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EC number: 263-139-8 | CAS number: 61790-47-4
- 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:
- 25 August 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- 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)
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Qualifier:
- according to guideline
- Guideline:
- other: Background Review Document (BRD): current status of in vitro test methods for identifying ocular corrosives and severe irritants: The Bovine Corneal Opacity and Permeability (BCOP) Test Method, March 2006
- Version / remarks:
- The Ocular Toxicity Working Group (OTWG) of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and the National Interagency Centre for the Evaluation of Alternative Toxicological Methods (NICEATM).
- Qualifier:
- according to guideline
- Guideline:
- other: In Vitro Techniques in Toxicology Database (INVITTOX) study plan 127. Bovine Opacity and Permeability (BCOP) Assay, 2006
- Qualifier:
- according to guideline
- Guideline:
- other: Gautheron P., Dukic M., Alix D. and Sina J.F., Bovine corneal opacity and permeability test: An in vitro assay of ocular irritancy. Fundam Appl Toxicol 18:442-449, 1992
- GLP compliance:
- yes
Test material
- Reference substance name:
- Amines, rosin
- EC Number:
- 263-139-8
- EC Name:
- Amines, rosin
- Cas Number:
- 61790-47-4
- Molecular formula:
- C19H31N1
- IUPAC Name:
- 1-[(1R,4aR,10aS)-1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,9,10,10a-octahydrophenanthren-1-yl]methanamine; 1-[1,4a-dimethyl-7-(propan-2-yl)-1,2,3,4,4a,9,10,10a-octahydrophenanthren-1-yl]methanamine
- Test material form:
- liquid: viscous
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Rosin amine 90
- Expiration date of the lot/batch: 31 March 2016
- Purity test date: No correction factor required
- pH (1% in water, indicative range) 7.2 – 8.5 (determined by WIL Research Europe)
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
No correction was made for the purity/composition of the test item. The test item was tested neat.
OTHER SPECIFICS:
Negative control:
A negative control, physiological saline (Eurovet Animal Health, Bladel, The Netherlands) was included to detect non-specific changes in the test system and to provide a baseline for the assay endpoints.
Positive control:
10% (w/v) Benzalkonium Chloride (Merck KGaA, Darmstadt, Germany) [CAS Number 63449-41-2] solution prepared in physiological saline.
Test animals / tissue source
- Species:
- other: Bovine eyes
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, 's Hertogenbosch, The Netherlands), where the ey
- Transport: Eyes were collected and transported in physiological saline in a suitable container under cooled conditions.
The eyes were checked for unacceptable defects, such as opacity, scratches, pigmentation and neovascularization by removing them from the physiological saline and holding them in the light. Those exhibiting defects were discarded.
PREPARATION OF CORNEAS
The isolated corneas were stored in a petri dish with cMEM (Eagle’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.
CORNEA SELECTION AND OPACITY READING
- Following the incubation period, the medium was removed from both compartments and replaced with fresh cMEM. Opacity determinations will be performed on each of the corneas using an opacitometer (BASF-OP3.0, BASF, Ludwigshafen, Germany).
- The opacity of each cornea will be read against a cMEM filled chamber, and the initial opacity reading thus determined will be recorded.
- Corneas that had an initial opacity reading higher than 7 were not used. Three corneas were selected at random for each treatment group.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 µl of either the test substance, negative or positive control was introduced onto the epithelium of the cornea.
- Duration of treatment / exposure:
- 10 ± 1 minutes at 32 ± 1°C
- Observation period (in vivo):
- Not applicable
- Duration of post- treatment incubation (in vitro):
- Not applicable
- Number of animals or in vitro replicates:
- Three corneas were selected at random for each treatment group.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Corneas were incubated in a horizontal position for 10 ± 1 minutes at 32 ± 1°C. 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.
- After the incubation period, the medium was removed from both compartments and replaced with fresh cMEM. Opacity determinations was 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.
- After the incubation the solutions were removed and the epithelium was washed with MEM with phenol red (Eagle’s Minimum Essential
Medium, Life Technologies) and thereafter with cMEM. Possible pH effects of the test item on the corneas were recorded. 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. After the completion of the incubation period opacity determination was
performed. Each cornea was inspected visually for dissimilar opacity patterns.
- Following the final opacity measurement, permeability of the cornea to Na-fluorescein (Merck Darmstadt, Germany) was evaluated.
SCORING SYSTEM:
- 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)
- Additionally the opacity and permeability values were evaluated independently to determine whether the test item induced irritation through only one of the two endpoints.
TOOL USED TO ASSESS SCORE: opacitometer
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Value:
- 29.9
- Negative controls validity:
- valid
- Remarks:
- -0.6
- Positive controls validity:
- valid
- Remarks:
- 97.1
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- in vitro irritation score
- Remarks:
- In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value).
- Value:
- 55.3
- Negative controls validity:
- valid
- Remarks:
- -0.6
- Positive controls validity:
- valid
- Remarks:
- 144.1
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- DEMONSTRATION OF TECHNICAL PROFICIENCY:
The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (10% (w/v) Benzalkonium Chloride) was 144 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.
ACCEPTANCE OF RESULTS: Yes
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 = Yes: the mean in vitro irritancy score of the positive control (10% (w/v) Benzalkonium Chloride) was 144 and was within two standard deviations of the current historical positive control mean
- The negative control responses should result in opacity and permeability values that are less than the upper limits of the laboratory historical range = Yes: the negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas
- Historical control data can be found in the 'Attached background information' below.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Rosin Amine 90 induced serious eye damage through both endpoints: Corneal Opacity and Permeability, resulting in a mean in vitro irritancy score of 55 after 10 minutes of treatment.
- Executive summary:
The eye hazard potential of the test substance, Rosin Amine 90, was evaluated using the Bovine Corneal Opacity and Permeability test (BCOP test), in a procedure compatible with OECD 437, EC Commission Regulation No. 440/2008, Part B: Methods for the Determination of Toxicity and other health effects, Guideline B.47 'Bovine corneal opacity and permeability method for identifying ocular corrosives and severe irritants, OTWG: The Bovine Corneal Opacity and Permeability (BCOP) Test Method (March 2006), In Vitro Techniques in Toxicology Database study plan 127: Bovine Opacity and Permeability (BCOP) Assay (2006) and Bovine corneal opacity and permeability test: An in vitro assay of ocular irritancy (Gautheron, P. et al., 1992).
The test substance's potential to cause eye damage was tested through topical application of 750 µl directly to the top of bovine corneas for 10 minutes. The same volume of positive and negative controls were also tested. The negative control was physiological saline, employed in order to detect non-specific change in the test system and to provide a baseline for the assay endpoints. The positive control used was 10% (w/v) Benzalkonium Chloride solution, prepared in physiological saline.
The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (10% (w/v) Benzalkonium Chloride) was 144 and was within two standard deviations of the current historical positive control mean. These results met the acceptability criteria, and therefore can be concluded that the test conditions were adequate and that the test system functioned properly.
Rosin Amine 90 induced serious eye damage through both endpoints, resulting in a mean in vitro irritancy score of 55 after 10 minutes of treatment. Therefore, it can be concluded that Rosin Amine 90 induces serious eye damage in the Bovine Corneal Opacity and Permeability test under the experimental conditions described in this report and should be classified category 1 according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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