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EC number: 210-283-4 | CAS number: 611-92-7
- Life Cycle description
- Uses advised against
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- Aquatic toxicity
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- Short-term toxicity to fish
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- Terrestrial toxicity
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- Toxicological Summary
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- Acute Toxicity
- Irritation / corrosion
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- 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

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 03.08.-04.08.2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1,3-dimethyl-1,3-diphenylurea
- EC Number:
- 210-283-4
- EC Name:
- 1,3-dimethyl-1,3-diphenylurea
- Cas Number:
- 611-92-7
- Molecular formula:
- C15H16N2O
- IUPAC Name:
- 1,3-dimethyl-1,3-diphenylurea
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals / tissue source
- Species:
- other: Bovine eye
- Details on test animals or tissues and environmental conditions:
- Bovine eyes source: Breeding service CHOVSERVIS a.s., division TORO® Hlavečník, Hradec Králové, Czech Republic
Eyes were collected by slaughterhouse employees The eyes were enucleated as soon as possible after death. No detergent was used. Only healthy animals (12 to 30 months old) considered suitable for entry into the human food chain were used as a source of corneas for use in the BCOP test. The risk of contamination was minimized (e.g., by keeping the container containing the eyes on ice, by adding antibiotics to the HBSS used to store the eyes during transport (e.g., penicillin at 100 IU/mL and streptomycin at 100 μg/mL).
Test system
- Vehicle:
- Hank's balanced salt solution
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- The test substance was tested as suspension prepared from test substance at 20% concentration in a 0.9% sodium chloride solution. 2g of the test substance was suspended in 10 mL of 0.9% sodium chloride solution.
- Duration of treatment / exposure:
- 4hr
- Duration of post- treatment incubation (in vitro):
- 1,5 hr
- Number of animals or in vitro replicates:
- Exposed group (test substance) - 3 corneas (No. 1, 2, 4)
Positive control group (20% Imidazole) – 3 corneas (No. 12, 14, 16)
Negative control group (0.9% NaCl) – 3 corneas (No. 5, 7, 13) - Details on study design:
- PROCEDURE SCHEME
Selection of corneas, mounting in holders → incubation with EMEM 1hour (32 ± 1°C) → removed EMEM, measurement of baseline opacity → treatment by positive and negative control substances and test substance (incubation 4 hours) → washing of epithelium, measurement of opacity after application → application of sodium fluorescein (5 mg/ml), incubation 1.5 hour (32 ± 1°C) → measurement of absorbance (490 nm).
SELECTION AND PREPARATION OF CORNEAS
The eyes, once they arrive at the laboratory, were carefully examined for defects including scratched, and neovascularisation. Only corneas from eyes free of such defects were used.
The isolated corneas, after achieve normal metabolic activity (inductive incubation at 32 ± 1°C for one hour), were examined again. The corneas that show macroscopic tissue damage (e.g., scratches, pigmentation, neovascularization) or an opacity >7 opacity units were discarded.
From 21 eyes the 6 eyes were eliminated after inductive incubation, because the baseline opacity values were >7. Nine corneas were used for the study (the corneas No. 1, 2, 4, 5, 7, 12, 13, 14 and 16,), 3 eyes was superfluous and remaining 3 were used for the testing of another substance.
QUALITY CHECK OF THE ISOLATED CORNEAS
The risk of contamination was minimized (e.g., by keeping the container containing the eyes on ice, by adding antibiotics to the HBSS used to store the eyes during transport (e.g., penicillin at 100 IU/mL and streptomycin at 100 μg/mL).
NEGATIVE CONTROL USED: YES
Name: 0.9% NaCl
Lot: 162748131
Expiration: 6/2019
Supplier: B.Braun Melsungen, Germany
POSITIVE CONTROL USED: YES
Name: Imidazole
Lot no: WXBC1234V
Expiration: 01/2024
Supplier: Sigma-Aldrich
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 0.32
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Table No. 3: Appearance of corneas
Group |
Cornea No. |
Appearance after exposure |
Negative control |
5 |
Without macroscopic damage |
|
7 |
Without macroscopic damage |
|
13 |
Without macroscopic damage |
Positive control |
12 |
Corneal opacity |
|
14 |
Corneal opacity |
|
16 |
Corneal opacity |
Test substance |
1 |
Without macroscopic damage |
|
2 |
Without macroscopic damage |
|
4 |
Without macroscopic damage |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The In Vitro Irritancy Score (IVIS) for Methylcentralit was 0.32.
This value of IVIS is ≤ 3 therefore the classification according to UN GHS criteria for eye irritation or serious eye damage is: No category. - Executive summary:
The test substance, Methylcentralit, was tested for the evaluation the potential ocular corrosivity or severe irritancy as measured by its ability to induce opacity and increased permeability in an isolated bovine cornea.
The test was performed according to the OECD Test Guideline No. 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, Adopted 26thJuly 2013
The test was performed using nine isolated bovine corneas. The testing was performed on three groups of corneas: test substance treatment group, positive control group and negative control group. Three corneas per group were used.
Closed-chamber method was used, because the test substance was applicable by micropipette. The opacity and permeability of each cornea were measured.The In Vitro Irritancy Score (IVIS) was calculated from the values of opacity and permeability.
The In Vitro Irritancy Score (IVIS) forMethylcentralit,was 0.32.
This value of IVIS is≤ 3 therefore the classification according to UN GHS criteria foreye irritation or serious eye damage is: No category.
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