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EC number: 941-637-2 | CAS number: 1384257-92-4
- 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:
- key study
- Study period:
- 2014-12-10 to 2015-02-12
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- yes
- Remarks:
- Histopathology included
- Qualifier:
- according to guideline
- Guideline:
- EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
- Deviations:
- yes
- Remarks:
- histopathology included
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- butyl 4-hydroxycyclohexanecarboxylate
- EC Number:
- 941-637-2
- Cas Number:
- 1384257-92-4
- Molecular formula:
- C11H20O3
- IUPAC Name:
- butyl 4-hydroxycyclohexanecarboxylate
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: DRZ22129-058
- Expiration date of the lot/batch: 2015-06-04
- Purity test date: 2014-06-04
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: controlled room temperature (15-25°C), below 70% RH
- Stability under test conditions: yes
Test animals / tissue source
- Species:
- other: Isolated chicken eyes
- Strain:
- other: COBB 500
- Details on test animals or tissues and environmental conditions:
- Source of chicken eyes: Chicken eyes were isolated from chicken heads, which were obtained from a slaughter house
Strain of chicken: COBB 500
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 30 µL of the test item was applied onto the entire surface of the cornea
- Duration of treatment / exposure:
- The eyes were rinsed with 20 mL physiological saline after an exposure period of 10 seconds from the end of application.
- Number of animals or in vitro replicates:
- Number of test material treated eyes: 3
Number of positive control treated eyes: 3
Number of negative control eye: 1 - Details on study design:
- The eye irritating potential of the test item was investigated in isolated chicken's eyes. The test was performed according to OECD TG No. 438.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- percent corneal swelling
- Remarks:
- at up to 75 min [%]
- Value:
- 3.2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- percent corneal swelling
- Remarks:
- at up to 240 min [%]
- Value:
- 6.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Value:
- 0.5
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- fluorescein retention score
- Value:
- 1.67
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
An in vitro eye irritation study of the test item was performed in isolated chicken’s eyes. The irritation effects of the test item were evaluated according to the OECD No.: 438 (26th July 2013). After the zero reference measurements, the eye was held in horizontal position and 30 µL of the liquid test item was applied onto the centre of the cornea such that the entire surface of the cornea was covered. After 10 seconds, the surface was rinsed with saline. The positive control eyes were treated with 30 µL of 5% (w/v) Benzalkonium chloride solution. The negative control eye was treated with 30 µL of physiological saline (Salsol solution, NaCl 0.9% w/v). Based on this in vitro eye irritation in the isolated chicken eyes test, the test item is not classified as a severe irritant and not classified as non-irritant. To further establish the classification, histopathological observations were made on two sections of each of the 3 corneas treated with test item (6 sections). Microscopic evaluation showed very slight erosion of the corneal epithelium (6/6). No stromal and endothelial changes were observed as well as no effects on integrity of basement, Bowman’s and Descemet’s membranes. Thus, the test item was categorized as Category 2 (sub-category 2B). Taking a weight of evidence approach, the overall results were categorized as Category 2 (sub-category 2B).
Applicant's summary and conclusion
- Interpretation of results:
- Category 2B (mildly irritating to eyes) based on GHS criteria
- Remarks:
- Migrated information
- Conclusions:
- Based on th eresults of this test, the test item should be classified as irritating to the eyes and categorized as Category 2 (sub-category 2B).
- Executive summary:
see above
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