / experiment:
- test item - mean out of all 3 eyes
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
- Range of historical values if different from the ones specified in the test guideline: yes - Interpretation of results:
- GHS criteria not met
- Conclusions:
- The eye irritation potential of Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs was evaluated in vitro in the Bovine Corneal Opacity and Permeability test method (BCOP) in accordance to OECD 437. The testing material (Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs) was concluded not to eye irritating properties, thus no classification applies.
- Executive summary:
The eye irritation potential of Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs was evaluated in vitro in the Bovine Corneal Opacity and Permeability test method (BCOP) in accordance to OECD 437.
Acceptance criteria for negative and positive controls as well as variability between replicate measures was met and the study was therefore considered valid.
The scores for cornes opacity and permeability for the testing material (Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs) was comparable to the negative control group and the In-Vitro Irritancy Score (IVIS) values did not indicate any eye irritative properties. Therefore, it was concluded that Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs does not to have eye irritating properties.
Thus, no classification applies in acordance to CLP (Regulation (EC) No 1272/2008).
Reference
Table 1: In-Vitro Irritancy Score (IVIS) values
IVIS | Mean IVIS | |
Negative Control |
0.78 | 1.15 |
0.77 | ||
1.90 | ||
Test substance | -1.43 | 0.0 |
-0.43 | ||
-0.41 | ||
Positive control | 70.61 | 67.84 |
66.52 | ||
66.38 |
Table 2: Opacity and Permeability values
Difference (t130-to) of Opacity | ||||||
Parameter | Opacity 1 | Opacity 2 | Opacity 3 | Mean opacity value | Permeability at 490 nm | Mean Permeability at 490 nm |
Negative control | 0 | 0 | 1 | 0.33 | 0.052 | 0.054 |
0.051 | ||||||
0.060 | ||||||
Test substance | -1.33* | -0.33* | -0.33* | - | -0.006* | - |
-0.006* | ||||||
-0.005* | ||||||
Positive control | 54.67* | 55.67* | 56.67* | - | 1.063* | - |
0.724* | ||||||
0.648* |
* = corrected values
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
The skin and eye irritation he acute oral toxicity of Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs was evaluated in accordance to OECD 439 and OECD 437, respectively. No skin and eye irritating properties was concluded.
Thus, no classification applies in acordance to CLP (Regulation (EC) No 1272/2008).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.