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Registration Dossier
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EC number: 615-231-8 | CAS number: 70983-58-3
Endpoint summary
Administrative data
Description of key information
Skin corrosion: In the presented Klimisch 2 OECD 431 GLP study the test item was applied topically to the EpiDerm tissue for 3 min and 60 min followed by immediate determination of cytotoxic effects via MTT reduction assay. Corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after both treatment periods had been compared to the corresponding negative control tissues.In this study under the given conditions the test item showed no corrosive effects. The test item is classified as “non-corrosive“.
Skin irritation: In the present Klimisch 1 OECD 439 GLP study the test item was applied topically to the EpiDerm tissue for 60 min followed by a 42 h post-incubation period and immediate determination of cytotoxic effects via MTT reduction assay. In this study under the given conditions the test item showed irritant effects. The test item is therefore classified as “irritant” in accordance with UN GHS “Category 2”.
Eye irritation: The eye irritancy potential of the test item was investigated in the bovine corneal opacity and permeability assay. The following mean in vitro irritation score was calculated to 152.17.
Therefore the test item was classified into UN GHS Category 1.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- 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)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Council Regulation 440/2008, Method B.40 BIS: “In Vitro Skin Corrosion: Human Skin Model Test
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Name: Poly(oxy-1,2-ethanediyl), .alpha.,.alpha.'-(iminodi-2,1-ethanediyl)bis[.omega.-hydroxy-, N-[3-(C10-16-alkyloxy)propyl] derivs., di-Et sulfate-quaternized
Product Description: C10-16-alkyletherpropylamine, ethoxylated, DES Quat
CAS No.: 70983-58-3
Physical state: yellowish to amber viscous liquid at 20 °C
Batch No.: PFS-755-173
Re-certification date of batch: 19 April 2018
Purity: 100 % (UVCB)
Color, Gardner 8.8
pH, 5% in water 5.76
Acid Value , mg KOH/g 20.1
Moisture, % 0.127
Total Amine, mg/g 11.18
Viscosity,cps, #4@60,25C 3280
Appearance @25C pass
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: not specified
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The test was carried out with the reconstituted three-dimensional human skin model EpiDerm (MatTek). This skin model consists of normal (non-cancerous), human-derived epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis. The NHEK are cultured on chemically modified, collagen-coated cell culture inserts. The EpiDerm skin model exhibits in vivo-like morphological and growth characteristics which are uniform and highly reproducible. It consists of organised basal, spinous, granular and cornified layers analogous to those found in vivo.
The test meets acceptance criteria if:
- mean OD570 nm of the two negative control tissues of the 3 min and 60 min treatment period is between 0.8 and 2.8,
- mean relative tissue viability of the two positive control tissues of the 60 min treatment period is < 15%,
- coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is <= 30%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- The test item was applied undiluted. Firstly, 100 µL aqua dest. was applied topically on the tissue surface. Then, 50 µL of the test item was dispensed directly atop the EpiDerm tissue.
Dose Groups
Negative control: 50 µL distilled water
Positive control: 50 µL 8 N KOH
Test Item: 50 µL (undiluted) - Duration of treatment / exposure:
- The test was performed on a total of 4 tissues per dose group, 2 replicates for each treatment period (3 min and 60 min exposure time).
- Duration of post-treatment incubation (if applicable):
- 3 min and 60 min experiment: after the 3 h MTT incubation period the MTT solution was aspirated. The wells were refilled with PBS and the PBS was aspirated. The rinsing was repeated twice and the tissues were dried. Then the inserts were transferred into 12-well “extraction plates“. 2 mL of isopropanol were pipetted into each insert, thus the insert was covered from both sides. The extraction plates were sealed in zip-bags to inhibit isopropanol evaporation. Extraction was carried out either over night without shaking at room temperature or, alternatively, at least 2 h with shaking at room temperature.
After the extraction period the inserts were pierced with an injection needle to allow the extracts to run through the tissues into the corresponding wells. Then the inserts were discarded and the extraction plates were placed on a shaker for 15 min.
Per each tissue 3 x 200 µL aliquots of the extract were transferred into a 96-well plate and OD was measured at 570 nm without reference wavelength in a plate spectrophotometer using isopropanol as a blank. - Number of replicates:
- The test was performed on a total of 4 tissues per dose group.
