[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:

From 25 January to 03 May 2022

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

conducted under GLP conditions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2022

Report date:

2022

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)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

impurity 1

Reference substance name:

1-(4-methoxyphenyl)-3-phenylpropan-1-one

Cas Number:

684-361-5

Molecular formula:

C16H16O2

IUPAC Name:

1-(4-methoxyphenyl)-3-phenylpropan-1-one

impurity 2

Reference substance name:

(Z)-1-methoxy-4-(3-phenylprop-1-en-1-yl)benzene

Cas Number:

183621-24-1

Molecular formula:

C16H16O

IUPAC Name:

(Z)-1-methoxy-4-(3-phenylprop-1-en-1-yl)benzene

Constituent 1

Reference substance name:

(E)-1-methoxy-4-(3-phenylprop-1-en-1-yl)benzene

Cas Number:

35856-81-6

Molecular formula:

C16H16O

IUPAC Name:

(E)-1-methoxy-4-(3-phenylprop-1-en-1-yl)benzene

Test material form:

liquid

Test animals / tissue source

Species:

other: Isolated bovine cornea

Strain:

other: Not applicable

Details on test animals or tissues and environmental conditions:

Bovine eyes will be obtained from the abattoir of J.W. TREUTH & SONS, Inc., Baltimore, MD. The eyes will be excised by an abattoir employee (as soon after slaughter as possible) and held in HBSS on ice. Once the required number of eyes has been obtained, the eyes will be transported to IIVS. Immediately upon receipt of the eyes into the laboratory, preparation of the corneas will be initiated .

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

100% for test material and controls

Duration of treatment / exposure:

10 minutes for test material and controls

Duration of post- treatment incubation (in vitro):

2 hours for test material and controls

Number of animals or in vitro replicates:

Test material: 3
Positive control: 3
Negative control: 3

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

0.8

Vehicle controls validity:

not examined

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

The BCOP assay was accepted when the positive control, ethanol, produced an In Vitro Score that fell within 2 standard deviations of the historical mean. The current acceptance range for ethanol is 38.0 – 63.1.

Any other information on results incl. tables

Evaluation of Test Results for BCOP:

The following prediction models were used to evaluate the ocular irritancy potential as described by Sina et al. (1995)2 for non-regulatory purposes or as described in OECD TG 437 (2017).

The prediction model according to Sina et. al based on a wide range of materials (note: While this classification system provides a good initial guide to interpretation of these in vitro data, these specific ranges may not be applicable to all classes of materials or other exposure times. Whenever possible, results should be compared to “benchmark” materials tested under similar exposure conditions.):

 

In Vitro Score	Sina et al Prediction
≤ 25	Mild irritant
> 25; ≤ 55	Moderate irritant
> 55	Severe irritant

 

Prediction model outlined in OECD TG 437:

 

In Vitro Irritation Score (IVIS)	UN GHS
≤3	No Category
>3; ≤55	No prediction can be made*
>55	Category 1

* - Additional testing would be required for a definitive classification of ocular irritation potential according to GHS

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The In Vitro Score of the test article was 0.8. According to the prediction model presented in OECD TG 437, the test article was predicted to not require classification or labelling for ocular irritation (GHS No Category).

Executive summary:

The Bovine Corneal Opacity and Permeability Assay (BCOP) was used to assess the potential ocular irritancy of the test article to isolated bovine corneas. Bovine corneas, obtained as a byproduct from freshly slaughtered animals, were mounted in special holders and exposed to the test article. An In Vitro Score was determined for the test article based on the induction of opacity and permeability (to fluorescein) in the isolated bovine corneas. The methods and procedures used in this assay were consistent with OECD Test 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 (2020).

 

The In Vitro Score of the test article was 0.8. According to the prediction model presented in OECD TG 437, the test article was predicted to not require classification or labelling for ocular irritation (GHS No Category).