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EC number: 236-060-1 | CAS number: 13126-12-0
- 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:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Non GLP and non guideline study, but sufficient for hazard assessment together with a read-across on a in vivo study with a structural analogue substance (Key.001.Read-Across.CsNO3.in vivo Eye irritation.TOXI-COOP.2013) and in vitro data (Supporting.002.in vitro Eye irritation.TOXI-COOP.2013).
- Justification for type of information:
- Rubidium nitrate (CAS no. 13126-12-0, EC no. 236-060-1)
Rubidium (Rb+) is an alkali metal which belongs to Group 1 of the periodic table sharing comparable physical and chemical properties with other Group 1 elements, including lithium, sodium, potassium, cesium and francium.
Therefore, accumulation and excretion of rubidium is similar to potassium, such that body K+ appears to be a reliable index to estimate retention of Rb+. Physiological similarity of rubidium and potassium was reported by the team of Relman AS in the sixties. In fact, Rb+ follows the movement of K+ in the body and competes with K+ for transport across cell membranes. Physiological experiments indicate exchangeability of rubidium for potassium in blood, plasma, and tissue (Relman AS, 1956).
Medical and toxicological literatures generally indicate a very low degree of toxicity (Johnson et al., 1975; Khamidulina, 1987; Wagner, 2011). In many cases, the health risks of rubidium compounds are associated with the anion, e.g., hydroxide, or fluoride, rather than the rubidium cation.
Literature
Hall PWH and Relman AS. 1960. Acid excretion in rubidium- and cesium-substituted rats. J Clin Invest. 39:171–177.
Johnson GT, Lewis RT, Wagner WD. 1975. Acute toxicity of cesium and rubidium compounds. Toxicol App Pharmacol. 32:239-245.
Khamidulina Kh. Kh. 1987. Gig. Tr. Prof. Zabol. (9), 55 (Russian paper)
Relman AS, Roy AM, Schwartz. 1955. The acidifying effect of Rubidium in normal and potassium-deficient alkalotic rats. J Clin Invest. 34: 538–544.
Relman AS. 1956. The physiological behaviour of Rubidium and Cesium in relation to that of potassium. Yale J Biol Med. 29:248-62.
Wagner FS. 2011. Rubidium and Rubidium Compounds. Kirk-Othmer Encyclopedia of Chemical Technology. John Wiley & Sons, Inc.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- water solubility
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 February 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 105 (Water Solubility)
- Version / remarks:
- OECD Method 105, adopted by the Council on 27 July 1995
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of method:
- other: In a preliminary test a portion (approximately 100 mg) of the test item was found to dissolve readily in 200 μL of purified water, forming a single phase with no separated material, indicating a solubility of greater than 500 g/L of solvent.
- Specific details on test material used for the study:
- Identity: Rubidium nitrate
Appearance: White crystalline powder
Storage conditions: Room temperature (15 to 25C), desiccated, dark
Batch number: 215091B002
Purity: 100%
Expiry date: September 2017
Date received: 03 November 2016 - Key result
- Water solubility:
- > 500 g/L
- Conc. based on:
- test mat.
- Remarks on result:
- completely miscible
- Conclusions:
- The test substance was found to have a solubility of greater than 500 g/L of water.
- Executive summary:
The purpose of this study was to determine the water solubility of the test substance. The study was conducted in accordance with accepted principles in order to meet the requirements of REACH Regulation (EU) No 1907/2006 of the European Parliament and of the Council, REACH Regulation (EC) No 440/2008 (as amended) of 30 May 2008 (Method A.6) and the OECD Guidelines for Testing of Chemicals (Method 105). The test substance was found to have a solubility of greater than 500 g/L of water.
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint conclusion:
- no adverse effect observed (not irritating)
- Endpoint conclusion:
- no adverse effect observed (not irritating)
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP and non guideline study, but sufficient for hazard assessment together with in vitro data (Key.001.Skin / corrosion.TOXI-COOP.2011).
