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EC number: 279-510-2 | CAS number: 80584-99-2
- 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 potential of VOELOFA Monomer (target substance) to induce eye irritation was tested in a suitable in vitro test method (OECD 492). In accordance with REACH regulation 1907/2006, column 2 of standard information requirement 8.1 it is not necessary to conduct an in vitro skin irritation/corrosion study as in an acute toxicity study by the dermal route no indication of skin irritation was noted at the limit dose of 2000 mg/kg bw. Based on the results, the target substance can be considered non-irritant to the skin and eye.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because an acute toxicity study by the dermal route does not indicate skin irritation up to the relevant limit dose level (2 000 mg/kg body weight)
Reference
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:
- 2016-07-06 to 2016-09-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according 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)
- Version / remarks:
- adopted 28 July 2015
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- - Justification of the test method: The EpiOcular^TM Eye Irritation Test (EIT) predicts the acute ocular irritation potential of chemicals by measurement of its irreversible tissue damage caused by cytotoxic effects in the human cornea model. Within a testing strategy, the EpiOcularTM EIT is used as a re-placement of the Draize Eye Irritation Test.
- Description of the cell system used: The EpiOcularTM tissue consists of normal, human-derived keratinocytes which have been cultured to form a stratified squamous epithelium similar to that found in the human cornea. It consists of highly organized basal cells. These cells are not transformed or transfected with genes to induce an extended life span. The EpiOcular^TM tissues are cultured in specially prepared cell culture inserts with a porous membrane through which nutrients can pass to the cells. The tissue surface is 0.6 cm² - 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): 50 μL - Duration of treatment / exposure:
- 28 minutes at 37 °C
- Observation period (in vivo):
- n.a.
- Duration of post- treatment incubation (in vitro):
- Post exposure post-soak plate: 12 min at room temperature
Post exposure post-treatment plate: 116 ± 4 min at 37 ± 1 °C - Number of animals or in vitro replicates:
- 2 tissues per dose group
- Details on study design:
- - Details of the test procedure used:
On the day of the start of the experiment, the MTT concentrate was thawed. The concentrate was diluted with the MTT solvent and the solution was stored at 2 - 8 °C in the dark. The assay medium was warmed in the water bath to 37 ± 1 °C. 6-well-plates were labelled with test item, resp. negative control, resp. positive control and filled with 1 mL assay medium in the appropriate wells. All 24 inserts were inspected for viability and the presence of air bubbles between agarose gel and insert. Viable tissues were transferred in the prepared 6-well-plate and incubated at 37 ± 1 °C, 5 ± 1% CO2 and 80 – 100 % relative humidity for 1 hour. After the pre-incubation, the medium was replaced and the wells were filled with 1 mL fresh assay medium. All 6-well-plates were incubated at 37 ± 1 °C, 5 ± 1% CO2 and 80 – 100% relative humidity for 16.5 hours (16 – 24 hours).
After overnight incubation, the tissues were pre-wetted with 20 µL DPBS buffer and then incubated at 37 ± 1 °C, 5 ± 1% CO2 and 80 – 100 % relative humidity for 30 minutes. Af-ter that, 50 µL of the controls and the test item were applied in duplicate in one-minute-intervals. This was done in such a fashion that the upper surface of the tissue was cov-ered. At the beginning of each experiment (application of negative controls), a stop watch was started. After dosing the last tissue of each plate, the plate was transferred into the incubator for 28 minutes at 37 ± 1 °C, 5 ± 1% CO2 and 80 – 100 % relative humidity. At the end of the exposure time, the inserts were removed from the plates in one-minute-intervals using sterile forceps and rinsed immediately. The inserts were thoroughly rinsed with DPBS. Then, the tissues were immediately transferred to and immersed in 5 mL of pre-warmed assay medium in a pre-labelled 12-well plate for 12 minutes post soak at room temperature.
After that, each insert was removed from the medium, the medium was decanted off the tissue and the insert was blotted on absorbent material and transferred into the respective well of a pre-labelled 6-well plate containing 1 mL assay medium. For post-treatment incubation, the tissues were incubated for 116 ± 4 minutes at 37 ± 1 °C, 5 ± 1% CO2 and 80 – 100% relative humidity. After the post-treatment incubation, the MTT Assay was performed. Thus, a 24-well-plate was prepared with 300 µL freshly prepared MTT-reagent in each well. The tissue inserts were blotted on absorbent material and then transferred into the MTT solution. The plate was incubated for 180 minutes at 37 ± 1 °C, 5 ± 1% CO2 and 80 – 100% relative humidity.
At last, each insert was thoroughly dried and set into the empty 24-well-plate. Into each well, 2 mL isopropanol were pipetted, taking care to reach the upper rim of the insert. The plate was firmly sealed to avoid evaporation of the solvent and stored in the refrigerator overnight. On the next day the plate was shaken for 2 hours at room temperature. The inserts were pierced with an injection needle, taking care that all colour is extracted. The inserts were then discarded and the content of each well was thoroughly mixed in or-der to achieve homogenisation. From each well, two replicates with 200 µL solution (each) were pipetted into a 96-well-plate. Eight wells with 200 µL isopropanol were pipetted, too. The plate was read in a plate spectral photometer at 570 nm.
- RhCE tissue construct used, including batch number:
The EpiOcular^TM tissue consists of normal, human-derived keratinocytes which have been cultured to form a stratified squamous epithelium similar to that found in the human cornea. It consists of highly organized basal cells. These cells are not transformed or transfected with genes to induce an extended life span. The EpiOcular^TM tissues are cultured in specially prepared cell culture inserts with a porous membrane through which nutrients can pass to the cells.
