4-(4-methoxyphenyl)butan-2-one

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20-11-2015

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

Deviations:

no

GLP compliance:

yes

Remarks:

Hessisches Ministerium für Umwelt, Klimaschutz, Landwirtschaft und Verbraucherschutz

Test material

Test material information

Constituent 1

Reference substance name:

4-(4-methoxyphenyl)butan-2-one

EC Number:

203-184-2

EC Name:

4-(4-methoxyphenyl)butan-2-one

Cas Number:

104-20-1

Molecular formula:

C11H14O2

IUPAC Name:

4-(4-methoxyphenyl)butan-2-one

Test animals / tissue source

Species:

cattle

Details on test animals or tissues and environmental conditions:

- Test system: Freshly isolated bovine cornea (at least 9 month old donor cattle)
- Source: Schlachthof Aschaffenburg 63739 Aschaffenburg, Germany

Test system

Vehicle:

unchanged (no vehicle)

Remarks:

undiluted

Controls:

yes

Amount / concentration applied:

Anterior compartment received the test item or negative or positive control at volume of 0.75 mL on the surface of the corneae.
TEST MATERIAL
- Amount(s) applied (volume): 0.75 mL
- Concentration (if solution): undiluted test item

Duration of treatment / exposure:

First incubation time: lasted 10 min at 32°+/-1°C in water bath in a horizontal position
Second incubation after rinsing: 2 hours at 32+/-1°C in a vertical position

Observation period (in vivo):

Measurement of opacity via opacitometer
Measurement of permeability via spectrophotometer

Number of animals or in vitro replicates:

3 corneae/group

Details on study design:

Negative control: saline solution (0.9% NaCl in deionized water)
Positive control: 2-Ethoxyethanol (purity 99%)

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

mean

Value:

2.22

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

In vivo

Irritant / corrosive response data:

Please see details on results under section "Any other information on results"

Any other information on results incl. tables

Results after 10 minutes Incubation time:

Test Group	Opacity value= Difference (t130-t0) of Opacity		Permeability at 490 nm (OD490)		IVIS	Mean IVIS	Proposed in vitro Irritancy Score
		Mean		Mean
Negative Control	0	0.00	0.052	0.064	0.78	0.96	Not categorized
	0		0.085		1.28
	0		0.055		0.83
Positive Control	64.00*		1744*		90.16	84.29	Category 1
	60.00*		1355*		80.33
	64.00*		1225*		82.38
Test Item	2.00*		0.141*		4.12	2.22	Not categorized
	0.00*		0.102*		1.53
	1.00*		0.000*		1.00

* Corrected values

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

According to the current study and under the experimental conditions reported, the test substance is not cagetorized.

Executive summary:

This in vitro study was performed to determine the corneal damage potential of the test substance according to the OECD guideline 437.

After the first opacity measurement of the fresh bovine cornea (t₀), the neat test item, the positive and the negative controls were applied to the corneae and incubated for 10 minutes at 32° +/- 1°C. After the incubation phase the test item, the positive and the negative controls were each rinsed from the corneae. Further, the corneae were incubated for another 120 minutes at 32°C +/- 1°C in incubation medium, and opacity was measured a second time (t₁₃₀).

After the opacity measurements the permeability of the corneea was determined by measuring spectrophotometrically the transfer of sodium fluorescein after incubation in a horizontal position for 90 minutes at 32 +/- 1°C.

The test substance was tested undiluted. Relative to the negative control, the test substance did not cause an increase of the corneal opacity or permeability. The calculated mean IVIS was 2.22 (threshold for serious eye damage: IVIS ≥ 55).

According to OECD 437 the test item is considered not irritant (and not categorized accoding to UN GHS).