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EC number: 232-477-8 | CAS number: 8050-18-8
- 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:
- 2020-10-27 to 2020-10-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 021
- Report date:
- 2021
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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Decarboxylated Rosin
- Cas Number:
- 8050-18-8
- Molecular formula:
- Not availabe for UVCB substance
- IUPAC Name:
- Decarboxylated Rosin
- Test material form:
- liquid
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- Eyes from adult cattle (typically 12 to 60 months old) were obtained from a local abattoir (Woolley Brothers, Sheffield) as a by-product from freshly slaughtered animals. The eyes were excised by an abattoir employee after slaughter, and were placed in Hanks’ Balanced Salt Solution (HBSS) supplemented with antibiotics (penicillin at 100 IU/mL and streptomycin at 100 μg/mL). They were transported to the test facility over ice packs on the same day of slaughter. The corneas were prepared immediately on arrival.
Test system
- Vehicle:
- Hank's balanced salt solution
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 0.75 mL of test item
- Duration of treatment / exposure:
- exposure period of 10 minutes
- Details on study design:
- 1 – Preparation of corneas
All eyes were macroscopically examined before and after dissection. Only corneas free of damage were used.
The cornea from each selected eye was removed leaving a 2 to 3 mm rim of sclera to facilitate handling. The iris and lens were peeled away from the cornea. The isolated corneas were immersed in a dish containing HBSS until they were mounted in Bovine Corneal Opacity and Permeability (BCOP) holders.
The anterior and posterior chambers of each BCOP holder were filled with complete Eagle’s Minimum Essential Medium (EMEM) without phenol red and plugged. The holders were incubated at 32 ± 1 ºC for 60 minutes. At the end of the incubation period each cornea was examined for defects. Only corneas free of damage were used.
2 – selection of corneas and opacity reading
The medium from both chambers of each holder was replaced with fresh complete EMEM.
A pre-treatment opacity reading was taken for each cornea using a calibrated opacitometer (Annex 2).
Three corneas were randomly allocated to the negative control. Three corneas were also allocated to the test item and three corneas to the positive control item.
3 – Treatment of cornea
The EMEM was removed from the anterior chamber of the BCOP holder and 0.75 mL of the test item or control items were applied to the appropriate corneas. The holders were gently tilted back and forth to ensure a uniform application of the item over the entire cornea. Each holder was incubated, anterior chamber uppermost, at 32 ± 1 °C for 10 minutes.
At the end of the exposure period the test item and control items were removed from the anterior chamber and the cornea was rinsed 3 times with fresh complete EMEM containing phenol red before a final rinse with complete EMEM without phenol red. The anterior chamber was refilled with fresh complete EMEM without phenol red. A post-treatment opacity reading was taken and each cornea was visually observed.
The holders were incubated, anterior chamber facing forward, at 32 ± 1 °C for 120 minutes.
After incubation the holders were removed from the incubator, the medium from both chambers was replaced with fresh complete EMEM and a final opacity reading was taken. Each cornea was visually observed.
4 – Application of sodium fluroscein
Following the final opacity measurement the permeability of the corneas to sodium fluorescein was evaluated. The medium from the anterior chamber was removed and replaced with 1 mL of sodium fluorescein solution (4 mg/mL). The dosing holes were plugged and the holders incubated, anterior chamber uppermost, at 32 ± 1 ºC for 90 minutes.
5 – Permeability Determinations
After incubation the medium in the posterior chamber of each holder was decanted and retained.
360 μL of media representing each cornea was dispensed into the appropriate wells of a pre-labeled 96-well plate. The optical density was measured (quantitative viability analysis) at 492 nm (without a reference filter) using the Labtech LT-4500 microplate reader.
6 – Histopathology
The corneas were retained after testing for possible conduct of histopathology. Each cornea was placed into a pre-labeled tissue cassette fitted with a histology sponge to protect the endothelial surface. The cassette was immersed in 10% neutral buffered formalin. With a clear negative result obtained it was considered that histopathology would not be required.
7 – Data Evaluation
Results from the two test method endpoints, opacity and permeability, were combined in an empirically derived formula to generate an In Vitro Irritancy Score.
8 – 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 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.
9 – 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.
