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EC number: 208-167-3 | CAS number: 513-77-9
- 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
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- Additional physico-chemical information
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- Endpoint summary
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- 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
Endpoint summary
Administrative data
Description of key information
Both the in vivo skin irritation study (OECD 404) and the in vitro skin irritation study (EpiSkinTM) performed with the analogue substance barium dichloride dihydrate did not show any skin irritation. An in vivo eye irritation study (OECD 405) is available for barium carbonate and did not show eye irritation.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-04-26 to 2010-06-07
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study reliable without restrictions
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guidelines for Testing of Chemicals, Draft Proposal for a New Guideline: In vitro skin irritation: Reconstructed Human Epidermis (RhE) Test method
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Commission regulation (EC) No. 440/2008 B.46
- Deviations:
- no
- GLP compliance:
- yes
- Test system:
- human skin model
- Source species:
- human
- Cell type:
- other: Adult human-derived epidermal keratinocytes
- Cell source:
- other: three-dimensional human epidermis model
- Justification for test system used:
- The EPISKIN model has been validated for irritation testing in an international validation study and its use is recommended by the relevant OECD guideline for irritation testing and therefore, it was considered to be suitable for this study.
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- TEST SYSTEM
EPISKIN Standard Model TM (EPISKIN-SM TM, 0.38 cm2, Lot no.: 10-EKIN-020; Source: SkinEthic Laboratories, Nice, France).
This model is a three-dimensional human epidermis model, which consists of adult human-derived epidermal keratinocytes which have been seeded on a dermal substitute consisting of a collagen type I matrix coated with type IV collagen. The keratinocytes were cultured for 13 days, which results in a highly differentiated and stratified epidermis model comprising the main basal, supra basal, spinous and granular layers and a functional stratum corneum.
TEST FOR REDUCTION OF MTT BY THE TEST SUBSTANCE
Barium chloride was checked for possible direct MTT reduction before the study was started. To assess the ability of the test substance to reduce MTT, approximately 10 mg of test substance was added to a 12 well plate filled with 2 ml MTT solution (0.3 mg/ml in PBS). The mixture was incubated for approximately 3 hours at 37 °C. A negative control, sterile Milli-Q water was tested concurrently. Because no colour change was observed it was concluded that barium chloride dihydrate did not interact with MTT.
APPLICATION/TREATMENT OF THE TEST SUBSTANCE
The test was performed on a total of 3 tissues per test substance together with a negative control (Phosphate buffered saline (PBS, Invitrogen Corporation, Breda, the Netherlands) and a positive control (5% (aq) Sodium dodecyl sulphate (SDS, Sigma Aldrich, Zwijndrecht, The Netherlands, CAS Number 151-21-3). At least 10 mg solid (with a small glass weight boat) with 5 µl Milli-Q water (Millipore Corp., Bedford, Mass., U.S.A.) was added into 12-well plates on top of the skin tissues. Three tissues were treated with 10 µl PBS (negative control) and 3 tissues with 10 µl 5% SDS (positive control) respectively. The positive control was re-spread after 7 minutes contact time. After the exposure period of 15 minutes at room temperature, the tissues were washed with phosphate buffered saline to remove residual test substance. After rinsing the cell culture inserts were each dried carefully. The skin tissues were kept in new 12-well plates on 2 ml pre-warmed maintenance medium until all tissues were dosed and rinsed. Subsequently the skin tissues were incubated for 42 hours at 37 °C.
CELL VIABILITY MEASUREMENT
After incubation, cell culture inserts were dried carefully to remove excess medium and were transferred into a 12-wells plate prefilled with 2 ml MTT-medium (0.3 mg/ml). The tissues were incubated for 3 h at 37 °C. After incubation the tissues were placed on blotting paper to dry the tissues. Total biopsy was made by using a biopsy punch. Epidermis was separated from the collagen matrix and both parts were placed in prelabeled microtubes and extracted with 500 µl isopropanol (Merck, Darmstadt, Germany). Tubes were stored refrigerated and protected from light for 70 hours. The amount of extracted formazan was determined spectrophotometrically at 570 nm in duplicate with the Multiskan Spectrum (Thermo Labsystems).
