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EC number: 418-420-1 | 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:
- 27 May 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
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
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- other: Crystalline semi-solid
- Details on test material:
- Identification: Reaction Mass of 4-tert-butyl-2-hydroxycyclohexyl methacrylate and 5-tert-butyl-2-hydroxycyclohexyl methacrylate
- Specific details on test material used for the study:
- Purity/composition correction factor: No correction factor requiredTest item handling: Use amber glassware or wrap container in aluminum-foilStability at higher temperatures: Not stableChemical name (IUPAC), synonym or trade name: Reaction Mass of 4-tert-butyl-2-hydroxycyclohexyl methacrylate and 5-tert-butyl-2-hydroxycyclohexyl methacrylateCAS Number: 128840-36-8Molecular formula: C14H24O3Molecular weight: 240.34
Test animals / tissue source
- Species:
- other: bovine
- Strain:
- other: Not applicable
- Details on test animals or tissues and environmental conditions:
- No data, Bovine eyes collected from abattoir straight after slaughter
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: positive and negative control bovine eyes were used
- Amount / concentration applied:
- 750 uL of the control, positive control or test item were apllied to the eppithelium of the cornea.
- Duration of treatment / exposure:
- 10 minutes
- Observation period (in vivo):
- ca. 130 minutes post exposure for opacity, and ca. 220 minutes post exposure for permeability.
- Number of animals or in vitro replicates:
- N/A
- Details on study design:
- Bovine corneas were collected immediatly after slaughter and were checked for defects e.g. opacity, scratches, pigmentation and neovascularization whilst being held in the light. Any showing defects were discarded.The isolated corneas were stored in petri dishes with Earle's Minimum Essential Medium (cMEM) containing 1 % (v/v) L-glutamine and 1 % (v/v)Foetal Bovine Serum. The isolated corneas were mounted in a holder (BASF) with the endothelial side against the O-ring of the posterior half of the holder.The corneal holder compartments were filled with cMEM (32 +/- 1 degrees C) and incubated for a minimum of 1 hour at the same tempreture. After incubation the medium was removed and opacity was checked of each cornea using an opacitometer (BASF-OP3.0, Ludwigshafen, Germany). Corneas with an initial opacity reading of more than 7 were discarded, measures were corrected against cMEM only values. Three corneas were selected without bias for each treatment. Medium was added to the posterior compartment at test initiation, with the anterior compartment filled with 750 uL of negative control, positive control (ethanol) or test item. The holders were slightly rotated, with the corneas maintained in a horizontal position, to ensure uniform distribution of the control or the test item over the entire cornea. Corneas were then incubated for 10 minutes, after which solutions were removed and the epithelium washed with MEM (Earle's Minimum Essential Medium only) with Phenol red, and thereafter cMEM. Possible pH effects on the cornea were recorded. The medium in the posterior compartment was then replaced with fresh cMEM. Subsequently the corneas were incubated for 120 +/- 10 minutes at 32 degrees C. After the completion of the incubation period opacity determination was performed. Each cornea was inspected visually for dissimilar opacity patterns.The opacity of a cornea was measured by the diminution of light passing through the cornea (calculation in full report).The change in opacity for each individual cornea (including the negative control) was calculated by subtracting the initial opacity reading from the final post-treatment reading. The corrected opacity for each treated cornea with the test item or positive control was calculated by subtracting