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 min experiment - mean of 2 tissues
- Value:
- 61.6
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 min experiment - mean of 2 tissues
- Value:
- 47.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- 3 min experiment: After 3 min of application, the first insert was removed from the 6-well plate with forceps. Using a wash bottle, the tissue was gently rinsed about 20 times with PBS (phosphate buffered saline) to remove any residual test item. Since the test item could not be removed completely from the tissue surface by rinsing, a Q-tip was used to remove the sticky test item and additional rinsing steps with PBS were performed. However, it was not possible to remove the test item completely. Excess PBS was removed by gently shaking the insert and blotting bottom with blotting paper.
60 min experiment: after 60 min application, the first insert was removed from the 6-well plate with forceps. Using a wash bottle, the tissue was gently rinsed about 20 times with PBS to remove any residual test item. Since the test item could not be removed completely from the tissue surface by rinsing, a Q-tip was used to remove the sticky test item and additional rinsing steps with PBS were performed. However, it was not possible to remove the test item completely. Excess PBS was removed by gently shaking the insert and blotting bottom with blotting paper.
Test Acceptance Criteria:
The test item could not be removed completely from the tissue surface after 3 min and 60 min treatment. Therefore, in consultation with the sponsor, 100 µL aqua dest was applied to the tissue surface before application of the test item and additional rinsing steps and manual removal by using a Q-tip were included. However, residuals of the test item were still visible. After 60 min treatment, viability of the two tissues treated identically with the test item showed high variability, exceeding the 30% threshold (32.7%). This is accepted regarding the stickiness of the test item. Under these exaggerated treatment conditions, the test item showed no corrosive effects. The mean relative tissue viability (% negative control) was >= 50% (61.6%) after 3 min treatment and >= 15% (47.9%) after 60 min treatment. The worst case value of the two tissues of the 60 min part of the experiment was 36.8% tissue viability, which indicates no corrosive effect.
The controls confirmed the validity of the study. The mean OD570 of the two negative control tissues was >= 0.8 and ≤ 2.8 for each exposure period. The mean relative tissue viability (% negative control) of the positive control was < 15% (8.7%) after 60 min treatment. The coefficient of variation (CV) (in the range of 20 – 100% viability) of replicate tissues of the control groups was >= 30% (0.2% - 4.0%).
All other test acceptance criteria were fulfilled except CV [%] in the range of 20 – 100% viability exceeded for test material (60 min experiment only). - Interpretation of results:
- GHS criteria not met
- Conclusions:
- In this study under the given conditions the test item showed no corrosive effects. The test item is classified as “non-corrosive“.
- Executive summary:
In the present Klimisch 1 OECD 431 GLP study the test item was applied topically to the EpiDerm tissue for 3 min and 60 min followed by immediate determination of cytotoxic effects via MTT reduction assay. Corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after both treatment periods had been compared to the corresponding negative control tissues. In this study under the given conditions the test item showed no corrosive effects. The test item is classified as “non-corrosive“.
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 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:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Name: Poly(oxy-1,2-ethanediyl), .alpha.,.alpha.'-(iminodi-2,1-ethanediyl)bis[.omega.-hydroxy-, N-[3-(C10-16-alkyloxy)propyl] derivs., di-Et sulfate-quaternized
Product Description: C10-16-alkyletherpropylamine, ethoxylated, DES Quat
CAS No.: 70983-58-3
Physical state: yellowish to amber viscous liquid at 20 °C
Batch No.: PFS-755-173
Re-certification date of batch: 19 April 2018
Purity: 100 % (UVCB)
Color, Gardner 8.8
pH, 5% in water 5.76
Acid Value , mg KOH/g 20.1
Moisture, % 0.127
Total Amine, mg/g 11.18
Viscosity,cps, #4@60,25C 3280
Appearance @25C pass
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light - Test system:
- human skin model
- Source species:
- human
- Cell type:
- non-transformed keratinocytes
- Cell source:
- other: not specified
- Source strain:
- Abyssinian
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- The test was carried out with the reconstituted three-dimensional human skin model EpiDerm (MatTek). This skin model consists of normal human epidermal keratinocytes (NHEK) which have been cultured to form a multilayered, highly differentiated model of the human epidermis. The NHEK are cultured on chemically modified, collagen-coated cell culture inserts (Millicell). The EpiDerm epidermis model exhibits in vivo-like morphological and growth characteristics which are uniform and highly reproducible. It consists of organised basal, spinous and granular layers and a multi-layered stratum corneum analogous to patterns found in vivo.