Cell viablity was calcuated for each tissue as a percentage of the mean of the negative control tissues. Skin irritation potential of the test substance was classified according to remaining cell viability following exposure of the test substance. - Control samples:
- yes, concurrent negative control
- yes, concurrent positive control
- Amount/concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): At least 10 mg of the solid test substance was applied directly on top of the skin tissue. Barium chloride was spread to match the size of the tissue.
VEHICLE
- Amount(s) applied (volume or weight with unit): Skin tissue was moistened with 5µl of Milli-Q water (Millipore Corp., Bedford, Mass., USA) to ensure close contact to the tissue. - Duration of treatment / exposure:
- 15 minutes
- Duration of post-treatment incubation (if applicable):
- 42 hours
- Number of replicates:
- 3 tissues
- Details on test animals or test system and environmental conditions:
- Not applicable - Since this is an in vitro study there is no information on test animals.
- Vehicle:
- water
- Irritation / corrosion parameter:
- % tissue viability
- Value:
- 80
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- It is concluded that this test is valid and that barium chloride dihydrate is non-irritant in the in vitro skin irritation test under the experimental conditions described in this report.
- Executive summary:
An in vitro skin irritation test of Barium chloride was performed in a reconstructed human epidermis model EPISKIN (SM). Disks of EPISKIN (three units) were treated with the test item and incubated for 15 minutes at room temperature. Exposure of the test item was terminated by rinsing with Phosphate Buffered Saline (PBS). The epidermis units were then incubated at 37°C for 42 hours in an incubator with 5% CO2. The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution in an incubator with 5% CO2 protected from light. The precipitated formazan crystals were then extracted using acidified isopropanol and quantified spectrophotometrically.
PBS and 5% (w/v) Sodium Dodecyl Sulphate (SDS) solution treated epidermis were used as negative and positive controls, respectively (three units / control). For each treated tissue, the viability was expressed as a % relative to the negative control. If the mean relative viability after 15 minutes exposure and 42 hours post incubation is less or equal (≤) to 50% of the negative control, the test item is considered to be irritant to skin.
Following exposure to the test substance, the mean cell viability was 80% compared to the negative control. This is above the threshold of 50%, therefore the test item was considered as being non-irritant to skin. The experiment met the validity criteria, therefore the study was considered to be valid.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 29 Jan 2021 (Study Plan) to 23 Feb 2021 (Final Report)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- This in vivo study is required by regulatory authorities for registration in a non EU region. An in vitro skin irritation study in the EPISKIN model performed by NOTOX B.V. (Project 493070) showed that the test item was non-irritant to skin and confirms that the test item is non-corrosive. The pH of the test item was determined at the Pharmacy of Charles River Laboratories Hungary Kft. and found to be 5.38. This was within the acceptable range given by the OECD guideline (If the pH is 2 or less or 11.5 or greater, the study will not be conducted), therefore the test item was permitted to be used in this study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Source: S&K-LAP Kft. 2173 Kartal, Császár út 135, Hungary
- Age at study initiation: 11 weeks
- Weight at study initiation: body weights were 2907-3008 g at dosing
- Housing: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Dumbbell Device were used as an additional enrichment.
- Diet: Standard diet for rabbits produced by Cargill Takarmány Zrt, ad libitum
- Water: Free access to tap water.
- Acclimation period: 11 days before start of treatment under the same controlled environment conditions as during the experimental period. At least prior to dosing, it was ensured that the animals were healthy and that the skin to be treated was intact and free from any abnormality.
