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EC number: 947-618-5 | CAS number: -
- 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
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
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- Nanomaterial specific surface area
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- Endpoint summary
- Stability
- Biodegradation
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- 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
EGGE 2806-1 is neither corrosive nor irritant to the skin in tests using reconstructed human epidermis (Wingenroth, 2016a+b). In vitro studies with EGGE 2806-1 reveal no potential to serious eye damage (BCOP; Gmelin, 2016) or to irritant effects to the eyes (HCE; Wingenroth, 2016c).
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:
- weight of evidence
- Study period:
- October 2014
- 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)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: test item was melted in a hot cabinet with 100 °C
FORM AS APPLIED IN THE TEST (if different from that of starting material): liquid (melted and cooled down test item) - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- commercially available test system
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: epiCS® (CellSystems, Troisdorf, Germany).
- Tissue batch number(s): Cat.-No.CS-100
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: RT (room temperature)
- Temperature of post-treatment incubation (if applicable): Incubator temperature: 37 ± 2° C (CO2 gas concentration: 5 %; Humidity: maximum)
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/ml
- Incubation time: 3 hours
- Spectrophotometer: EL808, Bio-Tek
- Wavelength: 570 nm
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION:
the optical density of the isopropanol-extracts of 3 insert was determined by duplicate per insert = 6 OD values.
PREDICTION MODEL / DECISION CRITERIA:
- The mean optical density (OD) values obtained with the test item was used to calculate the percentage of viability relative to the negative control, which is set at 100 %.
- According to UN GHS (Category 2 or Category 1) if the mean percent tissue viability after exposure and post treatment incubation is less than or equal (≤ ) to 50 %. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 30 μl
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 30 μl
- Concentration (if solution): 0.9% NaCl in water
POSITIVE CONTROL
- Amount(s) applied (volume or weight): 30 µl
- Concentration (if solution): 5% SDS in physiological saline - Duration of treatment / exposure:
- 20 min
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- three
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- ca. 81
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY:
- Reliability of the test was previously confirmed by interlaboratory validation
ACCEPTANCE OF RESULTS:
- 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:
- other: negative
- Executive summary:
A study was performed for the assessment of the skin irritancy of the test item with reconstructed human epidermis (RhE). The experiment was carried out using the commercially available test method epiCS®. The study was conducted in accordance with OECD TG 439 and EU Test Method B.46. The mean value of cell viability was recorded to be 81 %. The test item was thus shown to be not irritating to reconstructed human skin in vitro.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- October 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: test item was melted in a hot cabinet with 100 °C for approx. 3 hours
FORM AS APPLIED IN THE TEST (if different from that of starting material): liquid - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Justification for test system used:
- commercially available test system
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- RECONSTRUCTED HUMAN EPIDERMIS (RHE) TISSUE
- Model used: epiCS® (CellSystems, Troisdorf, Germany).
- Tissue batch number(s): Cat.-No.CS-1001
TEMPERATURE USED FOR TEST SYSTEM
- Temperature used during treatment / exposure: room temperature for 3 min- exposure and incubator (37 ± 2° C) for 60 min- exposure
MTT DYE USED TO MEASURE TISSUE VIABILITY AFTER TREATMENT / EXPOSURE
- MTT concentration: 1mg/ml
- Incubation time: 3 hours
- Spectrophotometer: EL808, Bio-Tek
- Wavelength: 570 nm
NUMBER OF INDEPENDENT TESTING RUNS / EXPERIMENTS TO DERIVE FINAL PREDICTION:
the optical density of the isopropanol-extracts of 3 inserts was determined by duplicate per insert = 6 OD values.
PREDICTION MODEL / DECISION CRITERIA:
- The mean optical density (OD) value obtained with the test item was used to calculate the percentage of viability relative to the negative control, which is set at 100 %.
- classification according to UN GHS: if the mean percent tissue viability after 3 min-exposure is less than (<) 50 % the test item is classified as corrosive (Category 1A); if the mean percent tissue viability after 3-min-exposure is greater than or equal (≥) to 50 % AND < 15% after 60-min exposure the test item is classified as corrosive (Category 1B/1C); if the mean percent tissue viability after 60-min-exposure is ≥ 50 % after 3-min exposure AND ≥ 15% after 60-min exposure the test item is considered as non-corrosive
The corrosive potential of the test item is assessed by determination of its cytotoxic effect on an in vitro reconstructed human epidermis. The test principle is based on the MTT assay reflecting the cell viability after exposure to the topically applied test item.
