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EC number: 616-017-7 | CAS number: 7377-08-4
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- Terrestrial toxicity
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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
- Study period:
- 04-July 2018 - 04-July 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- 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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-[(4-aminobenzoyl)amino]propanoic acid
- EC Number:
- 616-017-7
- Cas Number:
- 7377-08-4
- Molecular formula:
- C10 H12 N2 O3
- IUPAC Name:
- 3-[(4-aminobenzoyl)amino]propanoic acid
Constituent 1
- Specific details on test material used for the study:
- Batch no: 12/18
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- - Tissue source: The assay used isolated corneas obtained as a by-product from animals freshly slaughtered at the abattoir A. Moksel AG, Buchloe, Germany.
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
750 mg - Duration of treatment / exposure:
- 4 hours ± 5 minutes incubation at 32 ± 1 °C
- Duration of post- treatment incubation (in vitro):
- 90 minutes at 32 ± 1°C
- Number of animals or in vitro replicates:
- 3 corneas for the test item
3 corneas as negative controls
3 corneas as positive controls - Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
The assay uses isolated corneas obtained äs a by-product from animals freshly slaughtered at the abattoir A. Moksel AG, Buchloe, Germany
QUALITY CHECK OF THE ISOLATED CORNEAS
The eyes were carefully examined for defects and any defective eyes were discarded.
NUMBER OF REPLICATES
3
NEGATIVE CONTROL USED
3 corneas as negative controls treated with physiological saline 0.9% NaCI
POSITIVE CONTROL USED
3 corneas as positive controls treated with imidazole 20% in physioloaical saline 0.9% NaCI
APPLICATION DOSE AND EXPOSURE TIME
750 mg of the test item (open-chamber method) or 750 µL of the control substance
TREATMENT METHOD: Closed chamber
POST EXPOSURE PERIOD: 4 hours ± 5 minutes incubation at 32 ± 1 °C
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: Washed at least 3 times with MEM (containing phenol red).
POST-INCUBATION PERIOD: 90 minutes at 32 ± 1 °C.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity:
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry optical density at 490 nm
SCORING SYSTEM: In Vitro Irritancy Score (IVIS) using the following formula: IVIS = mean opacity value + (15 x mean permeability OD490 value)
DECISION CRITERIA: The IVIS cut-off values for identifying test substances as inducing serious eye damage UN GHS Category 1) and test substances not requiring classification for eye Irritation or serious eye damage (UN GHS No Category) was used (see table 1 in materials and methods)
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 4.17
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Opacity results
Cornea No. |
Test item |
Initial opacity |
Final opacity |
Change of opacity value |
Corrected opacity value |
1 |
Negative control |
0.69 |
1.02 |
0.34 |
|
2 |
1.06 |
0.95 |
-0.10 |
|
|
3 |
1.50 |
1.33 |
-0.17 |
|
|
MV |
1.08 |
1.10 |
0.02 |
|
|
4 |
Positive control |
2.03 |
71.26 |
69.23 |
69.21 |
5 |
1.96 |
82.72 |
80.76 |
80.74 |
|
6 |
2.42 |
65.05 |
62.62 |
62.60 |
|
MV |
2.13 |
73.01 |
70.87 |
70.85 |
|
7 |
Test item |
-2.07 |
0.92 |
2.99 |
2.97 |
8 |
-1.48 |
2.57 |
4.05 |
4.03 |
|
9 |
1.57 |
7.13 |
5.46 |
5.44 |
|
MV |
-0.63 |
3.54 |
4.17 |
4.15 |
MV = mean value
Table 2: Permeability results:
Cornea No. |
Test item |
OD490 |
Corrected OD490 value |
1 |
Negative control |
0.004 |
|
2 |
0.001 |
|
|
3 |
0.010 |
|
|
MV |
0.005 |
|
|
4 |
Positive control |
1.132 |
1.127 |
5 |
0.912 |
0.907 |
|
6 |
1.374 |
1.369 |
|
MV |
1.139 |
1.134 |
|
7 |
Test item |
0.013 |
0.008 |
8 |
0.004 |
-0.001 |
|
9 |
0.002 |
-0.003 |
|
MV |
0.006 |
0.001 |
MV = mean value
Table 3: In vitro irritation score
Cornea No. |
Test item |
Corrected opacity value |
Corrected OD490 value |
IVIS |
1 |
Negative control |
0.34 |
0.004 |
|
2 |
-0.10 |
0.001 |
|
|
3 |
-0.17 |
0.010 |
|
|
MV |
0.02 |
0.005 |
0.10 |
|
4 |
Positive control |
69.21 |
1.127 |
|
5 |
80.74 |
0.907 |
|
|
6 |
62.60 |
1.369 |
|
|
MV |
70.85 |
1.134 |
87.87 |
|
7 |
Test item |
2.97 |
0.008 |
|
8 |
4.03 |
-0.001 |
|
|
9 |
5.44 |
-0.003 |
|
|
MV |
4.15 |
0.001 |
4.17 |
MV = mean value
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- No prediction can be made regarding the classification of the test substance 4-Aminobenzoyl-b-alanine according to the evaluation criteria. However, it can be concluded that 4-aminobenzoyl-b-alanine is not corrosive to eyes.
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