ENVIRONMENTAL CONDITIONS
- Temperature: 18.2 - 22.6°C (target: 20 ± 3°C
- Humidity: 48 - 69% (target 30 - 70%)
- Air changes: 15-20 air exchanges/hour
- Photoperiod: 12-hour light/12-hour dark cycle
IN-LIFE DATES: From: 02 Feb 2021 To: 23 Feb 2021. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
Amount(s) applied: An amount of 0.5 g of the test item (pulverised) was applied. The test item was moistened with an appropriate amount of water, sufficient to ensure good contact with the skin using a syringe. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
Approximately 24 hours prior to the test the hair was clipped from the back and flanks of the animals.The test item was applied to an area of approximately 6 cm² of intact skin. Sterile gauze pads were placed on the skin of rabbits. These gauze pads were kept in contact with the skin by a patch with a surrounding adhesive hypoallergenic plaster. The entire trunk of the animals were then wrapped with plastic wrap held in place with an elastic stocking for 4 hours.
REMOVAL OF TEST SUBSTANCE
Four hours after application, the bandaging was removed and the any residual test item was removed by gently washing the skin with body temperature water.
OBSERVATION TIME POINTS
For ethical reasons, a single animal was treated with the test item first. One hour after application of the test item to the skin, the application site was examined. As neither a corrosive effect nor a severe irritant effect was observed at one hour, the bandage was replaced and the exposure was continued for a further 3 hours (a total 4-hour exposure). The initial animal was observed for signs of erythema and oedema immediately after patch removal. The test was completed using the 2 remaining animals.
Mortality/Viability: observation twice daily (at the beginning and end of each working day).
Clinical observations: any clinical signs of toxicity or signs of ill-health during the study was recorded daily.
Body Weights: body weights were recorded at the beginning and at the end of the observation period.
Irritation: Animals were examined for signs or effects of the test item. The degree of irritation was evaluated at 1 (± 5 min), 24 (± 30 min), 48 and 72 hours (± 60 min) following the patch removal. No sign of irritation was observed at 72 hours; therefore, the study was terminated. The irritation was assessed according to the following numerical scoring system. At each observation, the highest scores given were recorded:
SCORING SYSTEM:
Erythema and eschar formation:
No erythema ......................................................................................................................0
Very slight erythema (barely perceptible) ............................................................................. 1
Well defined erythema ....................................................................................................... 2
Moderate to severe erythema .............................................................................................. 3
Severe erythema (beef redness) to slight eschar formation (injuries in depth) ........................... 4
Oedema formation:
No oedema ..........................................................................................................................0
Very slight oedema (barely perceptible) ................................................................................. 1
Slight oedema (edges of area well-defined by definite raising) .................................................. 2
Moderate oedema (raised approximately 1 millimeter) ............................................................ 3
Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure)........ 4 - Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- all the 3 animals showed the same score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- first reading at 1h
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- all the 3 animals showed the same score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- no indication of irritation
- Remarks:
- first reading at 1h
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- Irritation: No skin irritation was caused by 4 hours exposure to Barium chloride dihydrate
Corrosion: There was no evidence of a corrosive effect on the skin.
Toxicity / Mortality: No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred. - Other effects:
- No histopathology was performed.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Barium chloride dihydrate does not have to be classified for skin irritation according to the CLP and the UN GHS.
- Executive summary:
The primary skin irritation/corrosion of Barium chloride dihydrate in the rabbit (4-hour semi-occlusive application) was investigated in a study performed according to the OECD Testing Guideline No.404 and under GLP.
Three young adult New Zealand rabbits were treated by topical application of 0.5 g test item to their intact shaved dorsal area. The duration of treatment was 4 hours. The scoring of skin reactions was performed at approximately 1, 24, 48 and 72 hours after removal of the dressing. The primary irritation index was calculated by totalling the mean cumulative scores at 24, 48 and 72 hours and then dividing by the number of data points.
No mortality occurred during the study and no clinical signs were observed. No local dermal signs were observed in the treated animals throughout the study and the primary irritation index was 0.00. The body weights of all rabbits were considered to be within the normal range of variability. As no clinical signs were observed at 72 hours after patch removal, the study was terminated after 72 hours of observation.