All tests were performed in triplets for each time point. The test item was applied at a 100% concentration, i.e. 50 µl per insert for 3 min. (room temperature) and 60 min. Cell viability was measured by the amount of MTT reduction (calculated on the basis of optical density of the negative control). - Control samples:
- yes, concurrent negative control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied: 50 μl
NEGATIVE CONTROL
- Amount(s) applied (volume or weight): 50 μl
- Concentration (if solution): 0.9% NaCl in water - Duration of treatment / exposure:
- 3 min and 60 min
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- exposure period: 3 min.
- Value:
- ca. 88
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not specified
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- exposure period: 60 min.
- Value:
- ca. 78
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- not specified
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY:
- Reliability of the test was previously confirmed by interlaboratory validation
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes, within regular intervals in the lab
- Acceptance criteria met for variability between replicate measurements: yes - Interpretation of results:
- other: negative
- Executive summary:
A study was performed for the assessment of the skin corrosion of the test item with reconstructed human epidermis (RhE). The experiment was carried out using the commercially available test method epiCS®. The study was conducted in accordance with OECD TG 431 and EU Test Method B.40 bis. The mean value of cell viability was recorded to be 88 % (3 min. exposure) and 78% (60 min. exposure). The test item was thus shown to be not corrosive to reconstructed human skin in vitro.
Referenceopen allclose all
Table 1: Tabular Summary of the results
Sample No. | Test item | OD mean* | StdDev | % Viability |
1 -3 | negative control, 0.9% NaCl | 2.49 | 0.05 | 100 |
4 -6 | positive control, 5% SDS | 0.04 | 0.03 | 1.53 |
10 -12 | EGGE 2806 -1 | 2.01 | 0.36 | 80.65 |
*6 values
Table 1: Tabular Summary of the results
Sample No. | Test item | Expousre time [min] | OD mean* | StdDev | % Viability |
1 -3 | negative control, 0.9% NaCl | 60 | 2.51 | 0.02 | 100 |
7 -9 | EGGE 2806 -1 | 60 | 1.96 | 0.29 | 78.19 |
10 -12 | negative control, 0.9% NaCl | 3 | 2.61 | 0.14 | 100 |
16 -18 | EGGE 2806 -1 | 3 | 2.3 | 0.12 | 88.11 |
*6 values
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:
- weight of evidence
- Study period:
- April 2016
- 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:
- 2013
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Solubility and stability of the test substance in the solvent/vehicle: Analytical determination of stability and homogeneity of the test item in the vehicle was not performed specifically for this study.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: The usage of physiological saline solution for formulation of the test item is plausible based on the current knowledge of the sponsor. No objections were seen particularly in regard to stability.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final dilution of a dissolved solid, stock liquid or gel: The test item was solved shortly prior to application in physiologic saline solution to achieve a concentration of 20 % (w/v).
FORM AS APPLIED IN THE TEST (if different from that of starting material): The preparation was visually described as solution (slight turbidity). - Species:
- cattle
- Strain:
- other: not applicable
- Details on test animals or tissues and environmental conditions:
- Bovine eyes of slaughtered cattle were extracted and transferred in containers with Hank’s balanced salt solution (HBSS) with penicillin/streptomycin solution. For transportation the containers were ice cooled.
