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EC number: 931-583-8 | CAS number: 66071-92-9
- 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:
- 27 April to 28 July 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD-Guideline 437, Bovine Corneal Opacity and Permeability Test Method (BCOP), 7th of September 2009.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. EPA (1996). Label Review Manual: 2nd Edition. EPA737-B-96-001. Washington, DC: U.S. Environmental Protection Agency.
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: UN (2007). Globally Harmonized System of Classification and Labelling of Chemicals (GHS). New York & Geneva: United Nations Publications.
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Not yet assigned
- IUPAC Name:
- Not yet assigned
- Reference substance name:
- Spent liquor from semi-chemical pulping containing spent inorganic process chemicals and dissolved organic substances originating from the wood raw material
- IUPAC Name:
- Spent liquor from semi-chemical pulping containing spent inorganic process chemicals and dissolved organic substances originating from the wood raw material
- Details on test material:
- Name: "SCP liquor 1".
Chemical name: Spent liquor from semi-chemical pulping.
Molecular formula: UVCB.
Batch No.: Not stated.
CAS No.: 66071-92-9
EC No.: 266-111-3.
Appearance: Brown and viscous liquid
Solubility: In water: The substance is a water solution.
pH: ~ 7.
Conditions of storage: Room temperature. Storage in the dark but may be used under light.
Stability at conditions of storage: Not available.
Expiry date: Not available.
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- other: Isolated corneas from the eyes of cows and bulls
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Corneas: Isolated corneas from the eyes of cows and bulls aged between 18 – 20 month and free of macroscopically visible defects.
Supplier: Slaughterhouse Kloiber, Neidlinger Straße 1, A-3121 Karlstetten.
Justification: According to the guidelines.
Number of corneas: Total of 9 corneas: 3 for the test substance, 3 for the negative control and 3 for the positive control.
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 750 µL per cornea
- Details on study design:
- Preparation of the positive control
A solution of 1 % sodium hydroxide in deionised water (sterile) was prepared freshly before use. No analyses of the preparation were performed.
Preparation of the test substance
The test substance was administered undiluted as received. No analyses of the test substance were performed.
Test design
Bovine corneas were isolated and mounted in cornea holders and equilibrated for one hour to achieve normal metabolic activity. After exclusion of corneas which did not achieve quality criteria, the corneas were distributed into groups (3 per group) and exposed to the test substance, the negative control and the positive control for 10 minutes. Then the substances were removed and the corneas were accurately washed. After a post exposure incubation of two hours the opacity and permeability of each cornea were recorded. Opacity was measured quantitatively with the aid of an opacitometer. Permeability was determined by the amount of sodium fluorescein dye that penetrated all cornea layers. For this purpose fluorescein solution was filled into the anterior chambers of the cornea holders followed by an incubation period of 90 minutes. The amount of sodium fluorescein that crossed into the posterior chambers was quantitatively measured with a spectrophotometer at OD490. Using opacity and permeability data an IVIS was calculated. The positive and negative control groups were simultaneously used for other, concurrently performed studies.
Application of test and control substances
750 µl test substance were introduced into the anterior chamber through the dosing holes on the top surface of the chamber, and the holes were subsequently sealed during exposure (close-chamber method). Then the corneas were exposed in a horizontal position for 10 minutes while ensuring that the test substance adequately covered the epithelial surface. Incubation temperature, monitored with a min / max thermometer, was 29.3 °C – 33.7 °C.
Post-Exposure Incubation
After the exposure period substances were removed from the anterior chamber and the epithelium was washed three times with EMEM+ to determine the effectiveness of rinsing acidic or alkaline materials and to remove the entire substance. cEMEM was used as a final rinse to ensure removal of the phenol red from the anterior chamber prior to the opacity measurement. Both chambers were then refilled with fresh cEMEM. The corneas were incubated for additional two hours. Incubation temperature, monitored with a min / max thermometer, was 29.3 °C – 33.7 °C.
Opacity Measurement
Opacity was determined by the amount of light transmission through the cornea. Corneal opacity was measured quantitatively in Lux with the aid of an opacitometer-kit BASF-OP2.0 (see Appendix 2), which was calibrated with a standard filter set before the corneas were measured.
Application of Fluorescein
1 ml sodium fluorescein solution was added to the anterior chamber of the cornea holder and then incubated in a horizontal position for 90 minutes. Incubation temperature, monitored with a min / max thermometer, was 29.3 °C – 33.7 °C.
Permeability Measurement
Permeability was determined by the amount of sodium fluorescein dye that penetrated all corneal cell layers. The amount of sodium fluorescein that crossed into the posterior chamber was quantitatively measured with the aid of a Bio-Tek EL800 microtiter plate reader at 490 nm. For measurement 360 µl of cEMEM from the posterior chamber were transferred into the wells of a 96-well microtiter plate (triplicates). Data were recorded as OD490 values which were equivalent to the OD490 values based upon a visible light spectrophotometer using a standard 1 cm path length.
To proof that the measurement was performed in the linear range wells containing ten concentrations (ranging from 0.625 µg/ml to 40 µg/ml) of fluorescein solutions were additionally prepared.