Under the conditions of this study barium chloride dihydrate is considered to be "non-irritant" to rabbit skin.
Referenceopen allclose all
TEST FOR REDUCTION OF MTT BY THE TEST SUBSTANCE
Because no colour change was observed it was concluded that barium chloride dihydrate did not interact with MTT.
Results after treatment with test substance:
Table 1. Individual OD measurements at 570 nm
|
A (OD570) |
B (OD570) |
C (OD570) |
Negative control OD570measurement 1 OD570measurement 2 |
0.901 0.877 |
0.884 0.875 |
0.897 0.870 |
Barium chloride dihydrate OD570measurement 1 OD570measurement 2 |
0.734 0.574 |
0.733 0.738 |
0.747 0.738 |
Positive control OD570measurement 1 OD570measurement 2 |
0.050 0.056 |
0.061 0.063 |
0.069 0.067 |
OD = Optical density
Triplicate exposures are indicated by A, B and C.
The mean absorption at 570 nm measured after treatment with barium chloride dihydrate and controls are presented in Table 2.
Table 2. Mean absorption in the in vitro skin irritation test with barium chloride dihydrate
|
A (OD570) |
B (OD570) |
C (OD570) |
Mean (OD570) |
SD |
Negative control |
0.889 |
0.879 |
0.883 |
0.884 |
0.005 |
Barium chloride dihydrate |
0.654 |
0.735 |
0.742 |
0.711 |
0.049 |
Positive control |
0.053 |
0.062 |
0.068 |
0.061 |
0.008 |
OD = optical density
SD = Standard deviation
Triplicate exposures are indicated by A, B and C.
In this table the values are corrected for background absorption. Isopropanol was used to measure the background absorption.
Table 3 shows the mean tissue viability obtained after 15 minutes treatment with barium chloride dihydrate compared to the negative control tissue.
Table 3. Mean tissue viability in the in vitro skin irritation test with barium chloride dihydrate
|
Mean tissue viability (percentage of control) |
Negative control |
100 |
Barium chloride dihydrate |
80 |
Positive control |
7 |
The positive control had a mean cell viability after 15 minutes exposure of 7 %.
Deviations:
There were two protocol deviations in the study. The title of 18.1. Justification of Test System and Number of Eyes section in the Study Plan was mistyped, the correct title is: Justification of Test System.
The initial animal was observed for signs of erythema and oedema immediately after patch removal; however, this activity was not mentioned in the Study Plan.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010-08-03 to 2010-08-13
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study reliable without restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- , 2002-04-24
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2009-11-12
- Species:
- rabbit
- Strain:
- Himalayan
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG, Branch Löhndorf, 24601 Löhndorf/Post Wankendorf, Germany
- Age at study initiation: Approx. 4.5 - 5.5 months
- Weight at study initiation: Animal 1: 2.5 kg; Animal 2: 2.4 kg; Animal 3: 3.1 kg
- Housing: For 8 hours following test item application, the animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn, wiping of the eyes with the paws and excluded irritation of the eye by excrements and urine. During the acclimatisation period and after the 8-hour period in restrainers, the animals were kept singly in cages with dimensions of 380 mm x 425 mm x 600 mm (manufacturer: Dipl.Ing. W. EHRET GmbH, 16352 Schönwalde, Germany).
- Diet (ad libitum): Commercial diet, ssniff7 K-H V2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany)
- Water (ad libitum before and after the exposure period): Tap water
- Acclimation period: At least 20 adaptation days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 °C +/- 3 °C (maximum range)
- Relative humidity: 30% - 70% (maximum range; aim was 50% - 60%)
- Photoperiod (hrs dark / hrs light): 12/12
No further information on the test animals was stated. - Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg of the test item were administered into one eye each of three animals. The test item was placed into the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as a control.