The test meets acceptance criteria if:
- mean absolute OD570 nm of the three negative control tissues is ≥ 0.8 and ≤ 2.8
- mean relative tissue viability of the three positive control tissues is <= 20%
- standard deviation (SD) of relative tissue viability obtained from each three concurrently tested tissues is ≤ 18%. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- Prior to treatment, all EpiDerm tissues were gently blotted to remove moisture. The test item was applied undiluted. 30 µL (47 µL/cm2) of the test item was dispensed directly atop the EpiDerm tissue. The test item was gently spread to match size of the tissue using a bulb-headed Pasteur pipette.
- Duration of treatment / exposure:
- Dose Groups
Negative control: 50 µL distilled water
Positive control: 50 µL 8 N KOH
Test Item: 50 µL (undiluted) - Duration of post-treatment incubation (if applicable):
- The plates were post-incubated at 37 +- 1 C, 5.0% CO2, humidified to 95%, for 24 +- 2 h. Following this incubation the tissues were transferred to new wells containing 0.9 mL fresh assay medium and incubated for additional 18 ± 2 h.
After this post-incubation period the bottom of the inserts were blotted on sterile blotting paper and the inserts were transferred in a prepared 24-well plate containing 300 µL pre-warmed MTT medium. This plate was incubated for 3 h +- 5 min at 37 +- 1 °C, 5.0% CO2, humidified to 95%. After the MTT incubation period, the tissues were rinsed three times with DPBS and afterwards placed on blotting paper to dry. The tissues were transferred into 12-well plates and immersed in 2 mL isopropanol, sealed to inhibit evaporation. Extraction was carried out protected from light at room temperature either overnight or, alternatively, at least 2 h with gentle shaking on a plate shaker. Before using the extracts, the plate was shaken for at least 15 min on a plate shaker and the inserts were pierced with an injection needle. The extract was pipetted up and down 3 times before 2 x 200 µL aliquots per each tissue were transferred into a 96-well plate. OD was measured at 570 nm with a filter band pass of maximum ± 30 nm without reference wavelength in a plate spectrophotometer using isopropanol as a blank. - Number of replicates:
- The test was performed on a total of 3 tissues per dose group.
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- Mean Relative Tissue Viability [%]
- Value:
- 5.3
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- In the present Klimisch 1 OECD 439 GLP study the test item was applied topically to the EpiDerm tissue for 60 min followed by a 42 h post-incubation period and immediate determination of cytotoxic effects via MTT reduction assay.
In this study under the given conditions the test item showed irritant effects. The test item is therefore classified as “irritant” in accordance with UN GHS “Category 2”. - Executive summary:
In this study under the given conditions the test item showed irritant effects. The test item is therefore classified as “irritant” in accordance with UN GHS “Category 2”.
Referenceopen allclose all
Pre-Experiments
The mixture of 50 µL test item per 1 mL MTT medium showed no reduction of MTT as compared to the solvent. The mixture did not turn blue/purple. Therefore, NSMTT equalled 0%.
The mixture of 50 µL test item per 300 µL Aqua dest. and per 90 µL isopropanol showed no colouring as compared to the solvent. Therefore NSC equalled 0%.
Results and discussion
The potential of the test item to induce skin corrosion was analysed by using the three-dimensional human skin model EpiDerm, comprising a reconstructed epidermis with a functional stratum corneum.
In the present study the test item was applied topically to the EpiDerm tissue for 3 min and 60 min followed by immediate determination of cytotoxic effects via MTT reduction assay.
Corrosivity potential of the test item was predicted from the relative mean tissue viabilities obtained after both treatment periods had been compared to the corresponding negative control tissues.
The test item shows no non-specific MTT-reducing or colouring potential, therefore no additional controls were necessary.