the average change in opacity of the negative control corneas from the change in opacity of each test item or positive control treated cornea.Permeability of the cornea to Na-fluorescein was evaluated after opacity. The medium of both compartments (anterior compartment first) was removed. The posterior compartment was refilled with fresh cMEM. The anterior compartment was filled with 1 ml of 4 mg Na-fluorescein (Sigma-Aldrich Chemie GmbH, Germany)/ml cMEM solution. The holders were slightly rotated, with the corneas maintained in a horizontal position, to ensure uniform distribution of the sodium-fluorescein solution over the entire cornea. Corneas were incubated in a horizontal position for 90 +/- 5 minutes at 32 degrees C.After the incubation period the posterior compartments medium was removed and 360 uL from each sample was transferred to a 96-well plate and the optical density was meaured at 490 nm. OD was corrected against a cMEM blank and mean OD was calculated. Mean opacity and permeability was used to estimate the in vitro irritancy score (IVIS) as follows: IVIS = mean opacity + (15 x mean OD490 value)
Results and discussion
In vivo
Results
- Irritation parameter:
- other: in vitro irritation score
- Basis:
- mean
- Time point:
- other: 90 miutes
- Score:
- 2.4
- Max. score:
- 6.7
- Reversibility:
- not specified
- Remarks on result:
- other: bovine corneas were checked 90 minutes after removal of exposure medium, total exposure to test condition was 10 minutes
- Irritant / corrosive response data:
- Response data (opactiy and permeability) and historical control data can be seen in Tables 1-6. Mean data and data per replicate are presented for comleteness.The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical rangeindicating that the negative control did not induce irritancy on the corneas (Table 6). The mean in vitro irritancy score of the positive control (Ethanol) was 49 and was within two standard deviations of the current historical positive control mean (Table 1 and Table 5). It was therefore concluded that the test conditions were adequate and that the test system functioned properly.The test item did notinduce ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 2.4 after 10 minutes of treatment (Table 1 and 5)
- Other effects:
- No pH effect of the test item was observed on the rinsing medium.
Any other information on results incl. tables
Table1 Summary of opacity, permeability and in vitro scores
Treatment | Mean Opacity1 | Mean Permeability1 | Mean In vitro Irritation Score1, 2 |
Negative control | -0.1 | -0.004 | -0.2 |
Positive control (Ethanol) | 24.9 | 1.579 | 48.6 |
Test item | 1.7 | 0.053 | 2.4 |
1 Calculated using the negative control mean opacity and mean permeability values for the positive control and test item.
2 In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490value).
Table2 Opacity score
Treatment | Opacity before treatment | Opacity after treatment | Final Opacity1 | Negative control corrected Final Opacity2 | Mean Final Opacity | |
| ||||||
Negative control | 2.5 | 1.7 | -0.8 |
| -0.1 | |
2.8 | 3.0 | 0.2 | ||||
3.5 | 3.7 | 0.3 | ||||
| ||||||
Positive control | 3.5 | 28.0 | 24.5 | 24.5 | 24.9 | |
3.8 | 30.9 | 27.1 | 27.1 | |||
2.7 | 25.9 | 23.2 | 23.2 | |||
| ||||||
Test item | 2.9 | 2.6 | -0.2 | -0.2 | 1.7 | |
2.5 | 7.5 | 4.9 | 4.9 | |||
2.6 | 2.9 | 0.3 | 0.3 | |||
1 Final Opacity = Opacity after treatment – Opacity before treatment.
2 Negative control corrected Final Opacity = Final opacity – Mean final opacity negative control.3
3 In case the mean final opacity of the negative control is below zero, no correction will be made.
4 Calculations are made without rounding off.
Table3 Permeability scoreindividual values (uncorrected)
Treatment | Dilution factor | OD490 1 | OD490 2 | OD490 3 | Average OD | Final OD | Mean final negative control | |||||
|
|
| ||||||||||
Negative control | 1 | -0.006 | -0.002 | -0.002 | -0.003 | -0.003 | -0.004 | |||||
