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EC number: 949-569-5 | 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:
- 2019-03-18 to 2019-04-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
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)
- Deviations:
- yes
- Remarks:
- The positive control is 2-Ethoxyethanol (purity: 99%) since the laboratory historical control data are established with this chemical.
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Bovine Corneal Opacity and Permeability (BCOP) Assay, SOP of Microbiological Associates Ltd., UK, Procedure Details, April 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Reaction mass of 1-(3,3-dimethylcyclohexyl)ethyl acetate and 2,6,6-trimethylcycloheptanol acetate
- EC Number:
- 949-569-5
- Molecular formula:
- C12H22O2
- IUPAC Name:
- Reaction mass of 1-(3,3-dimethylcyclohexyl)ethyl acetate and 2,6,6-trimethylcycloheptanol acetate
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- other: Freshly isolated bovine cornea
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: AB Schlachthof GmbH & Co. KG, 63739 Aschaffenburg, Germany
- Number of animals:
- Characteristics of donor animals: 14 month old donor cattle
- Storage, temperature and transport conditions of ocular tissue: The isolated eyes were stored in HBSS containing 1% (v/v) penicillin/streptomycin (100 units/mL penicillin and 100 μg/mL streptomycin) in the cooled slaughter-house and during transportation on the same morning to the laboratory using a Styrofoam box.
- Time interval prior to initiating testing:
- indication of any existing defects or lesions in ocular tissue samples: none
- Indication of any antibiotics used: none
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 0.75 mL test item, positiv or negativ control
- Duration of treatment / exposure:
- 10 minutes
- Number of animals or in vitro replicates:
- 3 replicates per test group
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
Freshly isolated bovine eyes of 14 month old donor cattle were collected from the abattoir. All eyes were carefully examined macroscopically for defects. The cornea was carefully removed from the eye using scalpel and rounded scissors. A rim of about 2 mm of tissue (sclera) was left for stability and handling of the isolated cornea. Each isolated cornea was mounted in a specially designed cornea holder, which consists of anterior and posterior compartments, which interface with the epithelial and the endothelial sides of the cornea, respectively. The endothelial side of the cornea was positioned against the sealing ring (O-ring) of the posterior part of the holder. The cornea was gently flattened over the O-ring but stretching was avoided. The anterior part of the holder was positioned on top of the cornea and fixed in place with screws. Both compartments of the holder were filled with incubation medium.
QUALITY CHECK OF THE ISOLATED CORNEAS
For equilibration, the corneae in the holder were incubated in a vertical position for about one hour at 32 ± 1 °C in a water-bath. At the end of the incubation period, the medium was changed before basal opacity measurement (t0). At the end of the incubation period, the basal opacity was determined (t0). Only corneae with a value of the basal opacity < 7 were used. Sets of three corneae were used for treatment with the test item and for the negative and positive controls.
NUMBER OF REPLICATES : three
NEGATIVE CONTROL USED : Saline (0.9% NaCl in deionised water)
POSITIVE CONTROL USED : 2-Ethoxyethanol (purity: 99%)
APPLICATION DOSE AND EXPOSURE TIME
The anterior compartment received the test item or the negative or positive controls at a volume of 0.75 mL on the surface of the corneae, respectively. The corneae were incubated in a horizontal position at 32 ± 1 °C in the water-bath. The incubation time lasted ten minutes (± 30 seconds).
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: at least 4 times - 3 times with EMEM containing phenol red and 1 time with cMEM without phenol red
- POST-EXPOSURE INCUBATION: The corneae were incubated at 32 ± 1 °C for further two hours in a vertical position, followed by a second opacity reading (t130). In the second step of the assay, permeability of the corneae was determined.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: opacitometer OP_KiT opacitometer (Electro Design, 63-Riom France); The opacitometer determines changes in the light transmission passing through the corneae, and displays a numerical opacity value.
- Corneal permeability: the optical density at 490 nm (OD490) was measured with a microplate reader (Versamax® Molecular Devices)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: Depending on the score obtained, the test item was classified according to OECD guideline 437.
IVIS UN GHS
≤ 3 No Category
> 3; ≤ 55 No prediction can be made
> 55 Category 1
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- test item group
- Value:
- 0
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Results after 10 Minutes Treatment Time
Test Group |
Opacity value = Difference (t130-t0) of Opacity |
Permeability at 490 nm (OD490) |
IVIS |
Mean IVIS |
Proposed in vitro Irritancy Score |
||
|
|
Mean |
|
Mean |
|
|
|
Negative Control |
1 |
0.33 |
0.094 |
0.078 |
2.41 |
1.51 |
No category |
0 |
0.072 |
1.08 |
|||||
0 |
0.069 |
1.04 |
|||||
Positive Control |
87.67* |
1.417* |
108.92 |
99.81 |
Category 1 |
||
75.67* |
1.059* |
91.55 |
|||||
82.67* |
1.087* |
98.97 |
|||||
Test Item |
-0.33* |
-0.032* |
0.00# |
0.00 |
No category |
||
-0.33* |
-0.030* |
0.00# |
|||||
-0.33* |
-0.024* |
0.00# |
With the negative control (saline), neither an increase of opacity nor permeability of the corneae could be observed (mean IVIS = 1.51).
The positive control (2-Ethoxyethanol) was tested undiluted and showed clear opacity and distinctive permeability of the corneae (mean IVIS = 99.81) corresponding to a classification as serious eye damaging (CLP/EPA/GHS (Cat 1)).
The test item was tested undiluted. Relative to the negative control, the test item did not cause any increase of the corneal opacity or permeability. The calculated mean IVIS was 0.00 (threshold for serious eye damage: IVIS > 55). According to OECD 437, the test item is not classified.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, according to the current study the test item is not an eye irritant.
- Executive summary:
To assess the corneal damage potential of the test item, an in vitro study according to OECD TG 437 was conducted. After a first opacity measurement of the fresh bovine cornea (t0), the undiluted test item, the positive control, and the negative control were applied to corneae fixed in an incubation chamber in horizontal position for 10 minutes at 32 °C. After the incubation phase the test item, the positive control, and the negative controls were each rinsed from the cornea. Further, the corneae were incubated for another 120 min at 32 °C in a vertical position. Afterwards, opacity was measured a second time (t130). Permeability of the cornea was also determined after opacity measurements.
The acceptance criteria for the negative and positive control were met. With the negative control (saline), neither an increase of opacity nor permeability of the corneae could be observed (mean IVIS = 1.51). The positive control (2-Ethoxyethanol) was tested undiluted and showed clear opacity and distinctive permeability of the corneae (mean IVIS = 99.81) corresponding to a classification as serious eye damaging (CLP/EPA/GHS (Cat 1)).
In comparison to the negative control, the test item did not cause any increase of the corneal opacity or permeability. The calculated mean IVIS was 0.00 (threshold for serious eye damage: IVIS > 55). According to OECD 437, the test item is not classified as serious eye damaging or as eye irritating.
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