The test item could not be removed completely from the tissue surface after 3 min and 60 min treatment. Therefore, in consultation with the sponsor, 100 µL aqua dest was applied to the tissue surface before application of the test item and additional rinsing steps and manual removal by using a Q-tip were included. However, residuals of the test item were still visible. After 60 min treatment, viability of the two tissues treated identically with the test item showed high variability, exceeding the 30% threshold (32.7%). This is accepted regarding the stickiness of the test item. Under these exaggerated treatment conditions, the test item showed no corrosive effects. The mean relative tissue viability (% negative control) was >= 50% (61.6%) after 3 min treatment and >= 15% (47.9%) after 60 min treatment. The worst case value of the two tissues of the 60 min part of the experiment was 36.8% tissue viability, which indicates no corrosive effect.
The controls confirmed the validity of the study. The mean OD570 of the two negative control tissues was >= 0.8 and ≤ 2.8 for each exposure period. The mean relative tissue viability (% negative control) of the positive control was < 15% (8.7%) after 60 min treatment. The coefficient of variation (CV) (in the range of 20 – 100% viability) of replicate tissues of the control groups was <= 30% (0.2% - 4.0%).
Table 1: Results of 3 min Experiment
| Name | Negative control | Test item | Positive control | |||
| Tissue | 1 | 2 | 1 | 2 | 1 | 2 |
| Absolute OD570 | 1.244 1.244 1.260 |
1.301 1.311 1.345 |
0.730 0.797 0.793 |
0.829 0.852 0.856 |
0.188 0.197 0.198 |
0.261 0.261 0.274 |
| OD570 - Blank Corrected | 1.198 1.197 1.214 |
1.255 1.264 1.299 |
0.684 0.750 0.746 |
0.783 0.805 0.810 |
0.142 0.150 0.152 |
0.215 0.214 0.228 |
| Mean OD570 of 3 Aliquots (blank corrected) | 1.203 | 1.273 | 0.727 | 0.799 | 0.148 | 0.219 |
| SD OD570 of 3 Aliquots | 0.010 | 0.033 | 0.042 | 0.028 | 0.026 | 0.026 |
| Total Mean OD570 of 2 Replicate Tissues (Blank Corrected) | 1.238* | 0.763 | 0.184 | |||
| SD OD570 of 2 Replicate Tissues | 0.049 | 0.051 | 0.050 | |||
Mean Relative Tissue Viability [%] |
100.0 | 61.6 | 14.8 | |||
| Coefficient Of Variation [%]*** | 4.0 | 6.7 | 27.3 | |||
* corrected mean OD570 of the negative control corresponds to 100% absolute tissue viability.
*** coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is <= 30%.
Table: Results of 60 min Experiment
| Name | Negative control | Test item | Positive control | |||
| Tissue | 1 | 2 | 1 | 2 | 1 | 2 |
| Absolute OD570 | 1.390 1.439 1.431 |
1.420 1.429 1.423 |
0.867 0.846 0.860 |
0.546 0.546 0.568 |
0.154 0.159 0.157 |
0.172 0.179 0.175 |
| OD570 - Blank Corrected | 1.344 1.393 1.385 |
1.374 1.383 1.377 |
0.820 0.799 0.814 |
0.499 0.499 0.521 |
0.108 0.113 0.110 |
0.125 0.133 0.128 |
| Mean OD570 of 3 Aliquots (blank corrected) | 1.374 | 1.378 | 0.811 | 0.507 | 0.110 | 0.129 |
| SD OD570 of 3 Aliquots | 0.026 | 0.026 | 0.027 | 0.028 | 0.025 | 0.026 |
| Total Mean OD570 of 2 Replicate Tissues (Blank Corrected) | 1.376* | 0.669 | 0.120 | |||
| SD OD570 of 2 Replicate Tissues | 0.003 | 0.215 | 0.013 | |||
Mean Relative Tissue Viability [%] |
100.0 | 47.9 | 8.7** | |||
| Coefficient Of Variation [%]*** | 0.2 | 32.7 | 10.9 | |||
* corrected mean OD570 of the negative control corresponds to 100% absolute tissue viability.
** mean relative tissue viability of the 60 min positive control < 15%.
*** coefficient of variation (CV) (in the range of 20 – 100% viability) between two tissues treated identically is <= 30%. This criterion failed for the test item treated tissues.
Pre-Experiments
The mixture of 30 µL test item per 1 mL MTT medium showed no reduction of MTT compared to the solvent. The mixture did not turn blue/purple. Therefore, NSMTT equalled 0%.
