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EC number: 696-130-6 | CAS number: 1364681-45-7
- 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:
- From 08 Oct 2012 to 24 Oct 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Resin acids and Rosin acids, reaction products with formaldehyde, calcium salts
- EC Number:
- 696-130-6
- Cas Number:
- 1364681-45-7
- Molecular formula:
- Unspecified
- IUPAC Name:
- Resin acids and Rosin acids, reaction products with formaldehyde, calcium salts
- Test material form:
- other: solid
- Details on test material:
- - Name of test material (as cited in study report): Resin acids and rosin acids, reaction products with formaldehyde, calcium salts
- Physical state: Solid
- Analytical purity: 96.0 % w/w
- Lot/batch No.: DMG 7245
- Expiration date of the lot/batch: July 05, 2016
- Stability under test conditions: The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage condition of test material: Room temperature
- Homogeneity: The test substance was homogeneous by visual inspection.
- Others:
pH-value: Ca. 5 (undiluted test substance, moistened with water)
Constituent 1
Test animals / tissue source
- Species:
- other: in vitro test on isolated bovine cornea
- Strain:
- other: not applicable
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not applicable
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): The solid test substance could not be prepared as a homogeneous 20% preparation in de-ionized water. Therefore 100 mg of the undiluted test substance was applied directly to the epithelial surface of the cornea covering the whole surface of the cornea. - Duration of treatment / exposure:
- 4 hours
- Observation period (in vivo):
- not applicable (in vitro test)
- Number of animals or in vitro replicates:
- not applicable (in vitro test); each treatment group consisted of 3 corneas
- Details on study design:
- TEST SYSTEM:
- Isolated bovine cornea: Target system is the isolated bovine cornea. Bovine eyes are obtained as a by-product of freshly slaughtered cattle (age of the animals: minimum 12 months, maximum 60 months).
OBJECTIVE:
- Corneal opacity was measured quantitatively as the amount of light transmission through the cornea.
- Permeability was measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea.
- Both measurements were used to calculate an In Vitro Irritancy Score of the test substance relative to the control corneas.
EXPERIMENTAL PROCEDURE:
- Preparation of the bovine corneas and measurement of initial corneal opacity:
• Corneas free of defects (opacity, scratches, pigmentation etc.) were dissected with a 2 to 3 mm rim of sclera and isolated corneas were mounted in corneal holders consisting of anterior and posterior chambers. Both chambers were filled to excess with Eagles's MEM (without phenol red) and then equilibrated in a vertical position at about 32 °C for at least 1 hour.
• After the equilibration period the medium in both chambers was replaced with fresh medium and initial corneal opacity readings were taken for each cornea with an opacitometer. Any corneas that show macroscopic tissue damage or an opacity value < 512 opacity units were discarded.
- Application of the test substance and washing
• Before application the medium in the anterior chamber was removed using a syringe.
Thereafter, 100 mg of the test substance was applied directly to the epithelial surface of the cornea covering the whole surface of the cornea (open chamber method). Subsequently, the corneas were incubated at about 32 °C for approximately 4 hours (non-surfactant solids).
Control tissues:
• Negative control, NC: 750 μL of de-ionized water
• Positive control, PC: 750 μL of 20% (w/v) solution of Imidazole in de-ionized water
• After the incubation period, NC and PC were removed from the anterior chamber using a syringe and the epithelium was washed at least 3 times with Eagle’s MEM (containing phenol red) and once with Eagle’s MEM (without phenol red). Both chambers were then refilled with fresh Eagle’s MEM (without phenol red).
The epithelium of the test substance treated corneas was rinsed with the open chamber method.
- Measurement of final corneal opacity
• Before measurement, each cornea was observed visually and observations were recorded. Final corneal opacity readings were taken for each cornea with an opacitometer.
- Determination of permeability
• For determination of permeability the medium in the anterior chamber was replaced by sodium fluorescein solution (5 mg/mL for solid test substances) and incubated for 90 ± 5 min at about 32 °C. The amount of sodium fluorescein that permeated through the corneas into the posterior chamber was measured spectrophotometrically. Three aliquots per cornea were transferred to a 96-well microtiter plate and the optical density (OD490) was determined.
DATA EVALUATION
The mean corneal opacity and permeability values of each treatment group were used to calculate an In Vitro Irritancy Score (IVIS).
- Calculation of the corneal opacity value:
First, the opacity was calculated using the opacitometer specific algorithm:
• opacity value = a * Io/I + b
a and b: device specific;
Io: illuminance (lux) through the empty corneal holder with windows and liquid
I: illuminance (lux) through the holder with the cornea
Then the opacity change per cornea was calculated by subtracting the initial from the final
• opacity (opacity change per cornea = final opacity - initial opacity).
Subsequently, the corrected opacity change was calculated by subtracting the mean opacity change of the negative control
• corrected opacity change = opacity change - mean opacity change of NC).
Finally, the mean opacity value for each test substance could be determined as the mean of all corrected opacity changes per treatment group
• mean opacity value = mean of all corrected opacity changes per group).
