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EC number: 234-371-7 | CAS number: 11128-29-3
- Life Cycle description
- Uses advised against
- Endpoint summary
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-01-24 - 2013-03-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Potassium pentaborate
- EC Number:
- 234-371-7
- EC Name:
- Potassium pentaborate
- Cas Number:
- 11128-29-3
- Molecular formula:
- B5KO8
- IUPAC Name:
- potassium 4-({4-[(oxoboranyl)oxy]-1,3,2,4-dioxadiboretan-2-yl}oxy)-1,3,2,4-dioxadiboretan-2-olate
- Details on test material:
- - Name of test material: potassium pentaborate tetrahydrate
- Physical state: White powder
- Analytical purity: > 99 %
- Lot/batch No.: MK01
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Kuiper Rabbit Ranch (Gary, IN).
- Age at study initiation: Approximately four months.
- Weight at study initiation: 3.24 – 3.4 kg
- Housing: The rabbits were housed individually in stainless steel cages suspended over excrement pans. Cage liners were placed in the pan below the stainless steel mesh floor of each animal cage to absorb liquids.
- Diet (e.g. ad libitum): Each rabbit was provided with approximately 150 g of Harlan Teklad (Harlan Laboratories, Madison, WI) Certified High Fiber Rabbit Diet #2031 daily.
- Water (e.g. ad libitum): Was Supplied ad libitum by means of an automatic watering system.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21°C to 22°C
- Humidity (%): 41% to 52%
- Photoperiod (hrs dark / hrs light): 12 hours of light followed by 12 hours of darkness.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Left eye served as a control and was not treated.
- Amount / concentration applied:
- 0.1 g
- Duration of treatment / exposure:
- 24 hours
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- Five per sex.
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Eyes were washed with room temperature water for 30 seconds using a volume and velocity that would not cause injury.
- Time after start of exposure: 24 hours after administration.
SCORING SYSTEM: For each animal, mean scores for corneal opacity, iris lesions, conjunctival redness and conjunctival chemosis were calculated by adding the 24-, 48- and 72-hour post-dose scores for the respective parameter and dividing by three. The irritation potential of the test substance was assessed according to the following criteria, based upon the European Parliament and the Council of the European Union guidelines (Regulation (EC) No. 1272/2008, Dec. 2008):
- The test substance will be considered a nonirritant if, in at least two animals, the corneal opacity mean score is less than 1.0, the iris lesion mean score is less
than 1.0, the conjunctival redness mean score is less than 2.0, and the chemosis mean score is less than 2.0.
- The test substance will be considered a Category 2 (reversible eye effects) irritant if at least two of the three rabbits have a corneal opacity mean score greater than or equal to 1.0 but less than 3.0 and/or an iris lesion mean score greater than or equal to 1.0 but less than 1.5 and/or a conjunctival redness mean score greater than or equal to 2.0 and/or a chemosis mean score greater than or equal to 2.0.
- The test substance will be considered a Category 1 (irreversible eye effects) irritant if the corneal opacity mean score is greater than or equal to 3.0 and/or the iris lesion mean score is greater than 1.5 in at least two of the three rabbits tested.
TOOL USED TO ASSESS SCORE: The eye examinations were performed using a slit penlight and the treated eyes were scored for ocular reaction of the cornea, iris, conjunctivae, lids and nictitating membranes. Fluorescein stain was used to aid in the examination for corneal lesions at the 24-hour scoring interval.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
Any other information on results incl. tables
Mortality
No rabbits died during the study prior to scheduled euthanisation, nor were any adverse clinical observations noted at any time during the study.
Ocular Observations
No positive irritation scores were observed in any animal throughout the study for any evaluated parameter.
Individual and Mean Eye Irritation Scores
1. Cornea (A = Density of Opacity; B = Area of Opacity)
Animal Number (Sex) | 1 Hour | 24 Hours | 48 Hours | 72 Hours | Meanb | ||||
A | B | A | B | A | B | A | B | ||
801 (M) | 0 | -a | 0 | - | 0 | - | 0 | - | 0.0 |
802 (M) | 0 | - | 0 | - | 0 | - | 0 | - | 0.0 |
803 (M) | 0 | - | 0 | - | 0 | - | 0 | - | 0.0 |
a- = not applicable (no opacity)
bMean = sum of individual animal "A" scores at the 24 -, 48- and 72 -hour scoring intervals divided by 3.
2. Iris
Animal Number (Sex) | 1 Hour | 24 Hours | 48 Hours | 72 Hours | Meana |
801 (M) | 0 | 0 | 0 | 0 | 0.0 |
802 (M) | 0 | 0 | 0 | 0 | 0.0 |
803 (M) | 0 | 0 | 0 | 0 | 0.0 |
aMean = sum of individual animal "A" scores at the 24 -, 48- and 72 -hour scoring intervals divided by 3.
3. Conjunctiva (A = Redness; B = Chemosis)
Animal Number (Sex) | 1 Hour | 24 Hours | 48 Hours | 72 Hours | Meana | |||||
A | B | A | B | A | B | A | B | A | B | |
801 (M) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.0 | 0.0 |
802 (M) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.0 | 0.0 |
803 (M) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0.0 | 0.0 |
aMean ("A" and "B" scores, respectively) = sum of individual animal scores at the 24 -, 48- and 72 -hour scoring intervals divided by 3.
Applicant's summary and conclusion
- Interpretation of results:
- other: EU GHS criteria not met
- Conclusions:
- Potassium pentaborate is classified as a nonirritant to the eyes of New Zealand White rabbits, based on corneal opacity mean scores of less than 1.0, iris lesion mean scores of less than 1.0, conjunctival redness mean scores of less than 2.0, and chemosis mean scores of less than 2.0 in at least two of the three rabbits tested [European Parliament and the Council of the European Union guidelines (Regulation (EC) No. 1272/2008, Dec. 2008)].
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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