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EC number: 939-396-3 | 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:
- weight of evidence
- Study period:
- 12-13 February 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- 10 January 2013
Test material
- Reference substance name:
- cis-α,α,4-trimethylcyclohexanemethanol
- EC Number:
- 230-795-1
- EC Name:
- cis-α,α,4-trimethylcyclohexanemethanol
- Cas Number:
- 7322-63-6
- Molecular formula:
- C10H20O
- IUPAC Name:
- cis-2-(4-methylcyclohexyl)propan-2-ol
- Reference substance name:
- trans-α,α,4-trimethylcyclohexanemethanol
- EC Number:
- 225-844-9
- EC Name:
- trans-α,α,4-trimethylcyclohexanemethanol
- Cas Number:
- 5114-00-1
- Molecular formula:
- C10H20O
- IUPAC Name:
- trans-2-(4-methylcyclohexyl)propan-2-ol
- Reference substance name:
- cis-4-isopropyl-1-methylcyclohexanol
- Cas Number:
- 3901-95-9
- Molecular formula:
- C10H20O
- IUPAC Name:
- cis-4-isopropyl-1-methylcyclohexanol
- Reference substance name:
- trans-4-isopropyl-1-methylcyclohexanol
- Cas Number:
- 3901-93-7
- Molecular formula:
- C10H20O
- IUPAC Name:
- trans-4-isopropyl-1-methylcyclohexanol
- Reference substance name:
- Non identified impurities
- Molecular formula:
- Not applicable
- IUPAC Name:
- Non identified impurities
- Test material form:
- liquid
- Details on test material:
- Batch No. MP8 du 29/10/2013
Purity: 98.8% (sum of the 4 main constituents)
Name of the test item (as cited in the study report): DIHYDROTERPINEOL MULTICONSTITUENT
IUPAC Name of the test item: Reaction mass of cis-2-(4-methylcyclohexyl) propan-2-ol and trans-2-(4-methylcyclohexyl) propan-2-ol and
cis- 4-isopropyl-1-methylcyclohexanol and trans- 4-isopropyl-1-methylcyclohexanol
Synonym: Reaction mass of cis-α,α-4-trimethyl-cyclohexanemethanol and trans-α,α-4-trimethyl-cyclohexanemethanol and cis-1-methyl-4-(1-methylethyl)-cyclohexanol and trans-1-methyl-4-(1-methylethyl)-cyclohexanol
Physical state: colourless – slightly amber liquid
Storage Conditions: +2°C to +8°C, under nitrogen and protected from light
Expiry Date: 28 October 2015
Constituent 1
Constituent 2
Constituent 3
Constituent 4
impurity 1
Test animals / tissue source
- Species:
- other: Bovine eye
- Details on test animals or tissues and environmental conditions:
- Origin: Bovine eyes were obtained from EVA, Saint-Pierre-sur-Dives, France.
Age: Bovine cattle were up to 12 months old.
Transport from supplier to testing laboratory: The eyes were transported to testing laboratory at ambient temperature, immerged in buffered Hanks medium containing an antibiotic [Hank’s Balanced Salts Solution (HBSS) plus penicillin/streptomycin (100 units/100 μg/mL final)]. A container with smooth internal surfaces was used for the transport to avoid damage to the corneas.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 μL (± 8 μL) of test item was applied on each cornea
- Concentration (if solution): undiluted
CONTROLS:
Negative control: 0.9 % sodium chloride solution
Positive control: 10 % sodium hydroxide solution - Duration of treatment / exposure:
- The test item was evaluated by using a treatment time of 10 minutes ± 30 seconds.
- Duration of post- treatment incubation (in vitro):
- 2 hours ± 10 minutes in a water bath at 32 ± 1°C.
- Number of animals or in vitro replicates:
- Total: 9 corneas - 3 corneas/group for test item, negative and positive controls
- Details on study design:
- Dose formulation application:
As the test item was a non-viscous liquid, the closed-chamber method was used as follows: the test and control items were introduced into the anterior chamber of the corneal holder through the dosing holes, to cover the epithelial side of the cornea. Then the dosing holes were sealed.
Treatment of corneas:
Corneas obtained from freshly slaughtered cattle (from abattoir) were mounted in corneal holders with the endothelial side against the O-ring of the posterior chamber. For pre-incubation, both chambers of the corneal holder were filled with MEM culture media supplemented with 1% fetal bovine serum plus penicillin/streptomycin (cMEM) and pre-incubated for 1 h and 5 minutes ± 5 minutes at 32 ± 1 °C. Then MEM was removed & then refilled with fresh cMEM and corneas were examined macroscopically for any defects. Then, the opacity of the cornea was measured to obtain OPT0. The medium was removed from anterior chamber and the test item was applied onto the epithelium of the cornea. After application of the dose formulation, the holders were incubated, vertically (cornea positioned horizontally with the treated side uppermost) in a water bath at 32 ± 1 °C, for 10 minutes. At the completion of the treatment period, the test and control items were removed from the front opening of the anterior chamber and the corneas were rinsed. The corneas were then incubated for 2 h ± 10 minutes in a water bath at 32 ± 1 °C and the second opacity measurement (OPT2) was performed.