Opacity
Opacity values were calculated as follows:
Opacity value = ax (I0/I) + b
I = illuminance (Lux) with the cornea
I0 = illuminance (Lux) without cornea
a, b = equipment-specific variables
The standard deviation for each group was calculated as well.
Permeability
To ensure that the permeability values measured were in the exponential range the linearity was determined by triple measurement of fluorescein solutions of ten concentrations. A linear calibration function and the correlation coefficient thereof was calculated.
As the OD490 values of corneas treated with 1 % sodium hydroxide lied outside of the linear range dilutions of 1:5 were measured.
The standard deviation for each group was calculated as well.
IVIS (In Vitro Irritancy Score)
The mean opacity and mean permeability values were corrected for background opacity and the negative control permeability values. The mean opacity and permeability values for each treatment group were combined in an empirically-derived formula to calculate the IVIS for each treatment group as follows:
IVIS = mean opacity value + (15 x mean permeability OD490 value)
The standard deviation for each group was calculated as well.
Assay acceptance criteria
This test is considered acceptable if it meets the following criteria:
1. The negative control response results in opacity and permeability values that are less than the upper limits for background opacity and permeability values of the historical data of the negative controls.
2. The IVIS of the positive control is within two standard deviations of the historical positive control mean.
The historical values of the negative and positive control includes all generated data of this year.
Interpretation of results
According to the guidelines, an irritation potential of a test substances is predicted if the mean IVIS of three individual corneas exposed to the test substance is ≥ 55.1.
Results and discussion
In vivo
- Irritant / corrosive response data:
- The Opacity value of "SCP liquor 1" was 1.0, 15 x Permeability value was 0.09 which resulted in an IVIS of 1.1.
The IVIS of "SCP liquor 1" was 1.1. No increase in opacity or permeability was observed. - Other effects:
- None
Any other information on results incl. tables
Table 1: Opacity, permeability and IVIS values
Substance |
Opacity |
Permeability (1x) |
Permeability (15x) |
IVIS |
|||||||
Individual |
Mean |
SD |
Individual |
Mean |
SD |
Mean |
SD |
Individual |
Mean |
SD |
|
Aqua dest. |
2.0 |
1.7 |
1.1 |
-0.001 |
0.000 |
0.001 |
0.000 |
0.015 |
2.0 |
1.7 |
1.1 |
0.5 |
-0.001 |
0.5 |
|||||||||
2.6 |
0.001 |
2.6 |
|||||||||
1 % Sodium hydroxide |
75.5 |
99.9 |
34.3 |
2.092 |
2.165 |
0.298 |
32.475 |
4.47 |
106.9 |
132.3 |
31.6 |
139.1 |
1.909 |
167.8 |
|||||||||
85.0 |
2.492 |
122.4 |
|||||||||
Test substance |
0.2 |
1.0 |
1.0 |
0.001 |
0.006 |
0.006 |
0.09 |
0.09 |
0.2 |
1.1 |
1.1 |
0.7 |
0.007 |
0.8 |
|||||||||
2.1 |
0.012 |
2.3 |
Unforeseen events
The temperature of the incubator was 29.3 °C – 33.7 °C instead of 31 °C – 33 °C. This deviation is considered to be of no relevance for the outcome of this study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- "SCP liquor 1" is regarded to be not an ocular corrosive or severe irritant, according to the OECD Guideline 437 for the testing of chemicals “Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants”.
According to the results of this study and the Directive 2001/59/EC for classification, the test substance "SCP liquor 1" needs not to be labelled as R41 (EU), Category 1 (EPA and GHS). - Executive summary:
TheBovine Corneal Opacity and Permeability Study (BCOP Test Method)was performed to reveal possible ocular corrosivity and severe irritation of"SCP liquor 1", according tothe OECD Guideline 437 for the testing of chemicals “Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants”,.
Fresh isolated and quality checked corneas were mounted in cornea holders and the initial opacity was determined. After equilibration 750 µl of the test substance (as is) were topicallyadministered to 3 isolated bovine corneas to the epithelial surfaces for 10 minutes. After a post-incubation period of 2 hours, the final opacity was measured. Then 1 ml of a fluorescein solution was added on the epithelial site and permeability was measured after 90 minutes.
Two groups of 3 corneas each served as positive and negative controls. Both control substances were administered under identical conditions as the test substance. The following solutions served as control substances:
- Negative control: sterile aqua dest.
- Positive control: 1 % sodium hydroxide.
Finally the IVIS (In Vitro Irritancy Score) was calculated as follows:
IVIS = mean opacity value + (15 x mean permeability).
The opacity and mean permeability values were corrected for background opacity and the negative control permeability values. The mean opacity value results from subtraction of final opacity from initial opacity. A substance that induces an IVIS≥55.1 is defined as ocular corrosive or severe irritant.
The IVIS for "SCP liquor 1" was 1.1.
IVIS of the negative control was 1.7 and for the positive control 132.3, thus demonstrating the validity of the experiment.
According to the results of this study and the OECD Guideline 437, the test substance "SCP liquor 1" is considered to be not an ocular corrosive or severe irritant.
According to the guidelines "SCP liquor 1" needs not to be labelled as R41 (EU), Category 1 (EPA and GHS).
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