1 | -0.007 | -0.004 | -0.004 | -0.005 | -0.005 | |||||||
1 | -0.008 | -0.002 | -0.004 | -0.005 | -0.005 | |||||||
|
|
| ||||||||||
Positive control | 6 | 0.373 | 0.373 | 0.374 | 0.373 | 2.240 |
| |||||
1 | 0.629 | 0.616 | 0.637 | 0.627 | 0.627 |
| ||||||
6 | 0.305 | 0.302 | 0.300 | 0.302 | 1.814 |
| ||||||
|
|
| ||||||||||
Test item | 1 | 0.026 | 0.023 | 0.023 | 0.024 | 0.024 |
| |||||
1 | 0.120 | 0.116 | 0.111 | 0.116 | 0.116 |
| ||||||
1 | 0.001 | 0.010 | 0.008 | 0.006 | 0.006 |
| ||||||
1 Calculations are made without rounding off.
Table4 Permeability score individual values (corrected)
Treatment | Dilution factor | Negative control corrected OD49011 | Negative control corrected OD49021 | Negative control corrected OD49031 | Negative control corrected OD490 Average | Negative control corrected final OD490 | Average OD |
| |||||||
Positive control | 6 | 0.377 | 0.377 | 0.378 | 0.378 | 2.266 | 1.579 |
6 | 0.633 | 0.620 | 0.641 | 0.632 | 0.632 | ||
6 | 0.309 | 0.306 | 0.304 | 0.307 | 1.840 | ||
| |||||||
Test item | 1 | 0.030 | 0.027 | 0.027 | 0.028 | 0.028 | 0.053 |
1 | 0.124 | 0.120 | 0.115 | 0.120 | 0.120 | ||
1 | 0.005 | 0.014 | 0.012 | 0.011 | 0.011 |
1 OD490values corrected for the mean final negative control permeability (-0.004).
2 Calculations are made without rounding off.
Table 5 In Vitro irritancy score
Treatment | Final Opacity2 | Final OD4902 | In vitro Irritancy Score1 |
| |||
Negative control | -0.8 | -0.003 | -0.8 |
0.2 | -0.005 | 0.1 | |
0.3 | -0.005 | 0.2 | |
| |||
Positive control | 24.5 | 2.266 | 58.5 |
27.1 | 0.632 | 36.6 | |
23.2 | 1.840 | 50.8 | |
| |||
Test item | -0.2 | 0.028 | 0.2 |
4.9 | 0.120 | 6.7 | |
0.3 | 0.011 | 0.4 |
1 In vitro irritancy score (IVIS) = opacity value + (15 x OD490value).
2 Positive control and test item are corrected for the negative control.
Table6 Historical control data for the BCOP studies
Negative control | Positive control | |||
Opacity | Permeability | In vitroIrritancy Score | In vitroIrritancy Score | |
Range | -2.9 – 3.0 | -0.016 – 0.029 | -2.8 – 3.0 | 35.8 – 72.9 |
Mean | 0.25 | 0.00 | 0.34 | 56.58 |
SD | 1.07 | 0.01 | 1.18 | 12.51 |
n | 51 | 43 | 45 | 21 |
SD = Standard deviation
n = Number of observations
Data over Feb 2015 - May 2016.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information No classification Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Since Reaction Mass of 4-tert-butyl-2-hydroxycyclohexyl methacrylate and 5-tert-butyl-2-hydroxycyclohexyl methacrylate induced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage (ECHA, Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Section 3.3, 2015.
- Executive summary:
Evaluation of the eye hazard potential of Reaction Mass of 4-tert-butyl-2-hydroxycyclohexyl methacrylate and 5-tert-butyl-2-hydroxycyclohexyl methacrylate using the Bovine Corneal Opacity and Permeability test (BCOP test).
An excess amount of the test item was applied as it is directly on top of the corneas. The eye damage of the test item was tested through topical application for 10 minutes.
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 49 and was within two standard deviations of the current historical positive control mean. One cornea had an opaque off white spot on it, which was assumed not to be an affect of the test item but potentially some undissolved test item.
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 2.4 after 10 minutes of treatment.
Since Reaction Mass of 4-tert-butyl-2-hydroxycyclohexyl methacrylate and 5-tert-butyl-2-hydroxycyclohexyl methacrylateinduced an IVIS ≤ 3, no classification is required for eye irritation or serious eye damage.
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