The mixture of 30 µL of the test item per 300 µl aqua dest. and per 300 µL isopropanol showed no colouring detectable by unaided eye-assessment. Therefore, NSC equalled 0%.
Results and Discussion
The potential of the test item to induce skin irritation was analysed by using the three-dimensional human epidermis model EpiDerm (MatTek) comprising a reconstructed epidermis with a functional stratum corneum. In the present study the test item was applied topically to the EpiDerm tissue for 60 min followed by a 42 h post-incubation period and immediate determination of cytotoxic effects via MTT reduction assay. Irritant potential of the test item was predicted from the relative mean tissue viabilities obtained compared to the corresponding negative control tissues concurrently treated with DPBS.
The test item shows no non-specific MTT-reducing or colouring potential, therefore no additional controls were necessary.
The test item could not be removed completely from the tissue surface after 60 min treatment. Therefore, residual test item remained on the tissue surface for the 42 h recovery period. Under these exaggerated conditions, the test item showed irritant effects. Mean relative tissue viability (% negative control) was ≤ 50% (5.3%). It must be pointed out that the prolongation of the treatment period from 60 min to 43 h due to the stickiness of the test item might have caused a false-positive outcome of the study. Additional rinsing procedures, pre-moistening of the tissue surface and manual removal of the test item using a Q-tip did not result in complete removal of the test item, as shown in Eurofins Munich Project No. 173553. Therefore, a repetition of this study was not performed.
The controls confirmed the validity of the study. The mean absolute OD570 of the three negative control tissues was >= 0.8 and ≤ 2.8. The mean relative tissue viability (% negative control) of the positive control was <= 20% (3.8%). Standard deviation of viability of replicate tissues of all dose groups was ≤ 18% (0.7% - 8.0%).
Table 1: Result of the test item
| Name | NK | PC | TM | ||||||
| Tissue | 1 | 2 | 3 | 1 | 2 | 3 | 1 | 2 | 3 |
Absolute OD570 |
1.923 1.901 |
2.198 2.146 |
2.195 2.236 |
0.100 0.099 |
0.125 0.128 |
0.125 0.128 |
0.147 0.147 |
0.135 0.142 |
0.168 0.165 |
OD570 (Blank-Corrected) |
1.882 1.860 |
2.156 2.105 |
2.154 2.195 |
0.059 0.058 |
0.084 0.087 |
0.091 0.090 |
0.106 0.106 |
0.094 0.101 |
0.127 0.123 |
Mean OD570 Of The Duplicates (Blank-Corrected) |
1.871 |
2.131 |
2.174 |
0.059 |
0.085 |
0.090 |
0.106 |
0.098 |
0.125 |
Total Mean OD570 of 3 Replicate Tissues (Blank-Corrected) |
2.059* |
0.078 |
0.109 |
||||||
SD OD570 |
0.164 |
0.017 |
0.014 |
||||||
Relative Tissue Viabilities [%] |
90.9 |
103.5 |
105. |
2.8 |
4.1 |
4.4 |
5.1 |
4.7 |
6.1 |
Mean Relative Tissue Viability [%] |
100.0 |
3.8** |
5.3 |
||||||
SD Tissue Viabilities [%]*** |
8.0 |
0.8 |
0.7 |
||||||
CV [% Viabilities] |
8.0 |
21.8 |
12.9 |
||||||
* Blank-corrected mean OD570 nm of the negative control corresponds to 100% absolute tissue viability.
** Mean relative tissue viability of the three positive control tissues is <= 20%.
*** Standard deviation (SD) obtained from the three concurrently tested tissues is ≤ 18%
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (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:
- 2017
- 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)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Name: Poly(oxy-1,2-ethanediyl), .alpha.,.alpha.'-(iminodi-2,1-ethanediyl)bis[.omega.-hydroxy-, N-[3-(C10-16-alkyloxy)propyl] derivs., di-Et sulfate-quaternized
Product Description: C10-16-alkyletherpropylamine, ethoxylated, DES Quat
CAS No.: 70983-58-3
Physical state: yellowish to amber viscous liquid at 20 °C
Batch No.: PFS-755-173
Re-certification date of batch: 19 April 2018
Purity: 100 % (UVCB)
Color, Gardner 8.8
pH, 5% in water 5.76
Acid Value , mg KOH/g 20.1
Moisture, % 0.127
Total Amine, mg/g 11.18
Viscosity,cps, #4@60,25C 3280
Appearance @25C pass
Stability: stable under test conditions
Storage condition of test material: Room temperature, protected from light - Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 µL of the test substance or the control substance.
