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EC number: 938-347-3 | CAS number: 28068-91-9
- 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
- Study period:
- 2 November 2010 - 9 December 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD guideline 438 (7 September 2009)
- Qualifier:
- according to guideline
- Guideline:
- other: EU Method B.48 (ICE test 8 December 2010)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of (2R,4R)-4-(2,3-dimethylbutan-2-yl)-2-methylcyclohexanone and (2S,4S)-4-(2,3-dimethylbutan-2-yl)-2-methylcyclohexanone
- EC Number:
- 938-347-3
- Cas Number:
- 28068-91-9
- Molecular formula:
- C13H24O
- IUPAC Name:
- Reaction mass of (2R,4R)-4-(2,3-dimethylbutan-2-yl)-2-methylcyclohexanone and (2S,4S)-4-(2,3-dimethylbutan-2-yl)-2-methylcyclohexanone
- Details on test material:
- - Name of test material (as cited in study report): Iriswood
- Substance type: pure active substance
- Physical state: undercooled liquid
1
Test animals / tissue source
- Species:
- other: Spring chicken
- Details on test animals or tissues and environmental conditions:
- The eyes collected from chickens obtained from a slaughterhouse. Heads have been removed immediately after sedation of the chickens by electric shock, and incision of the neck for bleeding. Because eyes were dissected in the laboratory, the intact heads were transported from the slaughterhouse at ambient temperature in polystyrene boxes humidified with towels moistened with isotonic saline.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- 30 µl of pure test substance or control was put onto enucleated chicken eyes during 10s.
- Duration of treatment / exposure:
- The test substance was applied for 10s and then rinsed from the eye with 20 ml isotonic saline incubation period was 10±1 min at 32±1.5°C.
- Observation period (in vivo):
- Corneal opacity, swelling and morphological effects were evaluated at 30, 75, 120, 180 and 240 minutes post-dosing. Fluorescein retention was determined at pretreatment and 30 minutes post-dosing.
- Number of animals or in vitro replicates:
- 3 eyes per dose group (except negative control: 1 eye).
- Details on study design:
- The eyelids were excised and dissected from the skull. The eyeball was pulled from the orbit and placed on an absorbent pad and the nictitating membrane and other connective tissue were cut away. The cornea of the enucleated eye was positioned vertically by a steel clamp and placed in a superfusion apparatus in such a way that the entire cornea was supplied with the isotonic saline drip.
The eyes were then examined with a slit-lamp microscope to ensure that they have not been damaged during the dissection procedure. Corneal thickness was measured at the corneal apex using the depth measuring device on the slit-lamp microscope. Eyes with; (i), a fluorescein retention score of > 0.5; (ii) corneal opacity > 0.5; or, (iii), any additional signs of damage were replaced. Individual eyes with a corneal thickness deviating more than 10% from the mean value for all eyes are to be rejected.
The approved eyes were incubated between 60 and 76 minutes prior to dosing. Following the equilibration period, a zero reference measurement was recorded for corneal thickness and opacity to serve as a baseline. The fluorescein score determined at dissection was used as the baseline measurement for that endpoint.
Following the zero reference measurements, the eye was removed from the superfusion apparatus, placed in a horizontal position. 30 μL of the test substance was applied to the cornea for 10 seconds, such that the entire surface of the cornea is evenly covered with the test item. The test substance was applied and then rinsed from the eye with 20 mL of isotonic saline at ambient temperature. The eye was subsequently returned to the superfusion apparatus in the original upright position for further measurements.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- 1
- Value:
- 1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- 1
- Value:
- 1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- corneal swelling
- Run / experiment:
- 1
- Value:
- 2
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Assessment eye corrosion/severe irritation of an eye exposed to physiological saline (negative control), 10% acetic acid (positive control) and the test substance.
time / min | |||||||
End-point | 0 | 30 | 75 | 120 | 180 | 240 | |
Negative control |
Corneal opacity | 0 | 0 | 0 | 0 | 0 | 0 |
Fluorescein retention | 0.5 | 0.5 | |||||
Corneal swelling / % | - | 4 | 4 | 4 | 4 | 4 | |
Positive control |
Corneal opacity | 0 | 2.0 | 2.0 | 2.0 | 2.0 | 2.0 |
Fluorescein retention | 0.2 | 3.0 | |||||
Corneal swelling / % | - | 22 | 46 | 33 | 35 | 27 | |
Test substance |
Corneal opacity | 0.0 | 0.0 | 0.0 | 0.5 | 0.5 | 0.5 |
Fluorescein retention | 0.2 | 0.0 | |||||
Corneal swelling / % | - | 2 | 3 | 9 | 9 | 8 |
ICE classification of the negative control, positive control and the test substance.
End-point | ICE | |
Negative control |
Corneal opacity | I (=1) |
Fluorescein retention | I (=1) | |
Corneal swelling | I (=1) | |
Positive control |
Corneal opacity | III (=3) |
Fluorescein retention | IV (=4) | |
Corneal swelling | IV (=4) | |
Test substance |
Corneal opacity | I (=1) |
Fluorescein retention | I (=1) | |
Corneal swelling | II (=2) |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- The test substance must not be classified as causing “irreversible effects on the eye” under the conditions of the in vitro test.
- Executive summary:
The eye irritancy of Iriswood was assessed according to the Isolated Chicken Eye Test as described in OECD method 438. 30ml test substance was applied to 3 enucleated chicken eyes during 10s. The eyes were subsequently rinsed with 10ml of physiological saline. Three other eyes were treated with a positive control and one eye with a negative control. The damage by the test substance was assessed by determination of corneal swelling, opacity, and fluorescein retention at 30, 75, 120, 180 and 240 minutes post-dose. The ocular reactions observed in the eyes treated with the test substance were slightly to moderate. Based on the results of the test, the test substance does not need to be classified as causing “irreversible effects on the eye”.
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