Registration Dossier

Diss Factsheets

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:
2020

Materials and methods

Test guideline
Qualifier:
according to guideline
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. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1-(4-methoxyphenyl)-2-methyl -2-morpholinopropan-1-one
EC Number:
849-913-3
Cas Number:
93216-90-1
Molecular formula:
C15H21NO3
IUPAC Name:
1-(4-methoxyphenyl)-2-methyl -2-morpholinopropan-1-one
Test material form:
solid

Test animals / tissue source

Species:
cattle
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Fresh bovine eyes were obtained on the day of the test. 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 within 1 hour.

Test system

Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
Replicate Amount
1 251.2 mg
2 249.2 mg
3 252.4 mg
Duration of treatment / exposure:
1 hour
Number of animals or in vitro replicates:
3

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Run / experiment:
Test Item 1-(4-methoxyphenyl)-2-methyl-2-(morpholin-4-yl)propan-1-one
Value:
-0.9
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Two experiments were performed.
The first experiment (Exp. 1) was not valid because die mean IVIS value of the positive control was not within the range of historical data. This experiment is not reported in this report, but the raw data are kept in the test facility in the GLP- archive.
The second experiment (Exp. 1b) was valid and the results are reported here.

Bovine corneas were used. They were collected from slaughtered cattle that were be-tween 12 and 60 months old.
The test item 1-(4-methoxyphenyl)-2-methyl-2-(morpholin-4-yl)propan-1-one was applied onto the cornea of a bovine eye which had been previously incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been measured.
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.
Hank’s Balanced Salt Solution (HBSS) was used as negative control. The negative con-trol showed no irritating effect on the cornea and the calculated mean IVIS (In Vitro Irri-tancy Score) was 1.93.
20% imidazole solution was used as positive control. The positive control induced serious eye damage on the cornea and was within two standard deviations of the current histori-cal mean. The calculated mean IVIS was 106.44.
Under the conditions of this study, the test item 1-(4-methoxyphenyl)-2-methyl-2-(morpholin-4-yl)propan-1-one showed no effects on the cornea of the bovine eye. The calculated mean IVIS was -0.90.

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