- Justification for type of information:
- Rubidium nitrate (CAS no. 13126-12-0, EC no. 236-060-1)
Rubidium (Rb+) is an alkali metal which belongs to Group 1 of the periodic table sharing comparable physical and chemical properties with other Group 1 elements, including lithium, sodium, potassium, cesium and francium.
Therefore, accumulation and excretion of rubidium is similar to potassium, such that body K+ appears to be a reliable index to estimate retention of Rb+. Physiological similarity of rubidium and potassium was reported by the team of Relman AS in the sixties. In fact, Rb+ follows the movement of K+ in the body and competes with K+ for transport across cell membranes. Physiological experiments indicate exchangeability of rubidium for potassium in blood, plasma, and tissue (Relman AS, 1956).
Medical and toxicological literatures generally indicate a very low degree of toxicity (Johnson et al., 1975; Khamidulina, 1987; Wagner, 2011). In many cases, the health risks of rubidium compounds are associated with the anion, e.g., hydroxide, or fluoride, rather than the rubidium cation.
Literature
Hall PWH and Relman AS. 1960. Acid excretion in rubidium- and cesium-substituted rats. J Clin Invest. 39:171–177.
Johnson GT, Lewis RT, Wagner WD. 1975. Acute toxicity of cesium and rubidium compounds. Toxicol App Pharmacol. 32:239-245.
Khamidulina Kh. Kh. 1987. Gig. Tr. Prof. Zabol. (9), 55 (Russian paper)
Relman AS, Roy AM, Schwartz. 1955. The acidifying effect of Rubidium in normal and potassium-deficient alkalotic rats. J Clin Invest. 34: 538–544.
Relman AS. 1956. The physiological behaviour of Rubidium and Cesium in relation to that of potassium. Yale J Biol Med. 29:248-62.
Wagner FS. 2011. Rubidium and Rubidium Compounds. Kirk-Othmer Encyclopedia of Chemical Technology. John Wiley & Sons, Inc. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not specified
- GLP compliance:
- no
- Specific details on test material used for the study:
- High purity material in excess of 99%
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or test system and environmental conditions:
- no data
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: abraded and intact skin was tested
- Vehicle:
- water
- Controls:
- other: positive (50% HCl) and negative (water) control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 5 % in water - Duration of treatment / exposure:
- 48 h (no rinsing up to the end of the observation periode)
- Observation period:
- 24 and 48 h
- Number of animals:
- 6 animals
- Details on study design:
- The backs of the animals were clipped free of hair. The skin on the right side of the backs was abraded at each of the test sites, while the skin on the
left side remained intact. The sites were abraded by uaing a crosshatch design, deep enough to penetrate the epidermis without bleeding. (Abrasions were made using two No. 11 Bard-Parker scalpel blades inserted in a cork stopper approximately 2 mm apart.) The test material (0.1 ml) was applied at each of the test sites. Each test site was covered with a gauze patch measuring 20 mm by 20 mm. Each animal was provided with a leather harness for the initial 24-hour exposure. - Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- of six animals
- Time point:
- other: 24 and 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: The max. score gives the theoretically highest reachable value.
- Irritation parameter:
- other: cellular toxicity on abraded skin
- Basis:
- mean
- Remarks:
- of six animals
- Time point:
- other: 24 h
- Score:
- >= 0 - <= 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: The max. score gives the theoretically highest reachable value.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Rubidium iodide was non-irritating to skin in this in vivo study in rabbits.
- Executive summary:
Rubidium iodide was non-irritating to skin in this in vivo study in rabbits. On intact skin a 5 % solution of Rubidium iodide in water induced no irritating effects, e.g. erythema, edema. Only a mild cellular toxic effect was observed on abraded skin which was fully reversible within 48 h. Therefore, RbI is considered safe for intact or abraded human skin.
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No GLP, equivalent or similar to OECD and EU guideline.
- Justification for type of information:
- Rubidium nitrate (CAS no. 13126-12-0, EC no. 236-060-1)
Rubidium (Rb+) is an alkali metal which belongs to Group 1 of the periodic table sharing comparable physical and chemical properties with other Group 1 elements, including lithium, sodium, potassium, cesium and francium.
