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EC number: 946-533-0 | CAS number: -
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- July 26th 2013
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- ß-Alanine, N-(2-aminoethyl)-N-(2-hydroxyethyl)-, N-(C12-C18 and C18unsatd. acyl) derivs., monosodium salts
- Cas Number:
- 93820-52-1
- Molecular formula:
- C12 fatty acid based: C19H37N2NaO4 - C18 fatty acids based: C23H45N2NaO4
- IUPAC Name:
- ß-Alanine, N-(2-aminoethyl)-N-(2-hydroxyethyl)-, N-(C12-C18 and C18unsatd. acyl) derivs., monosodium salts
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- dihydrogen oxide
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Aqueous solution of beta-Alanine, N-(2-aminoethyl)-N-(2-hydroxyethyl)-, N-cocoacyl derivs., monosodium salts
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- chicken
- Details on test animals or tissues and environmental conditions:
- TEST SYSTEM
- Chicken heads (Spring chickens (Gallus Gallus e.g. Ross 308 Broiler)), supplied by Baileys Turkeys Ltd., Cheshire, UK
- weight: 1.5 to 2.5 kg
- age: 7 weeks prior to being humanely killed for human consumption
PREPARATION OF THE EYES
Eyelids were carefully excised while taking care not to damage the cornea. The integrity of the cornea was measured usinf sodium fluorescein. An
acceptable eye for the ICE test was one where the fluorescein retention and corneal opacity scores were ≤0.5.
Acceptable eyes were dissected from the skull, enucleated eyes were transferred to an appropriate clamp keeping the cornea vertical. The temperature of the chambers was at 32 ±1.5 °C.
Eyes were examined again with a slit-lamp microscope. Corneal thickness was measured with an optical pachymeter on the slit lamp microscope at the center of each cornea. Eyes were replaced when:
i. the fluorescein score is >0.5
ii. the corneal opacity score is >0.5
iii. there is any additional signs of damage
iv. the corneal thickness measurements for individual eyes deviate more than 10% from the mean value for all eyes
Eyes were then incubated for 45 minutes for equilibrium purposes.
Time zero measurements for corneal thickness and opacity were taken to serve as a baseline. The baseline for the fluorescein measurements were taken at dissection.
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.03 mL
- Concentration (if solution): 40% (as supplied by the sponsor) - Duration of treatment / exposure:
- 10 seconds, then rinsed from the eye using 20 mL of isotonic saline
- Observation period (in vivo):
- 30, 75, 120, 180 and 240 minutes (±5 minutes) after the eyes had been rinsed
- Number of animals or in vitro replicates:
- negative control (0.9% sodium chloride): 2
positive control (BAC 5% (w/v)): 3
test group: 3 - Details on study design:
- REMOVAL OF TEST SUBSTANCE - Washing (if done): 20 mL saline
- Time after start of exposure: 10 s
SCORING SYSTEM: according to ICE classification criteria OECD TG 438
TOOL USED TO ASSESS SCORE: slit lamp microscope / fluorescein
ENDPOINTS EXAMINED: corneal opacity, swelling, fluorescein retention and morphological effects (e.g. pitting, sloughing or roughening of the epithelium)
All of the endpoints, with the exception of fluorescein retention (which is only determined at 30 minutes after test substance exposure) were determined at each of the above time points.
After the final examinations at the 240 minute time point, the eyes were preserved in neutral buffered formalin, sectioned, stained ans histopathologically evaluated.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: corneal swelling [%]
- Value:
- 20.09
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Value:
- 2.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- fluorescein retention score
- Value:
- 0.7
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- histopathological observations
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Remarks:
- Serious eye damage based on corneal epithelial changes (erosion, necrosis and vacuolation of the corneal epithelium).
In vivo
- Irritant / corrosive response data:
- Corneal Opacity
Easily discernible translucent areas or severe opacity was noted in the test item treated eyes. Very faint opacity was noted in the negative control treated eyes during the study period. Complete corneal opacity was noted in all the positive control eyes. No morphological effects were noted in the test item or negative control eyes. Sloughing (loosening of the epithelium) was noted in all the positive control eyes.
