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EC number: 305-053-6 | CAS number: 94333-72-9
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Citronellol
- EC Number:
- 203-375-0
- EC Name:
- Citronellol
- Cas Number:
- 106-22-9
- Molecular formula:
- C10H20O
- IUPAC Name:
- 3,7-dimethyloct-6-en-1-ol
- Reference substance name:
- Geraniol
- EC Number:
- 203-377-1
- EC Name:
- Geraniol
- Cas Number:
- 106-24-1
- Molecular formula:
- C10H18O
- IUPAC Name:
- (E)-3,7-dimethylocta-2,6-dien-1-ol
- Reference substance name:
- (E)-6,10-dimethylundeca-3,9-dien-2-one
- Cas Number:
- 19870-49-6
- Molecular formula:
- C12H20O
- IUPAC Name:
- (E)-6,10-dimethylundeca-3,9-dien-2-one
- Reference substance name:
- Dipentene
- EC Number:
- 205-341-0
- EC Name:
- Dipentene
- Cas Number:
- 138-86-3
- Molecular formula:
- C10H16
- IUPAC Name:
- 1-methyl-4-(prop-1-en-2-yl)cyclohex-1-ene
- Reference substance name:
- Linalool
- EC Number:
- 201-134-4
- EC Name:
- Linalool
- Cas Number:
- 78-70-6
- Molecular formula:
- C10H18O
- IUPAC Name:
- 3,7-dimethylocta-1,6-dien-3-ol
- Reference substance name:
- (±)-(1α,2β,5α)-5-methyl-2-(1-methylvinyl)cyclohexan-1-ol
- EC Number:
- 256-557-7
- EC Name:
- (±)-(1α,2β,5α)-5-methyl-2-(1-methylvinyl)cyclohexan-1-ol
- Cas Number:
- 50373-36-9
- Molecular formula:
- C10H18O
- IUPAC Name:
- rel-(1R,2S,5R)-5-methyl-2-(prop-1-en-2-yl)cyclohexanol
- Reference substance name:
- (1α,2β,4β)-1-methyl-2,4-bis(methylvinyl)-1-vinylcyclohexane
- EC Number:
- 251-713-0
- EC Name:
- (1α,2β,4β)-1-methyl-2,4-bis(methylvinyl)-1-vinylcyclohexane
- Cas Number:
- 33880-83-0
- Molecular formula:
- C15H24
- IUPAC Name:
- rel-(1R,2R,4S)-1-methyl-2,4-di(prop-1-en-2-yl)-1-vinylcyclohexane
- Reference substance name:
- (1E,6E)-8-isopropyl-1-methyl-5-methylenecyclodeca-1,6-diene
- Cas Number:
- 105453-16-5
- Molecular formula:
- C15H24
- IUPAC Name:
- (1E,6E)-8-isopropyl-1-methyl-5-methylenecyclodeca-1,6-diene
- Reference substance name:
- rel-(1R,4aR,8aS)-1-isopropyl-4,7-dimethyl-1,2,4a,5,6,8a-hexahydronaphthalene
- Cas Number:
- 31983-22-9
- Molecular formula:
- C15H24
- IUPAC Name:
- rel-(1R,4aR,8aS)-1-isopropyl-4,7-dimethyl-1,2,4a,5,6,8a-hexahydronaphthalene
- Reference substance name:
- rel-(1R,4aS,8aS)-1-isopropyl-7-methyl-4-methylene-1,2,3,4,4a,5,6,8aoctahydronaphthalene
- Cas Number:
- 39029-41-9
- Molecular formula:
- C15H24
- IUPAC Name:
- rel-(1R,4aS,8aS)-1-isopropyl-7-methyl-4-methylene-1,2,3,4,4a,5,6,8aoctahydronaphthalene
- Reference substance name:
- rel-(1R,8aS)-1-isopropyl-4,7-dimethyl-1,2,3,5,6,8ahexahydronaphthalene
- Cas Number:
- 60305-17-1
- Molecular formula:
- C15H24
- IUPAC Name:
- rel-(1R,8aS)-1-isopropyl-4,7-dimethyl-1,2,3,5,6,8ahexahydronaphthalene
- Reference substance name:
- rel-2-((1R,3S,4S)-4-methyl-3-(prop-1-en-2-yl)-4-vinylcyclohexyl)propan-2-ol
- Cas Number:
- 23811-48-5
- Molecular formula:
- C15H26O
- IUPAC Name:
- rel-2-((1R,3S,4S)-4-methyl-3-(prop-1-en-2-yl)-4-vinylcyclohexyl)propan-2-ol
- Reference substance name:
- 5,9-dimethyl-2-(6-methylhept-5-en-2-yl)deca-2,8-dienal
- Cas Number:
- 82451-80-7
- Molecular formula:
- C20H34O
- IUPAC Name:
- 5,9-dimethyl-2-(6-methylhept-5-en-2-yl)deca-2,8-dienal
- Reference substance name:
- Likely oxygenated constituent
- IUPAC Name:
- Likely oxygenated constituent
- Reference substance name:
- Unknown Impurities
- IUPAC Name:
- Unknown Impurities
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
Constituent 8
Constituent 9
Constituent 10
Constituent 11
Constituent 12
Constituent 13
Constituent 14
Constituent 15
- Specific details on test material used for the study:
- Name: Baccartol Crude
Batch no.: VE00364716
Appearance: yellow liquid
Composition: OILS, CITRONELLA, REACTION PRODUCTS WITH ACETONE
Purity: Substance is a UVCB - cannot be determined
Expiry date 02. Apr. 2017
Storage: Room Temperature (20 ± 5°C); Keep away from light; Dry, well ventilated, preferably full, hermetically sealed.
