[No public or meaningful name is available]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

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)

Version / remarks:

No data

Deviations:

no

Remarks:

No deviations ocurred that negatively impacted the integrity of the study.

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of 1,10-decanediol dimethacrylate (CAS 6701-13-9) and 10-methacryloyl-oxy-decylphosphate

Molecular formula:

C18H30O4 and C14H27O6P

IUPAC Name:

Reaction mass of 1,10-decanediol dimethacrylate (CAS 6701-13-9) and 10-methacryloyl-oxy-decylphosphate

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source (i.e. manufacturer or supplier) and lot/batch number of test material:
3M Company,
- Purity, including information on contaminants, isomers, etc.:
Reaction product as described in the general information section.

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
At room temperature
- Stability and homogeneity of the test material in the vehicle/solvent under test conditions (e.g. in the exposure medium) and during storage:
NA
- Stability in the medium, i.e. sensitivity of the test material to hydrolysis and/or photolysis:
No data
- Solubility and stability of the test material in the solvent/vehicle and the exposure medium:
No data
- Reactivity of the test material with the incubation material used (e.g. plastic ware):
No data

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
: None, dosed neat.

Test animals / tissue source

Species:

cattle

Details on test animals or tissues and environmental conditions:

SOURCE OF COLLECTED EYES
- Source: Spear Products
- Number of animals: No data
- Characteristics of donor animals (e.g. age, sex, weight): No data
- Storage, temperature and transport conditions of ocular tissue: Eyes were transported under refrigeration.
- Time interval prior to initiating testing: The eyes were dosed the same day as they arrived.
- Indication of any existing defects or lesions in ocular tissue samples: Only eyes free of defects were used.
- Indication of any antibiotics used: Penicillin-streptomycin was used.
- Selection and preparation of corneas: The eyes were examined prior to use on the day of dosing. Any eye with a cornea exhibiting evidence of vascularization, pigmentation, opacity or scratches was discarded. Corneas from eyes that were free of defects were dissected from the surrounding tissues. A 2-3 mm rim of sclera was left attached to each cornea. The corneas were then placed in a container of fresh HBSS.
- Quality check of the isolated corneas: The dissected corneas were mounted in specially designed holders that were separated into anterior and posterior chambers and filled separately. Each cornea was mounted allowing the epithelium of the cornea to project into the anterior chamber. The posterior chamber was filled with MEM solution ensuring contact with the endothelium. The anterior chamber was filled with MEM solution, ensuring contact with the epithelium. Each cornea was visually inspected again to ensure there were no defects. The entire holder was incubated at 32 (±1)°C and allowed to equilibrate for at least one hour, but not longer than two hours. A pre-exposure determination of opacity was made for each cornea by measuring each against the blank supplied by the opacitometer. Any cornea with a value greater than 7 units was discarded.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL
- Concentration (if solution): neat

VEHICLE: None

Duration of treatment / exposure:

10 minutes

Duration of post- treatment incubation (in vitro):

2 hours

Number of animals or in vitro replicates:

3 ex vivo replicates

Details on study design:

NUMBER OF REPLICATES : 3

NEGATIVE CONTROL USED : Minimal Essential Media

SOLVENT CONTROL USED: NA

POSITIVE CONTROL USED : 100% Ethanol

APPLICATION DOSE AND EXPOSURE TIME : 0.75 mL for 10 minutes

TREATMENT METHOD: Closed chamber

REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: At least 2

- POST-EXPOSURE INCUBATION: 2 hours

METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: A
measurement of opacity was taken with each treated cornea compared to the blank supplied with the OP-KIT. This reading was used in the final IVIS calculations.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV spectrophotometry (OD490)


SCORING SYSTEM: In Vitro Irritancy Score (IVIS)

DECISION CRITERIA: Per OECD 437

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

cornea opacity score

Run / experiment:

Mean

Value:

82.7

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation parameter:

fluorescein leakage

Run / experiment:

Mean (OD 490 nm)

Value:

0.264

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Results 3

Irritation parameter:

other: Corrected Mean Optical Density

Remarks:

Corrected Mean Optical Density

Run / experiment:

Mean

Value:

0.241

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Results 4

Irritation parameter:

in vitro irritation score

Run / experiment:

Mean

Value:

86.28

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Remarks:

IVIS = 0.35

Positive controls validity:

valid

Remarks:

IVIS = 25.83

Remarks on result:

positive indication of irritation

Other effects / acceptance of results:

OTHER EFFECTS:
- Visible damage on test system: None

DEMONSTRATION OF TECHNICAL PROFICIENCY: The lab is proficient in running OECD 437.

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: No data
- Acceptance criteria met for positive control: The ethanol positive control IVIS was 25.83, which fell within the acceptance range of 16.96 - 37.00
(± 2 standard deviations of the historical mean).
- Range of historical values if different from the ones specified in the test guideline: Per OECD 437.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

Based on the results of the study (IVIS = 86.28), MDP is corrosive (GHS Category 1) in the Bovine Corneal Opacity and Permeability Test (BCOP).

Executive summary:

The eye irritancy/corrosion potential of MDP was evaluated in the Bovine Corneal Opacity and Permeability Test (BCOP). The study was conducted according to OECD 437 in compliance with OECD GLP. Corneas (N=3) were exposed to 0.75 mL of the test article (MDP), negative control (MEM), or positive control (100% Ethanol) for 10 minutes. Corneal opacity was determined at 10 minutes and 2 hours post-exposure. Corneal permeability was determined following a 90 minute incubation with fluorescein on the anterior side of each cornea. The amount of dye that passed through the cornea was measured by spectrophotometer at 490 nm. Exposure to MDP resulted in a mean corneal opacity score of 82.7, mean corneal permeability of 0.264 and mean corrected optical density of 0.241, resulting in an In Vitro Irritancy Score (IVIS) of 86.28. Based on the results of the study (IVIS = 86.28), MDP is corrosive (GHS Category 1) in the Bovine Corneal Opacity and Permeability Test (BCOP).