Therefore, accumulation and excretion of rubidium is similar to potassium, such that body K+ appears to be a reliable index to estimate retention of Rb+. Physiological similarity of rubidium and potassium was reported by the team of Relman AS in the sixties. In fact, Rb+ follows the movement of K+ in the body and competes with K+ for transport across cell membranes. Physiological experiments indicate exchangeability of rubidium for potassium in blood, plasma, and tissue (Relman AS, 1956).
Medical and toxicological literatures generally indicate a very low degree of toxicity (Johnson et al., 1975; Khamidulina, 1987; Wagner, 2011). In many cases, the health risks of rubidium compounds are associated with the anion, e.g., hydroxide, or fluoride, rather than the rubidium cation.
Literature
Hall PWH and Relman AS. 1960. Acid excretion in rubidium- and cesium-substituted rats. J Clin Invest. 39:171–177.
Johnson GT, Lewis RT, Wagner WD. 1975. Acute toxicity of cesium and rubidium compounds. Toxicol App Pharmacol. 32:239-245.
Khamidulina Kh. Kh. 1987. Gig. Tr. Prof. Zabol. (9), 55 (Russian paper)
Relman AS, Roy AM, Schwartz. 1955. The acidifying effect of Rubidium in normal and potassium-deficient alkalotic rats. J Clin Invest. 34: 538–544.
Relman AS. 1956. The physiological behaviour of Rubidium and Cesium in relation to that of potassium. Yale J Biol Med. 29:248-62.
Wagner FS. 2011. Rubidium and Rubidium Compounds. Kirk-Othmer Encyclopedia of Chemical Technology. John Wiley & Sons, Inc. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- not specified
- Remarks:
- , e.g. 9 instead of 10 animals
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- not specified
- Remarks:
- , e.g. 9 instead of 10 animals
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
- Specific details on test material used for the study:
- High purity material in excess of 99%
- Species:
- rat
- Strain:
- other: Charles River albino rats
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, cesarian-derived albino rats
- Weight at study initiation: 175 -250 g
- Fasting period before study: yes (overnight, 16 h) - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Justification for choice of vehicle: good solubility in water - Doses:
- First main test: 820, 1170, 1660, 2350, 3340, 4750 mg/kg
Second main test: 1890, 2120, 2515, 2680, 3010 mg/kg - No. of animals per sex per dose:
- 9 male rats
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 1 and 4 h following administration and dayly thereafter for the 14-day period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology, behavioral observations - Statistics:
- The LD50 values and their 95% confidence limits were calculated by probit analysis of Finney (1971).
- Preliminary study:
- not applicable; however, range finding study was performed:
The test material was administered as a single dose, orally by stomach tube, to caesarean-derived rats weighing between 175 and 250 grams. Eight test groups of three animals per group (24 total) were used. The animals were fasted from food for approximately 16 hours prior to dosing. The test material was dissolved in deionized and distilled water. Observations for morbidity and mortality were recorded at 1 and 4 hours following administration and daily thereafter for the 7-day period. Gross necropsy observations were made on all animals which died or were sacrificed at the end of the 7-day observation period. - Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 4 708 mg/kg bw
- Based on:
- test mat.
- Remarks:
- RbI
- 95% CL:
- ca. 4 413 - ca. 5 026
- Mortality:
- yes. All deaths occured within the first 72 hr after dosing.
- Body weight:
- No data on body weight.
- Other findings:
- The most notable necropsy findings in rats that died following the administration of RbI were congested, cyanotic lungs with petechial hemorrhages and fluid-distended stomach which appeared to result from spasm of the pyloric sphincter following the dosing. All deaths occured within the first 72 hr after dosing.
- Interpretation of results:
- not classified
- Conclusions:
- The acute oral LD50 of Rubidium iodide in albino rats was determined to be 4708 mg/kg bw.
- Executive summary:
In an acute oral toxicity study, groups of 9 fasted male albino rats were given a single oral dose of Rubidium iodide (> 99 %) in water at 11 different doses and observed for 14 days.
