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EC number: 939-017-1 | CAS number: 1469982-94-2
- 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:
- The study was performed on 03 August 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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 (incl. QA statement)
- Remarks:
- Date of Inspection : 10 July 2012 Date of Signature : 07 February 2013
Test material
- Reference substance name:
- Isostearamide DEA
- IUPAC Name:
- Isostearamide DEA
- Test material form:
- other: Liquid
- Details on test material:
- Sponsor's identification : Isostearamide DEA
Description : amber coloured liquid
Batch number : OE11124 (6/202593/00)
Purity : 100% - UVCB
Date received : 14 May 2012
Expiry date : not supplied
Storage conditions : room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- other: Excised Bovine Cornea
- Strain:
- other: Not Applicable
- Details on test animals or tissues and environmental conditions:
- Not applicable
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST ITEM
-Amounts(s) applied (volume or weight with unit):
0.75 mL of the test item was applied to triplicate corneas.
-Concentration (if solution):
The test item was used as supplied.
VEHICLE
No vehicle used - Duration of treatment / exposure:
- The undiluted test item was applied for 10 minutes followed by an incubation period of 120 minutes.
- Observation period (in vivo):
- Not applicable
- Number of animals or in vitro replicates:
- Not applicable
- Details on study design:
- TEST SITE
-Area of exposure
0.75 mL of the test item was applied to triplicate corneas.
-% coverage:
The test item was topically applied to the cornea. The holders were gently tilted back and forth to ensure a uniform application of the item over the entire cornea.
-Type of wrap used:
None used
REMOVAL OF TEST ITEM
-Washing (if done):
At the end of the exposure period the test item was removed from the anterior chamber and each cornea was rinsed three times with fresh complete MEM containing phenol red before a final rinse with complete MEM without phenol red.
-Time after start of exposure:
10 minutes post exposure
EVALUATION OF RESULTS
Results from the two test method endpoints, opacity and permeability, were combined in an empirically derived formula to generate an In Vitro Irritancy Score.
Opacity Measurement-
The change in opacity for each cornea (including the negative control) was calculated by subtracting the initial opacity reading from the final opacity reading. These values were then corrected by subtracting from each the average change in opacity observed for the negative control corneas. The mean opacity value of each treatment group was then calculated by averaging the corrected opacity values of each cornea for that treatment group.
Permeability Measurement
The corrected OD492 was calculated by subtracting the mean OD492 of the negative control corneas from the OD492 value of each treated cornea. The OD492 value of each treatment group was calculated by averaging the corrected OD492 values of the treated corneas for the treatment group.
In Vitro Irritancy Score
The following formula was used to determine the in vitro score:
In Vitro Irritancy Score = mean opacity value + (15 x mean OD492 value)
Additionally, the opacity and permeability values were evaluated independently to determine whether the test item induced a response through only one of the two endpoints.
Visual Observation
The condition of the cornea was visually assessed immediately after rinsing and at the final opacity measurement.
DATA INTERPRETATION
A test item that induces an in vitro irritancy score greater than or equal to 55.1 is defined as an ocular corrosive or severe irritant.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 1
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: not ocular corrosive or severe irritant
Any other information on results incl. tables
RESULTS
Corneal Opacity and Permeability Measurement
Individual and mean corneal opacity measurements and individual and mean corneal permeability measurements are given in Table 1.
Corneal Epithelium Condition
The condition of the cornea immediately after rinsing and at the final opacity measurement is given in Table 2.
The corneas treated with the test item were clear post treatment and post incubation. The corneas treated with the negative control item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation.
In Vitro Irritancy Score
The results are summarised as follows:
Treatment |
In Vitro Irritancy Score |
Test Item |
1.0 |
Negative Control |
1.5 |
Positive Control |
33.4 |
Criteria for an Acceptable Test
The positive control In Vitro irritancy Score was within the range of 30.9 to 67.7. The positive control acceptance criterion was therefore satisfied.
Table 1 Individual and Mean Corneal Opacity and Permeability Measurements
Treatment |
Cornea Number |
Opacity |
Permeability (OD) |
In vitroIrritancy Score |
|||||
Pre-Treatment |
Post-Treatment |
Post-Incubation |
Post-Incubation-Pre‑Treatment |
Corrected Value |
|
Corrected Value |
|||
Negative Control |
1 |
4 |
4 |
5 |
1 |
|
0.042 |
|
|
2 |
3 |
2 |
4 |
1 |
|
0.030 |
|
|
|
3 |
4 |
4 |
5 |
1 |
|
0.031 |
|
|
|
|
|
|
|
1.0* |
|
0.034+ |
|
1.5 |
|
Positive Control |
4 |
2 |
27 |
28 |
26 |
25.0 |
0.408 |
0.374 |
|
5 |
2 |
28 |
26 |
24 |
23.0 |
0.556 |
0.522 |
|
|
6 |
4 |
37 |
37 |
33 |
32.0 |
0.476 |
0.442 |
|
|
|
|
|
|
|
26.7· |
|
0.446· |
33.4 |
|
Test Item |
7 |
2 |
5 |
6 |
4 |
3.0 |
0.025 |
0.0 |
|
8 |
5 |
4 |
5 |
0 |
0.0 |
0.016 |
0.0 |
|
|
9 |
4 |
3 |
5 |
1 |
0.0 |
0.013 |
0.0 |
|
|
|
|
|
|
|
1.0· |
|
0.000· |
1.0 |
OD = Optical density * = Mean of the post incubation-pre‑treatment values + = Mean permeability · = Mean corrected value
Table 2 Corneal Epithelium Condition
Treatment |
Cornea Number |
Observation |
|
Post Treatment |
Post Incubation |
||
Negative Control |
1 |
clear |
clear |
2 |
clear |
clear |
|
3 |
clear |
clear |
|
Positive Control |
4 |
cloudy |
cloudy |
5 |
cloudy |
cloudy |
|
6 |
cloudy |
cloudy |
|
Test Item |
7 |
clear |
clear |
8 |
clear |
clear |
|
9 |
clear |
clear |
Calibration of Opacitometer TX307 |
|||
Balance dial = 0 |
Target |
Readingdisplayed |
Acceptable |
Calibrator number 1 |
75 |
75 |
Yes |
Calibrator number 2 |
150±2% |
149 |
Yes |
Calibrator number 3 |
225±2% |
224 |
Yes |
Applicant's summary and conclusion
- Interpretation of results:
- other: Non-Corrosive
- Remarks:
- Criteria used for interpretation of results: expert judgment
- Conclusions:
- The test item was considered not to be an ocular corrosive or severe irritant.
- Executive summary:
Introduction. A study was performed to assess the ocular irritancy potential of the test item to the isolated bovine cornea. The method was designed to be compatible with the following:
OECD Guidelines for the Testing of Chemicals No. 437 (2009) “Bovine Corneal Opacity and Permeability Assay”
Method. The undiluted test item was applied for 10 minutes followed by an incubation period of 120 minutes. Negative and positive control items were tested concurrently. 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 anIn VitroIrritancy Score (IVIS).
Results. Thein vitroIrritancy scores are summarised as follows:
Treatment
In VitroIrritancy Score
Test Item
1.0
Negative Control
1.5
Positive Control
33.4
Conclusion. The test item was considered not to be an ocular corrosive or severe irritant.
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