Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

Materials and methods

Test guideline
Qualifier:
according to
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)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
a off-white powdery solid, without irritating odor

Test animals / tissue source

Species:
cattle
Strain:
other: slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany
Details on test animals or tissues and environmental conditions:
The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hanks’ Balanced Salt Solution with 1% Penicillin-Streptomycin solution (Penicillin 100 U/mL, Streptomycin 100 µg/mL) in a suitable cooled container.

Test system

Vehicle:
not specified
Amount / concentration applied:
750 µL
Duration of treatment / exposure:
4 hours at 32 ± 1 °C

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
ca. -1.1
Negative controls validity:
valid
Positive controls validity:
valid
Other effects / acceptance of results:
In the negative control, no signs of eye irritation were observed.
The positive control induced serious eye damage, which would be classified as GHS category I.
The test item 1-(9,9-Dibutyl-9H-fluoren-2-yl)-2-methyl-2-morpholin-4-yl-propan-1-one showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is -1.10.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
This in vitro study was performed to assess corneal damage potential of 1-(9,9-Dibutyl-9H-fluoren-2-yl)-2-methyl-2-morpholin-4-yl-propan-1-one by quantitative measurements of changes in opacity and permeability in a bovine cornea.
The test item 1-(9,9-Dibutyl-9H-fluoren-2-yl)-2-methyl-2-morpholin-4-yl-propan-1-one was brought onto the cornea of a bovine eye which previously had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been determined. The test item was incubated on the cornea for 4 hours at 32 ± 1 °C. After removal of the test item, opacity and permeability values were measured.

The test item was tested as 20% suspension.
Under the conditions of this test, the test item 1-(9,9-Dibutyl-9H-fluoren-2-yl)-2-methyl-2-morpholin-4-yl-propan-1-one showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is -1.10.
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.

The negative control (HBSS) and the positive control (20% imidazole solution) have met the validity criteria.

No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.