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EC number: 231-151-2 | CAS number: 7440-42-8
Toxicological information
Eye irritation
Currently viewing:
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2001-03-07 to 2001-03-11
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted 1987-02-24
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Boron
- EC Number:
- 231-151-2
- EC Name:
- Boron
- Cas Number:
- 7440-42-8
- Molecular formula:
- B
- IUPAC Name:
- borane
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Boron amorphous
- Physical state: powder
- Storage condition of test material: room temperature
- Average particle size: 0.9 µm
- Specific surface area: 11.1 m^2/g
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Highgate Farm, Market Rasen, Lincolnshire, England
- Age at study initiation: at least 10 weeks of age
- Weight at study initiation: 2.7 to 3.4 kg
- Housing: the animals were housed individually in metal cages with perforated floors.
- Diet (ad libitum): a standard laboratory rabbit diet (Special Diet Services STANRAB (P) SQC pellet); the animals were fed hay on arrival and subsequently three times a week.
- Water (ad libitum): drinking water
- Acclimation period: a minimum period of eight days prior to the start of the study
During the acclimatisation and study period the animals were given small (approximately 5 cm x 2 cm x 2 cm) soft white untreated wood blocks for environmental enrichment.
ENVIRONMENTAL CONDITIONS
- Temperature: 19 ± 2°C
- Relative humidity: 30 to 70%
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): A volume of 0.1 mL of the test substance (53 to 66 mg of the test material; mean weight 61 mg) was placed in the lower everted lid of one eye of each animal.
The eyelids were then gently held together for one second before releasing. The contralateral eye remained untreated. - Duration of treatment / exposure:
- not applicable
- Observation period (in vivo):
- 1 hour and approximately 24, 48 and 72 hours after instillation
- Number of animals or in vitro replicates:
- 3 male rabbits
- Details on study design:
- The eyes of each animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iridial inflammation or conjunctival irritation.
INITIAL AND CONFIRMATORY TESTS
One animal was treated in advance of the other two, to ensure that if a severe response was produced, no further animals would be exposed.
SCORING SYSTEM: according to the Draize scoring system
TOOL USED TO ASSESS SCORE:
Observation of the eyes was aided by the use of a handheld light.
OBSERVATIONS:
- Clinical signs: all animals were observed daily for signs of ill health or toxicity.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- animal #1
- 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
- Remarks on result:
- other: Conjunctival redness (grade 1) was observed at the 1 hour observation.
- Irritation parameter:
- chemosis 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:
- iris score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: Conjunctival redness (grade 1) was observed at the 1 hour observation.
- Irritation parameter:
- chemosis 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 #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 3
- Remarks on result:
- other: Conjunctival redness (grade 1) was observed at the 1 hour observation.
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- No corneal damage or iridial inflammation was observed.
Transient hyperaemia of the blood vessels of the conjunctivae was seen in all three animals, resolving completely by one day after instillation - Other effects:
- - Clinical signs: there were no signs of toxicity or ill health in any rabbit during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- A single instillation of boron amorphous into the eye of the rabbit elicited transient, very slight conjunctival irritation in all animals.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not classified as eye irritant.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as eye irritant.
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