Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
from 13-Oct-2009 to 22-Jan-2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: state of the art experiment that is limited to distinguish corrosive from non-corrosive substances

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
no guideline available
Guideline:
other: recommended initial/alternative test
Deviations:
not applicable
Principles of method if other than guideline:
The potential of a test substance to cause serious damage to the eyes/mucous membranes is assessed by a single topical applicationof the undiluted and diluted test substance to the chorioallantoic membrane (CAM) of fertilized and incubated hen eggs.
Three eggs per test-substance concentration were observed up to 90 (undiluted test
substance) or 160 seconds (10% solution in olive oil) and the occurrence of vascular injury or
intravascular coagulation in response to the test substance was recorded.
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Cyclohexylphenylketone
IUPAC Name:
Cyclohexylphenylketone
Details on test material:
cyclohexylphenylketone

Test animals / tissue source

Species:
other: hen eggs
Details on test animals or tissues and environmental conditions:
fresh fertilized hen eggs produced under SPF conditions

Test system

Vehicle:
other: olive oil
Amount / concentration applied:
25 μL bulk volume (about 26 mg) of the undiluted test substance and
0.3 mL of a 10% test-substance solution in olive oil
Duration of treatment / exposure:
90 seconds (undiluted test material) or 160 seconds (diluted test material)
Observation period (in vivo):
not applicable
Number of animals or in vitro replicates:
3 eggs per concentration

Results and discussion

In vivo

Results
Irritation parameter:
other: HET-CAM
Basis:
other: chorioallantoic membrane, hen egg
Time point:
other: 90 seconds (undiluted test material) or 160 seconds (diluted test material) after application
Score:
0
Max. score:
3
Reversibility:
other: no findings
Irritant / corrosive response data:
The chorioallantoic membrane of the eggs treated with the undiluted test substance or with
the 10% test-substance solution in olive oil did not show any irritation effects.
Other effects:
none

Applicant's summary and conclusion