Fluorescein Retention
Very minor single cell staining or single cell staining scattered throughout the treated area of the corneas was noted on the test eyes. Very minor single cell staining was noted in one of the negative control eyes. Confluent large areas of the cornea retaining fluorescein was noted in all the positive control eyes.
Histopathology
Application of test item resulted in changes indicating serious eye damage, based on corneal epithelial changes. Changes comprised erosion, necrosis and vacuolation of the corneal epithelium. The classification was based on vacuolation being graded as ½ in the lower third of the epithelium in two out of three eyes
Any other information on results incl. tables
Test Item
Maximal mean score for corneal opacity : 2.3, ICE Class III
Mean score of Fluorescein Retention : 0.7, ICE Class II
Maximal Corneal swelling : 20.09%, ICE Class III
Positive Control Item
Maximal mean score for corneal opacity : 4.0, ICE Class IV
Mean score of Fluorescein Retention : 3.0, ICE Class IV
Maximal Corneal swelling : 52.36%, ICE Class IV
Negative Control Item
Maximal mean score for corneal opacity : 0.5, ICE Class I
Mean score of Fluorescein Retention : 0.3, ICE Class I
Maximal Corneal swelling : 3.73%, ICE Class I
Individual Scores and Mean Scores for Corneal Effects – Test Item
Endpoint |
Eye number |
Time (after washing) [min] |
|||||
0 |
30 |
75 |
120 |
180 |
240 |
||
Corneal Opacity |
3A |
0.5 |
0.5 |
2 |
3 |
3 |
3 |
4A |
0.5 |
0.5 |
1 |
2 |
2 |
2 |
|
7A |
0 |
0.5 |
2 |
2 |
2 |
2 |
|
Mean |
0.3 |
0.5 |
1.7 |
2.3 |
2.3 |
2.3 |
|
ICE class |
III |
||||||
Fluorescein Retention |
3A |
--- |
0.5 |
--- |
--- |
--- |
--- |
4A |
--- |
1 |
--- |
--- |
--- |
--- |
|
7A |
--- |
0.5 |
--- |
--- |
--- |
--- |
|
Mean |
--- |
0.7 |
--- |
--- |
--- |
--- |
|
ICE class |
II |
||||||
Corneal Thickness |
3A |
0.74 |
0.78 |
0.82 |
0.82 |
0.84 |
0.83 |
4A |
0.72 |
0.70 |
0.78 |
0.76 |
0.79 |
0.77 |
|
7A |
0.68 |
0.71 |
0.84 |
0.92 |
0.94 |
0.94 |
|
Mean |
0.71 |
0.73 |
0.81 |
0.83 |
0.86 |
0.85 |
|
Mean Corneal Swelling (%) |
--- |
2.34 |
14.02 |
16.82 |
20.09 |
18.69 |
|
ICE class |
III |
||||||
ICE classes combined: 2 x III, 1 x II |
Individual Scores and Mean Scores for Corneal Effects – Positive Control Item
Endpoint |
Eye number |
Time (after washing) [min] |
|||||
0 |
30 |
75 |
120 |
180 |
240 |
||
Corneal Opacity |
2A |
0.5 |
3 |
4 |
4 |
4 |
4 |
6A |
0 |
4 |
4 |
4 |
4 |
4 |
|
8A |
0.5 |
4 |
4 |
4 |
4 |
4 |
|
Mean |
0.3 |
3.7 |
4 |
4 |
4 |
4 |
|
ICE class |
IV |
||||||
Fluorescein Retention |
2A |
--- |
3 |
--- |
--- |
--- |
--- |
6A |
--- |
3 |
--- |
--- |
--- |
--- |
|
8A |
--- |
3 |
--- |
--- |
--- |
--- |
|
Mean |
--- |
3 |
--- |
--- |
--- |
--- |
|
ICE class |
IV |
||||||
Corneal Thickness |
2A |
0.72 |
0.78 |
0.96 |
0.88 |
0.98 |
0.98 |
6A |
0.68 |
0.90 |
0.88 |
0.88 |
0.98 |
1.10 |
|
8A |
0.72 |
0.92 |
0.95 |
1.00 |
1.09 |
1.15 |
|
Mean |
0.71 |
0.87 |
0.93 |
0.92 |
1.02 |
1.08 |
|
Mean Corneal Swelling (%) |
--- |
22.64 |
31.60 |
30.19 |
43.87 |
52.36 |
|
ICE class |
IV |
||||||
ICE classes combined: 3 x IV (sloughing in all eyes) |
