4'-bromo-3-chloropropiophenone

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Feb 25, 2020 - May 27, 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

Version / remarks:

July 28, 2015

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: DB-ALM Protocol No. 164: Ocular Irritation Assay for Chemicals using EpiOcular™ EIT,

Version / remarks:

September 14, 2015

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: EpiOcular Eye Irritation Test (OCL-200-EIT) for the prediction of acute ocular irritation of chemicals; For use with MatTek Corporation`s Reconstructed Human EpiOcular Model; MatTek Corporation

Version / remarks:

June 29, 2015

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4'-bromo-3-chloropropiophenone

EC Number:

250-784-5

EC Name:

4'-bromo-3-chloropropiophenone

Cas Number:

31736-73-9

Molecular formula:

C9H8BrClO

IUPAC Name:

1-(4-bromophenyl)-3-chloropropan-1-one

Test material form:

solid: bulk

Specific details on test material used for the study:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: No pre-treatment, the test item was applied neat to the tissues.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL: 50 mg per tissue

NEGATIVE / VEHICLE CONTROL: 50 µL per tissue

Sterile deionized water was used as negative control.


POSITIVE CONTROL: 50 µL per tissue

Designation: Art. 8.09711
Synonym: Methyl acetate
Supplier: Merck KGaA
CAS No.: 79-20-9
Batch No.: S7451611
Appearance: Liquid
Assay (GC, area%): 99.6 % (a/a)
Minimum shelf life: June 30, 2022
Storage conditions: Tightly closed, dark, at room temperature (15 – 25°C)

Duration of treatment / exposure:

6 hours

Number of animals or in vitro replicates:

in vitro: duplicate design

Results and discussion

In vitro

Results

Irritation parameter:

other: Viability %

Run / experiment:

Run 1 / Experiment 1

Value:

1.6

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Remarks:

According to OECD 492 no prediction can be made regarding the eye irritating potential.

Other effects / acceptance of results:

OTHER EFFECTS:
- Visible damage on test system: No observations

ACCEPTANCE OF RESULTS:
1. The negative control OD is >0.8 and <2.5 (1.671 and 1.474).
2. The mean relative viability of the positive control is below 50% of the negative control viability (40.0%).
3. The difference of viability between the two relating tissues of a single chemical is <20% (values between 1.1% to 12.5%) in the same run (for positive and negative control tissues and tissues of single chemicals).

The study met all acceptance criteria

Any other information on results incl. tables

	Mean OD	Mean Viability
Negative Control	1.573	100.0 %
Positive Control	0.629	40.0 %
Test Item	0.025	1.6 %

Applicant's summary and conclusion

Interpretation of results:

other: UN GHS Category 1 or Category 2

Conclusions:

Under the conditions of the present study, the test item did show an eye hazard potential. The test item is considered to be UN GHS Category 1 or Category 2.

Executive summary:

Objective

The objective of the present study was to investigate the potential of the test item to induce eye irritation in an in vitro human cornea model.

 

Study Design

The test item was applied topically to a reconstructed human cornea-like epithelium model (EpiOcular) followed by determination of the cell viability. Cell viability was determined by enzymatic conversion of vital dye MTT into a blue formazan salt and measurement of the formazan salt after extraction from tissues. The percent reduction of cell viability in comparison to untreated negative controls was used to predict the eye irritation potential. Duplicates of the EpiOcular-model were treated with the test item, the negative or the positive control for 6 hours (± 15 minutes). 50 mg of the test item and 50 µL of either the negative control (sterile deionized water) or the positive control (methyl acetate) were applied to the tissues.

 

Results

After treatment with the negative control (sterile deionized water) the mean OD was 1.573 (study acceptance criterion: >0.8 and <2.5). Treatment with the positive control (methyl acetate) revealed a mean viability value of 40.0 % (study acceptance criterion: < 50 %). Thus, the acceptance criteria were met.

 

Following treatment with the test item, the tissue viability was 1.6 % and, thus, lower than 60%, i.e.according to OECD 492 the test item is considered to be UN GHS Category 1 or Category 2.

 

Conclusion

Under the conditions of the present study, the test item did show an eye hazard potential. The test item is considered to be UN GHS Category 1 or Category 2.