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EC number: 214-189-4 | CAS number: 1112-39-6
- 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:
- 9 Nov 2021
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 022
- Report date:
- 2022
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:
- adopted 26 June 2020
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dimethoxydimethylsilane
- EC Number:
- 214-189-4
- EC Name:
- Dimethoxydimethylsilane
- Cas Number:
- 1112-39-6
- Molecular formula:
- C4H12O2Si
- IUPAC Name:
- dimethoxydimethylsilane
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: slaughterhouse (Vitelco, 's Hertogenbosch, The Netherlands)
- Storage, temperature and transport conditions of ocular tissue: Eyes were collected and transported in physiological saline in a suitable container under cooled conditions.
- Time interval prior to initiating testing: Eyes were tested the day of arrival in the laboratory.
- Indication of any existing defects or lesions in ocular tissue samples: no
- Indication of any antibiotics used: no
- Quality check of the isolated corneas: The eyes were checked for unacceptable defects, such as opacity, scratches, pigmentation and neovascularization by removing them from the physiological saline and holding them in the light. Those exhibiting defects were discarded.
- Selection and preparation of corneas: The isolated corneas were stored in a petri dish with cMEM (Eagle’s Minimum Essential Medium containing 1% (v/v) L-glutamine and 1% (v/v) Foetal Bovine Serum).
The isolated corneas were mounted in a corneal holder (one cornea per holder) with the endothelial side against the O-ring of the posterior half of the holder. The anterior half of the holder was positioned on top of the cornea and tightened with screws. The compartments of the corneal holder 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 period, the medium was removed from both compartments and replaced with fresh cMEM. Opacity determinations were performed on each of the corneas using an opacitometer. The opacity of each cornea was read against a cMEM-filled chamber, and the initial opacity reading thus determined was recorded. Corneas that had an initial opacity reading higher than 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
- Concentration: neat
Negative and positive control
- Amount(s) applied: 750 µL
- Duration of treatment / exposure:
- 10 ± 1 min at 32 ± 1°C
- Duration of post- treatment incubation (in vitro):
- 120 ± 10 minutes at 32 ± 1°C
- Number of animals or in vitro replicates:
- triplicates for each treatment and control groups
- Details on study design:
- TREATMENT METHOD:
The medium from the anterior compartment was removed and 750 µL of either the negative control, positive control or test item was introduced onto the epithelium of the cornea. 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 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 (Eagle’s Minimum Essential Medium, Life Technologies) and thereafter with cMEM. Possible pH effects of the test item on the corneas were recorded. The medium in the posterior compartment was removed and both compartments were refilled with fresh cMEM. Subsequently the corneas were incubated for 120 ± 10 minutes at 32 ± 1°C.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: The opacity of a cornea was measured by the diminution of light passing through the cornea.
The light was measured as illuminance (I = luminous flux per area, unit: lux) by a light meter.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of a microtiter plate reader (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS) = mean opacity value + (15 x mean OD490 value)
DECISION CRITERIA:
Test substance with an IVIS > 55 was regarded as serious eye damage and labelled Category 1 according to CLP/EPS/GHS.
Test substance with an IVIS ≤ 3 was regarded as non-irritant and labelled in no category.
Test substance with an IVIS > 3; ≤ 55 no prediction can be made.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Remarks:
- mean value of 3 corneas
- Run / experiment:
- 10 min exposure
- Value:
- 16
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- no definite prediction on ocular irritation can be made
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: The corneas treated with the positive control and test item were observed to be turbid after the 10 min treatment.
- pH effects: No pH effects of the negative and positive controls as well as of the test item were observed on the rinsing of the corneas with MEM (with phenol red).
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes for two negative controls: the negative control responses resulted in opacity and permeability values that were less than the upper limits of the laboratory historical range. One of the negative control eyes was excluded from the analysis since the permeability was increased. This resulted in an IVIS above the cut-off value of 3.0. This had no impact on the study validity.
- Acceptance criteria met for positive control: yes: the positive control gave an in vitro irritancy score that fell within two standard deviations of the current historical mean.
Any other information on results incl. tables
Table 1: Summary of Opacity, Permeability and In Vitro Scores
Treatment |
Mean Opacity1 |
Mean Permeability1 |
Mean In vitro Irritation Score1, 2 |
Negative control |
-0.3 |
-0.018 |
-0.6 |
Positive control (Ethanol) |
19 |
1.110 |
36 |
Test item |
8.7 |
0.474 |
16 |
1 Calculated using the negative control corrected 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 OD490 value).
Table 2: Opacity Score
Treatment |
Opacity before treatment |
Opacity after treatment |
Final Opacity1 |
Negative control corrected Final Opacity2 |
Mean Final Opacity |
Negative control |
3.7* |
2.5* |
-1.2* |
|
-0.3
|
1.9 |
2.1 |
0.2 |
|||
1.9 |
1.0 |
-0.9 |
|||
Positive control |
3.4 |
22.5 |
19.1 |
19 |
19
|
1.5 |
17.5 |
15.9 |
16 |
||
3.5 |
25.8 |
22.3 |
22 |
||
Test item |
2.7 |
10.5 |
7.8 |
7.8 |
8.7 |
2.2 |
11.2 |
9.0 |
9.0 |
||
0.9 |
10.0 |
9.1 |
9.1 |
Calculations are made without rounding off.