10 – In Vitro Irritancy Score
The following formula was used to determine the In Vitro Irritancy Score:
In Vitro Irritancy Score = mean opacity value + (15 x mean permeability 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.
11 – Visual Observation
The condition of the cornea was visually assessed post treatment and post incubation.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Positive control
- Value:
- 41.4
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Negative control
- Value:
- 0.1
- Negative controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Test item
- Value:
- 2
- Other effects / acceptance of results:
- For an acceptable test the following positive control criterion should be achieved:
Neat ethanol was used for positive control purposes. The test was acceptable if the positive control produced an In Vitro Irritancy Score which fell within two standard deviations of the historical mean collated during the previous 12 months for this testing facility.
Ethanol (a known ocular irritant was included to verify that an appropriate response was induced. If the BCOP assay is being used only to identify corrosive or severe irritants, then the positive control substance should induce a severe response in vivo as well as in the BCOP assay. However, to ensure variability in the positive control response across time can be assessed, the magnitude of the severe response should not be excessive.
For an acceptable test the following negative control criterion should be achieved:
Sodium chloride 0.9% w/v was used for negative control purposes. The test was acceptable if the negative control produced an In Vitro Irritancy Score which is less than or equal to the upper limit for background opacity and permeability values calculated from the previous 12 months data for this testing facility.
Any other information on results incl. tables
Table 1 – individual and Mean Corneal Opacity and Permeability Measurements
Treatment |
Cornea Number |
Opacity |
Permeability (OD492) |
In Vitro Irritancy Score |
|||||
Pre -Treatment |
Post - Treatment |
Post Incubation |
Post Incubation – Pre- Treatment |
Corrected Value |
|
Corrected Value |
|||
Negative Control |
2 |
4 |
3 |
3 |
0 |
|
0.012 |
|
|
3 |
4 |
3 |
3 |
0 |
0.006 |
||||
6 |
3 |
3 |
3 |
0 |
0.011 |
||||
|
0.0 * |
0.010 ◊ |
0.1 |
||||||
0 |
0.003 ▪ |
|
|||||||
Positive Control |
9 |
5 |
34 |
30 |
25 |
25.0 |
0.755 |
0.745 |
|
11 |
4 |
36 |
34 |
30 |
30.0 |
1.157 |
1.147 |
||
12 |
3 |
31 |
29 |
26 |
26.0 |
0.999 |
0.989 |
||
|
27.0 ● |
|
0.961 ● |
41.4 |
|||||
2.6 ▪ |
0.203 ▪ |
|
|||||||
Test Item |
14 |
3 |
5 |
5 |
2 |
2.0 |
0.014 |
0.004 |
|
15 |
4 |
5 |
5 |
1 |
1.0 |
0.014 |
0.004 |
||
16 |
4 |
6 |
7 |
3 |
3.0 |
0.009 |
0.000 |
||
|
2.0 ● |
|
0.003 |
2.0 |
|||||
1.0 ▪ |
0.0 ▪ |
|
OD = Optical density
* = Mean of the post-incubation – pre-treatment values
◊ = Mean permeability
● = Mean corrected value
▪ = Standard deviation
Table 2 – Corneal Epithelium Condition Post Treatment and Post Incubation
Treatment |
Cornea Number |
Observations |
|
Post Treatment |
Post Incubation |
||
Negative Control |
2 |
Clear |
Clear |
3 |
Clear |
Clear |
|
6 |
Clear |
Clear |
|
Positive Control |
9 |
Cloudy |
Cloudy |
11 |
Cloudy |
Cloudy |
|
12 |
Cloudy |
Cloudy |
|
Test Item |
14 |
Clear |
Clear |
15 |
Clear |
Clear |
|
16 |
Clear |
Clear |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to UN GHS Classification, the test item AA-948-61 (Decarboxylated Rosin, CAS no. 8050-18-8) is given No Category classification under the conditions of the test.
- Executive summary:
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 an In Vitro Irritancy Score (IVIS).
The in vitro irritancy scores are summarised as follows: test item – 2.0; negative control – 0.1; positive control – 41.4.
According to UN GHS Classification, the test item AA-948-61 (Decarboxylated Rosin, CAS no. 8050-18-8) is given No Category classification under the conditions of the test.
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