Oral LD50 Males = 4708 mg/kg bw (95% C.L: 4413 - 5026 mg/kg)
Rubidium iodide is not classified after oral administration based on the LD50 obtained in male rats.
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Non GLP and non guideline study, but sufficient for hazard assessment together with a read-across on a in vivo study with a structural analogue substance (Key.001.Read-Across.CsNO3.in vivo Eye irritation.TOXI-COOP.2013) and in vitro data (Supporting.002.in vitro Eye irritation.TOXI-COOP.2013).
- Justification for type of information:
- Rubidium nitrate (CAS no. 13126-12-0, EC no. 236-060-1)
Rubidium (Rb+) is an alkali metal which belongs to Group 1 of the periodic table sharing comparable physical and chemical properties with other Group 1 elements, including lithium, sodium, potassium, cesium and francium.
Therefore, accumulation and excretion of rubidium is similar to potassium, such that body K+ appears to be a reliable index to estimate retention of Rb+. Physiological similarity of rubidium and potassium was reported by the team of Relman AS in the sixties. In fact, Rb+ follows the movement of K+ in the body and competes with K+ for transport across cell membranes. Physiological experiments indicate exchangeability of rubidium for potassium in blood, plasma, and tissue (Relman AS, 1956).
Medical and toxicological literatures generally indicate a very low degree of toxicity (Johnson et al., 1975; Khamidulina, 1987; Wagner, 2011). In many cases, the health risks of rubidium compounds are associated with the anion, e.g., hydroxide, or fluoride, rather than the rubidium cation. In the specific case of rubidium hydroxide; it needs to be taken into account the higher alkaline efficiency due to the hydroxide.
Literature
Hall PWH and Relman AS. 1960. Acid excretion in rubidium- and cesium-substituted rats. J Clin Invest. 39:171–177.
Johnson GT, Lewis RT, Wagner WD. 1975. Acute toxicity of cesium and rubidium compounds. Toxicol App Pharmacol. 32:239-245.
Khamidulina Kh. Kh. 1987. Gig. Tr. Prof. Zabol. (9), 55 (Russian paper)
Relman AS, Roy AM, Schwartz. 1955. The acidifying effect of Rubidium in normal and potassium-deficient alkalotic rats. J Clin Invest. 34: 538–544.
Relman AS. 1956. The physiological behaviour of Rubidium and Cesium in relation to that of potassium. Yale J Biol Med. 29:248-62.
Wagner FS. 2011. Rubidium and Rubidium Compounds. Kirk-Othmer Encyclopedia of Chemical Technology. John Wiley & Sons, Inc. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Principles of method if other than guideline:
- the test materials at various concentrations (0.1, 0.5, 1.0, and 5.0%) was placed in one eye of each animal by pulling the lower lid of the eyeball to form a cup into which the compounds under investigation were instilled. The eyelids were held together for approximately 1 set and the animal was then released. The animals were exposed to the test compound for either 5 min or 24 hr before washing the eye with approximately 300 ml of distilled water instilled over a 2-min period. The eyes were examined with the aid of fluorescein but without the aid of a hand slit-lamp at 1, 24, 48, and 72 hr and at 7 days; if any injury persisted, the eyes were reexamined at 14 and 21 days.
