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EC number: 833-005-9 | CAS number: 1003218-33-4
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- Mar 03 2008 - Apr 17 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
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: Hen's egg test on the chorioallantoic membrane (HET-CAM) for irritating potential
- Principles of method if other than guideline:
- During the second part of the 80' s, with a growing number of chemicals to be tested and due to an increasing awareness towards the need to protect animals from painful experiments, the hen's egg chorioallantoic membrane test (HET-CAM) was developed. The chorioallantoic membrane (CAM) of fertilized and incubated hen eggs provides a suitable model for membranes with an intact and functional vascular system. The CAM has no nerve fibers in the early stages of development and is regarded as being insensitive to pain. For these reasons, the HET-CAM is believed to be a reliable alternative to the primary eye irritation test in rabbits, which does not conflict with ethical and egal aspects of animal protection.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-butoxy-4-[4-(trans-4-ethylcyclohexyl)-1-cyclohexen-1-yl]-2,3-difluorobenzene
- EC Number:
- 833-005-9
- Cas Number:
- 1003218-33-4
- Molecular formula:
- C24H34F2O
- IUPAC Name:
- 1-butoxy-4-[4-(trans-4-ethylcyclohexyl)-1-cyclohexen-1-yl]-2,3-difluorobenzene
- Test material form:
- solid
Constituent 1
Test animals / tissue source
- Species:
- other: hen's eggs, fertilized
- Strain:
- other: White leghorn
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
-Source: LSL Rhein Main Geflügelvermehrungsbetrieb, Dieburg, Germany
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- Amount / concentration applied:
- The tip of a spatula of the test item was applied on the vascular chorioallantoic membrane (CAM). The application volume of the reference material was 0.3 mL.
- Duration of treatment / exposure:
- Only eggs without injuries of the membrane or other abnormalities were used for testing. After application of the test material, the blood vessels, including the capillary system, and the albumin were examined and scored for irritating effects (haemorrhage, lysis, and coagulation) over a period of 300 sec. The period between treatment and the onset of the reactions was measured in seconds and recorded with stopwatch and protocol.
- Number of animals or in vitro replicates:
- 6 eggs were used
- Details on study design:
- The irritating potential of the test item was determined in the hen's egg test on the chorioallantoic membrane (HET-CAM). Fertile hen eggs on day 10 of incubation provided the test system. The eggshell was removed around the air cell by means of a dentist drill and 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 chorioallantoic membrane (CAM) of the 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 (haemorrhage, lysis, and coagulation) over a period of 300 sec. As reference material Dodecyl sulfate sodium salt was tested and evaluated to ensure the sensitivity of the system.
Scoring system according to: Lüpke, NP (1985) Hen's egg chorioallantoic membrane test for irritation potential. Fd. Chem. Toxic. 23 (2), 287-291.
Cumulative score Assessment of irritancy
0 – 0.9 None
1 – 4.9 Mild
5 - 8.9 Moderate
9 - 21 Severe
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 0
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks:
- Score: 9.69
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the given experimental conditions the test item showed no irritating effects in the HET-CAM test.
- Executive summary:
Study design
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 chorioallantoic membrane (CAM) of the 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 (haemorrhage, lysis, and coagulation) over a period of 300 sec. As reference material Dodecyl sulfate sodium salt was tested and evaluated to ensure the sensitivity of the system.
Results
For the test item a cumulative score of 0 (no irritancy) was obtained, while dodecyl sulfate sodium salt as reference material gave a score of 10.59 (severe irritancy).
Conclusion
Under the given experimental conditions, the test item showed no irritating effects in the HET-CAM test.
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