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EC number: 235-060-9 | CAS number: 12064-62-9
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1990-10-24 to 1990-11-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: FHSA 16 CFR 1500.42
- Deviations:
- not specified
- Principles of method if other than guideline:
- No further data.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Digadolinium trioxide
- EC Number:
- 235-060-9
- EC Name:
- Digadolinium trioxide
- Cas Number:
- 12064-62-9
- Molecular formula:
- Gd2O3
- IUPAC Name:
- Digadolinium trioxide
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Identification: Lot #9
- Description: white powdered solid
- Date received: 1990-10-16
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Davidson's Mill Farm, South Brunswick, NJ, USA
- Age at study initiation: No data
- Weight at study initiation: No data
- Housing: Individually housed in suspended stainless steel caging with mesh floors.
- Diet (e.g. ad libitum): ad libitum, Pelleted Purina Rabbit chow
- Water (e.g. ad libitum): ad libitum, tap water supplied by automatic watering system
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 66-76°F
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data
IN-LIFE DATES: From: 1990-12-31 To: 1991-01-03
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the left eye of each animal remained untreated and served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Undiluted; 0.1 g was applied into the conjunctival sac of the right eye.
- Duration of treatment / exposure:
- 30 seconds for 3 of the treated eyes (washed eyes) and up to 72 hours for the 3 others (the upper and lower lids were gently held together for about 1 second to prevent loss of the test material).
- Observation period (in vivo):
- 72 hours (observation at 24, 48, and 72 hours after instillation)
- Number of animals or in vitro replicates:
- 3 males and 3 females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): 3 of the treated eyes were rinsed with 30 mL saline 30 seconds post-instillation. The remaining three eyes were not irrigated.
SCORING SYSTEM: According to the method of Draize. The eye scores were further classified by the system of Kay and Calandra, Modified. Special care was taken to look for and notate any unusual effects, such as pannus, blistering of the conjunctivae, ulceration and other indicators of corrosive action.
The maximum mean total score (MMTS) was determined for both washed and unwashed eyes, and classification was determined as follows:
0.0-0.5 - non-irritating
0.6-2.5 - practically non-irritating
2.6-15.0 - minimally irritating
15.1-25.0 - mildly irritating
25.1-50.0 - moderately irritating
50.1 - 80.0 - severely irritating
80.1 - 100.0 - extremely irritating
100.1 - 110.0 - maximally irritating
If more than 40% of the rabbits tested have scores > 10 or if an individual rabbit score is > 30, the preliminary classification is raised to the next highest level.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 1,2,3
- Remarks:
- unwashed eye
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 4,5,6
- Remarks:
- washed eye
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal: 1,2
- Remarks:
- unwashed eye
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Reversibility:
- other: not applicable
- Irritation parameter:
- iris score
- Basis:
- animal: 3
- Remarks:
- unwashed eye
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- iris score
- Basis:
- animal: 4,5,6
- Remarks:
- washed eye
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 2
- Reversibility:
- fully reversible within: 48 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 1,2
- Remarks:
- unwashed eye
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 3
- Remarks:
- unwashed eye
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Remarks:
- scores after 24, 48 and 72 h were 2, 1 and 1, respectively
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 4
- Remarks:
- washed eye
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 5
- Remarks:
- washed eye
- Time point:
- 24/48/72 h
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 72 h
- Remarks:
- scores after 24, 48 and 72 h were 1, 2 and 1, respectively
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 6
- Remarks:
- washed eye
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 1,2
- Remarks:
- unwashed eye
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- chemosis score
- Basis:
- animal: 3
- Remarks:
- unwashed eye
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 72 h
- Remarks:
- scores after 24, 48 and 72 h were 1, 1 and 1, respectively
- Irritation parameter:
- chemosis score
- Basis:
- animal: 4
- Remarks:
- washed eye
- Time point:
- 24/48/72 h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Basis:
- animal: 5,6
- Remarks:
- washed eye
- Time point:
- 24/48/72 h
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritant / corrosive response data:
- One unwashed and three washed eyes had iritis at 24 hours only. All animals had slight conjunctival irritation which had cleared from most treated eyes by 72 hours. No corneal opacity was noted during the study. The test material is considered to be minimally irritating to the unwashed eye and mildly irritating to the washed eye, when considering the Maximum Mean Total Scores.
Maximum Mean Total Score for washed eyes: 11.7
Maximum Mean total Score for unwashed eyes: 6.3
- mean of 3 rabbits / unwashed eyes at 24h: 6.3
- mean of 3 rabbits / unwashed eyes at 48h: 2.7
- mean of 3 rabbits / unwashed eyes at 72h: 1.3
- mean of 3 rabbits / washed eyes at 24h: 11.7
- mean of 3 rabbits / washed eyes at 48h: 4.0
- mean of 3 rabbits / washed eyes at 72h: 0.7
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test material produced minimal irritation to both the unwashed and washed eyes. Based on the individual data for cornea opacity, iritis, conjunctival redness and chemosis, no classification of the test substance according to the CLP Regulation is required.
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