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EC number: 226-841-5 | CAS number: 5502-88-5
- 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:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
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)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-isopropyl-1-methylcyclohexene
- EC Number:
- 226-841-5
- EC Name:
- 4-isopropyl-1-methylcyclohexene
- Cas Number:
- 5502-88-5
- Molecular formula:
- C10H18
- IUPAC Name:
- 1-methyl-4-(propan-2-yl)cyclohex-1-ene
- Reference substance name:
- rel-(1R,4R)-1-isopropyl-4-methylcyclohexane
- Cas Number:
- 1678-82-6
- Molecular formula:
- C10H20
- IUPAC Name:
- rel-(1R,4R)-1-isopropyl-4-methylcyclohexane
- Reference substance name:
- rel-(1S,4S)-1-isopropyl-4-methylcyclohexane
- Cas Number:
- 6069-98-3
- Molecular formula:
- C10H20
- IUPAC Name:
- rel-(1S,4S)-1-isopropyl-4-methylcyclohexane
- Test material form:
- liquid
Constituent 1
impurity 1
impurity 2
- Specific details on test material used for the study:
- Identification: Para-Menthene
Appearance: Colourless to pale yellow liquid
Batch: VE00460490
Purity/Composition: See Certificate of Analysis
Test item storage: In refrigerator (2-8°C) protected from light
Stable under storage conditions until: 16 December 2018 (expiry date)
Additional information
Test Facility test item number: 208591/A
Purity/Composition correction factor: No correction factor required
Test item handling: Use amber glassware or wrap container in aluminum-foil
Test animals / tissue source
- Species:
- cattle
- Strain:
- other: Cornea only used.
- 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 minimize 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:
- physiological saline
- Controls:
- yes
- Amount / concentration applied:
- The medium from the anterior compartment was removed and 750 l of either the negative control, positive control (Ethanol) or test item was introduced onto the epithelium of the cornea.
- Duration of treatment / exposure:
- Corneas were incubated in a horizontal position for 10 1 minutes at 32 1C. After the incubation the solutions were removed and the epithelium was washed with MEM with phenol red (Earle’s Minimum Essential Medium, Life Technologies) and thereafter with cMEM.
- Duration of post- treatment incubation (in vitro):
- Possible pH effects of the test item on the corneas were recorded. The medium in the posterior compartment was removed and both compartments were refilled with fresh cMEM. Subsequently the corneas were incubated for 120 10 minutes at 32 1C. After the completion of the incubation period opacity determination was performed. Each cornea was inspected visually for dissimilar opacity patterns.
- Number of animals or in vitro replicates:
- Three corneas were selected at random for each treatment group.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- The corneas treated with the test item showed opacity values ranging from -1.7 to 2.8 and permeability values ranging from -0.006 to 0.005.
- Value:
- 1.1
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
In vivo
- Irritant / corrosive response data:
- The individual in vitro irritancy scores for the negative controls ranged from -0.4 to 1.2. The individual positive control in vitro irritancy scores ranged from 28 to 48. The corneas treated with the positive control item were turbid after the 10 minutes of treatment.
The corneas treated with the test item showed opacity values ranging from -1.7 to 2.8 and permeability values ranging from -0.006 to 0.005. Two corneas were translucent and one slightly translucent after the 10 minutes of treatment with the test item. No pH effect of the test item was observed on the rinsing medium. Hence, the in vitro irritancy scores ranged from -1.8 to 2.8 after 10 minutes of treatment with the test item.
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 (Ethanol) was 35 and 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.
The test item did not induce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 1.0 after 10 minutes of treatment. - Executive summary:
The test item did not induce ocular irritation after 10 minutes of treatment.
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