1 Final Opacity = Opacity after treatment – Opacity before treatment.
2 Negative control corrected Final Opacity = Final opacity – Mean final opacity negative control.
3 In case the mean final opacity of the negative control is below zero, no correction will be made.
* Excluded from analysis.
Table 3: Permeability Score Individual Values (Uncorrected)
Treatment |
Dilution factor |
OD490 |
OD490 |
OD490 |
Average OD |
Final OD |
Mean final negative control |
1 |
2 |
3 |
|||||
Negative control |
1 |
0.583* |
0.589* |
0.587* |
0.586* |
0.586*1 |
-0.018 |
1 |
-0.011 |
-0.020 |
-0.018 |
-0.016 |
-0.016 |
||
1 |
-0.022 |
-0.019 |
-0.020 |
-0.020 |
-0.020 |
||
Positive control |
1 |
1.381 |
1.378 |
1.380 |
1.380 |
1.380 |
|
1 |
1.051 |
1.042 |
1.040 |
1.044 |
1.044 |
|
|
1 |
0.853 |
0.852 |
0.852 |
0.852 |
0.852 |
|
|
Test item |
1 |
0.400 |
0.395 |
0.394 |
0.396 |
0.396 |
|
1 |
0.477 |
0.477 |
0.481 |
0.478 |
0.478 |
|
|
1 |
0.496 |
0.493 |
0.486 |
0.492 |
0.492 |
|
* Excluded from analysis.
Calculations are made without rounding off.
Table 4: Permeability Score Individual Values (Corrected)
Treatment |
Dilution factor |
Negative control corrected OD490 1# |
Negative control corrected OD490 2# |
Negative control corrected OD490 3# |
Negative control corrected OD490 Average |
Negative control corrected final OD490 |
Average OD |
Positive control |
1 |
1.399 |
1.396 |
1.398 |
1.398 |
1.398 |
1.110 |
1 |
1.069 |
1.060 |
1.058 |
1.063 |
1.063 |
||
1 |
0.871 |
0.870 |
0.870 |
0.871 |
0.871 |
||
Test item |
1 |
0.418 |
0.413 |
0.412 |
0.415 |
0.415 |
0.474 |
1 |
0.495 |
0.495 |
0.499 |
0.497 |
0.497 |
||
1 |
0.514 |
0.511 |
0.504 |
0.510 |
0.510 |
Calculations are made without rounding off.
# OD490 values corrected for the mean final negative control permeability (-0.018).
Table 5: In Vitro Irritancy Score
Treatment |
Final Opacity2 |
Final OD4902 |
In vitro Irritancy Score1 |
Negative control |
-1.2* |
0.586* |
7.6* |
0.2 |
-0.016 |
0.0 |
|
-0.9 |
-0.020 |
-1.2 |
|
Positive control |
19 |
1.398 |
40 |
16 |
1.063 |
32 |
|
22 |
0.871 |
35 |
|
Test item |
7.8 |
0.415 |
14.1 |
9.0 |
0.497 |
16.5 |
|
9.1 |
0.510 |
16.7 |
1 In vitro irritancy score (IVIS) = opacity value + (15 x OD490 value).
2 Positive control and test item are corrected for the negative control.
* Excluded from analysis.
Table 6: Historical
Control Data for the BCOP Studies
|
Negative control |
Positive control |
||
|
Opacity |
Permeability |
In vitro Irritancy Score |
In vitro Irritancy Score |
Min |
-2.50 |
-0.017 |
-2.50 |
26 |
Max |
3.70 |
0.065 |
4.00 |
86 |
Mean |
0.86 |
0.002 |
0.89 |
50 |
SD |
1.26 |
0.009 |
1.28 |
14 |
n |
143 |
143 |
143 |
143 |
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 2018 to May 2021.
Applicant's summary and conclusion
- Interpretation of results:
- other: non-corrosive
- Conclusions:
- In a BCOP test according to OECD TG 437 and in compliance with GLP, dimethoxy(dimethyl)silane induced ocular irritation as assessed for both endpoints (corneal opacity and
permeability), resulting in a mean in vitro irritancy score (IVIS) of 16 after 10 minutes of treatment. Since the test substance induced an IVIS > 3 ≤ 55, no definitive prediction on ocular irritation can be made.
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