Grading of the severity of the eye irritation was performed by a modification of the method of Draize (1944) based upon the presence and degree of ulceration or opacity of the cornea and iris and erythema, chemosis and ulceration or necrosis of the conjunctival mucosa. - GLP compliance:
- no
- Specific details on test material used for the study:
- High purity material in excess of 99%
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 - 3 kg - Vehicle:
- water
- Controls:
- other: the untreated eye of each animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 5 % - Duration of treatment / exposure:
- 5 min (5 animals) and 24 h (3 animals)
- Observation period (in vivo):
- 1 h, 24 h, 48 h, 72 h, 7 days; in case of persistent damage: 24 days, 21 days
- Number of animals or in vitro replicates:
- 8 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: 250 ml water
- Time after start of exposure: 5 min or 24 h, respectively
SCORING SYSTEM:
- Cornea: 0-4
- Iris: 0-2
- Conjunctive Redness: 0-3
- Chemosis: 0-4 - Irritation parameter:
- other: Draize method (1944)
- Basis:
- animal #1
- Time point:
- other: 5 minutes
- Reversibility:
- not specified
- Remarks on result:
- positive indication of irritation
- Remarks:
- Extremely irritant and corrosive
- Irritant / corrosive response data:
- - RbOH (5%) - 5 min exposure: Extremely irritant and corrosive (only one animal used) - 24 hours exposure: no data
- RbOH (1%) - 5 min exposure: Marginal (5 animal used) - 24 hours exposure: negative (3 animals used) - Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Rubidium hydroxide is higly irritating and corrosive for the eyes of rabbits. However, the corossivity is due to the hydroxide. In the context of the registration of rubidium nitrate, this study needs to be disregarded.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Acute toxicity of cesium and rubidium compounds
- Author:
- Johnson, G.T.; Lewis, R.T. and Wagner, W.D.
- Year:
- 1 975
- Bibliographic source:
- Toxicology and applied pharmacology 32, 239-245 (1975)
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Principles of method if other than guideline:
- the test materials at various concentrations (0.1, 0.5, 1.0, and 5.0%) was placed in one eye of each animal by pulling the lower lid of the eyeball to form a cup into which the compounds under investigation were instilled. The eyelids were held together for approximately 1 set and the animal was then released. The animals were exposed to the test compound for either 5 min or 24 hr before washing the eye with approximately 300 ml of distilled water instilled over a 2-min period. The eyes were examined with the aid of fluorescein but without the aid of a hand slit-lamp at 1, 24, 48, and 72 hr and at 7 days; if any injury persisted, the eyes were reexamined at 14 and 21 days.
Grading of the severity of the eye irritation was performed by a modification of the method of Draize (1944) based upon the presence and degree of ulceration or opacity of the cornea and iris and erythema, chemosis and ulceration or necrosis of the conjunctival mucosa. - GLP compliance:
- no
Test material
- Reference substance name:
- Rubidium iodide
- EC Number:
- 232-198-1
- EC Name:
- Rubidium iodide
- Cas Number:
- 7790-29-6
- Molecular formula:
- IRb
- IUPAC Name:
- Rubidium iodide
Constituent 1
- Specific details on test material used for the study:
- High purity material in excess of 99%
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2 - 3 kg
Test system
- Vehicle:
- water
- Controls:
- other: the untreated eye of each animal served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 5 % - Duration of treatment / exposure:
- 5 min (5 animals) and 24 h (3 animals)
- Observation period (in vivo):
- 1 h, 24 h, 48 h, 72 h, 7 days; in case of persistent damage: 24 days, 21 days
- Number of animals or in vitro replicates:
- 8 animals
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing: 250 ml water
- Time after start of exposure: 5 min or 24 h, respectively
SCORING SYSTEM:
- Cornea: 0-4
- Iris: 0-2
- Conjunctive Redness: 0-3
- Chemosis: 0-4
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- of 8 animals
- Time point:
- other: 1 h, 24 h, 48 h, 72 h, 7 days
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: The max. score gives the theoretically highest reachable value.
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- of 8 animals
- Time point:
- other: 1 h, 24 h, 48 h, 72 h, 7 days
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: The max. score gives the theoretically highest reachable value.
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- of 8 animals
- Time point:
- other: 1 h, 24 h, 48 h, 72 h, 7 days
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: The max. score gives the theoretically highest reachable value.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 1 h, 24 h, 48 h, 72 h, 7 days
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: The max. score gives the theoretically highest reachable value.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Rubidium iodide was non-irritating to eyein this in vivo study in rabbits.
- Executive summary:
Rubidium iodide was non-irritating to eye in this in vivo study in rabbits. There were no effects on cornea, iris and conjuctivae or the incidence of chemosis to any time point.
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