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EC number: 909-129-5 | 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:
- 10 July 2018 - 07 August 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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)
- Version / remarks:
- 9 October 2017
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reaction mass of m,alpha-dimethylstyrene and p,alpha-dimethylstyrene (IPT)
- Cas Number:
- Not available.
- Molecular formula:
- No data available.
- IUPAC Name:
- Reaction mass of m,alpha-dimethylstyrene and p,alpha-dimethylstyrene (IPT)
- Test material form:
- liquid
- Details on test material:
- Manufacturer: Mitsui Chemicals Inc.
Storage conditions: at room temperature
Appearance: clear colourless liquid
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: young cattle, obtained from the slaughterhouse Vitelco, 's-Hertogenbosch, The Netherlands.
- Storage, temperature and transport conditions of ocular tissue: eyes were excised by a slaughterhouse employee as soon as possible after slaughter. Subsequently, eyes were collected an transported in physiological saline in a suitable container under cooled conditions.
- The eyes were checked for unacceptable defects and those exhibiting defects were discarded.
- Preparation for use: isolated corneas were stored in a petri dish with cMEM medium containing 1% (v/v) L-glutamine and 1% (v/v) Foetal Bovine Serum, they were mounted in a corneal holder of which the compartments were filled with cMEM of 32 ± 1°C. The corneas were incubated for the minimum of 1 hour at 32 ± 1°C. After the incubation, opacity determinations were performed and corneas that had an initial opacity reading of >7 were not used.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 750 µL
NEGATIVE CONTROL: Physiological saline
- Amount applied: 750 µL
POSITIVE CONTROL: Ethanol
- Amount applied: 750 µL - Duration of treatment / exposure:
- 10 ± 1 minutes
- Duration of post- treatment incubation (in vitro):
- 120 ±10 minutes in cMEM for opacity measurements and subsequently 90 ±5 minutes in sodium-fluorescein for permeability determinations
- Number of animals or in vitro replicates:
- 3 for the negative control, the positive control and the treatment group each in the first test and 3 for the negative control, the positive control and the treatment group each in the repeat test
- Details on study design:
- TREATMENT METHOD: The medium from the anterior compartment was removed and 750 µl of either the negative control, the positive control or test item was introduced onto the epithelium of the cornea. Corneas were incubated in a horizontal position for 10 ± 1 minutes at 32 ± 1°C.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: 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.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: opacity meter (OP-KIT)
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of a microtiter plate reader (TECAN Infinite® M200 Pro Plate Reader, OD490). OD490 values of less than 1.500 were used in the permeability calculation.
- Other: possible pH effects of the test substance on the corneas were recorded.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
OTHER: As the results of the first test were inconclusive, a repeat test was performed under the same conditions as the first test.
DECISION CRITERIA (see table 1):
A test substance that induces an IVIS ≤ 3 is not classified for eye irritancy (UN GHS: no category);
A test substance that induces IVIS >55 is defined as a corrosive or severe irritant (UN GHS: category 1);
For a test substance that induces an IVIS >3 and ≤55, no prediction on irritant potency can be made.
ACCEPTABILITY CRITERIA:
- The positive control gives an in vitro irritancy score that falls within two standard deviations of the current historical mean.
- The negative control responses should result in opacity and permeability values that are less than the upper limits of the laboratory historical range.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean of 3 replicates
- Value:
- 2.4
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: first test
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean of 3 replicates
- Value:
- 7.8
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: repeat test
- Other effects / acceptance of results:
- RESULTS (first test):
- The corneas treated with the test item showed mean OD values values between 0.008 and 0.025, (corrected) permeability values ranged from 0.007 to 0.023 and resulting IVIS were 1.7, 1.7 and 3.8 (n=3).
- The corneas were clear after the 10 minutes treatment with the test item.
- No pH effect of the test item was observed on the rinsing medium.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, results were within the historical range (IVIS ranging from -1.1 to 0.5)
- Acceptance criteria met for positive control: yes, results were within historical range (IVIS ranging from 44-58). Corneas were turbid after 10 minutes of treatment.
RESULTS (repeat test):
- The corneas treated with the test item showed mean OD values between 0.112 and 0.468, (corrected) permeability values ranged from 0.100 to 0.456 and resulting IVIS were 8.7, 5.5 and 9.3 (n=3).
