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EC number: 700-923-5 | CAS number: 10305-39-2
- 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:
- 23 Augustus 2019 - 24 September 2019
- 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 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 October 09, 2017
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 3-octoxypropane-1,2-diol
- Cas Number:
- 10438-94-5
- Molecular formula:
- C11H24O3
- IUPAC Name:
- 3-octoxypropane-1,2-diol
- Test material form:
- liquid
- Details on test material:
- Storage Conditions: At room temperature protected from light container flushed with nitrogen.
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: Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, 's Hertogenbosch, The Netherlands), where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter.
- Transport: Eyes were collected and transported in physiological saline in a suitable container under cooled conditions.
- Indication of any existing defects or lesions in ocular tissue samples: no
- Indication of any antibiotics used: no
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 750 µL, undiluted - Duration of treatment / exposure:
- 10 ± 1 minutes
- Duration of post- treatment incubation (in vitro):
- 120 ± 10 minutes
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
The isolated corneas were stored in a petri dish with cMEM (Earle’s Minimum Essential Medium (Life Technologies, Bleiswijk, The Netherlands) containing 1% (v/v) L-glutamine
(Life Technologies) and 1% (v/v) Foetal Bovine Serum (Life Technologies)). The isolated corneas were mounted in a corneal holder (one cornea per holder) of BASF (Ludwigshafen,
Germany) 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.
QUALITY CHECK OF THE ISOLATED CORNEAS
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 (BASF-OP3.0, BASF, Ludwigshafen, Germany). 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.
NUMBER OF REPLICATES
Three corneas were selected at random for each treatment group.
NEGATIVE CONTROL USED
Physiological saline
POSITIVE CONTROL USED
Ethanol
TREATMENT METHOD:
The medium from the anterior compartment was removed and 750 µL of either the negative control, positive control (Ethanol) 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: Once with cMEM and once with MEM. Possible pH effects of the test item on the corneas were recorded.
POST-EXPOSURE INCUBATION:
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 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. The mean opacity value of each treatment group was calculated by averaging the corrected opacity values of the treated corneas for each treatment group.
- Corneal permeability: Following the final opacity measurement, permeability of the cornea to Na-fluorescein was evaluated. 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 ± 1°C. After the incubation period, the medium in the posterior compartment of each holder was removed and placed into a sampling tube labelled according to holder number. 360 μL of the medium from each sampling tube was transferred to a 96-well plate. The optical density at 490 nm (OD490) of each sampling tube was measured in triplicate using a microplate reader (TECAN Infinite® M200 Pro Plate Reader).
SCORING SYSTEM: In Vitro Irritancy Score (IVIS) :
The mean opacity and mean permeability values (OD490) were used for each treatment group to calculate an in vitro score:
In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
ACCEPTABILITY CRITERIA:
The assay is considered acceptable if:
- 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.
DECISION CRITERIA:
The IVIS cut-off values for identifying the test items as inducing serious eye damage (UN GHS Category 1) and test items not requiring classification for eye irritation or serious eye damage (UN GHS No Category) are given in table 1 (see other information on materials and methods).
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Experiment 1
- Value:
- 68
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 0.5
- Positive controls validity:
- valid
- Remarks:
- 36
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- cornea opacity score
- Remarks:
- mean
- Run / experiment:
- Experiment 1
- Value:
- 5.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 0.5
- Positive controls validity:
- valid
- Remarks:
- 16
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- other: Mean permeability
- Run / experiment:
- Experiment 1
- Value:
- 4.161
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- 0.000
- Positive controls validity:
- valid
- Remarks:
- 1.319
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: no
DEMONSTRATION OF TECHNICAL PROFICIENCY:
The mean in vitro irritancy score of the positive control (Ethanol) was 36 and within two standard deviations of the current historical positive control mean (mean 51.31, SD 13.72). The opacity and permeability values for the negative control varied between 2.0 - 3.3 and -0.004 - 0.011, respectively which is less than the upper limits of the laboratory historical ranges (3.0 for opacity and 0.1 for permeability). It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
Any other information on results incl. tables
Table 1
Summary of Opacity, Permeability and In Vitro Scores
Treatment |
Mean Opacity1 |
Mean Permeability1 |
MeanIn vitroIrritation Score1, 2 |
Negative control |
0.5 |
0.000 |
0.5 |
Positive control (Ethanol) |
16 |
1.319 |
36 |
SaskineTM80 |
5.9 |
4.161 |
68 |
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 OD490value).