The viscosity of the test item was relatively high, it was applied directly onto the cornea by removing the window-locking ring and glass window prior to treatment. - Duration of treatment / exposure:
- 750 µL of the test substance or the control substance was introduced into the anterior chamber. As the viscosity of the test item was relatively high, it was applied directly onto the cornea by removing the window-locking ring and glass window prior to treatment. After 10 minutes incubation at 32 +- 1 °C either the test substance or the control substance was removed and the epithelium washed at least three times with MEM (containing phenol red). Once the medium was free of test substance, the cornea was finally rinsed with complete RPMI (without phenol red).
- Duration of post- treatment incubation (in vitro):
- The cornea was finally rinsed with complete RPMI (without phenol red). The anterior chamber expect of cornea no. 8 was refilled with complete RPMI and an illuminance measurement was performed after 2 hours incubation at 32 +- 1 °C. Also, each cornea was observed visually and pertinent observations were recorded.
After the illuminance measurement was performed, the medium was removed from both chambers of the holder. The posterior chamber was refilled with fresh complete RPMI. 1 mL of a 4 mg/mL sodium fluorescein solution was added to the anterior chamber and the corneas were incubated for 90 minutes at 32 +- 1 °C. Then the medium from the posterior chamber was removed and its optical density at 490 nm (OD490) was determined, using a spectrophotometer (UV/VIS). - Number of animals or in vitro replicates:
- 3 corneas for the test item
3 corneas as negative controls treated with physiological saline 0.9% NaCl
3 corneas as positive controls treated with ethanol 100% - Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean value of 3 corneas
- Value:
- 152.17
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- other: The positive control is slightly increased (deviation of 5.47 SD) in comparison to the two standard deviations of the current historical mean. The deviation of the positive control did not influence the quality or integrity of the study.
- Other effects / acceptance of results:
- The positive control is slightly increased (deviation of 5.47 SD) in comparison to the two standard deviations of the current historical mean. The deviation of the positive control did not influence the quality or integrity of the study.
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- According to the evaluation criteria the test item is classified into UN GHS Category 1.
- Executive summary:
The eye irritancy potential of the test item was investigated in the bovine corneal opacity and permeability assay. The following mean in vitro irritation score was calculated to 152.17.
Therefore the test item was classified into UN GHS Category 1.
Reference
Results
The eye irritancy potential of the test item was investigated in the bovine corneal opacity and permeability assay. The test item was tested as provided by the sponsor. All of the 3 corneas treated with the test item showed strong opacity of the tissue.The following mean in vitro irritation score was calculated: 152.17
Therefore the test item was classified into UN GHS Category 1.
The positive control is slightly increased (deviation of 5.47 SD) in comparison of the two standard deviations of the current historical mean. The deviation of the positive control did not influence the quality or integrity of the present study and therefore this assay is considered valid. The negative control response resulted in opacity and permeability values that are less than the established upper limits for background bovine corneas treated with the respective negative control.
Table 1: In Vitro Irritation Score
| Cornea No. | Test item | Corrected opacity | Corrected OD490 value | IVIS |
| 1 | Negative control | 0.49 | 0.006 | - |
| 2 | Negative control | 2.01 | 0.011 | - |
| 3 | Negative control | 1.26 | 0.034 | - |
| MV | Negative control | 0.93 | 0.017 | 1.18 |
| 4 | Positive control | 26.38 | 3.788 | - |
| 5 | Positive control | 26.62 | 2.753 | - |
| 6 | Positive control | 28.97 | 2.898 | - |
| MV | Positive control | 27.33 | 3.146 | 74.52 |
| 7 | Test item | 86.80 | 5.068 | - |
| 8 | Test item | 101.09 | 3.358 | - |
| 9 | Test item | 79.86 | 4.158 | - |
| MV | Test item | 89.25 | 4.195 | 152.17 |
MV = mean value
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
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