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EC number: 942-597-9 | CAS number: -
- 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:
- 2015
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- [(1R,2S)-1-methyl-2-[(2R)-5-methylhex-4-en-2-yl]cyclopropyl]methanol; [(1R,2S)-1-methyl-2-[(2S)-5-methylhex-4-en-2-yl]cyclopropyl]methanol; [(1S,2R)-1-methyl-2-[(2R)-5-methylhex-4-en-2-yl]cyclopropyl]methanol; [(1S,2R)-1-methyl-2-[(2S)-5-methylhex-4-en-2-yl]cyclopropyl]methanol
- EC Number:
- 942-597-9
- Cas Number:
- 1655500-83-6
- Molecular formula:
- C12H22O
- IUPAC Name:
- [(1R,2S)-1-methyl-2-[(2R)-5-methylhex-4-en-2-yl]cyclopropyl]methanol; [(1R,2S)-1-methyl-2-[(2S)-5-methylhex-4-en-2-yl]cyclopropyl]methanol; [(1S,2R)-1-methyl-2-[(2R)-5-methylhex-4-en-2-yl]cyclopropyl]methanol; [(1S,2R)-1-methyl-2-[(2S)-5-methylhex-4-en-2-yl]cyclopropyl]methanol
- Test material form:
- other: Liquid
- Details on test material:
- Batch VE00340479
Purity 87.8 % (Sum of the four isomers)
Constituent 1
- Specific details on test material used for the study:
- GR-50-1408 is the Givaudan identification code which was employed for ROSYFOLIA during the early, developmental and testing period.
Test animals / tissue source
- Species:
- other: Bovine eyes
- Strain:
- other: not applicable
- Details on test animals or tissues and environmental conditions:
- 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.
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. Bovine eyes were used as soon as possible after slaughter on the same day.
The eyes were collected and transported in physiological saline in a suitable container under cooled conditions.
Test system
- Vehicle:
- unchanged (no vehicle)
- Remarks:
- The test substance was tested neat
- Controls:
- other: not applicable, in vitro test (see report)
- Amount / concentration applied:
- 750 μl of either the negative control, positive control (10% (w/v) Benzalkonium Chloride) or test substance was introduced onto the epithelium of thecornea.
- Duration of treatment / exposure:
- Corneas were incubated in a horizontal position for 10 ± 1 minutes at 32 ± 1°C.
- Observation period (in vivo):
- not applicable, in vitro test (see report)
- Duration of post- treatment incubation (in vitro):
- After exposure the cornea was thoroughly rinsed to remove the test substance and incubated for 2 hours with fresh medium
- Number of animals or in vitro replicates:
- not applicable, in vitro test (see report)
- Details on study design:
- The eyes were checked for unacceptable defects, such as opacity, scratches, pigmentation and neovascularization by removing them from the physiological saline and holding them in the light. Those exhibiting defects were discarded.
The isolated corneas were stored in a petri dish with cMEM (Eagle’s Minimum Essential Medium (Invitrogen Corporation, Breda, The Netherlands) containing 1% (v/v) L-glutamine (Invitrogen Corporation) and 1% (v/v) Foetal Bovine Serum (Invitrogen Corporation)). The isolated corneas were mounted in a corneal holder (one cornea per holder) of MC2 (Clermont-Ferrand, France) with the endothelial side against the O-ring of the posterior half of the holder. The anterior half of the holder was positioned on top of the cornea and tightened with screws. The compartments of the corneal holder were filled with cMEM of 32 ± 1°C. The corneas were incubated for the minimum of 1 hour at 32 ± 1°C.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean after 10 mins of treatment
- Value:
- ca. 14.1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- No prediction on the classification can be made
- Other effects / acceptance of results:
- Rosyfolia induced ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of IVIS of 14.1 after 10 minutes of treatment.
IVIS UN GHS
< 3 No Category
> 3; < 55 No prediction can be made
> 55 Category 1
Since rosyfolia induced an IVIS > 3 ≤ 55, no prediction on the classification can be made.
Acceptance criteria:
The assay is considered acceptable if:
- The positive control gives an in vitro irritancy score that falls within the laboratory historical mean value
- The negative control responses should result in opacity and permeability values that are less than the upper limits of the laboratory historical range
All acceptance criteria were met.
Any other information on results incl. tables
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 substance induced irritation through only one of the two endpoints.
Table 1 Summary of opacity, permeability and in vitro scores | |||||
Treatment | Mean Opacity1 |
Mean Permeability1 |
Mean In vitro Irritation Score1, 2 | ||
Negative control | -1 | 0 | -0.7 | ||
Positive control (Benzalkonium Chloride) |
91 | 3.571 | 144.2 | ||
Rosyfolia | 13 | 0.051 | 14.1 | ||
1 Calculated using the negative control mean opacity and mean permeability values. | |||||
2 In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value). |
The treated corneas showed opacity values ranging from 12 to 15 and permeability values ranging from 0.033 to 0.067. The corneas were slightly turbid with spots after the 10 minutes of treatment with rosyfolia. No pH effect of the test substance was observed on the rinsing medium.
Rosyfolia induced ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 14.1 after 10 minutes of treatment.
Since rosyfolia induced an IVIS > 3 ≤ 55, no prediction on the classification can be made.
Applicant's summary and conclusion
- Interpretation of results:
- other: Rosyfolia mean in vitro irritancy score of 14.1 showed a lack of severe irritation after the exposure period
- Remarks:
- GHS Category 2
- Conclusions:
- Rosyfolia induced ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 14.1 after 10 minutes of treatment. Since rosyfolia induced an IVIS > 3 ≤ 55, no prediction on the classification can be made
- Executive summary:
The Bovine Corneal Opacity and Permeability Assay (BCOP) was used to assess the potential ocular irritancy of the test article to isolated bovine corneas. The methods and procedures used in this assay were consistent with OECD Test 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 (2013) and EC Guideline B.47 under GLP. Rosyfolia was topically applied undiluted to the epithelium of the bovine cornea for 10 minutes. After exposure, the cornea was thoroughly rinsed to remove the test substance and incubated for 2 hours with fresh medium followed by opacity measurement and the permeability of the corneas was determined after a 90 minutes incubation period with sodium fluorescein. A negative control of saline and a positive control of 10% benzalkonium chloride were included concurrently in the experiments. 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 144 and was within the historical positive control data range. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. Rosyfolia induced ocular irritation through both endpoints, with an IVIS > 3 ≤ 55, indicating that no prediction on the classification can be made. However, the
resulting mean in vitro irritancy score of 14.1 after 10 minutes of treatment does indicate that rosyfolia is not a severe irritant.
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