Table 2
Opacity Score
Treatment |
Opacity before treatment |
Opacity after treatment |
Final Opacity1 |
Negative control corrected Final Opacity2 |
Mean Final Opacity |
|
|
||||||
Negative control |
2.7 |
2.1 |
-0.6 |
|
0.5 |
|
2.9 |
3.8 |
0.9 |
||||
2.0 |
3.3 |
1.3 |
||||
|
||||||
Positive control |
2.0 |
17.6 |
15.6 |
15 |
16 |
|
1.9 |
19.2 |
17.3 |
17 |
|||
1.8 |
18.1 |
16.3 |
16 |
|||
|
||||||
SaskineTM80 |
2.6 |
9.8 |
7.3 |
6.8 |
5.9 |
|
2.6 |
7.3 |
4.8 |
4.2 |
|||
-0.8 |
6.3 |
7.1 |
6.6 |
|||
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.
Table 3
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 |
1 |
1.449 |
1.462 |
1.445 |
1.452 |
1.452 |
1.319 |
1 |
0.808 |
0.796 |
0.787 |
0.797 |
0.797 |
||
6 |
0.284 |
0.284 |
0.288 |
0.285 |
1.710 |
||
|
|||||||
SaskineTM80 |
6 |
0.767 |
0.772 |
0.777 |
0.772 |
4.630 |
4.161 |
6 |
0.707 |
0.702 |
0.716 |
0.708 |
4.248 |
||
6 |
0.598 |
0.607 |
0.598 |
0.601 |
3.604 |
Calculations are made without rounding off.
1 OD490values corrected for the mean final negative control permeability (0.000).
Table 4
In Vitro Irritancy Score
Treatment |
Final Opacity2 |
Final OD4902 |
In vitroIrritancy Score1 |
|
|||
Negative control |
-0.6 |
0.001 |
-0.6 |
0.9 |
-0.003 |
0.8 |
|
1.3 |
0.003 |
1.3 |
|
|
|||
Positive control |
15 |
1.452 |
37 |
17 |
0.797 |
29 |
|
16 |
1.710 |
41 |
|
|
|||
SaskineTM80 |
6.8 |
4.630 |
76 |
4.2 |
4.248 |
68 |
|
6.6 |
3.604 |
61 |
1 In vitro irritancy score (IVIS) = opacity value + (15 x OD490value).
2 Positive control and test item are corrected for the negative control.
Table 5
Historical Control Data for the BCOP Studies
|
Negative control |
Positive control |
||
|
Opacity |
Permeability |
In vitroIrritancy Score |
In vitroIrritancy Score |
Range |
-2.0 – 3.0 |
-0.034 – 0.100 |
-2.2 – 3.0 |
24.0 – 89.6 |
Mean |
0.54 |
0.00 |
0.58 |
51.31 |
SD |
1.23 |
0.01 |
1.26 |
13.72 |
n |
120 |
120 |
120 |
108 |
SD = Standard deviation
n = Number of observations
Applicant's summary and conclusion
- Interpretation of results:
- other: Serious eye damage (category 1)
- Remarks:
- According to Regulation (EC) No. 1272/2008 and its amendments.
- Conclusions:
- In a Bovine Corneal Opacity and Permeability test performed according to OECD TG 437 the substance induced an IVIS ≥ 55 and is concluded to induce serious eye damage.
- Executive summary:
A Bovine Corneal Opacity and Permeability (BCOP) test was performed according to OECD TG 437 and in accordance with GLP principles. The test item was applied as it is (750 µL) directly on top of the corneas. The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range. The mean in vitro irritancy score of the positive control (Ethanol) was 36 and was within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly. The substance induced ocular irritation through both endpoints, resulting in a mean in vitro irritancy score of 68 after 10 minutes of treatment. In conclusion, the substance induced an IVIS ≥ 55 and is considered to induce serious eye damage in the BCOP and should be classified category 1 according to Regulation (EC) No. 1272/2008 and its amendments.
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