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EC number: 273-868-3 | CAS number: 69103-01-1
- 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 guideline
- 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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- p-menth-1-en-8-yl acetate
- EC Number:
- 201-265-7
- EC Name:
- p-menth-1-en-8-yl acetate
- Cas Number:
- 80-26-2
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 1-methyl-1-(4-methylcyclohex-3-en-1-yl)ethyl acetate
- Reference substance name:
- Myrcenyl acetate
- EC Number:
- 214-262-0
- EC Name:
- Myrcenyl acetate
- Cas Number:
- 1118-39-4
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 1,1-dimethyl-5-methylenehept-6-en-1-yl acetate
- Reference substance name:
- (E)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- EC Number:
- 308-183-1
- EC Name:
- (E)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- Cas Number:
- 97890-04-5
- Molecular formula:
- C12H20O2
- IUPAC Name:
- (E)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- Reference substance name:
- (Z)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- EC Number:
- 308-184-7
- EC Name:
- (Z)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- Cas Number:
- 97890-05-6
- Molecular formula:
- C12H20O2
- IUPAC Name:
- (Z)-2-(3,3-dimethylcyclohexylidene)ethyl acetate
- Reference substance name:
- Geranyl acetate
- EC Number:
- 203-341-5
- EC Name:
- Geranyl acetate
- Cas Number:
- 105-87-3
- Molecular formula:
- C12H20O2
- IUPAC Name:
- (E)-3,7-dimethylocta-2,6-dien-1-yl acetate
- Reference substance name:
- 1-methyl-4-(1-methylethylidene)cyclohexyl acetate
- EC Number:
- 233-564-3
- EC Name:
- 1-methyl-4-(1-methylethylidene)cyclohexyl acetate
- Cas Number:
- 10235-63-9
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 4-isopropylidene-1-methylcyclohexyl acetate
- Reference substance name:
- 4-(5-methyl-1-methylene-4-hexenyl)-1-(4-methylpent-3-enyl)cyclohexene
- EC Number:
- 208-546-3
- EC Name:
- 4-(5-methyl-1-methylene-4-hexenyl)-1-(4-methylpent-3-enyl)cyclohexene
- Cas Number:
- 532-87-6
- Molecular formula:
- C20H32
- IUPAC Name:
- 4-(5-methyl-1-methylenehex-4-en-1-yl)-1-(4-methylpent-3-en-1-yl)cyclohexene
- Reference substance name:
- cis-1-methyl-4-(1-methylvinyl)cyclohexyl acetate
- EC Number:
- 244-028-3
- EC Name:
- cis-1-methyl-4-(1-methylvinyl)cyclohexyl acetate
- Cas Number:
- 20777-47-3
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 4-isopropenyl-1-methylcyclohexyl acetate
- Reference substance name:
- p-menth-1-en-8-ol
- EC Number:
- 202-680-6
- EC Name:
- p-menth-1-en-8-ol
- Cas Number:
- 98-55-5
- Molecular formula:
- C10H16O
- IUPAC Name:
- 2-(4-methylcyclohex-3-en-1-yl)propan-2-ol
- Reference substance name:
- Neryl acetate
- EC Number:
- 205-459-2
- EC Name:
- Neryl acetate
- Cas Number:
- 141-12-8
- Molecular formula:
- C12H20O2
- IUPAC Name:
- (Z)-3,7-dimethylocta-2,6-dien-1-yl acetate
- Reference substance name:
- 1-(3,3-dimethylcyclohex-1-en-1-yl)ethyl acetate
- Cas Number:
- 150461-96-4
- Molecular formula:
- C12H20O2
- IUPAC Name:
- 1-(3,3-dimethylcyclohex-1-en-1-yl)ethyl acetate
- Reference substance name:
- Tentative monoterpene diacetate
- IUPAC Name:
- Tentative monoterpene diacetate
- Reference substance name:
- Tentative oxygenated monoterpene acetate
- IUPAC Name:
- Tentative oxygenated monoterpene acetate
- Reference substance name:
- Tentative Diterpene hydrocarbon
- IUPAC Name:
- Tentative Diterpene hydrocarbon
- Reference substance name:
- Unresolved/non-elucidated mixed terpene/diterpene/oxygenated terpene/terpene acetate derivatives
- IUPAC Name:
- Unresolved/non-elucidated mixed terpene/diterpene/oxygenated terpene/terpene acetate derivatives
- 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:
- Identification: Neobergamate Forte
Appearance: Pale yellow liquid
Batch: SC00015234
Purity/Composition: See Certificate of Analysis
Test item storage: At room temperature protected from light
Stable under storage conditions until: 07 November 2016 (expiry date)
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- Test System: Bovine eyes were used as soon as possible after slaughter.
Rationale: In the interest of sound science and animal welfare, a sequential testing strategy is recommended to minimise the need of in vivo testing (1-6). As a consequence a validated and accepted in vitro test for eye irritation should be performed before in vivo tests are conducted. One of the proposed validated in vitro eye irritation tests is the Bovine Corneal Opacity and Permeability (BCOP) test.
Source: Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, 's Hertogenbosch, The Netherlands), where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter.
Transport: Eyes were collected and transported in physiological saline in a suitable container under cooled conditions.
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test item was tested neat. To protect the test item from light, glassware was wrapped in tinfoil.
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- >= 1 - <= 2
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- In vitro irritancy score
The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:
In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value)
Additionally the opacity and permeability values were evaluated independently to determine whether the test item induced irritation through only one of the two endpoints.
The IVIS cut-off values for identifying the test items as inducing serious eye damage (UN GHS Category 1) and test items not requiring classification for eye irritation or serious eye damage (UN GHS No Category) are given hereafter:
In vitro score range UN GHS
≤ 3 No Category
> 3; ≤ 55 No prediction can be made
>55 Category 1
Acceptability of the assay
The assay is considered acceptable if:
- The positive control gives an in vitro irritancy score that falls within two standard deviations of the current historical mean.
- The negative control responses should result in opacity and permeability values that are less than the upper limits of the laboratory historical range
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (10% (w/v) Benzalkonium Chloride) was 141 and was within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
Neobergamate Forte did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 1.4 after 10 minutes of treatment.
Since Neobergamate Forte induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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