Eyes with defects were sorted out and disposed of, eyes without any defects were transferred into fresh HBSS supplemented with penicillin/streptomycin solution and 1 % FBS and stored overnight at 2-8 °C. On the next day (day of testing) the containers with the eyes were placed in an incubator at 32 ° C (± 1 ° C) for about 2 hours before preparation of the corneas. - Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µl per cornea and chamber
-Concentration: 20% (w/v)
VEHICLE
- Amount(s) applied (volume or weight with unit): 750 μL per cornea and chamber
- Concentration (if solution): 0.9% NaCl (w/v) - Duration of treatment / exposure:
- 4 hours
- Duration of post- treatment incubation (in vitro):
- no further incubation required
- Number of animals or in vitro replicates:
- three
- Details on study design:
- Details on study design:
Immediately before application, the medium was aspirated from the anterior chamber. 750 μL of the test material formulations were applied to the corneas, each through the holes of the anterior chamber. The holes of both chambers were sealed with adhesive tape and the holders were kept with the front side up, so that the formulations covered the cornea sufficiently (closed chamber method). The holders were transferred into the incubator at 32 °C (± 1 °C) for the exposure time of 4 hours. After the exposure, the formulations were aspirated from the anterior chamber and the corneas were rinsed at least 3 times with phenol red containing MEM to show effectiveness of test substance removal. During the final rinse cycle the corneas were rinsed again with pure MEM medium in order to remove residues of the dye. The anterior chamber was then filled again with MEM medium to avoid drying out of the cornea. Before measuring opacity, fresh MEM medium was filled in the chambers and the holes were sealed with tape.
Positive control: 20 % Imidazole in physiologic saline (w/v; 750 μL)
TREATMENT METHOD: closed chamber
POST-INCUBATION PERIOD: no
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: The opacity of a cornea was measured by the diminution of light passing through the cornea. The measurements of opacity were carried out using an opacitometer BASF OP3.0 (with integrated light meter testo 545 and Comfort 3.4 SP6 software from Testo AG, Lenzkirch). Before each measurement the opacitometer was adjusted to about 1000 LUX and a filter calibration measurement was carried out by using 3 different filters.
- Corneal permeability:The medium in anterior chamber of each holder was replaced by 1ml of fluorescein sodium solution (concentration 5 mg/mL). Afterwards the holders were incubated at 32 °C (± 1 °C) for about 90 minutes. After the incubation period, the medium of the posterior chamber was aspirated by a syringe and filled into a 10 mL tube. Three wells of a 96 well plate were filled with 300 μL of each tube (triplicate determination). In addition, a standard series of 5 mg/mL sodium fluoresceinsolution was prepared and also filled into the 96-well plate, in triplicates. The permeability was determined by measuring the amount of fluorescein sodium which diffused through all cell layers of the cornea. The measurement was carried out at a wavelength of 490 nm (OD490) by an ELISA - Reader (Bio-Tek EL 808, Software Gen5).
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:decision criteria as indicated in the OECD TG 437 - Irritation parameter:
- in vitro irritation score
- Remarks:
- (IVIS)
- Run / experiment:
- mean
- Value:
- -4.1
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Interpretation of results:
- other: negative
- Executive summary:
The test item (20 % (w/v) in physiologic saline) was tested in the BCOP test according to OECD TG 437. For determination of corneal damage opacity as well as tissue permeability was measured after a 4 hour exposure time. Based on these data, in comparison to the vehicle control, the In Vitro Irritancy Score (IVIS) value was calculated to be -4.1 which is below the IVIS cut-off threshold of 55 and thus identifying the test item as not inducing serious eye damage. The results of the positive (20 % imidazole solution) and vehicle (physiologic saline solution) controls confirmed the validity of the test system.
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- December 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Principles of method if other than guideline:
- PRINCIPLE of TEST:
Assessment of ocular irritation potential of the test substance by determination of cytotoxic effects on a human corneal epithelium (HCE) cell model (similar to EpiOcular).
The HCE model is currently involved in the eye irritation validation conducted by COLIPA following ECVAM guidelines. Furthermore, it is routinely used by the major Cosmetic and Pharmaceutical companies, and has already been prevalidated in 2004 (van Goethem et. al., Tox in Vitro 20, 2006, 1-17). This model is recognized as the model of choice and scientifically relevant as documented by several publications (e.g. Alepee et. al., Toxicology in Vitro 34 (2016) 55–70). - GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: test item was melted in a hot cabinet with 100 °C
FORM AS APPLIED IN THE TEST (if different from that of starting material): melted and cooled down liquid - Species:
- other: human corneal epithelial cells
- Strain:
- other: not applicable
- Details on test animals or tissues and environmental conditions:
- The experiment was carried out on a Human Corneal Epithelial (HCE) Model, which is standardized and commercially available (SkinEthicTM Human Corneal Epithelial Model (HCE), SkinEthic, France). Inserts were of 0.5 cm² size. When cultivated at the air-liquid interface in a chemically defined medium, the immortalized human cornea epithelial cells reconstruct a corneal epithelial tissue (mucosa), without a stratum corneum, ultra-structurally (tissue morphology and thickness) similar to the corneal mucosa of the human eye.
