Registration Dossier

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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
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

Constituent 1
Chemical structure
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).