Individual Scores and Mean Scores for Corneal Effects – Negative Control Item
Endpoint |
Eye number |
Time (after washing) [min] |
|||||
0 |
30 |
75 |
120 |
180 |
240 |
||
Corneal Opacity |
1A |
0.5 |
0.5 |
0.5 |
0.5 |
0.5 |
0.5 |
5A |
0 |
0.5 |
0.5 |
0.5 |
0.5 |
0.5 |
|
Mean |
0.3 |
0.5 |
0.5 |
0.5 |
0.5 |
0.5 |
|
ICE class |
I |
||||||
Fluorescein Retention |
1A |
--- |
0 |
--- |
--- |
--- |
--- |
5A |
--- |
0.5 |
--- |
--- |
--- |
--- |
|
Mean |
--- |
0.3 |
--- |
--- |
--- |
--- |
|
ICE class |
I |
||||||
Corneal Thickness |
1A |
0.67 |
0.66 |
0.68 |
0.70 |
0.69 |
0.70 |
5A |
0.67 |
0.66 |
0.65 |
0.69 |
0.68 |
0.66 |
|
Mean |
0.67 |
0.66 |
0.67 |
0.70 |
0.69 |
0.68 |
|
Mean Corneal Swelling (%) |
--- |
-1.49 |
-0.75 |
3.73 |
2.24 |
1.49 |
|
ICE class |
I |
||||||
ICE classes combined: 3 x I |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Based on the results from this Isolated Chicken Eye test, Amphopropionates C12-18 is considered to cause irreversible effects to the eyes under the experimental conditions described in this report.
- Executive summary:
The eye irritation potential of Amphopropionates C12-18 (40% a.i.) was examined in an in vitro eye irritation study according to OECD Guideline 438 (adopted on July 26th 2013).
Approximately 7 weeks old chickens (obtained from slaughter animals for human consumption) were used as eye-donors. 0.03 mL of the test item was applied onto the cornea of each of three enucleated eyes. A further three enucleated eyes were treated with positive control item (5% (w/v) Benzalkonium Chloride (BAC)). A further two enucleated eyes were treated with saline to serve as the negative control (0.9% NaCl in water).
The isolated chicken eyes were exposed to a single application of the test sample for 10 seconds followed by a 20 mL saline rinse. Three main parameters were measured 30, 75, 120, 180 and 240 minutes after rinsing to disclose possible adverse eye effects: corneal thickness (expressed as corneal swelling), corneal opacity and fluorescein retention of damaged epithelial cells.
Corneal Opacity: Easily discernible translucent areas or severe opacity was noted in the test item treated eyes.
Fluorescein Retention: Very minor single cell staining or single cell staining scattered throughout the treated area of the corneas was noted on the test eyes.
Histopathology: Application of test item resulted in changes indicating serious eye damage, based on corneal epithelial changes. Changes comprised erosion, necrosis and vacuolation of the corneal epithelium. The classification was based on vacuolation being graded as ½ in the lower third of the epithelium in two out of three eyes.
Based on the overall in vitro irritancy criteria, no prediction for eye irritation could be made.
However, semi-quantitative microscopic evaluation of the corneas from eyes exposed to Amphopropionates C12-18 (40% a.i.) gave scores which exceeded the threshold for classification of this material as Category 1 (irreversible effects on the eyes).
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