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 30 µl per insert
- Duration of treatment / exposure:
- 60 min at room temperature
- Duration of post- treatment incubation (in vitro):
- 16 hours in the incubator (37°C, 5% CO2, maximum humidity)
- Number of animals or in vitro replicates:
- three
- Details on study design:
- The irritation potential of the test item is assessed by determination of its cytotoxic effect on an reconstructed human ocular epithelium. The test principle is based on the MTT assay reflecting the cell viability after exposure of the cornea equivalent to topically applied test item.
The test item is applied pure. Since the test item is a solution (ca. 40% in ethyl acetate) the solvent is tested in parallel to distinguish potential toxic effects of the test item from the effects of the solvent.
After the post-exposure incubation of 16 hours in the incubator (37 +/- 2 °C, 5 % CO2, maximum humidity) MTT reduction is performed. Cell viability is measured by the amount of MTT reduction, i.e. an OD value following exposure to the negative or positive control substances or the test item.
A test substance is predicted to be an ocular irritant if the mean relative tissue viability (%) exposed to the test substance is ≤ 50 %. - Irritation parameter:
- other: cell viability (%)
- Value:
- ca. 99
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Interpretation of results:
- other: negative
- Executive summary:
The reconstructed human corneal epithelial tissue-based in vitro test method (SkinEthic™ HCE) was conducted with the test item. The undiluted test item was applied topically to the reconstructed HCE tissue. After an exposure period of 60 minutes followed by a 16 hours post-treatment incubation period the cell viability was measured to be about 99% by the MTT conversion assay. Thus the test item is predicted as non-irritant under the conditions of this test method.
Referenceopen allclose all
Table 1: Individual values of opacity, permeability and IVIS
|
Table 1: Tabular Summary of the results
Sample No. | Test item | OD mean* | StdDev | % Viability |
1 -3 | negative control, PBS | 0.68 | 0.03 | 100.00 |
4 -6 | positive control, 0.3% SDS | 0.12 | 0.04 | 17.31 |
13 -15 | EGGE 2806 -1 | 0.67 | 0.07 | 99.04 |
*6 values
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
A study was performed for the assessment of the skin corrosion of the test item with reconstructed human epidermis (RhE) according to OECD TG 431 (Wingenroth, 2016a). The experiment was carried out using the commercially available test method epiCS®. The mean value of cell viability was recorded to be 88 % (3 min. exposure) and 78% (60 min. exposure). The test item was thus shown to be not corrosive to reconstructed human skin in vitro.
A study was performed for the assessment of the skin irritancy of the test item with reconstructed human epidermis (RhE) according to OECD TG 439 (Wingenroth, 2016b). The experiment was carried out using the commercially available test method epiCS®. The mean value of cell viability was recorded to be 81 %. The test item was thus shown to be not irritating to reconstructed human skin in vitro.
The test item (20 % (w/v) in physiologic saline) was tested in the BCOP test according to OECD TG 437 (Gmelin, 2016). For determination of corneal damage opacity as well as tissue permeability was measured after a 4 hour exposure time. Based on these data, in comparison to the vehicle control, the In Vitro Irritancy Score (IVIS) value was calculated to be -4.1 which is below the IVIS cut-off threshold of 55 and thus identifying the test item as not inducing serious eye damage.
The reconstructed human corneal epithelial tissue-based in vitro test method (SkinEthic™ HCE) was conducted with the test item (Wingenroth, 2016c). The undiluted test item was applied topically to the reconstructed HCE tissue. After an exposure period of 60 minutes followed by a 16 hours post-treatment incubation period the cell viability was measured to be about 99% by the MTT conversion assay. Thus the test item is predicted as non-irritant under the conditions of this test method.
Justification for classification or non-classification
Skin and eye irritation
Based on the study results of in vitro skin and eye irritation/corrosion tests a classification according to Regulation (EC) No. 1272/2008 (CLP) is not required.
Respiratory irritation
Based on the study results of an acute and a subacute (4-week) inhalation study in rats a classification according to Regulation (EC) No. 1272/2008 (CLP) is not required.
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