Test animals / tissue source
- Species:
- other: Bos primigenius Taurus (fresh bovine corneas)
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Fresh bovine eyes were obtained from the slaughterhouse Müller Fleisch GmbH, Enzstr. 2-4, 75217 Birkenfeld, Germany, on the day of the test. The cattle were between 12 and 60 months old. The eyes were transported to the test facility in Hank’s balanced salt solution (supplemented with 0.01% streptomycin and 0.01% penicillin). Then, the corneas were dissected and incubated in medium at 32 ± 1 °C in an incubation chamber for 1 h.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 μL
- Duration of treatment / exposure:
- 10 mins
- Duration of post- treatment incubation (in vitro):
- 2 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Preparations
After having carefully cleaned and sterilised the cornea holders, they were kept in the incubation chamber at 32 ± 1 °C.
On the day of the assay, the MEM without phenol red was supplemented with sodium bicarbonate, L-glutamine and 1% fetal calf serum (= complete MEM) and stored in a water bath at 32 ± 1 °C.
The same was performed with the MEM with phenol red, but without addition of sodium bicarbonate.
After the arrival of the corneas, they were examined and only corneas which were free from damages were used. The corneas were excised with a scalpel and cut from the globe with a 2-3 mm ring of sclera around the outside. Each cornea was transferred to a cornea holder in which pre-warmed cMEM without phenol red (32 ± 1 °C) was filled. The holders were then incubated for 1 h in the incubation chamber at 32 ± 1 °C.
Experimental Parameters
Date of treatment: 14. Apr. 2016
Incubation time: 10 min
Negative control: 0.9 % sodium chloride solution
Positive control: Dimethylformamide (undiluted)
Method Description
After the initial incubation, the medium was changed and the baseline opacity for each cornea was recorded. None of the corneas showed tissue damage; therefore, all corneas were used.
The baseline opacity was measured by placing the holder with the cornea in a spectral photometer and recording the absorbance at 570 nm.
For each treatment group (negative control solution, test item and positive control), three replicates were used. After removal of the pre-incubation medium (cMEM without phenol red), 750 μL negative control solution resp. test item resp. positive control were applied to each replicate.
According to the characteristics of the test item, the following treatment procedure was
performed:
Closed Chamber Method
The “closed chamber-method” is used for liquid substances.
The respective substance (negative control solution, test item or positive control) was applied by pipetting 750 μL of the appropriate liquid through the refill hole in the holder on the cornea. The test item was given on the epithelium in such a manner that as much as possible of the cornea was covered with the test item.
Exposure time on the corneas was 10 min at 32 ± 1 °C. After thorough rinsing with cMEM with phenol red and final rinsing with cMEM without phenol red, the anterior chamber was filled with cMEM without phenol red, and the corneas were stored for additional 2 h at 32 ± 1 °C (post-incubation).
After the post-incubation, the cMEM without phenol red was renewed in both chambers. Then, the final opacity value of each cornea was recorded (again by measurement at 570 nm). The cMEM without phenol red was removed from the front chamber, and 1 mL
sodium fluorescein solution (concentration: 4 mg/mL) was added to the front chamber.
The chambers were then closed again and incubated for 90 min at 32 ± 1 °C. After incubation, the content of the posterior chamber was thoroughly mixed. Then, the permeability of the cornea was measured as optical density of the liquid at 490 nm.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 2.71
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- In the negative control, no signs of eye irritation were observed.
The positive control induced showed effects on the cornea of the bovine eye.
The test item Baccartol Crude showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 2.71.
The experiment is considered as sufficient for the classification of the test item, because all three replicates of the test item lead to the same assessment for the test item.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- This in vitro study was performed to assess corneal damage potential of Baccartol Crude by quantitative measurements of changes in opacity and permeability in a bovine cornea. The test item Baccartol Crude was brought onto the cornea of a bovine eye which previously had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 h and whose opacity had been determined. The test item was incubated on the cornea for 10 min at 32 ± 1 °C. After removal of the test item and 2 h post-incubation, opacity and permeability values were measured.
The test item was tested pure.
Under the conditions of this test, the test item Baccartol Crude showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 2.71.
According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.
The negative control (physiological sodium chloride solution) and the positive control (undiluted dimethylformamide) have met the validity criteria.
No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.
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