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EC number: 459-290-6 | CAS number: -
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 2005 january 31st to 2005 february 4th
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to the OECD Guideline 405.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- SRID No. : DEV75332
Physical State and Appearance : Solid, Tan powder
Source of Test Substance : Eastman Kodak Company
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- Test System
Six albino rabbits (Hra:(NZW)SPF) obtained from Covance Research Products, Inc .
(Denver, PA) were assigned to the study. The rabbits were young adults (at least three months
old). Rabbits were chosen for this study because they are a common representative species for
eye irritation studies. The rabbit is the species recommended for use in the OECD Guideline.
The protocol was approved by the Institutional Animal Care and Use Committee.
Husbandry
Housing
Animals were housed in an Association for Assessment and Accreditation of Laboratory
Animal Care International-accredited vivarium in accordance with the Guide for the Care
and Use of Laboratory Animals (National Research Council, 1996). The rabbits were
singly housed in suspended, stainless-steel mesh cages. Cages and racks were washed
once a week. Absorbent paper, used to collect excreta, was changed every other day.
Environmental Conditions
The study room was maintained at 19.9 to 23.0 °C and 42.2 to 62.0% relative humidity. .
A photoperiod of 12 hours light was maintained.
Acclimation Period
The animals were isolated upon arrival and allowed to acclimate for a period of 5 days.
Animals were judged to be healthy prior to testing.
Feed
Certified High Fiber Rabbit Diet (PMI #5325) was available ad libitum. Feed containers
were cleaned and refilled at least once a week. No known contaminants which would
interfere with the outcome of this study were present in the feed. Analyses of feed are
maintained on file within the testing laboratory.
Water
Water was available ad libitum through an automatic watering system. The source of the
water was the local public water system. There have been no contaminants identified in
previous water analyses that would be expected to interfere with the conduct of the study.
Semiannual analyses of water are maintained on file within the testing laboratory.
Identification
Upon arrival, all rabbits were identified by uniquely-numbered ear tags. Cage cards
contained the study-specific animal number and the ear tag number.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- The test substance, a solid, was administered as received.
A single dose of 0.1 gram of the test substance was placed into the conjunctival sac of
one eye (left) of each animal. - Duration of treatment / exposure:
- Test Substance Exposure
The treated eyes of three animals were immediately washed
with running distilled water; the eyes of the other three animals were not irrigated. - Observation period (in vivo):
- Eyes were observed immediately after instillation of the test substance and 1,24,48, and
72 hours thereafter. Observations included indications of immediate sensory irritation
and estimations of chemosis and redness of the adnexal structures. Also evaluated were
effects on the iris, the presence of corneal opacity, andor discharge from the eye. Eyes
were treated with a 2% ophthalmic solution of fluorescein at 24 hours and observed for
staining. - Number of animals or in vitro replicates:
- Six albino rabbits
- Details on study design:
- Test Procedures
This study was conducted according to the Organisation for Economic Cooperation and
Development (OECD) Guideline for Testing of Chemicals: Guideline 405, Acute Eye
IrritatiodCorrosion; and European Economic Community (EEC): Annex V., Test B.5,
Acute Toxicity (Eye Irritation).
Distribution of Animals
Animals were distributed into 2 groups
Not irrigated 3 animals numbered 805,806 and 807
Irrigated 3 animals numbered 808, 809 and 810
Preparation of Animals
Both eyes of each rabbit selected for the study were examined within 24 hours of
administration of the test substance. Animals showing eye irritation, ocular defects, or
pre-existing corneal injury were not used.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: irrigated and not irrigated
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: Irrigated and not irrigated
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: irrigated and not irrigated
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: irrigated and not irrigated
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: irrigated and not irrigated
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: irrigated and not irrigated
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: irrigated and not irrigated
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: irrigated and not irrigated
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: irrigated
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- ca. 0.66
- Max. score:
- 2
- Remarks on result:
- other: not irrigated
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: irrigated and not irrigated
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: irrigated and not irrigated
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: irrigated and not irrigated
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 hour
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: irrigated and not irrigated
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: irrigated and not irrigated
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 48 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: irrigated and not irrigated
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- ca. 0
- Max. score:
- 0
- Remarks on result:
- other: irrigated and not irrigated
- Other effects:
- Description of Other Ocular Lesions, Including Fluorescein Staining
No other lesions were noted for the unwashed or washed eyes during the 72-hour observation
period. Staining was not evident for unwashed or washed eyes when tested with fluorescein dye
24 hours after administration of the test substance.
Effects of Immediate Washing
Immediate irrigation of the eyes was slightly palliative.
Toxic Effects
No toxic effects were noted during the study.
Any other information on results incl. tables
Prior to initiation of the eye irritation study, a screening procedure was performed in an attempt to avoid testing substances that might produce significant irritation of the rabbit eye. First, the pH of the test substance was measured and the value obtained (5.622) demonstrated that the test substance was neither strongly acid (pH =< 2.0) nor strongly alkaline (pH >= 11.0). Subsequently, an in vitro test (IrritectionTMA ssay) designed to identify eye irritants was conducted. The results of this test suggested that the test substance had the potential to cause, at most, minimal to mild eye irritation. Furthermore, results from an acute dermal irritation study determined that the test substance would not be classified as irritating to skin. Therefore, an in vivo eye irritation study was conducted in which, initially, the eyes of two animals were tested. After instillation of the test substance into one eye of each animal, the treated eye of one animal was washed. Only minimal irritant effects, redness (grade 2) at the one-hour examinations, were noted for the unwashed eye. No signs of irritation were noted for the washed eye one hour after dosing. At the 24-hour examinations, both the unwashed eye and the washed eye appeared clinically normal. Based on the observations in the single unwashed eye and washed eye, the remaining four eyes were dosed in order to complete the full in vivo eye irritation study (a total of three unwashed and three washed eyes). In the in vivo eye irritation study, no signs of irritation were noted for two of the three unwashed eyes and all three washed eyes during the 72-hour observation period. Signs of irritation for the remaining unwashed eye were limited to redness (grade 2) one hour after dosing. At the 24-hour examinations, all unwashed and washed eyes appeared clinically normal. Staining was not evident in unwashed or washed eyes when fluorescein dye was applied. Immediate irrigation of the eyes was slightly palliative. Complete reversibility of the irritant effect was observed by the 24-hour examinations.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on these results, the test substance requires no eye irritation classification as defined in the
28th Adaptation of the EC Classification, Packaging and Labelling of Dangerous Substances
Directive.
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