The EpiOcular™ tissues were provided as kit (e.g. OCL-200-EIT, batch 23719; MatTek).
- Doses of test chemical and control substances used:
1. Negative Control: 50 µL sterile water (Laus GmbH, batch 20160426)
2. Positive Control: 50 µL methyl acetate (CAS No. 79-20-9 (positive control; Lot No.: 102015ZSA)
3. Test Item: 50 µL
- Duration and temperature of exposure, post-exposure immersion and post-exposure incubation periods (where applicable):
Exposure: 28 min at 37 ± 1 °C, 5% CO2 and 80-100% relative humidity
Post exposure post-soak plate:12min at room temperature
Post exposure post-treatment plate: 116 ± 4 min at 37 ± 1 °C, 5% CO2 and 80-100% relative humidity
- Indication of controls used for direct MTT-reducers and/or colouring test chemicals:
See section "Pre-experiments" in box "Any other information on materials and methods incl. tables"
- Number of tissue replicates used per test chemical and controls (positive control, negative control, NSMTT, NSCliving and NSCkilled, if applicable): 2 tissues per group
- Wavelength and band pass (if applicable) used for quantifying MTT formazan, and linearity range of measuring device (e.g. spectrophotometer): 570 nm
- Description of evaluation criteria used including the justification for the selection of the cut-off point for the prediction model:
Mean tissue viability (% negative control) <= 60 %: GHS “Category 1” or “Category 2”
Mean tissue viability (% negative control) > 60%: No GHS Category for eye irritation
Test Acceptance Criteria:
- mean absolute OD570 nm of the negative control is ≥ 0.8 and ≤ 2.5
- mean relative tissue viability of the positve control is < 50% of negative control
- Variation within replicates < 20% - Irritation parameter:
- other: Relative Tissue Viability (%)
- Run / experiment:
- Mean of replicates
- Value:
- 97.2
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The test item showed no irritant effects. The mean relative tissue viability (% negative control) was < 60% (97.2%). For detailed information please refer Tables 1-6 in box "Any other information on results incl. tables" .
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no irritant effects. The test item is classified as “non-irritant“ in accordance with UN GHS “No Category” for eye irritation.
- Executive summary:
In the present study the eye irritant potential of VOELOFA Monomer (100% purity) was analysed according to OECD 492 using the three-dimensional human corneal epithelium model EpiOcular, consisting of normal, human-derived epidermal keratinocytes mimicking characteristics of the corneal epithelium. Hereby, 50 µL of the test item was applied directly atop the EpiOcular™ tissue. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT compared to those of the concurrent negative control. The test item showed no irritant effects. The mean relative tissue viability of two replicates (% negative control) was > 60% (97.2%). Therefore, the test item is considered to be non-irritating to the eye in accordance with UN GHS “No Category”.
Reference
Table 1: Absorbance Values Blank Isopropanol (OD at 570 nm)
Replicate |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
Mean |
Absorbance |
0.037 |
0.037 |
0.034 |
0.036 |
0.036 |
0.037 |
0.036 |
0.037 |
0.036 |
Table 2: Absorbance Values Negative Control, Positive Control and Test Item (OD at 570 nm)
Designation |
Measurement |
Negative Control |
Positive Control |
VOELOFA Monomer |
Tissue 1 |
1 |
2.043 |
0.548 |
1.916 |
2 |
1.957 |
0.530 |
1.865 |
|
Tissue 2 |
1 |
1.936 |
0.555 |
1.907 |
2 |
1.901 |
0.529 |
1.929 |
Table 3: Mean Absorbance Negative Control, Positive Control and Test Item
Designation |
Negative Control |
Positive Control |
VOELOFA Monomer |
Mean – blank (Tissue 1) |
1.964 |
0.503 |
1.855 |
Mean – blank (Tissue 2) |
1.883 |
0.506 |
1.882 |
Table 4: % Viability Positive Control and Test Item
Designation |
Positive Control |
VOELOFA Monomer |
% Viability (Tissue 1) |
26.2% |
96.4% |
% Viability (Tissue 2) |
26.3% |
97.9% |
% Viability Mean |
26.2% |
97.2% |
Table 5: Assessment of Eye Irritation
% Viability |
Assessment |
GHS classification |
> 60 % |
Non eye irritant |
No GHS category for eye irritation |
≤ 60 % |
Eye irritant |
GHS category 1 or 2 |
Table 6: Validity
Criterion |
Demanded |
Found |
OD of negative control |
≥ 0.8 and ≤ 2.5 |
1.9 |
% Formazan production of positive control |
< 50% of negative control |
26.2% |
Variation within replicates |
< 20% |
4.2% (negative control) 0.2% (positive control) 1.4% (test item) |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The potential of VOELOFA Monomer (target substance) to induce eye irritation was tested in a suitable in vitro test method (OECD 492). In accordance with REACH regulation 1907/2006, column 2 of standard information requirement 8.1 it is not necessary to conduct an in vitro skin irritation/corrosion study as in an acute toxicity study by the dermal route no indication of skin irritation was noted at the limit dose of 2000 mg/kg bw. Based on the results, the target substance can be considered non-irritant to the skin and eye.
Justification for classification or non-classification
Based on the available results, the target substance can be considered non-irritant to the skin and eye and thus, no classification is warranted.
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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