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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP conform study which was performed following US regulation for the enforcement of the "Federal Hazardous Substances Act 16 CFR 1500". Study protocol is slightly different to actual OECD guideline 403. Reports are not as detailed as modern protocols but includes all necessary information. The principles and methodology used for testing is comparable to modern guidelines. Observation period was shorter than according to OECD 403 guideline and the dose was smaller. Evaluation of results (scoring system) identical to OECD 403 guideline. The shorter observation period is not considered critical regarding reliability of the study as 5 of six animals did not show any symptoms 48 h after application. Therefore, the study is considered to be reliable.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
shorter observation period, dose smaller than recommended in OECD guideline
Qualifier:
according to guideline
Guideline:
other: US regulation for the Enforcement of the Federal Hazardous Substances Act (16 CFR 1500)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
boranylidyneamine
EC Number:
701-292-9
Cas Number:
10043-11-5
Molecular formula:
BN
IUPAC Name:
boranylidyneamine
Details on test material:
- Name of test material (as cited in study report): 89-006 (UHP 2020)
- Substance type: inorganic
- Physical state: solid
- Analytical purity: < 98.5 %
- Impurities (identity and concentrations): B2O3 0.1 %, carbon 0.4 %, ammonia 90 ppm, lead 20 ppm
- Stability under test conditions: stable
- Storage condition of test material: room temperature in plastic bag
- Particle size: D50 4.3 µm

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Clerko Research Farm
- Age at study initiation: young adult
- Housing: housed singly in suspension cages with wire mesh floors
- Diet (e.g. ad libitum): purina laboratory rabbit chow
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: min 1 day

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.048 g to one eye of each animal
Duration of treatment / exposure:
48 h (eyes were not rinsed)
Observation period (in vivo):
48 h (observations 1h, 24h and 48h after start of exposure)
Number of animals or in vitro replicates:
6
Details on study design:
Test substance was applied to one eye, the other served as control.
SCORING SYSTEM: identical to OECD 403 guideline
Observation according to the method of Draize (1959)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 1h
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: Only conjunctival redness grade 1 was observed
Irritation parameter:
overall irritation score
Basis:
animal #1
Time point:
other: 24h
Score:
0
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 1h
Score:
4
Max. score:
110
Reversibility:
fully reversible within: 48h
Remarks on result:
other: Only conjunctival redness grade 2 was observed
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 24h
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 48h
Remarks on result:
other: Only conjunctival redness grade 1 was observed
Irritation parameter:
overall irritation score
Basis:
animal #2
Time point:
other: 48h
Score:
0
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 1h
Score:
2
Max. score:
110
Reversibility:
not fully reversible within: 48h
Remarks on result:
other: Only conjunctival redness grade 1 was observed
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 24h
Score:
2
Max. score:
110
Reversibility:
not fully reversible within: 48h
Remarks on result:
other: Only conjunctival redness grade 1 was observed
Irritation parameter:
overall irritation score
Basis:
animal #3
Time point:
other: 48h
Score:
2
Max. score:
110
Reversibility:
not fully reversible within: 48h
Remarks on result:
other: Only conjunctival redness grade 1 was observed
Irritation parameter:
overall irritation score
Basis:
animal #4
Time point:
other: 1h
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 24h
Remarks on result:
other: Only conjunctival redness grade 1 was observed
Irritation parameter:
overall irritation score
Basis:
animal #4
Time point:
other: 24h
Score:
0
Max. score:
110
Reversibility:
not fully reversible within: 24h
Irritation parameter:
overall irritation score
Basis:
animal #5
Time point:
other: 1h
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 24h
Remarks on result:
other: Only conjunctival redness grade 1 was observed
Irritation parameter:
overall irritation score
Basis:
animal #5
Time point:
other: 24h
Score:
0
Max. score:
110
Reversibility:
fully reversible within: 24h
Irritation parameter:
overall irritation score
Basis:
animal #6
Time point:
other: 1h
Score:
2
Max. score:
110
Reversibility:
fully reversible within: 24h
Remarks on result:
other: Only conjunctival redness grade 1 was observed
Irritation parameter:
overall irritation score
Basis:
animal #6
Time point:
other: 24h
Score:
0
Max. score:
110
Reversibility:
fully reversible within: 24h

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
When hexagonal boron nitride was applied to the eyes of New Zealand white rabbits, 1h after instillation, all animals showed conjunctivae redness grade 1 (5 of 6 animals) or grade 2 (one animal). 24 h after exposure, 3 of 6 animals still showed conjunctivae redness grade 1 and 48 h after exposure in only one animal conjunctivae redness grade 1 was observed. No other responses (of coroneal opacy or iris or conjunctival redness) have been observed during the observation period (48h after the test material has been applied to the eye) and no evidence of corrosion was noted. Against this background, the short observation period is not considered critical as 48 h after application 5 of six animals showed no symptoms. The reduced dose (0.048 g instead of 0.1 g) is also not considered critical regarding reliability of the study as all effects observed (conjunctival redness) most likely result from the physical properties of the substance and application of the twofold dose is assumed not to cause different or severe effects. Hexagonal boron nitride is therefore not classified as an irritant by occular application and does not have to be classified as corrosive to the eye.