Registration Dossier
Registration Dossier
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EC number: 211-923-5 | CAS number: 712-50-5
Eye irritation
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:
- 2 010
- 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
- Reference substance name:
- Cyclohexylphenylketone
- IUPAC Name:
- Cyclohexylphenylketone
- Details on test material:
- cyclohexylphenylketone
Constituent 1
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
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