- The corneas were slightly translucent after the 10 minutes of treatment with test item.
- No pH effect of the test item was observed on the rinsing medium.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes, results were within the historical range (IVIS ranging from 1.9 to 3.5)
- Acceptance criteria met for positive control: yes, results were within historical range (IVIS ranging from 66-78). Corneas were turbid after 10 minutes of treatment.
Any other information on results incl. tables
Table 2 In Vitro Irritancy Scores (first test)
Treatment |
Final Opacity2 |
Final OD4902 |
In vitroIrritancy Score1 |
|
|||
Negative control |
-1.1 |
-0.001 |
-1.1 |
0.4 |
0.004 |
0.5 |
|
-0.6 |
0.001 |
-0.6 |
|
|
|||
Positive control |
28 |
1.066 |
44 |
28 |
1.970 |
58 |
|
29 |
1.193 |
46 |
|
|
|||
Test item |
1.4 |
0.023 |
1.7 |
1.5 |
0.010 |
1.7 |
|
3.7 |
0.007 |
3.8 |
1 In vitro irritancy score (IVIS) = opacity value + (15 x OD490value).
2 Positive control and test item are corrected for the negative control.
Table 3 In Vitro Irritancy Scores (repeat test)
Treatment |
Final Opacity2 |
Final OD4902 |
In vitroIrritancy Score1 |
|
|||
Negative control |
1.7 |
0.016 |
1.9 |
3.4 |
0.009 |
3.5 |
|
2.5 |
0.012 |
2.7 |
|
|
|||
Positive control |
18 |
3.171 |
66 |
20 |
3.871 |
78 |
|
21 |
3.089 |
68 |
|
|
|||
Test item |
4.2 |
0.300 |
8.7 |
4.0 |
0.100 |
5.5 |
|
2.4 |
0.456 |
9.3 |
1 In vitro irritancy score (IVIS) = opacity value + (15 x OD490value).
2 Positive control and test item are corrected for the negative control.
Table 4 Historical Data for the BCOP Studies
|
Negative control |
Positive control |
||
|
Opacity |
Permeability |
In vitro Irritancy Score |
In vitro Irritancy Score |
Range |
-2.9 – 3.0 |
-0.034 – 0.100 |
-2.8 – 3.0 |
28.0 – 110.9 |
Mean |
0.25 |
0.00 |
0.31 |
55.03 |
SD |
1.13 |
0.01 |
1.19 |
15.08 |
n |
118 |
118 |
118 |
94 |
SD = Standard deviation
n = Number of observations
The above mentioned historical control data range of the controls were obtained by collecting all data over the period of May 2015 to May 2018.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Results are inconclusive
- Conclusions:
- In the Bovine Corneal Opacity and Permeability test (BCOP) performed according to OECD guideline 437 and GLP principles, no prediction could be made on the classification for eye irritation of Reaction mass of m, alpha-dimethylstyrene and p, alpha-dimethylstyrene as the test item induced an IVIS > 3 ≤ 55 in 4 out of 6 corneas.
- Executive summary:
A Bovine Corneal Opacity and Permeability test (BCOP) was performed with Reaction mass of m, alpha-dimethylstyrene and p, alpha-dimethylstyrene according to OECD guideline 437 and GLP principles. The test item was applied undiluted (750 µL/ cornea, n=6, in two experiments). The mean in vitro irritancy score of the positive control (Ethanol) for the first and second experiments were 50 and 71, respectively, and the mean in vitro irritancy score of the negative control (physiological saline) were -0.4 and 2.7, respectively. It was therefore concluded that the test conditions were adequate and that the test system functioned properly in both experiments. In the first experiment, the test item did induce ocular irritation through one endpoint (opacity) in 1 out of the 3 eyes. This resulted in individual IVIS scores which were spread over two categories (1.7, 1.7 and 3.8, respectively). In the repeat experiment, the test item induced ocular irritation through both endpoints, resulting in individual in vitro irritancy scores of 8.7, 5.5 and 9.3 (mean = 7.8) after 10 minutes of treatment. Since Reaction mass of m, alpha-dimethylstyrene and p, alpha-dimethylstyrene induced an IVIS > 3 ≤ 55 in 4 out of 6 corneas, no conclusion on the classification can be drawn based on this data.
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