Registration Dossier
Registration Dossier
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EC number: 807-577-5 | CAS number: 1182844-21-8
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- November 12, 2008 - November 12, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: HET-CAM
- Version / remarks:
- according to Lüpke (1985) with the modification described by Kalweit (1990)
- GLP compliance:
- not specified
Test material
- Reference substance name:
- trans-5-butyl-2-(3',3'',4'',5''-tetrafluoro-1,1':4',1''-terphenyl-4-yl)-1,3-dioxane
- EC Number:
- 807-577-5
- Cas Number:
- 1182844-21-8
- Molecular formula:
- C26H24F4O2
- IUPAC Name:
- trans-5-butyl-2-(3',3'',4'',5''-tetrafluoro-1,1':4',1''-terphenyl-4-yl)-1,3-dioxane
- Test material form:
- solid: bulk
Constituent 1
Test animals / tissue source
- Species:
- other: hen eggs
- Details on test animals or tissues and environmental conditions:
- - Source:
LSL Rhein Main Geflügelvermehrungsbetrieb, 64807 Dieburg, Germany
- The hen eggs were put in an incubator (Grumbach Brutgeräte, Motorbrüter type BSS 160). The trays rotated the eggs four times a day automatically. An optimum breeding temperature of 37.0 ± 1.0 °C and a relative humidity of 65 ± 5 % were maintained. On day 10 the eggs were screened. Eggs, which did not develop a normal vascular system during embryogenesis were discarded.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): tip of a spatula
- Duration of treatment / exposure:
- 300 sec
- Details on study design:
- On day 10 of incubation the egg shell was opened above the air cell by a dentist's rotary (Micro-Motor type 52601, Albrecht) and a saw (type 321524 2000, Albrecht). The shell with attached outer membrane and inner egg membrane was carefully opened. After the inner membrane had been moistened for about 2 minutes with isotonic sodium chloride solution it was removed to expose the chorioallantoic membrane (CAM) of the fertilized eggs, lying immediately below.
After application of the test material, the blood vessels, including the capillary system, and the albumin were examined and scored for irritating effects (hemorrhage, lysis, and coagulation) over a period of 300 sec.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Run 1
- Value:
- 0
- Vehicle controls validity:
- not examined
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the given experimental conditions, the test material exerted no irritating potential in the HET-CAM test.
- Executive summary:
The irritating potential of the test item was determined in the hen's egg test on the chorioallantoic membrane (HET-CAM).This test is routinely used as a screening assay prior to in vivo tests in rabbits. Fertile hen eggs on day 10 of incubation provided the test system.The egg shell was removed around the air cell by means of a dentist drill. The shell with attached outer membrane and inner egg membrane was carefully opened.After the membrane had been moistened with isotonic sodium chloride solution, it was removed to expose the choriollantoic membrane (CAM) ofthe fertilized eggs, which lies immediately below.
After application of the test material, the blood vessels, including the capillary system, and the albumin were examined and scored for irritating effects (hemorrhage, lysis, and coagulation) over a period of 300 sec. As reference material a 1 % Sodium Dodecyl Sulfate solution was tested and evaluated to ensure the sensitivity of the system.
Under the given experimental conditions, the test material exerted no irritating potential in the HET-CAM test.
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