No further information on the amount/concentration applied was stated. - Duration of treatment / exposure:
- 1 hour (One hour after application the eyes were rinsed.)
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after the administration
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- The test was performed initially using one animal. As no corrosive or severe irritant effects were observed in this animal, 2 further animals were employed 24 hours after start of the initial test.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes were rinsed with portions of 20 mL 0.9 % aqueous NaCl solution, each.
- Time after start of exposure: 1 hour after administration
SCORING SYSTEM: draize scoring system
TOOL USED TO ASSESS SCORE: The eyes were examined ophthalmoscopically with a slit lamp prior to the administration and 1, 24, 48 and 72 hours after the administration. The eye reactions were observed and registered.
24 hours after administration, fluorescein (Fluorescein SE Thilo drops (ALCON PHARMA GmbH, 79108 Freiburg, Germany) was applied to the eyes before being examined to aid evaluation of the cornea for possible lesions.
OTHER OBSERVATIONS: Any further lesions not covered by the scoring system were recorded. Body weight of all animals was measured at the beginning of the study and at the end of the study. Behaviour and food consumption were monitored.
No further information on the study design was stated. - Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- Conjunctival redness (grade 1 (Some blood vessels hyperaemic (injected)) was observed in all animals 1 hour after instillation. This effect was reversible after 24 hours.
In addition, secretion was observed in all animals 1 hour after instillation.
The cornea and the irises were not affected by instillation of the test item and the fluorescein test performed 24 hours after instillation did not reveal any changes. - Other effects:
- There were no systemic intolerance reactions.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the present test conditions barium carbonate was non-irritating to eyes
- Executive summary:
In a GLP compliant eye irritation study according to OECD 405, 100 mg barium carbonate was placed into the conjunctival sac of the right eye of Himalayan rabbits (3 males). One hour after application the eyes were rinsed. Observations were made 1, 24, 48 and 72 hours after the administration and they ey reactions were observed and registered.
Conjunctival redness (grade 1) was observed in all animals 1 hour after instillation. This effect was reversible after 24 hours. In addition, secretion was observed in all animals 1 hour after instillation. The corneae and the irises were not affected by instillation of the test item and the fluorescein test performed 24 hours after instillation did not reveal any changes. There were no systemic intolerance reactions.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Reason for read across from BaCl2 to BaCO3:
The toxicity of barium carbonate and barium chloride may reasonably be considered to be determined by availability of Ba2+cations. As a first surrogate for bioavailability, the water solubility of a test substance may be used. Barium carbonate is poorly soluble in water whereas barium chloride is well water soluble. Hence, read-across to barium carbonate based on worst case consideration is justified and will likely lead to rather conservative no-effec levels. Further information on the read-across justification is included as attachment in Section 13.
Justification for classification or non-classification
Skin irritation:
The primary skin irritation/corrosion of the analogue substance barium chloride in the rabbit (4-hour semi-occlusive application) was investigated in a study performed according to the OECD Testing Guideline No.404 and under GLP (Nagy, 2021). Three rabbits were exposed to 0.5 grams of barium chloride, moistened with water by application onto clipped skin for 4 hours using a semi-occlusive dressing. Skin reactions were assessed 1, 24, 48 and 72 hours after exposure. No skin irritation was caused by 4 hours exposure to barium chloride. Barium chloride was also non-irritant in the in vitro skin irritation study (Verbaan, 2010). The classification criteria according to regulation (EC) 1272/2008 as irritating to skin are not met, hence no classification is required for skin irritation.
Eye irritation:
An in vivo eye irritation test according to OECD 405 with barium carbonate is considered as the key study for eye irritation and will be used for classification. The overall irritation results are as follows: Corneal opacity, iritis, chemosis and conjunctivae, 24, 48 and 72h after application: max score=0. The classification criteria according to regulation (EC) 1272/2008 as irritating to eyes are not met, no classification and labelling for barium carbonate is required.
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