trans-2-(4-Bromo-3-fluorophenyl)-5-butyl-[1,3]dioxane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Nov 20, 2018 - Jan 10, 2019

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2019

Report date:

2019

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:

October 9, 2017

Deviations:

no

Test guideline 2

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:

trans-2-(4-Bromo-3-fluorophenyl)-5-butyl-[1,3]dioxane

EC Number:

940-307-5

Cas Number:

1465827-17-1

Molecular formula:

C14H18BrFO2

IUPAC Name:

trans-2-(4-Bromo-3-fluorophenyl)-5-butyl-[1,3]dioxane

Test material form:

solid

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL: 50 µL 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
Content (GC): 99.6 % (a/a)
Expiry Date: June 30, 2022
Storage conditions: Tightly closed, dark, at room temperature (15 – 30°C)

Duration of treatment / exposure:

30 ± 2 minutes

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:

116.4

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

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 (1.971 and 2.076).
2. The mean relative viability of the positive control is below 50% of the negative control viability (22.2%).
3. The difference of viability between the two relating tissues of a single chemical is <20% (values between 0.5% to 5.2%) 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	2.024	100.0%
Positive Control	0.449	22.2%
Test Item	2.335	116.4%

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of the present study, the test item did not show an eye hazard potential. The test item is identified as not requiring classification and labeling according to UN GHS (No Category).

Executive summary:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 492.

Under the conditions of the present study, the test item did not show an eye hazard potential. The test item is identified as not requiring classification and labeling according to UN GHS (No Category).