- Calculation of permeability value:
First, the OD490 value was calculated by subtracting the mean blank OD490 (blank = Eagle´s MEM w/o phenol red) from the OD490 of each cornea.
• OD490 value = OD490 - mean blank OD490
If the OD490 value of the treated cornea was above 1.5, the OD490 of a 1:5 dilution was used to calculate the OD490 value:
• OD490 value = 5 * (OD490 of a 1:5 dilution - mean blank OD490)
Subsequently, the corrected OD490 value was calculated by subtracting the mean OD490 value of the negative control.
• corrected OD490 value = OD490 value - mean OD490 value of NC
Finally, the mean OD490 value for each test substance could be determined as the mean of all corrected OD490 values per treatment group.
• mean OD490 value = mean of all corrected OD490 values per group
- Calculation of the In Vitro Irritancy Score (IVIS)
The IVIS could be calculated per treated cornea and finally the mean IVIS per treatment group ± standard deviation was determined:
• IVIS per cornea = corrected opacity change + 15 * corrected permeability OD change
• IVIS per treatment group = mean opacity value + 15 * mean permeability OD value
ACCEPTANCE CRITERIA
- In case one of the below given acceptance criteria is not covered, repetition of the test was considered.
• A study is considered acceptable if the positive control gives an IVIS 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 established upper limits.
• Since the IVIS per treatment group is determined from the mean of three single corneas, the variability between the corneas treated per test substance should be acceptably low. If no clear prediction is possible, e.g. different predictions are obtained for single corneas, the test will be repeated.
EVALUATION OF RESULTS
- Rules for assessment:
IVIS > 55: risk of serious damage to the eyes
IVIS ≤ 55: no risk of serious damage to the eyes
Results and discussion
In vivo
Results
- Irritation parameter:
- other: In Vitro Irritancy Score (IVIS)
- Time point:
- other: 4 h
- Score:
- -7.2
- Reversibility:
- other: not applicable
- Remarks on result:
- other: in vitro test on isolated bovine cornea
- Irritant / corrosive response data:
- IVIS NC: 6.1
IVIS PS: 117.5 - Other effects:
- No other effects.
Any other information on results incl. tables
Table 1: Opacity score
Test substance |
Cornea No. |
Initial Opacity |
Final Opacity |
Opacity Change |
Corrected Opacity Change |
Mean |
SD |
Test substance |
25 |
3.7 |
1.6 |
-2.1 |
-8.2 |
-7.2 |
0.9 |
26 |
3.7 |
2.7 |
-1.1 |
-7.2 |
|||
27 |
5.0 |
4.8 |
-0.2 |
-6.3 |
|||
NC |
19 |
4.6 |
11.3 |
6.7 |
NA |
6.1 |
2.3 |
20 |
3.3 |
6.9 |
3.6 |
NA |
|||
21 |
3.8 |
11.8 |
8.0 |
NA |
|||
PC |
22 |
3.9 |
93.5 |
89.6 |
83.5 |
67.2 |
14.2 |
23 |
4.2 |
71.2 |
67.0 |
60.9 |
|||
24 |
3.1 |
66.3 |
63.2 |
57.2 |
Table 2: Permeability score
Test substance |
Cornea No. |
Mean OD490 |
Dilution Factor |
Mean Corrected OD490 |
Mean |
SD |
Test substance |
25 |
0.004 |
1 |
0.002 |
0.001 |
0.002 |
26 |
0.004 |
1 |
0.002 |
|||
27 |
0.001 |
1 |
-0.001 |
|||
NC |
19 |
-0.001 |
1 |
NA |
0.002 |
0.004 |
20 |
0.007 |
1 |
NA |
|||
21 |
0.000 |
1 |
NA |
|||
PC |
22 |
0.584 |
5 |
2.916 |
3.354 |
0.383 |
23 |
0.705 |
5 |
3.521 |
|||
24 |
0.725 |
5 |
3.625 |
Table 3:In Vitro Irritancy Score (IVIS)
Test substance |
Cornea No. |
Opacity per cornea |
Permeability per cornea |
IVIS |
||
Per cornea |
Per group |
|||||
mean |
SD |
|||||
Test substance |
25 |
-8.2 |
0.002 |
-8.1 |
-7.2 |
0.9 |
26 |
-7.2 |
0.002 |
-7.1 |
|||
27 |
-6.3 |
-0.001 |
-6.4 |
|||
NC |
19 |
6.7 |
-0.001 |
6.7 |
6.1 |
2.2 |
20 |
3.6 |
0.007 |
3.7 |
|||
21 |
8.0 |
0.000 |
8.0 |
|||
PC |
22 |
83.5 |
2.916 |
127.2 |
117.5 |
8.5 |
23 |
60.9 |
3.521 |
113.7 |
|||
24 |
57.2 |
3.625 |
111.5 |
NC = negative control
PC = positive control
Applicant's summary and conclusion
- Interpretation of results:
- other: no serious eye damage
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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