Permeability determination
- Application of sodium fluorescein: After the second opacity measurement, the medium of the anterior chamber was removed and filled with a fluorescein solution (4 mg/mL). The holders were then incubated vertically (cornea positioned horizontally with the fluorescein-treated side uppermost) in a water bath at 32 ± 1 °C for 90 ± 5 minutes. At the end of the incubation, the optical density at 490 nm (OD490) of the solution from the posterior chamber of each holder was measured in order to determine the permeability of the cornea.
OTHERS:
- Macroscopic examination: After permeability determination, the corneas were removed from the holders and observed for opaque spots, other irregularities and any separation of the epithelium.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 1
- Value:
- 0
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 2
- Value:
- 93
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- 3
- Value:
- 20
- Negative controls validity:
- valid
- Positive controls validity:
- valid
In vivo
- Irritant / corrosive response data:
- - Macroscopic examinations: No notable opaque spots or irregularities were observed on negative control corneas. Fluorescein fixation was observed on all test item-treated corneas. Opacity, fluorescein fixation and thickening of the corneas were observed on those treated with the positive control.
- In Vitro Irritancy Score (IVIS) for test item and positive control were 20 and 187, respectively. - Other effects:
- None
Any other information on results incl. tables
Table 7.3.2/1: Eye irritation – results
GROUP |
OPACITY |
PERMEABILITY |
SCORE |
|||||
|
Holder |
OPT0 |
OPT2 |
OPT2-OPT0 |
cOPT |
OD490 nm |
cOD490 nm |
|
Negative control |
22 |
3 |
2 |
-1.0 |
- |
0.002 |
- |
- |
35 |
3 |
2 |
-1.0 |
- |
0.004 |
- |
- |
|
8 |
3 |
2 |
-1.0 |
- |
0.021 |
- |
- |
|
Mean |
- |
- |
-1.0 |
- |
0.009 |
- |
- |
|
SD |
- |
- |
0.0 |
- |
0.010 |
- |
- |
|
Test item |
45 |
2 |
0 |
-2.0 |
-1.0 |
0.106 |
0.097 |
0 |
5 |
3 |
15 |
12.0 |
13.0 |
1.744 |
1.735 |
39 |
|
38 |
3 |
16 |
13.0 |
14.0 |
0.439 |
0.430 |
20 |
|
Mean |
- |
- |
- |
8.7 |
- |
0.754 |
20 |
|
SD |
- |
- |
- |
8.4 |
- |
0.866 |
19.3 |
|
Positive control |
42 |
3 |
129 |
126.0 |
127.0 |
5.248 |
5.239 |
206 |
18 |
3 |
111 |
108.0 |
109.0 |
5.312 |
5.303 |
189 |
|
16 |
4 |
115 |
111.0 |
112.0 |
3.736 |
3.727 |
168 |
|
Mean |
- |
- |
- |
116.0 |
- |
4.756 |
187 |
|
SD |
- |
- |
- |
9.6 |
- |
0.892 |
18.9 |
OD: optical density
cOD: corrected optical density
cOPT: corrected corneal opacity
SD: standard deviation
OPT0: corneal opacity before treatment
OPT2: corneal opacity after the 2 h recovery period
Applicant's summary and conclusion
- Interpretation of results:
- other: not predictable
- Conclusions:
- The ocular corrosive or severe irritant potential of test item dihydroterpineol multiconstituent could not be predicted. The test item could not be identified as inducing serious eye damage (UN GHS Category 1) or as a test chemical not requiring classification for eye irritation or serious eye damage (no Category).
According to OECD Guideline 437, further testing should be conducted for classification and labeling purposes. - Executive summary:
In an in vitro eye irritation study performed according to OECD Guideline 437 and in compliance with GLP, 750 μL (± 8 μL) of undiluted test item dihydroterpineol multiconstituent was applied to isolated bovine corneas for 10 minutes followed by an incubation period of 2 h at 32 °C. Three corneas were used for each treated series (undiluted test item; negative control; positive control). The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability), were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS).
No notable opaque spots or irregularities were observed on negative control corneas. Fluorescein fixation was observed on all test item-treated corneas. Opacity, fluorescein fixation and thickening of the corneas were observed on those treated with the positive control. In Vitro Irritancy Score (IVIS) for test item and positive control were 20 and 187, respectively.
Therefore, the ocular corrosive or severe irritant potential of the test item could not be predicted. The test item could not be identified as inducing serious eye damage (UN GHS Category 1) or as a test chemical not requiring classification for eye irritation or serious eye damage (no Category).
According to OECD Guideline 437, further testing should be conducted for classification and labeling purposes.
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